ABSTRACT BOOK
ONE DAY NATIONAL LEVEL CONFERENCE
“Pharmacovigilance: Current Scenario and Emerging Trends”
(3rd August, 2019)
Organized By Shree Naranjibhai Lalbhai Patel College of Pharmacy
Sponsored by GUJCOST
Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh, Bardoli, Surat website : www.snlpcp.ac.in ABOUT TRUST
The Vidyabharti Trust was registered as Public Education Trust under the Bombay Public Trust Act, 1950 in 18/09/1980, registration no. E-1852-Surat, with a pious aim to impart quality education and training to the children from Primary to the terminal of higher education and allied research. The trust also received exemption under section 80(G) of the income-tax act for accepting donations.
The Vidyabharti Trust campus is in the vicinity of Bardoli, the nucleus of the political activity during our freedom struggle and ship anchor of the well known Bardoli Satyagraha of Shri Sardar Vallabhbhai Patel. The campus is situated in an area of 38 acres of land. It catalyses and manifests educational activities in a peaceful natural environment.
The Vidyabharti Trust has fulfilled many motives pertaining to education in the present arena. Currently, the Trust has obtained recognizable position in the society.
SHREE NARANJIBHAI LALBHAI PATEL COLLEGE OF PHARMACY Vidyabharti Campus, At & Po Umrakh Ta: Bardoli, Dist: Surat, Gujarat, India, Pin: 394345 [email protected] MESSAGE
Vidyabharti Trust is a leading organization offering variety of courses ranging from School studies to Doctorate research. VBT group of Colleges has made a constant endeavor to provide quality education and a platform for overall development to its students. To provide rich and complete study experience to its students through cutting – edge amenities, research and innovation that will assist students in building a successful professional path, Shree N L Patel College of Pharmacy, Umrakh has once again organized National seminar in sponsorship with Gujarat Council of Science and Technology (GUJCOST). I sincerely welcome and thank all speakers, invited guests and delegates for participating whole heartedly in the seminar. Inspired and encouraged by your good wishes we will continue to contribute towards progress and prosperity of Pharmacy education.
Shri Kiritbhai N. Patel Secretary, Vidyabharti Trust, Umrakh MESSAGE
I extend my warm welcome to one and all who have accepted our invitation and marked their presence here today or registered as delegates/ partners with National Seminar at Shree N L Patel College of Pharmacy, Umrakh. This seminar is crossing another mile stone towards its journey to accomplish the Vision and Mission. I wish to express my profound thanks and gratitude to our Principal Dr. Dhiren Shah, teaching and non-teaching staff members and students to make it successful. I wish this seminar a grand success.
Shri Ashwinbhai H. Patel Joint Secretary, Vidyabharti Trust, Umrakh MESSAGE
I take this opportunity to appreciate the dynamic and spirited efforts put in by the entire team of Shree N L Patel College of Pharmacy, Umrakh under the leadership of Dr. Dhiren Shah for organizing a National seminar. SNLPCP, Umrakh, has successfully hosted national level seminar in past, and now, this National seminar adds another feather in the cap of Shree N L Patel College of Pharmacy, Umrakh. I congratulate our principal, Dr. Dhiren Shah, his staff members for this mile stone achievement. My good wishes to all and wish Shree N L Patel College of Pharmacy, Umrakh, to contribute towards progress and prosperity of Pharmacy education.
Dr. Ajay V. Shah Campus Director, Vidyabharti Trust, Umrakh MESSAGE
On the eve of this unique event of National Seminar at Shree N L Patel College of Pharmacy, Umrakh, sponsored by Gujarat Technological University, Ahmedabad, I would like to extend my greetings to all of you.
We are all grateful to our esteemed speakers for having accepted our invitation and the overwhelming support received from the pharmaceutical fraternity and the event sponsors to make the seminar a success story.
All my teaching, non-teaching and administrative staff at Shree N L Patel College of Pharmacy, Umrakh, deserves a special applause for carving out this beautiful event and working hard for its success.
I am sure the seminar will help our pharmaceutical professionals to design the strategy for their future.
Let us all join hands together to make a great professional organization whose ultimate aim is to improve the quality in various field of Pharmaceuticals.
Dr. Dhiren Shah Principal, Shree N L Patel College of Pharmacy, Umrakh. Dr. Vijay B. Lambole
Organizing Secretary
MESSAGE
It is my proud privilege to state that our institute Shree Naranjibhai Lalbhai Patel College of Pharmacy is organizing a one-day National Conference on “Pharmacovigilance: Current Scenario and Emerging Trends” in sponsorship with Gujarat Council of Science and Technology (GUJCOST). The idea of holding such a conference is to bring academicians, researchers, industry leaders, pharmacy consultants, pharma experts and students on a common platform to discuss the various concepts, fundamentals and prospective of pharmacovigilance. Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle. Pharmacovigilance is still in its infancy in India and there exists very limited knowledge about the discipline. There is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product.
I am sure that these scientific discussions and deliberations would provide a good information and knowledge of current scenario and future trends in pharmacovigilance. I am thankful to the management for their full support for organizing the conference. I would like to express my gratitude to Dr. Dhiren Shah for his valuable guidance and direction. I would like to place on record the constant cooperation extended by the Registration committee, Scientific Committee, Stage Committee, Multimedia and graphics committee, Food committee, Finance committee and Hospitality committee.
I also deliver my thanks to the GUJCOST for their sponsorship and timely support. Dr. V. Addepalli Director
SVKM’s Shri C. B. Patel Research Centre Vile Parle (West), Mumbai – 400 056. Maharashtra, India Ph. + 91 22 4235 5961
Pleased to note that Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh (SNLPCP) (Formerly known as Vidyabharti Trust College of Pharmacy, Umrakh), a self-finance college is organising one day national conference on Pharmacovigilance: current Scenario & Future Trends on 3rd August, 2019 sponsored by Gujarat Council of Science & Technology (GUJCOST). The seminar will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv and its further development. It is indeed a need of the hour and wish the seminar a great success
Title of Talk : Pharmacovigilance - Present status and future perspective.
Abstract:
Drug development has undergone a drastic change in recent times. The era is witnessing rapid revolution as exemplified by targeted therapies and personalized therapies for disease management. Every patient who is taking a drug of any system of medicine is at high risk for developing Adverse Drug Reactions (ADR). Pharmacovigilance has therefore had an important impact on the public health environment. The talk will throw light upon the role of Pharmacovigilance and its importance in Healthcare, present status in India and future perspective. Mr. Bharat B. Doshi Founder, BioDev Services, Ahmedabad
Message for Abstract
Back in 1990s - career options after a Pharmacy graduation or post- graduation were limited to Manufacturing, Marketing and rarely a R&D job. However, over the years many more job-roles have become prominent. With this change, one of the most common ambition shown by students of Pharmacy (i.e. after completion of their course); is to get into a profession that allows them to sit in a corporate environment, work on computers, earn possibly in dollars & build a career in MNC company.
Pharmacovigilance is one such career option - that possibly meets the above vague definition narrated by pharma career aspirants. Unfortunately, everyone knows what they want (as narrated above) - but they don't know how; Nor do they know the deeper nuances of PV activities.
The proposed discussion will give students an overview of Pharmacovigilance industry under following points:
What happens in a PV set-up as on today, Why those activities are done
What it is? R&D? Marketing? How PV activities are linked to other activities
PV as a business: Economic drivers for PV industry
What's new? what are the upcoming trends?
PV in India
Skills required for a career in PV industry Mr Nayan Prajapati Head Training. Cliantha Research, Ahmadabad. Email: [email protected]
Topic: How shall I Perform best in Pharmacovigilance!!
Abstract:
Pharmacovigilance has been accepted as an important public health function which which aims at reducing the medicine related harms. Intensive efforts are currently ongoing in the country to strengthen the system of Pharmacovigilance Programme of India (PvPI) to ensure safety of medicines.
The objective of seminar was to provide transformative professional development experience. As the entire professionals are important stakeholders in Pharmacovigilance, the session was conducted to train and educate students on various aspects of Pharmacovigilance. Two major points were covered in session. First part was about basics of Pharmacovigilance. This portion helped students to understand basics of Pharmacovigilance, terminologies, essential elements, various activities and role of each profile in Pharmacovigilance. Students found second portion of great use to understand skill and knowledge required to perform best in each profile. What all shall One endure in his/her personality to perform best, not only survive but to grow in Pharmacovigilance industry was explained in an effective way to get practical knowledge with huge experience of industry people.
This presentation was overall aimed to provide the understanding and importance of Skill and Attitude along with Knowledge required to perform excellent. LOCAL ORGANIZING COMMITTEE
Chief Patron Shri Manharbhai L. Patel (Managing Trustee)
Patrons Shri Kiritbhai N. Patel (Secretary, VBT)
Shri Ashwinbhai H. Patel (Co-Secretary, VBT)
Dr. Ajay V. Shah (Campus Director)
Chairman Dr. Dhiren P. Shah (Principal)
Coordinator Dr. Vijay B. Lambole
Registration Dr. Dixit C. Modi committee Mr. Vipul G. Gajera Mr. Tejas Patel Mrs. Pooja Chaudhari
Scientific Dr. Rumit Shah committee Dr. Jitendra Singh Yadav Mr. Sagar Patel Mrs. Rachita Desai
Stage Committee Mrs. Sonal Solanki Mrs. Jasmina Surati Miss. Sonia J Patel Mr. Bhumin Pathak
Hospitality and Dr. Biren Shah Transport Dr. Dipansu Sahu Committee Finance Dr. Ashok Akbari Committee Multimedia Dr. Hemal Bhuva committee REGISTRATION COMMITTEE
Mrs. Pooja Dr. Dixit Modi Mr. Vipul Gajera Mr. Tejas Patel Chaudhari
SCIENTIFIC COMMITTEE
Dr. Jitendra Singh Dr. Rumit Shah Mr. Sagar Patel Mrs. Rachita Desai Yadav STAGE COMMITTEE
Mr. Bhumin Mrs. Sonal Solanki Mrs. Jasmina Surati Miss. Sonia J Patel Pathak
HOSPITALITY AND TRANSPORT COMMITTEE FINANCE MULTIMEDIA COMMITTEE COMMITTEE
Dr. Biren Shah Dr. Dipansu Sahu Dr. Ashok Akbari Dr. Hemal Bhuva GUJCOST Sponsored One Day National Level Conference
““Pharmacovigilance: Current Scenario and Emerging Trends” (3rd August, 2019)
Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh
INDEX
Poster Code Department Page No Pharmaceutics / Pharmaceutical Technology 15 - 26 PCT-01 to PCT-25 /NDDS / Microbiology / Bio – Technology Pharmacology / Clinical / 27 - 43 PCO-01 to PCO-38 Pharmacovigilance/ Pharmacy Practice Pharmaceutical Chemistry/ Pharmaceutical Analysis / 44 PQA-01 to PQA-02 Quality Assurance / Regulatory Affairs Pharmacognosy / Herbal Drug PCG-01 to PCG-06 45 - 48 Technology/ Phyto-Chemistry Pharmacovigilance: Current Scenario and Emerging Trends
PCT-01 FORMULATION, OPTIMIZATION AND CHARACTERIZATION OF TRANSDERMAL FILM BASED ON NANOPARTICLES OF CHOLINESTERASE INHIBITORS FOR THE TREATMENT OF ALZHEIMER’S. Kapoor Devesh Umesh Dr. Dayaram Patel Pharmacy College, Sardar Baug, Station Road, Bardoli Solid lipid nanoparticles play vital role for delivering drugs to the brain because of their enormous potential for the transport of numerous drugs to the brain which are not able to cross blood brain barrier (BBB). The nanoparticles can be fabricated to enhance the growth and release of numerous pharmacological agents at the diverse pathological sites, enhance the healing effectiveness by superior bioavailability, water solubility and better pharmacokinetics. The aim of current research to fabricate donepezil hydrochloride transdermal film by using full factorial design. The design expert software (version 10) is employed for the fabrication of different formulations. Modified solvent emulsification method employing surface active agent, lipid, permeation enhancer and diverse solvents for the fabrication of nanoparticles. The solvent casting method is employed for the fabrication of transdermal films having plasticizer, polymers, permeation enhancer and solvents. These films are characterized for in-vitro release studies, drug content, flatness, tensile strength and ex vivo skin permeation study. All the formulation of films was found to be flat. The range of drug content and tensile strength was 97.49±1.4 to 97.76±2.2% and 5.67±0.54 to 12.23±0.97 N/mm2 (Newton/millimeter2) respectively. The in vitro release of drug and ex vivo skin permeation study after 24 hrs was 88.45±1.34 to 97.23±1.11% and 87.54±0.97 to 98.12±0.34%. On the basis of outcome it can be suggested that transdermal films of donepezil hydrochloride can be employed for human applications. It is a safe, convenient, painless and cost effectual drug delivery system for patients of Alzheimer’s.
PCT - 02 BIOSENSORS: PRINCIPLE, TYPES AND APPLICATIONS Patel Anjali, Patel Jaimi Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Biosensor is a device, probe or electrode having immobilized biocatalyst which, upon making contact with an appropriate sample, converts the presence of the desired analyte into a physical, chemical or electrical signals which can be measured. Biosensor consists of three parts: a component that recognizes the analyte and produces a signal, a signal transducer, and a reader device. In comparison with any other currently available diagnostic device, biosensors are much higher in performance in terms of sensitivity and selectivity both. Types of biosensors based on tansducer are: Calorimetric biosensor, Potentiometric biosensor, Piezoelectric biosensor, Amperometric biosensor and Optical biosensor. Biosensors have found potential applications in the general healthcare monitering, screening for diseases, clinical analysis and diagnosis of diseases, industrial processing and monitoring, environmental pollution control, also in agricultural and food industries. Important features for commercialization of the biosensors are selectivity, sensitivity, stability, reproducibility
15 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends and low cost. This poster reviews the basic principle, the various types of biosensors available and its applications. Keyword: - Biosensors, Principle, Types and Applications.
PCT – 03 BIONIC EYE Modi Preet, Mistry Parth Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Retinitis pigmentosa(RP) is group of genetic eye conditions that leads to incurable blindness .it further result in tunnel vison ,people pigmentosa are notr legally blind untill their 40s or 50s ,while in some cases patients may become blind due to ROP as early as in their childhood .however ,patient who gone blind because of retinitis pigmentosa are a step closer to perhaps.....device exemption to conduct a clinical studty of the new decvice -dybbed the argus II bionic retinal system .apart from these there have been breakthroughs in devlopment of bionic eye in number of institutions throghout the world .this review paper deals the technology & the working of the device which of the device which would help in eradicating blindness in the near future KEYWORDS:BIONIC EYE ,RETINITIS PIGMENTOSA,ARGUS II
PCT - 04 PLASTIC EATING BACTERIA- IDEONELLA SAKAIENSIS Gamit Zeel Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh A Gram-stain-negative, aerobic, non-spore-forming, rod-shaped bacterium, designed strain 201-F6T, was isolated from a microbial consortium that degrades poly(ethylene terephthalate) (PET) collected in Sakai city, Japan, and was characterized on the basis of a polyphasic taxonomic study. The cells were motile with a polar flagellum. The strain contained cytochrome oxidase and catalase. It grew within the pH range 5.5-9.0 (optimally at pH 7-7.5) and at 15-42 ºC (optimally at 30-37 ºC). Phylogenetic analysis using the 16S rRNA gene sequences showed that strain 201-F6T was affiliated to the genus Ideonella, and was closely related to Ideonella dechloratans LMG 28178T (97.7 %) and Ideonella azotifigens JCM 15503T (96.6 %). Strain 201-F6T could be clearly distinguished from the related species of the genus Ideonella by its physiological and biochemical characteristics as well as by its phylogenetic position and DNA-DNA relatedness. Therefore, the strain represents a novel species of the genus Ideonella, for which the name Ideonella sakaiensis sp. nov. (type strain 201-F6T=NBRC 110686T=TISTR 2288T) is proposed.
16 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCT - 05 3D PRINTING OF DRUGS Prajapati Manish Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Three-dimensional (3D) printing is a manufacturing method in which objects are made by fusing or depositing materials in successive layers laid down under computer control. To develop a standard conventional solid dosage form like tablets it include the operations involving like milling, mixing, granulation, drying and compression which able to result in different qualities of the final products concerning the loading of the drug, the release of the drug, stability of the drug and pharmaceutical dosage form stability. To overcome some challenges of conventional pharmaceutical unit operations, 3DP is gaining more attention in the pharmaceutical formulation in the future. 3DP can successfully overcome the issues relating to the drug delivery of peptides, potent drugs, water-soluble drugs, and the release of multi-drugs, etc. The ideal opportunity of this technology is the preparation of personalized doses to state individual patient needs. 3D printing in pharmaceuticals has been used to produce many novel dosage forms like microcapsules, Complex Drug-Release Profiles, nano- suspensions, and multilayered drug delivery devices. From industrial point of view, it also offers important advantages like, cost-effectiveness, increased productivity, democratization of design and manufacturing, and enhanced collaboration. Keeping in view the recent approval given by USFDA to the first 3D printed antiepileptic drug the focus has now shifted to the personalized medicine as it offers an important benefit to patients who need medications that have narrow therapeutic indices or a higher predilection to be influenced by genetic polymorphisms. 3D printer is now seen as a valuable, efficient and economical tool to manufacture individualized medications, tailored to specific patients based on their needs and thereby change the future of pharmacy practice in general and pharmaceutical care. Here, we present an outline and the perspective of 3DP in the development of novel drug delivery systems.
PCT - 06 POLYMERASE CHAIN REACTION AND ITS APPLICATION Patel Jaimi, Patel Anjali Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh "The Polymerase Chain Reaction (PCR) has revolutionised molcular biology and DNA technology. Invented in the 1980s by kary b muliis, it enables us to produce large quantites of DNA from very small samples in a remarkably short time. This in turn makes it possible for us to analyse tiny samples of DNA and unravel the mysteries of the individual genes. The polymerase chain reaction (PCR) is a scientific technique in molecular biology to amplify a single or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. PCR is now a common and often indispensable technique used in medical and biological research labs for a variety of applications. There are three major steps involved in the PCR technique: denaturation, annealing, and extension. PCR is useful in the investigation and diagnosis of a growing
17 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends number of diseases. Qualitative PCR can be used to detect not only human genes but also genes of bacteria and viruses. PCR is also used in forensics laboratories and is especially useful because only a tiny amount of original DNA is required. PCR can identify genes that have been implicated in the development of cancer. Molecular cloning has benefited from the emergence of PCR as a technique. The present poster is an attempt to review basics of PCR. KEY WORDS: PCR, Principles, Application
PCT - 07 B.HEALTHY ONE STOP SOLUTION Parekh Brijesh, Jain Kevil, Modi Preet, Patel Nil, Patel Sagarkumar Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh These days, the life style of the people gets hectic; therefore, they do not have much time. If they get everything at home; they might not prefer to go out. Considering this scenario, We have a thought to improve health of a person by providing everything from consultation to delivering of medicine through a new and modified online platform, which deals with health related issues and diseases. This system also deals with the loopholes of existing online platforms. This platform provides the facility of online consultation from the physician, which becomes huge convenience for the patient and if they need any laboratory support or reports, the platform can provide it. Online pharmacy is the emerging field in our nation. There are some loopholes in the existing system of online pharmacy, like lack of qualified staff in the delivery of drugs and time consuming. The platform also addresses the issues of online pharmacy. Some the features of B healthy are Consultation with medical practitioner, All health related issues and their solution on single platform and Fast delivery of medicines by registered Pharmacist
PCT - 08 NANOPARTICLE LOADED HYDROGEL: A PROMISING APPROACH FOR LOCALIZED DRUG DELIVERY (REVIEW ARTICLE) Patel Dhruvkumar, Patel Tejas Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Nanoparticles have offered a unique set of properties for drug delivery including high drug loading capacity, combinatorial delivery, controlled and sustained drug release, prolonged stability and lifetime, and targeted delivery. To further enhance therapeutic index, especially for localized application, nanoparticles have been increasingly combined with hydrogels to form a hybrid biomaterial system for controlled drug delivery. Herein, we review recent progresses in engineering such nanoparticle hydrogel hybrid system with a particular focus on its application for localized drug delivery. Specifically, we highlight four research areas where NP-gel has shown great promises, including passively controlled drug release, stimuli- responsive drug delivery, site-specific drug delivery, and detoxification. Overall, integrating therapeutic nanoparticles with hydrogel technologies creates a unique and robust hybrid biomaterial system that enables effective localized drug delivery.
18 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCT - 09 ORALLY DISINTEGRATING FILMS: A MODERN EXPENSION IN DRUG DELIVERY SYSTEM Chaudhary Priyavanda, Singh Neha, Modi Dixit Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API) within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.
PCT - 10 DESIGN & DEVELOPMENT OF SYRINGEABLE THERMOSENSITIVE IN SITU MUCOADHESIVE GEL DELIVERY SYSTEM FOR PERIODONTITIS” Master Ruchi, Patel Asmi, Dalal Mittal, Barot Tularam Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi A new concept of in situ gel was developed to overcome the shortcomings of conventional formulations which deal with Periodontitis. In situ mucoadhesive gel of Chlorhexidine gluconate & Lidocaine hydrochloride was prepared using the cold method using Pluronic F127 & PVP K30 for their thermosensitive gelation and mucoadhesive nature respectively. The optimized formulation was subjected to stability study and from data fits it was concluded that PVP K30 showed good mucoadhesion and also provides desired drug release from in situ gel. Further, our results also suggest no evidence of interaction between the two drugs or with the excipients. Hence we can conclude that the above formulation can be used for the treatment of periodontitis.
19 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCT - 11 DESIGN DEVELOPMENT AND CHARACTERIZATION OF KETOPROFEN MICROSPHERES LOADED GEL FOR TOPICAL DRUG DELIVERY Thakor Heli, Patel Harsh, Shah Rumit Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh The present work was aimed to prepare Ketoprofen Microspheres for topical delivery by using Ethyl cellulose as a polymer with the purpose of developing a dosage form for control release characteristics of the therapeutic effect by continuously releasing medication over an extended period of time. The objective in designing topical gel based control release delivery system is to reduce the frequency of dosing or to increase the effectiveness of drug by localizing at the site of action, and to improve the bioavailability and to localize drug within the epidermis by reducing its transdermal penetration which may increase residence time into the body without being absorbed into systemic compartment, hence may avoid the systemic side effects. To give control and modify release characteristics of the drug and hence to decrease dose and dose frequency which may improve patient compliance.
PCT - 12 FORMULATION AND IN-VITRO EVALUATION OF COLON SPECIFIC DRUG DELIVERY SYSTEM USING NATURAL GUM CONTAINING METHOTREXATE Patel Mohini1, Garasiya Sujit 1, Yadav Jitendra Singh1, Gupta Arti 2 1Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh 2Maliba Pharmacy College, Uka Tarsadia University The present research work was aimed to prepare colon specific matrix tablets of Methotrexate with the purpose of developing a dosage form for prolonged therapeutic effect by continuously releasing medication over an extended period of time. The objective in designing oral sustained delivery systems to reduce the frequency of the dosing or to increase the effectiveness of drug by localizing at the site of action, reducing the dose required or provide uniform drug delivery, thereby also improving patient compliance using naturai polymers.
PCT – 13 DESIGN DEVELOPMENT ABD CHARACTERIZATION OF NANOSTRUCTURED LIPID CARRIERS FOR PREVENTIVE THERAPY OF BREAST CANCER. Mistry Stuti, Solanki Sonal Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Present study was to Design, Development and Characterization of Nanostructured lipid carrier for preventive therapy of Breast cancer. Nanostructured lipid carrier can be made up using stearic acid, oleic acid and poloxamerl88 by Melt emulsification and solvent evaporation method. It was found that the Curcumin release 75% and 63% from NLCs and NLC based gel respectively within 24 hr (in-vitro). The NLC based gel gives 53.17% drug release after 12 hrs (Ex-vivo). It showed sustained release of Curcumin over 24 hrs in NLCs
20 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends and NLCgel. It can be concluded that the optimized NLCs and NLC-gel exhibit faster onset and prolonged action. Curcumin Loaded NLC Shows good cytotoxicity profile against MCF- 7 Breast cancer cell line. Which suggest that it can be used in Breast cancer.
PCT - 14 DESIGN DEVELOPMENT AND CHARACTERIZATION OF BUCCAL FORMULATION OF RIZATRIPTAN BENZOAT Patel Sejalkumari, Patel Tejas Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Rizatriptan benzoate is an anti migraine drug and belong to BCS class 2 and is absorbs orally and having 45% bioavailability. The present research work was aimed to prepare buccal film of the drug rizatriptan benzoatr with the purpose of developing a dosage form for a quick onset of action and to enhance the bioavailability to the and dissolution rate of a drug, which is beneficial in management of migraine to the patient with swallowing difficutiies or travelling patient not having the access of water and as a result it increase the patient compliance. The pre formulation work was fist carried out FTIR studies were carried out for checking the interaction between drug and polymer. Fiml forming polymer, superdisintrgrant and plasticizer were screemed and selected. The film were prepared by solvent casting method using HPMC E10 as a polymer, PEG-400 as plasticizer, kyron as a super disintegrant , SLS permeation enhancer, citric acid as a saliva stimulating agent, sodi. Saccharine as sweetener and peppermint oil as flavoring agent. The optimize batch was subjected for the stability studies and also the compression between the optimize batch and marketed formulation was done. The pre formulation studies showed no interaction between drug and excipient. The optimize formulation F10 was obtaine from the 32 Factorial design was subjected for various evalution such as content uniformity, uniformity of weight, surface pH,folding endurance, disintegration time, tensile strength, and % elongation stability analysis was done which show no significant change in the formulation.It was conclude that buccal film of rizatriptan benzoate can be prepare using suitable polymer for the treatment of migrane for the quick onset of action which is beneficial in management of migrane to the patient with swallowing difficulties and in emergency condition.
PCT - 15 NANOSPONGES: A NOVEL DRUG DELIVERY SYSTEM AND ITS ROLE IN TARGETED DELIVERY AND DETOXIFICATION Devadiga Bhagyashree, Gupta Garima, Yadav Jayhind Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi Nanosponge is an innovative technology, capable of safely removing a broad class of dangerous toxins from the blood stream and can also be employed as effective drug delivery systems. Nanosponge consist of polymeric nanoparticle core surrounded by red blood cell membrane, just one cell membrane can make thousands of nanosponge, material used are polymer, co-polymer and cross-linker. Nanosponges form a three dimensional network that is
21 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends biodegradable, having a mesh like structure. They are solid in nature and each sponge has a size less than 1 micrometer. Nanosponges can be formulated in oral, I.V, topical and inhalation dosage form. Toxins produce by MRSA (methicillin-resistant staphylococcus aureus), E. coli, snake venom and bees or pore forming toxins in the blood stream can be easily entrapped into the porous structure of nanosponge and then metabolized in the liver. Nanosponges are also effective in targeted drug delivery and can be used to carry medication into specific part of body (e.g., site of tumor) and release drug in controlled manner, thus also reducing adverse effects on other tissues.
PCT - 16 FORMULATION AND IN-VITRO EVALUATION OF IMMEDIATE RELEASE SOFTGEL OF NAPROXEN SODIUM Swain Soumya Ranjan Swain, Mishra Amiya Bhusan Mishra, Badatya Ashish Kumar Badatya, Mahanty Rakesh Mahanty Roland Institute Of Pharmaceutical Sciences Brahmapur, Odisha, India Oral drug delivery has been known for decades as the most widely utilized route of administered among all the routes that have been employed for the systemic delivery of drug via various pharmaceutical products of different dosage forms. The reasons that the oral route achieved such popularity may be in part attributed to its ease of administration and the belief that oral administration of the drug is well absorbed. One such area of research is design of Softgel technology. Softgel technology is one of the most attractive and promising approach for increasing oral bioavailability by means of increasing solubility of the poorly soluble drug. Naproxen Sodium is one of the most important Non-steroidal anti-inflammatory agents used in the treatment of acute to chronic pains, inflammation and it belongs to BCS class-II drug so as to increase its aqueous solubility for enhancing the bioavailability, it is formulated as a liquid filled soft gelatin capsules.
PCT - 17 BIODEGRADABLE POLYMER-CLAY-HYDROXYAPATITE NANOCOMPOSITES AS NOVEL DRUG DELIVERY Umate Minal, Yengade Mayuri, Roul Jyotiranjan Institute Of Pharmaceutical Education And Research, Borgaon Meghe, Wardha Biodegradable polymer based nanocomposites have been used for various drug delivery systems and biomedical applications as compared to synthetic polymer composites because of the biocompatible and biodegradable behavior of natural polymers. These nanocomposites also possess improved mechanical properties, swelling behavior, drug loading efficiency and controlled release behavior as compared to polymer matrices. The objective of the present study was to design and characterize nanocomposites based on hydroxyapatite and biodegradable polymer chitosan and montmorillonite clay. The nanocomposites were successfully prepared and their structures were characterized by powder x-ray diffraction (XRD), particle size analyzer (Beckman coulter), scanning electron microscopy (SEM), and
22 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends fourier transmission infrared spectroscopy (FT-IR) techniques. FT-IR studies provided the evidence of molecular interaction among the constituents of the nanocomposite. SEM provided the shapes and surface topography of polymer nanocomposites. Particle size analyzer provides the intensity distributions and average size and polydispersity index of particles. XRD provided the information on the degree of hybrid structure generated and crystal size. The average diameters of particles in the nanocomposites were found to be below 300nm. This work represents the design of novel clay–chitosan–hydroxyapatite nanocomposite with improved properties that has potential applications in novel drug delivery.
PCT - 18 BIOPOLYMER/RECTORITE NANOCOMPOSITE BEADS: STRUCTURE, AND DRUG DELIVERY BEHAVIOUR Yengade Mayuri, Roul Jyotiranjan, Umate Minal Institute Of Pharmaceutical Education And Research, Borgaon Meghe, Wardha The present study aims at the formulation development of rectorite nanocomposite beads as drug delivery carrier and its evaluation. Nanocomposite beads were prepared by gelation method. Prepared samples were evaluated and compared simultaneously by Powder X-Ray Diffraction, scanning electron microscope, Fourier transform infrared spectroscopy and Particle size analyzer (zeta sizer). For all batches of nanocomposite beads, there was no variation of their bead size. The large size of wet beads suggested high swelling and water retention capability. The average particle diameter of the optimized nanocomposite beads was found to be around 90nm, whereas polydispersity index of particles was found to be 0.674. By applying Scherrer equation, the crystallite size of the optimized nanocomposite beads was found to be around 150 nm. From the in vitro release study, it is confirmed that addition of clay decreases the release of drug at basic pH. It also confirmed that prepared polymer/clay nanocomposite beads showed extended release period of drug as compared to the pristine sodium alginate.
PCT - 19 A COMPREHENSIVE REVIEW ON CRYSTALLO CO-AGGLOMERATION Bode Harshita, Dewani Sunil Institute Of Pharmaceutical Education And Research, Borgaon Meghe, Wardha Crystallo-co-agglomeration is a novel particle engineering/design technique developed to overcome the limitations of spherical crystallization. It is a type of spherical agglomeration technique, which enables both crystallization and agglomeration to be done simultaneously of two or more drugs to yield complex agglomerates of drug and excipients. Basically, it’s single step process used for size enlargement of single, two or more, small dose or large dose drugs, in combination with or without diluent. This process involves simultaneous crystallization and agglomeration of drug/s with/without excipients/s from good solvent and/or bridging liquid by addition of a non-solvent. These techniques are useful to yield
23 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends directly compressible crystal/agglomerates to achieve fast dissolving tablet as well as modify the drug release for controlled release dosage form.
PCT - 20 SOLID DISPERSION TECHNIQUES FOR IMPROVEMENT OF ORAL BIOAVAILABILITY OF POOR WATER SOLUBLE DRUGS: A COMPREHENSIVE REVIEW Parshuramkar Trupti, Dewani Sunil Institute Of Pharmaceutical Education And Research, Borgaon Meghe, Wardha The poor solubility and low dissolution rate of poorly water soluble drugs in the aqueous gastro-intestinal fluids often cause insufficient bioavailability. This may be achieved by incorporating the drug in a hydrophilic carrier material obtaining products called solid dispersions. Solid dispersions are one of the most promising strategies to improve the oral bioavailability of poorly water soluble drugs. By reducing drug particle size to the absolute minimum, and hence improving drug wettability, bioavailability may be significantly improved. They are usually presented as amorphous products, mainly obtained by two major different methods, for example, melting and solvent evaporation. Recently, surfactants have been included to stabilize the formulations, thus avoiding drug recrystallization and potentiating their solubility. So this presentation highlights various approaches for the preparation of solid dispersion, technology involved, detail description of poorly water soluble drugs & carriers.
PCT - 21 A COMPREHENSIVE REVIEW ON USE OF MONTMORILLONITE CLAY IN NANOPARTICULATE DRUG DELIVERY Sarode Madhuri, Roul Jyotiranjan, Hadke J Institute Of Pharmaceutical Education And Research, Borgaon Meghe, Wardha In the preparation of final dosage form of a drug, it is necessary to disperse the drug in a biologically inert matrix such as polymeric matrices or clay particles, for improved drug delivery. In these cases it is necessary to produce systems that not only release the drug an appropriate rate but also have suitable mechanical properties for the particular application. To optimize biological activity and therapeutic effect of the drug, the drug delivery compositions with modified release systems are developed where the drug is released at a controlled rate such as the controlled release oral drug delivery systems. Clay minerals like montmorillonite, rectorite find wide range of applications, in various areas of science, like drug delivery systems due to their natural abundance and the propensity with which they can be chemically and physically modified to suit practical technological needs. Montmorillonite has been extensively applied for prolonged release of drugs as it can retain large amounts of drug due to its high cation exchange capacity. It may interact with active drug molecules, but also with inactive components like polymers. On the basis of these interactions, montmorillonite and its modified forms can be effectively used to modify drug delivery systems. This review
24 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends emphasizes the modifications of montmorillonite clay, its interactions with drug molecules and its applications in novel nanoparticulate drug delivery systems.
PCT - 22 FORMULATION OPTIMIZATION AND CHARACTERIZATION OF NANOSUSPENSION OF ACYCLOVIR Poojari Anusha, S Mounika Jayamukhi College of Pharmacy Acyclovir, BCS class III drug, shows only 20% bioavailability, very low permeability and high onset of action. Direct nanoparticle uptake is one of the promising methods of improving the bioavailiability for such compounds. Transcytosis of the nanoparticle takes place with the help of Microfold cells(M CELLS) of peyer patches in the small intestine. But, the problem is these M cells represent typically less than 1% of the total intestine area, which makes the selective delivery to these sites more difficult. So, surface modification technology was incorporated which includes the use of Eudragit Coating nanosuspension of Acyclovir was prepared by emulsification solvent evaporation method with Eudragit EPO as polymeric stabilizer and Tween 80 as surfactant stabilizer. 32 full factorial design was applied for optimization of the formulation parameters. The prepared formulation were evaluated for particle size and zeta potential, % entrapment efficiency, % drug release, ex- vivo diffusion study, Transmission Electron Microscopy etc.were performed and best batch was optimized. The results showed that nanosuspension containing Acyclovir higher bioavailability as compared to the marketed product and can be used as best alternative to the viral diseases.
PCT - 23 NEED OF BIOAVAILABILITY STUDIES IN PAEDIATRIC DOSAGE FORM Singaram Mounika Jayamukhi College of Pharmacy The bioavailability (BA) studies explains rate of absorption of drug availability in body. Paediatrics has immature organ and body system so paediatric dosage forms have to comply with specific regulation. The paediatric use marketing authorisation (PUMA) helps under article 45& article 46 for the development of expired or going to expire patent medicines for children trials. It also creates support measures to manage the operation of the paediatric regulation including the paediatric committee within the European medicinal agency, US Food and Drugs Administration and other regulatory authorities. The BA studies are done to formulate requirements for their design, conduct, and evaluation for Patient/ volunteer ranges between 0-14 years i.e. under 1 year (Infants) system & organ are not developed & immatured;1-4 years (Toddlers) organs are developing but not matured ;5-9 years (Early Childhood) organs & system are developed ; 10-14 years (Middle Childhood)similar to adult.
25 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCT – 24 FORMULATION TECHNIQUES FOR HIGH DOSE DRY POWDERS Gomathi Joshi Jayamukhi Institute Of Pharmaceutical Sciences Delivery of drugs to the lungs via dry powder inhaler (DPI) is a promising approach for the treatment of both local pulmonary conditions and systemic diseases. Though DPIs are widely used for the pulmonary deposition of potent bronchodilators, anticholinergics, and corticosteroids, there is growing interest in the utilization of this delivery system for the administration of high drug doses to the lungs, as made evident by recent regulatory approvals for anti-microbial, anti-viral and osmotic agents. However, the formulation of high dose DPIs carries several challenges from both a physiological and physicochemical standpoint. This review describes the various formulation techniques utilized to overcome the barriers associated with the pulmonary delivery of high dose powders.
PCT - 25 FORMULATION AND DEVELOPMENT OF MICROSPHERES TO STUDY THE EFFECT OF PH ON PARTICLE SIZE AND ENTRAPMENT EFFICIENCY Bhoyar Milind, Sathe Bhushankumar, Roul Jyotiranjan Institute Of Diploma In Pharmacy, Borgaon (Meghe), Wardha The aim of present study was to formulate microspheres of ‘ibuprofen’ to provide controlled release as well as to minimize local side effect associated with upper gastrointestinal tract by modifying the release of drug. The lipid polymer, modifier and dispersant were used for the formulation of microspheres by melt dispersion method which is more beneficial than the solvent evaporation method because of total absence of organic solvents during the preparation process. The main objective of this research work was to study the effect of pH on the particle size, entrapment efficiency as well as evaluation characteristics of microspheres. Effect of different variables on evaluation parameters and in-vitro release of ibuprofen were also studied. The effect of pH showed maximum entrapment efficiency and size optimization at pH 3.5 as compare to other pH range. The microspheres form the lumps at low pH 1.2 to 3.0 and shows less entrapment efficiency at higher pH 5.0 to 6.5. The optimized batch of lipid microspheres was formulated with drug-lipid ratio (1:2), at pH 4.5 of aqueous medium and suitable modifier. The obtained results showed the highest entrapment efficiency (about 84.27%) of ibuprofen and drug loading (18.91%). Here from the result, it was observed that the pH of external phase affecting directly the entrapment efficiency, release and morphology of the microspheres.
26 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO-01 A BRIEF REVIEW ON INTERNATIONAL NON-PROPRIETARY NAME : UNIQUE IDENTITY OF PHARMACEUTICAL DRUGS Mulla Kaynat*, Kalan Maitri, Merai Ankit Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi
The International Non-Proprietary Name (INN) is an official generic & non- proprietary name given to a pharmaceutical drug or an active ingredient. There are different naming standard followed in several countries for INN. Having standard names for each drug is essential, as the drug may be sold by various brand names or branded medication may contain more than one drug. Each INN is unique and contains a word stem shared with other drugs of the same class. This review provides a brief idea on the various naming systems followed by several countries as per INN. It also provide the guidelines for naming medicines, different brands & generic names across world-wide.
Keywords :- International Non-Proprietary Name, Pharmaceutical drug, Brand name, Generic name.
PCO-02 ONLINE ADR REPORTING TOOL’S : AN ADVANCE STEP TO PHARMACOVIGILANCE Kalan Maitri*, Mulla Kaynat, Merai Dr. Ankit Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi
Adverse Drugs Reaction (ADR) is one of the cause for morbidity & mortality. At present, there are various tools available to report ADRs, yet there is low rate of reporting world- wide. The rate limiting factors in reporting are legal aspect, complacency, diffidence, indifference, ignorance, lack of time period etc. Along with that major hurdle is, the confusion regarding which kind of information have to report in ADRs reporting. So, this include information regarding a brief view on ADRs reporting process, the data flows of the reported cases, the various form available to report & the various tool’s available to report ADRs (such as Vigiflow, Aris G, Argus) with their special feature, benefits and compatibility with respective ADRs reporting forms and the limitations of it. Thus, mainly emphasis on promoting ADRs reporting via online process which may serve, less tedious & time saving to healthcare stake-holder’s and add up to improve health-care system status regarding safety & safe use of medicine.
Keywords: Adverse Drug Reaction, ADRs reporting tools, ADRs reporting forms.
PCO-03 STUDY ON EFFECTIVENESS AND SAFETY OF THRICE WEEKLY SUBCUTANEOUS ADMINISTRATION OF RECOMBINANT ERYTHROPOIETIN IN TREATMENT OF CHRONIC RENAL ANAEMIA IN NON-DIALYSIS PATIENTS Lakhani Ruchita*, Menon Megha, Dalal Mittal, Bhatti Hanif Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi To assess effectiveness and safety, by subcutaneous administration, of recombinant erythropoietin (Rh-EPO) in treatment of chronic renal anaemia in non-dialysis patients.
27 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
Single arm open label study design was used for this study. The study involved the evaluation of demographics, past medical history, etiology of CKD, blood pressure and pulse rate of patients suffering from chronic renal anaemia and receiving Rh-EPO (subcutaneous) dose of 50 IU/kg. Further for efficacy of Rh-EPO, Hb and haematocrit were evaluated every 4 weeks and for safety other hematological parameters and any reported adverse events were evaluated in these patients. After administering Rh-EPO mean change in Hb conc. (g/dl) was analysed by using paired t-test.
The therapeutic strategy used in this study was found to produce a significant increase in Hb value (p<0.05). The few adverse events reported, include hypertension, hypotension, diarrhoea, constipation, upper respiratory tract infection, headache, back pain and cough. However, no causal association could be established with Rh-EPO.
Conclusion : The results of this program indicated that the thrice weekly dose of the drug maintains the Hb level above 11 and also improves the quality of life of patient.
PCO-04 EVALUATION OF STATIN THERAPY IN TYPE 2 DIABETES MELLITUS PATIENTS OF AGE BETWEEN 35-75 YEARS : A RETROSPECTIVE STUDY Davda Bhakti*, Kumar Santhana, Dalal Mittal Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi
In type 2 Diabetes Mellitus (T2DM) patient usage of Statin therapy is recommended by most clinical guidelines as prophylaxis for Cardiovascular disease (CVD) and seems to be effective for primary or secondary CVD prophylaxis. This research article points to summarize the current evidence confirming the role of statins and respective dose regimen which is effective in T2DM patients based on prescriptions and also considers the factors affecting clinical practices. Results from our study indicate a widespread prophylactic use of statins by physicians in study population. Also, Atorvastatin and Rosuvastatin was found to be most prescribed statin. Ensuring proper statin prescribing and utilization can help in achieving better clinical outcomes of statin therapy in T2DM Patients.It was found that the intensity of statin therapy was empirical and there is a need in inclusion of use of statins in primary prevention of ASCVD in patients with T2DM.
PCO-05 COMPARISON OF HEALTH CARE COST IN END STAGE RENAL DISEASE PATIENTS UNDERGOING PERITONIAL DIALYSIS OR HEMODIALYSIS Tandel Divya*, Dalal Mittal, Mehta Neha Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi
Hemodialysis (HD) and Peritoneal dialysis (PD) are the main modalities for dialysis in patients with end stage renal disease (ESRD), involving complete failure of kidney function. This study was done with an aim to compare the COST of patients with ESRD undergoing HD or PD. A randomised, open labelled, observational clinical study was conducted in patients undergoing HD or PD. As expected, cost of the therapy of HD was found to be more in private hospitals over civil hospitals. Results from our study suggest a higher direct cost of PD compared to HD but a lower indirect cost of PD compared to HD. Further, the total cost 28 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends of therapy was found to be higher in PD. It was also noted that the convenience attributed to the procedure, as reported by patients was more in PD.
PCO-06 Effect of Chronic DHT exposure in pre-pubertal rats on histological presentation of uterus and its reversal by Bauhinia purpurea and Anetheum graveolens Tailor Shivangi*, Dalal Mittal Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi
Androgen receptor agonist can affect the hypothalamic-pituitary-ovarian (HPO) axis in several ways, producing alterations in the female reproductive tract that may be detected histologically. Potent Androgen receptor agonist such as Dihydrotestosterone typically cause overt histological changes in the vagina, uterus and ovary. This study was aimed to evaluate the effect of chronic administration of 83 µg/day Dihydrotestosterone (DHT) in prepubertal rats on the histological presentation in uterus. The rats treated with DHT cause oestrus acyclicity and destruction of follicular cells and absence of corpus luteum in the ovaries. In the uterus, DHT was found to produce morphological alterations, characterized by presence of vacuolated epithelium and endometrial stroma fibrosis. There was also evidence of increased angiogenesis. Treatment of Bauhinia and Anetheum was found to reverse some of these effects, though not all. Further studies are necessary to evaluate the mechanism of these effects.
Keywords: Dihydrotestosterone, uterus, histology, Bauhinia purpurea, Anetheum graveolens
PCO-07 RHEUMATOID ARTHRITIS- WITH HOPE AND CHALLENGES Patel Het*, Pathan Shahbaz, Patel Anish, Tarafdar Dipayan C. K. Pithawalla Institute Of Pharmaceuticalscience & Research, Surat
Rheumatoid arthritis (RA) is a chronic inflammatory disorder which affects the joints by destroying body tissues. Pain and fatigue are very common and often reported symptoms for RA. The progress of pain and fatigue in RA is related with problematic moods, psychosocial resources and burdens. Current therapies tend to treat symptoms or slow down the disease progression but no cure exists at the moment. Recent research creates a hope for new in this autoimmune disease with the knowledge of the effect of genetic, environment, epigenetics. With advances of therapy, clinical outcomes have improved dramatically and remission is possible for many patients. These advances have come with many challenges, prompting consideration of strategies to improve diagnosis and treatment and implement more cost-effective care. The present discussion is an attempt to explore the pros and cons of new therapies with a hope for better clinical outcomes.
29 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO-08 ANTI FUNGAL RESISTANCE AND ITS EVOLUTION : AN INCREASING CONCERN Malek Kavsar*, Patel Sahina, Dipayan Tarafder C. K. Pithawalla Institute Of Pharmaceuticalscience & Research, Surat
Fungal infections are an issue of increasing concern, and it is necessary to develop new strategies in order to mitigate mortality rates caused by these types of pathogens. Fungi exhibit different resistance mechanisms, ranging from genetic mutations to metabolic adaptations to the action of several anti-fungal compounds available for clinical treatments. However, some anti-fungal resistance are no-evident and need to be studied in order to avoid rising of new resistant fungal strains. Moreover, it is well known that drug resistance is linked to fungal evolution. For this reason, it is important to understand adaptation mechanisms carried out by fungi to resist anti-fungal action, such as amino acid mutations or different metabolic responses of fungal species to several anti-fungal drugs. In order to design both new anti-fungal compounds or strategies for treating fungal infections. The present discussion is an attempt to explore the effects of evolution in fungi in order to evade anti fungal effects.
PCO-09 CLINICAL ORGAN TRANSPLANTATION AND ITS BARRIER : AN EMERGENT CONCERN Patel Minu*, Patel Tulsi, Patel Mili, Bharatia Rishi, Tarafder Dipayan C. K. Pithawalla Institute Of Pharmaceuticalscience & Research, Surat
Clinical organ transplantation has been recognized as one of most gripping medical advantage of century in the way of giving gift of life to vital organ failure patients. Global shortage of organ is cause of countless fatalities across the world. Major source of organ deceased donor after brain death, many from liver donation and from non-heart-beating donor. Immunological barrier remain main obstacle to widespread use of transportation as replacement therapy for terminal organ failure. With the development of faster, larger drones, long-distance drone organ shipment may result in substantially reduced cold ischemia times, subsequently improved organ quality, and thousands of lives saved.
PCO-10 ARTIFICIAL BLOOD - A GAME CHANGER WITH CHALLENGES Patil Bhumika*, Shahani Priti, Singh Mamta, Tarafder Dipayan C. K. Pithawalla Institute Of Pharmaceuticalscience & Research, Surat
Artificial blood is a new concept of biotechnology used to mimic and fulfil some functions of biological blood. Biological blood is essential for transport of essential nutrients and oxygen to cells and to remove waste product away from those cells. When natural blood is not available in case of cardiac surgery, trauma or any other emergency conditions with huge blood loss, artificial blood can be used. The present discussion is an attempt to explore the pros and cons using artificial blood.
30 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO-11 EBOLA VIRUS - OUTBREAK Nishad Vandana*, Yahya Moolla C. K. Pithawalla Institute Of Pharmaceuticalscience & Research, Surat
Ebola virus are pathogenic agent which cause severe, fatal disease in humans and animals. In equatorial Africa 4 species of this virus have been identified. The transmission will occur by contact to body fluid which results in major epidemics. This happens mostly in unresourced settings. This disease can characterised by following symptoms, immune suppression, inflammatory responses, deficiency of major electrolytes and fluids in body. Despite of progress in the treatment of this virus the mortality rate is high. Case management is necessarily supportive, which manages severe multiple organ failure because of immune mediated cell damage. In 2013-16 outbreak, WHO classified it as public health emergency of international concerns, questioning scientific, clinical and societal preparation to handle future activities.
PCO-12 HER-2 BIOMARKER PROBE: A REVIEW Mansuri Anjuman*,Desai Jital Smt. B. N. B. Swaminarayan Pharmacy College, Salvav,Pardi, Vapi. Chemical probes are becoming more vital reagents to investigate the pathological and biological mechanisms with its etiological reason in major diseases like cancer. As we know breast and gastric cancer are among the highest prevailing types in cancer in world. In this study, we will discuss regarding brief review on involvement of chemical probes in breast and gastric cancer. DNA probe is nucleic acid molecule (single stranded DNA) having a strong affinity towards specific target. Hybridization of nucleic acid probes has been a key technique used in exploration of the molecular biology of the cell. Coupling of hybridization with amplification of nucleic acids in vitro, will results in extremely sensitive detection of specific nucleic acids. As we know precise monitoring of human epidermal growth factor receptor 2 (HER2) status is important for most favorable patient management with trastuzumab (Herceptin). HER2 DNA probe is a biomarker which is mainly used in detection of breast and gastric cancer. A literature review of published studies explained that there are more than 50 DNA probes available vital biomarker, amongst this, HER2 DNA probe is more popular. The HER2 gene and Chr17 centromere were detected using the HER 2 Probe and its mechanism is briefly summarized in this content. How the HER2 probes helps in determine the HER2 gene status within the morphological context of the tumour. How the HER2 DNA probe used in detection of amplification by light microscopy of the HER2 gene. This review helps in increasing the information regarding the mechanism and application of latest HER2 probes as biomarker in breast and gastric cancer. Keywords: Breast cancer, gastric cancer, HER gene, HER2 Probe, DNA Probe
PCO-13 PHANTOM VIBRATION SYNDROME(PVS): AN EMERGING PHENOMENON Panchal Nikita*, Patel Chandni, Patel Pinesh, Lambole Vijay Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Mobile phones are innovation of new era’s technology. Around 5 billion people are using mobile phone worldwide. Mobile phone is an essential part of urban life. People spent more time on cell phones and it is affecting their physical and mental health. mobile phone is 31 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends causing serious health issues related to psychology and social behavior. Newly reported disorders, like Phantom Vibration Syndrome, Nomophobia and possible risk for sleep disorders and infertility among medical. A phenomenon known as ‘‘phantom vibration syndrome’’ This refers to when phone users perceive their device to vibrate, indicating that a call or text is incoming, when in fact the phone did not vibrate at all. They might be considered as a normal brain mechanism. People are using vibration alert mode in silence zone and its frequent use lead towards phantom vibration syndrome (PVS). In 2003, Mr. Robert D. Jones described the term Phantom vibration syndrome. Phantom vibration syndrome is an emerging disorder due to excessive use of mobile phones. PVS is concern with psychological or neurological changes. Prevalence of Phantom vibration syndrome is more than 70% among the medical students. This tactile hallucination causes by repeated use of cell phone, vibration alert mode and using same location for carrying mobile phone. PVS may lead toward anxiety, depression and affective disorders. Phantom vibration syndrome can manage by changing habits towards utilization and carrying of cell phone. By using mobile phones in proper way, one can avoid these syndromes, or at least can ameliorate the symptoms. It is also avoided by turning off the vibration, cell phone fast or by reducing volume of ring.
PCO-14 CRISPR-THE GENETIC TECHNIQUE AGAINST THE HIV Patel Heli*, Trivedi Milind, Mistry Parth Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh
HIV (Human Immunodeficiency Virus) which can lead to AIDS ( Acquired Immunodeficiency Syndrome) . AIDS is not curable by drugs due to its direct effect on the genetics factor of immune CD4+ T cells. We can suppress the HIVs replication by the ART drugs (Anti-Retro Viral Therapy) – Protease inhibitors, Integrase inhibitors, Nucleoside reverse transcriptase inhibitors. If they are stopped, HIV rebounds, renewing replication and fueling the development of AIDS. But now the new genetic technique namely CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is emerged as powerful technology to edit the genomes and is now widely used in basic biomedical research to explore gene function in combination with LASER ART (Long acting slow effecting release antiretroviral therapy) which is developed by the researchers at the Temple university and The university of Nebraska medical center. According to the study, the potential of CRISPR technology to edit the HIV genome and block the expressions, has opened new door to remove the HIV.
PCO-15 HORMONE REPLACEMENT THERAPY Patel Reema*, Patel Nil, Patel Jaimi, Shah Gunjan Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh
Hormone Replacement Therapy is supplementing women with hormones that are lost during the menopausal transition. To relieve the symptoms associated with menopause, conventional HRT includes an estrogen and progesterone components to mimic the hormones created by human ovary. It can also be used in male hormonal therapy and treatment for individuals who undergo a sex change. The role of hormone replacement therapy has been debated. During menopause, the estrogen levels fall. From the recent trials held by Women’s health initiative 32 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
(WHI), if HRT is initiated soon after menopause, consistent reduction is observed in Coronary Heart Disease, improve muscle function and mortality. It may help to keep skin young but it can not reverse delay the overall effect of aging. It also significantly decrease the incidence of various symptoms of menopause like hot flashes, weight gain, hair loss, osteoporosis, insomnia, etc. It has side effects like vaginal dryness, blood clot, breast cancer, stroke, heart disease. To avoid the risks, HRT should be primarily estrogen based. Use of only estrogen is associated with reduced onset of young-onset of breast cancer. Use of both estrogen and progesterone was not associated with increased risk. It can delivered by creams or gels, vaginal rings, tablets and skin patches.
PCO-16 A NEW APPROACH TO TREATMENT OF PROSTATE CANCER PARMAR RAJATKUMAR*, DEVDHARA FORAM, LAMBOLE VIJAY Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh
The Prostate is a gland in the male reproductive system located just below the bladder and in front of rectum.The main function of prostate gland is to produce and store fluid which comes out from man’s penis during ejaculation.There are various types of prostate cancer like adecarcinomas, prostatic interaepithelia neoplasia (PIN), prostate carcinoma, benign prostatic hyperplasia(BPH) and prostate enlarges.It is mainly occurs in the man with a high fat diet, tire plant workers & who has been exposed to cadmium.The main symptoms of prostate cancer(PCa) is dribbling, slow urination & blood in urine.Prostate cancer (PCa) is the second most common cause of cancer and the sixth leading cause of cancer death among men worldwide.PCa is treated by surgery and various therapies like radiation & hormone therapy.The new approved drugs for treatment of prostate cancer like apalutamide and enzalutamide having a good result against PCa.These drugs are previously used in the last stage of prostate cancer, but researchers applied it into the first stage of cancer which shown extremely beneficial results in first stage of prostate cancer.Use of those drugs in early stages by giving it along with the other androgen depressive drugs can decrease the death rate.It is analysed that lives of about 72% patient’s have been saved with the help of this new androgen depression therapy.
PCO-17 STEM CELL TRANSPLANT Jain Kevil*, Parekh Brijesh, Modi Preet, Patel Nil Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Cancer is an incurable disease, which arises due to uncontrollable growth of normal cells and infection of carcinogenic agents .Various types of cancer are based on the site at which the cells show tumor formation, such as breast cancer, colon cancer, lung cancer, melanoma, leukemia etc. There are various types of therapies used for the treatment of cancer. One of the therapies used is stem cell transplant. Stem cell transplant is the therapy in which the patient is provided with stem cells as they are deficient in normal cells due to disease condition or radiation therapy. Stem cells are the primitive cells that have the ability of totipotency and can differentiate into various cells that aid into normal functioning of the body. Stem cell transplant can be done by following ways: Autologous transplantation, allogeneic, reduced- intensity stem cell transplantation, syngeneic transplantation.
33 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO-18 ANTI-HIV DRUG SUPRESSES HIV VIRUS FOR ALMOST TWO YEARS WHEN OTHER ANTI-RETROVIRAL TREATMENTS FAIL. Chaudhari Falguni*, Lambole Vijay Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh
Human immunodeficiency virus-1 (HIV-1) infection currently requires lifelong therapy with drugs that are used in combination to control HIV infection. Even in the era of modern HAART regimen, antiretroviral (ARV) therapy gets failure and emergence of drug resistance is still a problem worldwide. New classes with different mechanisms of action are needed to overcome this challenge. After the integrase inhibitors were launched, more than a decade ago, no new classes were added to the ARV.
A first-in-class HIV treatment developed by the UK company ViiV Healthcare has suppressed the virus in people who have become resistant to other antiretroviral drugs, providing protection for at least 96 weeks. The phase III trial tested by ViiV Healthcare’s first-in-class drug fostemsavir in 272 HIV-infected people who had failed to respond to approved antiretroviral drugs. Given twice per day, the drug was able to suppress the HIV virus in 60% of the patients for at least 96 weeks. Fostemsavir is a prodrug that is metabolised to the active compound, temsavir, a first-in-class attachment inhibitor that binds to glycoprotein 120 (gp120) on the envelope of the HIV, locking gp120 in a conformational state that inhibits initial interaction between the virus and host immune cells, preventing viral attachment and entry into the host CD4+ T-cell.
PCO-19 AN INNOVATIVE NUTRITION BASED APPROACH TO MANAGE KIDNEY STONE Patel Charmi*, Lambole Vijay Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh
Kidney stones arise from an excessive urinary excretion of oxalate or hyperoxaluria. Dietary oxalate can become actively harmful when too much of it is absorbed; oxalate is a component of the most common type of kidney stones. 75% kidney stones in patients in the United States consist of calcium oxalate. Oxalate can cause complications in patients who have inflammatory bowel disease and short-bowel syndrome however as oxalate is contained in many different foods, often at different levels in a single food, avoiding oxalate consumption while maintaining a balanced diet is difficult. Up to approximately 25 percent of the oxalate consumed in the diet is absorbed into the human bloodstream through the intestines. captozyme has developed enzyme products that degrade oxalate, thereby promoting its removal from both diet and the body. captozyme has taken the innovative approach of reducing the oxalate concentration in food through adding an oxalate degrading enzyme. captozyme has addressed these problems by using oxalate degrading enzymes to remove oxalate in the digestive tract and reduces the oxalate concentration in food.
34 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO-20 EFFECT OF POLYHERBAL PREPARATION ON HIGH FAT DIET INDUCED HYPERLIPIDEMIA IN FEMALE SPRAGUE DAWLEY RATS. Patel Sonia*, Vyas Bhavin Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh From time immemorial plants have been used as a source for health care by human society. In this study, a polyherbal preparation was prepared using extracts of five medicinal plants such as Commiphora mukul hook ex stocks., Cedrus deodar roxb- loud., Bauhinia variegate., Achyranthes aspera linn. And Picrorrhiza kurroa royle ex. Benth.. The present study is undertaken to evaluate Anti-hyperlipidemic potentials through in-vivo methods of the polyherbal preparation prepared in-house. The rats were fed with high fat diet for the induction of hyperlipidemia for 4 weeks. Upon confirmation of disease induction the animal experiments were conducted as per standard protocols. The hyperlipidemic rats were administered two graded doses of polyherbal preparation and the standard control group was treated with Atorvastatin (10 mg/kg) orally for 14 days. After treatment blood samples from normal/positive control/control (HFD) /standard/polyherbal preparation (low/high) dose were collected and lipid profile, atherogenic index, serum biochemistry examination of liver and renal function were determined. After sacrificing the animal, histopathological study suggested that polyherbal preparation produced significant hypocholesterolemic effect. Keywords: High fat diet, Hyperlipidemia, Lipid profile, Polyherbal formulation.
PCO 24 CHRONIC USE OF PPIs: - CAUSE FOR CONCERN Qadri Misbah*, Vyas Bhavin, Desai Bhargavi Maliba Pharmacy College Proton pump inhibitors (PPIs) are the most potent acid suppressing drugs available and millions of individuals are currently using these medications. Hence, risk of potential long- term side effects associated with the use of PPIs is increasing. Events like nephritis, tetany, anaemia, pneumonia, osteoporosis and increased the risk of birth defects if taken for a longer period of time during pregnancy. Even its frequent use increases the risk of C. Diffule infection. The treatment with proton pump inhibitors was associated with increased risk for pneumonia in stroke patients. On March 2, 2011, the US FDA informed the public of the risk of hypomagnesaemia associated with prolonged usage of PPIs. The use of proton pump inhibitors has been associated with the several events causing hypomagnesaemia leading to hypocalcaemia further leads to risk of fracture by interfering with calcium absorption through induction of hypochlorhydria but they also may reduce bone resorption through inhibition of osteoclastic vacuolar proton pumps. The researchers also used laboratory parameters to look at the risk of kidney diseases progression; they found that patients in the PPI group were more likely to experience a doubling of serum creatinine level. In recent years, concerns have been raised about potential adverse drug events (ADEs) associated with chronic PPI use by doing clinical studies on several patients (approx. 1,00,000). This review aimed to investigate the longitudinal studies published in the last years on the relationship between PPIs and its side effects.
35 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO 25 SAFETY ASSESSMENT OF BEVACIZUMAB IN PATIENT WITH DIFFERENT TYPES OF CANCERS Patel Drashti*,Manjarawala Kinjal, Vyas Bhavin Maliba Pharmacy College Bavacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biological activity of human vascular endothelial growth factor. Bevacizumab is the 1st line targeted therapy which is use in case of frontline treatment, platinum sensitive recurrent diseases or platinum resistant disease or persistent, recurrent or metastatic carcinoma. The main objective of this study was to assess the safety of Bevacizumab by evaluating different parameters like ECG pattern for cardiac abnormalities and comparison between laboratory values and blood pressure at screening visit and after 2 follow up (after 21 days of dosing). A total number of 86 patients were enrolled in study having different types of cancer in age group of 18 to 65 years belonging to both genders. According to data there is no significant effect on ECG interval and blood pressure due to chosen dose of Bevacizumab. Data shows that there are minor changes observed in laboratory values like Hb level, SGPT, SGOT, Absolute neutrophil count, Platelet counts, Total Bilirubin, Serum Creatinine, Direct and Indirect Bilirubin, Total Protein. From present study it can be concluded that the chosen dose of Bevacizumab is safe in all type of cancer.
PCO 26 PHARMACOVIGILANCE: SAFETY AND EFFICACY OF FIXED DOSE COMBINATIONS Bhikadiya Vishal*, Khadela Avinash, Vyas Bhavin Maliba Pharmacy College Pharmacovigilance is the science associated with the detection, understanding, monitoring and prevention of adverse drug reactions. In the present scenario, where the development and marketing of an ever-growing array of medicines has rendered their safety and therapeutic efficacy, which is a key to determine the success of a drug. The rationality of a fixed dose combination (FDC) is the most controversial and debated issue in today’s clinical practice. The FDC is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Though there are many advantages of fixed-dose combinations, namely simplification of therapy, increased patient compliance, reduction of total daily dose and side effects, reduction of overall cost of therapy, there are several disadvantages too. The safety of FDCs are justifiable only when they have been developed according to rational pharmacokinetic and pharmacodynamic criteria. The pharmacovigilance should ensure the safety and efficacy of FDCs in clinical practice. Adverse Event Monitoring Centers (AMCs) under Pharmacovigilance Programme of India can be optimally utilized for conducting education and awareness programs on periodic screening of FDCs by considering the latest scientific evidence.
36 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO 27 CICHRIUMINTYBUS IN METABOLIC SYNDROME: A PARALLEL ALTERNATIVE TO STATINS Desai Priya*, Rathod Mohini, Vaidya Rutvi Maliba Pharmacy College Cichriumintybus in Metabolic Syndrome: A Parallel Alternative to Statins INTRODUCTION: Metabolic Syndromeis constellation of an interconnected physiological, biochemical, clinical, and metabolic factors directly increasing risk of cardiovascular disease, Type2 diabetes, and all-cause mortality. Sinister intake of carbohydrate as well as saturated fatrich diet induces complications including MetS, CVD and non-alcoholic fatty liver disease. Absence of monotherapy and adverse effect on chronic use of Statins have led to need of alternatives. AIM AND OBJECTIVE: To identify effect of synthetic and plant based lipid lowering agent in the treatment of MetS induced by high carbohydrate high fat diet in rat. MATERIAL METHODS: High-Carbohydrate-High-Fat diet (15 gm/day)was fed to Wistar albino rat of wither sex for 112 days to induce MetS.Either Atorvastatin (10mg/kg)and Aqueous root extract of Cichoriumintybus (200and400mg/kg)were used as treatment for 28 days once daily p.o. To ensure the induction of clustering factors of MetS parameters such as cardiovascular, biochemical, molecular parameter were measured. RESULT Synthetic- atorvastatin and plant based – aqueous root extract of Cichoriumintybus showed significant lipid lowering and pleiotropic effect in treatment of MetS induced by HCHF diet. Conclusion: Atorvastatin and CI extract have effectiveness in treatment of metabolic syndrome.
PCO 28 DEVELOPMENT AND EVALUATION OF ANTISTRESS ACTIVITY OF NOVEL HEALTH PROMOTING TEA FORTIFIED WITH HERBS Marathe Dipika*, Rajpurohit Kirthi, Pal Roy Samaresh, Vyas Bhavin Maliba Pharmacy College The present study was designed to develop and evaluate antistress property of a health promoting tea comprising of poly herbal formulation containing ethanolic extracts of four plant Withania somnifera (ashwagandha), Justicia adhatoda (vasaka), Trigonella foenum (methi), Vitis vinifera (grape seed). The antistress activity was evaluated with the adult rats by swimming endurance test (SET), anoxia tolerance test (ATT) and immobilization stress test (IST). Here, five group of animal six in each were taken and rats were subjected to chronic unpredictable stress (CUS) like restraint stress, ether anesthesia, tilted cage, tail pinch for 14 days depending on study design. The treatment was given for 21 days depending on study design. The efficacy of the different doses of Poly herbal extract (PHE) 200 mg/kg; 400 mg/kg) was evaluated as compared with the standard drug and marketed herbal preparation Mentat from Himalayan herbals. The level of neurotransmitters serotonin and dopamine and nor epinephrine were estimated in brain homogenate of rats using spectrofluorimeter. In swimming endurance test our poly herbal extract showed a dose dependent significant result by decreasing in immobility time on rat which is almost comparable to standard Mentat. In
37 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends the similar fashion in anoxia tolerance test PHE increased the convulsion time on rat which was again statistically significant. In case of immobilization stress test the estimated biochemical parameters (Cortisol, Glucose, triglyceride and Cholesterol) showed significant dose dependant antistress activity of polyherbal extract. The level of neurotransmitters serotonin and dopamine and nor epinephrine were found to be increase when treated with the PHE as compare to stress control group. So, the present study reveals that poly herbal extract possesses significant anti-stress activity in different experimental animal models. Therefore by using these four ethanolic extract of the herbs we have prepared polyherbal tea for the management of stress.
PCO 29 A PROSPECTIVE STUDY OF CLINICAL PROFILE AND DRUG PRESCRIBING PATTERN FOR OSTEOPOROSIS IN A MULTI SPECIALITY HOSPITAL Tailor Neelam*, Pavagadhi Divya, Pal Roy Samaresh Maliba Pharmacy College The purpose of the present investigation was to study the trends in utilization of drug pattern and evaluate risk factor as well as cost of treatment for the management of osteoporosis. A Propective observational study was carried out in which subjects were enrolled within the duration of 6 months at Hospital, who were diagnosed with osteopenia and osteoporosis and also vitamin D3 deficiency. A total of 120 subjects were enrolled out of which 47.5% were men and 52.5% were women. The ratio of men and women was 4:5. Out of them, 69.1% patients were having osteopenia and 30.8% patients were osteoporotic. The majority of osteoporosis and osteopenia was prevalent in the age group of 41-60 being 22.5% in 41-50 and 27.5% in 51-60. Hypertension was the most common co-morbid condition found among the osteoporosis subjects being 27%. Most common clinical feature among them was joint pain followed by low back pain. A positive correlation was found among the socio economic and socio personal variables like menopausal status, dietary habits, BMI with severity of disease except for age. The most commonly prescribed medicines were vitamin D and calcium supplements being 60% followed by analgesics, muscle relaxants and biphosphonates being 22% and 9% respectively. The ratio of men and women in our study was found to be 4:5. Cost benefit analysis could be done through long term studies to measure quality of life of the subjects.
PCO 30 A SEARCH FOR PROTEINS INVOLVED INTO THE PATHOGENESIS OF RHEUMATOID ARTHRITIS Sarangi Deepak Kumar*, Sarangi, Sriwastawa Keshari Kumar, Tarini Charan Tripathy Roland Institute of Pharmaceutical Sciences Brahmapur, Odisha, India Rheumatoid arthritis (RA) is a chronic autoimmune disease. Certain autoantigens have been implied to contribute to the induction and maintenance of inflammatory reactions against the
38 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends host tissue(s). Therefore the identification of novel autoantigens in RA appears to be very important for a better understanding of specific disease mechanisms. SEREX (Serological Analysis of Recombinant cDNA Expression Libraries) is a valuable tool widely used in searching for autoantigens. The method is based on screening gene expression libraries constructed from tissue samples to find potential proteins triggering the production of autoantibodies. We used a modified SEREX method with synovial fluid from RA patient as source of antibodies. We found numerous novel autoantibodies. There were reports that fibromodulin is a newly defined autoantigen in RA. We were also able to identify decorin, vimentin, aldolase A and eEF1A-1 as autoantigens in RA which have been previously identified to be involved into the immune response in rheumatoid arthritis. Our results confirm the validity of results obtained using the SEREX system and that the SEREX technique is useful for the identification of novel autoantigens that play a potential role in the pathogenesis of the disease. Such proteins identified as autoantigens might help to better understand the pathophysiology of RA.
PCO 31 MYRISTOYL COA: PROTEIN N-MYRISTOYL TRANSFERASE: A TARGET FOR STRUCTURE-AIDED DESIGN IN THE DEVELOPMENT OF A NOVEL ANTI- MALARIAL DRUG Sahoo Priti Ranjan*, Upadhyaya Sangram, Keshari Upadhyaya, Jain Anand Roland Institute of Pharmaceutical Sciences Brahmapur, Odisha, India Malaria, an illness caused by protozoan parasites of the genus Plasmodium, continues to be a key global health issue; around 40% of the world’s populations are at risk and more than 1 million people are killed each year. It is transmitted via bites of infected female mosquitoes (Anopheles) and its severest form, falciparum malaria, can cause blocked blood vessels, cerebral malaria, coma, and death if left untreated. There is a variety of drugs available to counter malarial infection, however effective malarial treatment is complex due to interweaved factors such as drug resistance and socioeconomic development. We have identified an enzyme from the parasite, myristoyl CoA:protein N-myristoyl transferase (NMT), which if inhibited will lead to parasite death. NMT catalyses the co-translational transfer of myristic acid to an N terminal glycine of certain substrate proteins and it is known that this enzyme is essential for viability of these protozoa. Initial screening using in vitro tests of enzyme activity as well as P. falciparum infected erythrocytes has allowed us to identify a series of specific benzothiazole compounds that act as inhibitors of P. falciparum NMT. It is known that these benzothiazoles compete with binding of the peptide substrate within the NMT enzyme-binding cleft. We are currently following a strategy of structure- based drug design where we will exploit slight differences in the peptide binding pockets of P. falciparum and human NMTs to produce selective and potent inhibitors, which we hope will lead to effective new anti-malarial treatments.
39 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO 32 A ROLE FOR LIPID RAFTS IN CERAMIDE-INDUCED INSULIN RESISTANCE Padhi Ansik Kumar*, Priyadarshini Tabassum, Swain Priyanka. Roland Institute of Pharmaceutical Sciences Brahmapur, Odisha, India Type II diabetes is characterised by a loss in responsiveness of both muscle and adipose tissue to insulin, the main hormone that regulates the body’s energy stores. Although the precise mechanisms that underlie this pathogenesis still remain unclear there is strong evidence that suggests that an increase in circulating free fatty acids may play a role in the observed reduction in insulin sensitivity in tissues such as skeletal muscle. We investigate the mechanisms by which fatty acids such as ceramide, a main intermediate in the sphingomyelin pathway, trigger insulin resistance and impair insulin signalling in cultured skeletal muscle cells and adipocytes. Ceramide activates an atypical Protein Kinase C zeta (PKCz) and promotes its association with the protein kinase B (PKB), a key protein in the insulin signalling, which in turn become inhibited. Whether the complex is targeted to a specific cellular compartment has been unknown. We investigated whether lipids rafts within the plasma membrane could serve to sequester and retain PKB in its inactive state. We show that lipid rafts elicit increased abundance of both PKCz and PKB following cell treatment with ceramide. Lipid rafts dispersion by cholesterol depletion of cells reduces the ceramide- mediated increase of both kinases. As a consequence the insulin-dependent activation of PKB is restored. Our findings indicate that ceramide inhibits the hormonal activation of PKB by its association with PKCz and retention in specialised microdomains of the plasma membrane. This implies that therapeutic manipulation of PKCz activity or lipid raft composition may provide opportunities for enhancing insulin sensitivity of tissues such as skeletal muscle and fat.
PCO 33 NEPHROPROTECTIVE EFFECT OF TABERNAEMONTANA DIVARICATA FLOWER EXTRACT AGAINST DICLOFENAC INDUCED RENAL DAMAGE IN RATS Syeda Nishat* Jayamukhi College of Pharmacy The present study was carried out to evaluate the beneficial nephroprotective effect of ethanolic extract of Tabernaemontana divaricata flower against diclofenac induced renal damage. In the present study wistar albino rats were divided into four groups containing 6 animals in each group. Group-I was treated as Normal Control group, Group II was treated as Nephotoxic group (diclofenac sodium 50 mg/kg), Group-III was treated as Nephroprotective group (silymarin 150 mg/kg)and Group-IV was treated as Test group (Tabernaemontana divaricata flower extract 500 mg/kg) being treated with diclofenac sodium for 14 days. On 15th day blood samples were collected by retro orbital plexus and biochemical renal functional tests urea, creatinine as well as lipid peroxidation and antioxidant activities such as superoxide dismutase (SOD) and superoxide catalase (CAT) were assessed. Results of this study revealed that the serum markers in the animals treated with diclofenac alone were
40 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends significantly increased indicating severe renal damage by diclofenac, whereas the blood samples from the animals treated with ethanolic extract of Tabernaemontana divaricata flower showed significant reduction in the serum markers indicating the effect of the plant extract in restoring the normal functional ability of the nephrons. The present study reveals that the ethanolic extract of Tabernaemontana divaricata flower could afford a significant protection against diclofenac induced renal damage as it can normalized the oxidative stress.
PCO 34 PHARMACOLOGICAL EVALUATION OF IN-VITRO ANTI-INFLAMMATORY ACTIVITY OF ETHANOLIC BAUHINIA SEMLA ROOT EXTRACT AGAINST CARRAGEENAN INDUCED PAW EDEMA IN RATS Gadegoni Hemalatha* Jayamukhi College of Pharmacy Bauhinia semla has widely been used in the indigenous and traditional systems of medicine because of its wide therapeutic profile. Traditionally the flowers are used for management of gout, biliousness, dropsy, epilepsy, convolutions and hysteria. The present study was carried out to evaluate the effect of ethanolic Bauhinia semla flower extract against carrageenan induced paw edema in Rats using Indomethacin as standard drug. Acute oral toxicity study as per ICH Topic S7A guidelines and OECD 423 guidelines was carried out and 250 mg/kg body weight of dose was selected for further study. The extract showed significant reduction in paw volume after carrageenan Injection. Thereby it can be concluded that ethanolic Bauhinia semla flower extract has potential anti-inflammatory property.
PCO 35 BETA CATENIN – A NOVEL APPROACH IN TREATMENT OF STRESS AND DEPRESSION Hajira Ummay*, Syeda Nishat Fathima Jayamukhi College of Pharmacy Depression is a common mental disorder, affecting as many as 1 in 4 people in the course of their lifetime. Moreover, between 5% and 10% of the population suffer from this psychological disorder at some point, to varying degrees. All current antidepressants activate norepinephrine or serotonin in the brain. They are very nonspecific, so the drugs are useful for a wide range of disorders, not specifically depression. A single brain protein beta-catenin appears to mediate resilience to stress and susceptibility to depression that may offer targets for novel and more effective antidepressants. Beta-catenin activity in D2-type dopamine receptor neurons in the nucleus accumbens plays a central role in the ability to deal with stress and be resilient to depression. Moreover, activity is reduced in the brains of depressed patients. By targeting β-catenin, we just might be able to come up with a new cure for depression that is also much more effective than current treatment. The focus is on addressing the negative impacts of stress, but, the new way of treating depression might instead involve scientists activating beta-catenin resilience mechanisms in order to stave off depression.
41 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCO 36 FIBROBLAST GROWTH FACTOR: CONNOTATION IN ANGIOGENESIS Vankudothu Ganapathi*, Syeda Nishat Fathima Jayamukhi College of Pharmacy Angiogenesis is the growth of blood vessels from the existing vasculature. Angiogenic therapies are designed to control the growth and regression of blood capillaries can be used to improve the survival of poorly perfused tissues that are essential to the body (heart, brain, skeletal muscle, etc.) and to rid the body of unwanted tissues (tumors). FGFs are homeostatic factors and function in tissue repair and response to injury. When inappropriately expressed, some FGFs can contribute to the pathogenesis of cancer. A subset of the FGF family, expressed in adult tissue, is important for neuronal signal transduction in the central and peripheral nervous systems. Fibroblast growth factors (FGFs) are potent mitogens for vascular and capillary endothelial cells and can stimulate the formation of blood capillaries (angiogenesis). Basic FGF can stimulate processes that are characteristic of angiogenesis, including endothelial cell migration, proliferation of capillary endothelial cells, invasion, and production of plasminogen activator. They, thus promote Angiogenesis represents an excellent therapeutic target for the treatment of cardiovascular disease. Basic and acidic fibroblast growth factors are prototypes of the family of fibroblast growth factors. They stimulate the proliferation of fibroblasts and endothelial cells that give rise to angiogenesis and developing granulation tissue; both increase blood supply and fill up a wound space/cavity early in the wound-healing process. Early clinical studies with protein- based therapeutics largely focused on the intravenous or intracoronary administration of a particular growth factor to stimulate angiogenesis in the affected tissue or organ. This review highlights the therapeutic importance of fibroblast growth factors in cardiovascular disorders. Most of the clinical trials reveal that the treatment especially with a single agent was not a viable option to treat ischemic cardiovascular success. The clinical protocols give renewed hope that Angiogenesis therapy will be a treatment choice for sufferers of CVS diseases. This lead to a resurgence of interest in returning to protein based therapy especially fibroblast to stimulate angiogenesis.
PCO 37 ANTIMICROBIAL ACTIVITY OF NOVEL CHITOSAN/CLOISITE 10A NANOCOMPOSITE: PREPARATION, OPTIMIZATION, CHARACTERIZATION AND DRUG DELIVERY BEHAVIOR Roul Jyotiranjan* Institute of Pharmaceutical Education And Research, Borgaon (Meghe), Wardha The objectives of the present research project were to formulate, evaluate and perform antimicrobial study and drug delivery behavior of nanocomposite material based on biopolymer chitosan and organically modified montmorillonite clay; i.e. cloisite 10A. In the present study, chitosan / cloisite 10A nanocomposite material was formulated by solution mixing and optimized. The nanocomposite material was characterized by FTIR, zeta sizer, XRD, and SEM. Polymer/clay nanocomposite material is evaluated for its antimicrobial
42 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends activity against both gram- negative and gram- positive bacteria. It was also studied for potential drug carrier system using diclofenac sodium as a model drug. Drug incorporation efficiency and drug content were also determined. SEM provided the composite shape and its surface topography. XRD data revealed the nanocrystalline composition and crystallite size. The average diameters of particles in the nanocomposite were found to be around 80 nm from both XRD report, calculated by applying Scherrer equation and zeta sizer. The antimicrobial activity report revealed that nanocomposite exhibited stronger inhibition against the microorganisms as compared to that of pure chitosan. From the in vitro drug-release study, it is observed that biopolymer/clay nanocomposite exhibited extended release period of drug as compared to the pristine chitosan. This research work provides a platform for further research on the polymer/clay nanocomposites for biomedical and drug delivery applications.
PCO 38 PHARMACOVIGILANCE: INDIAN PROSPECTIVE Mishra Bhawna* Institute of Pharmaceutical Education And Research, Borgaon (Meghe), Wardha Pharmacovigilance is the science dealing with the detection, assessment, collection and prevention of adverse reaction related to the pharmaceutical product in context of pharmacology. This study holds a wide horizon of scope as it deals with the safety patient care and public health. This can be used to promote understanding, clinical training and effective communication to healthcare professionals and the public. In a nutshell pharmacovigilance is concerned with the detection of hazards linked with pharmaceutical products and reduce the risk of any potential harm that may occur. Pharmacovigilance programme of India (PvPI), started by AIIMS, New Delhi on 14th July 2010 is one of the leading pharmacovigilance facility in India. The sector has been expanding in recent years due to the stringent rules of regulatory authorities regarding the drug safety. Clearly pharmacovigilance is increasingly important worldwide, especially to avoid the reoccurrences of serious problems that are damaging to the health care system and the industry. This is designed to provide crucial data on the effects of the drugs which can aid in drug development and marketing if harnessed properly, being a boon than the hindrance.
43 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PQA 01 THE MODERN ROLE OF SMARTPHONE IN ANALYTICAL CHEMISTRY Zaveri Sufiyan*,Patel Kuldeep Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Main trends in development of analytical instrumentation involve design a measuring instruments, which are able to provide the largest possible amount of analytical information about analyzed material, but simultaneously also simplification and scaling-down analytical instruments towards a possible use directly by users without specialized training. Both those development trends are associated with another important tendency, which is the elimination of direct human effort in carrying out different operations in chemical analytical procedures by design of measuring systems, which are mechanized, robotized, or even completely automated involving various contributions of artificial intelligence. One of elements used also for further instrumental progress, is in recent decade the application of mobile phones in further modification of analytical devices for remote and personal use. The potential utility value of a concept to equip mobile- phones in chemical sensors can be considered as a very efficient way for improving the access to a personal analytical devices for instance in bioanalytical applications, smartphone-based biosensors, and integration of microfluidic devices and smartphones.
PQA 02 DISCOVERY OF NOVEL ANTIBACTERIAL AGENTS Ahirrao Damini*, Bhuva Hemal Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh The need for novel antimicrobials become essential to face the increasing resistance towards older ones. This review summarises the discovery of some recently approved antimicrobial agents. In 2018, eravacycline (first fully synthetic fluorocycline) and omadacycline (C-9 substituted derivative of minocycline) were approved in an order to be active against tetracycline resistance mechanism.In 2017, delafloxacin (to increase activity in acidic medium by lacking strong basic heterocyclie ring and to increase stability) and ozenoxacin (to be effective topically in impetigo) were approved.Rapidly increasing the resistance tocarbapenemsdue toKlebsiellapneumoniaecarbapenemase enzyme and with reports that boronic acids inhibit β-lactamase enzyme, new β-lactamase inhibitorVaborbactam was discovered with cyclic boronic acid pharmacophore. Its combination with meropenem was approved in 2017. In an order to find covalent, reversible β-lactamase inhibitor, avibactam with diazabycyclooctane nucleus was discovered and its combination with ceftazidime was approved in 2015.
44 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
PCG 01 CONCEPT OF PHARMA RESTAURENT Chaudhari Umesh*, Shah Biren Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Let the food be your medicine".The main aim for the establishment of the pharma restaurent is to serve the qualitative meal according to the disease of the person.For the prevention and the cure of the disease. We provide the hygine food with proper nutritional requirement. This may help the person to develop the strong immunity and help to produce ressistant for the disease.For the diabetic patient we have proper recipe like Jamun ka jalwa and other recipe kiwi ki masti etc.They are most probably rich in fibers and vitamins which reduces blood sugar level in the body and they are poor in carbohydrates. The most of the food is coocked in olive oil which contain omega-3 fatty acids(which reduce the risk of heart disease and also promote healthy skin).They are also used along the diet and exercise to help lowerlevels of a certain blood fat(triglyceride)and rise the level of HDL( good cholestrol).
PCG 02 Jalkumbhi: A polluting monster or a therapeutic boon? Salunke Snehal*, Vashi Jainee, Dalal Mittal Rofel, Shri G. M. Bilakhia College Of Pharmacy, Vapi Jalkumbhi with the scientific name Pistia stratiotes, is an aquatic plant that is widely found in lakes, rivers and other stagnant water bodies. It is distributed in the tropical and subtropical region of Asia, Africa and America. The plant spreads on the surface of water. It has mostly been portrayed as a water pollutant but it also has various medicinal uses, which are yet to be explored. It is propagated by seeds or more rapidly by stolons. It forms a dense mass on the water surface and causes serious clogging of water ways. A large number of medicinal properties are attributed to the plant, particularly the leaves. Leaves are rich in vitamin A and C, and also contain vitamin B. The ash is rich in potassium and other minerals. Other biologically active chemical constituents of P. stratiotes are alkaloids, glycosides, flavonoids, and steroids. The plant is considered antiseptic, antitubercular, and antidysentric. This commonly available economical plant has a lot more to offer, in terms of its therapeutic properties. Keyword: A Sea monster, boon, clogging water, dense mass, medicinal plant.
PCG 03 ANIMAL SELF-MEDICATION Parmar Bhumika*, Shah Biren Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh The consumption of plants, insects, dirt and microbes by animals for prophylactic or therapeutic use by themselves in illness or to improve their own health is termed as Zoo Pharmacognosy or animal self-medication. Different species of animals use different substances derived from nature which possesses therapeutic properties. Zoo Pharmacognosy
45 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends can show us the solutions quicker. We must now take responsibility of our mismanagement, overuse and disregard of the species of this world. Once we are able to unlock all the potential benefits of Zoo Pharmacognosy and its positive implications for conservation, then and only then, can we revolutionize our world. The mechanism underlying the selection by animals of specific plants during illness is still unclear. The reasons of self-medication by animals include parasitism, indigestion, stomach upset, infections, neutralize toxins, etc. This particular behavior of animal self-medication like fur rubbing with plants, resins, citrus fruits, ant-eating, eating dirt, etchas driven attention to study further in order to discover new drugs. This paper describes various types, methods and reasons of Zoo Pharmacognosy by various animals.
PCG 04 GOMUTRA (COW URINE): A MULTIDIMENSIONAL DRUG THERAPY Patel Nil*, Jain Kevil, Modi Preet, Parekh Brijesh Shree Naranjibhai Lalbhai Patel College Of Pharmacy, Umrakh Gomutra is important part of Indian tradition. It is not only holy but also has various important medicinal uses. Classical treatises in Ayurved i.e. Charka, Sushruta and Vagbhata Samhita has described Ashta mutra (eight types of urine) along with their properties, indication and formulations. Cow urine is one of them. Cow urine is one of the five contents of Panchagavya which are obtained from cow (urine, milk, ghee, curd and dung). Cow based treatment is called as Panchagavya Chikitsa (Cowpathy). Panchagavya is a term used in Ayurveda to describe five important substances obtained from cow namely Urine, Dung, Milk, Ghee and Curd. Many people use Panchgavya in some rituals (puja) and for medicinal purposes. In this modern era, the diseases related to life style like cancer, autoimmune diseases, diabetes, AIDS etc. are increasing day by day. A work carried out on modern approaches has showed that cow urine has different activities like antioxidant, anti-diabetic, wound healing property, immunomodulator also act as bioenhancer to increase the efficacy of antibiotics, nutrients and anticancer drugs like taxol. Irrational use of antibiotics is also responsible for increase in antibiotic resistant infectious diseases. Various actions and researches on cow urine are summarized in this article. However, more studies experimental as well as clinical can throw better light on it.
PCG 05 A BRIEF REVIEW ON REGULATORY GUIDELINE ON HERBAL MEDICINES IN INDIA Singh Diksha*, Mithani Namira, Rohit Vrushti Smt. B. N. B. Swaminarayan Pharmacy College, Salvav,Pardi, Vapi. Herbal medicines have gained enormous popularity throughout the world now, and also gained popularity throughout India. This enormous spread now brings up a huge question for the safety, efficacy and reliability of the drugs being used. There is as such no specific guideline available regarding herbal, poly herbal and herbo mineral products. The
46 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends manufacturer claims them to be safe and effective but it always need a regulatory body to check on. The clinical and preclinical trials which has been carried on for some herbal products also demand for a specific guideline, as there is no clarification regarding clinical guidelines. The department of AYUSH and D&C Act 1945 are regulating the herbal medicines and related regulatory guidelines but still it limits at the point of rationality many a times. There is a major drawback regarding the specific criteria to undergo animal studies, which needs great modifications so only approved drugs undergo studies and reduce preclinical load in country. A regulatory rule regarding drugs which can proceed for trial, its trial period needs to be established. Pharmacovigilant data and studies need to be taken under consideration when the drugs are intended to be used for a long period. Hence, development of a body which solely governs the herbal medicine is necessary . With the aid of AYUSH this can be established even quicker and efficiently. Else the guidelines provided by the department needs constant reassessment and specifications.
Keywords: Herbal drugs, AYUSH, D&C ACT, Pharmacovigilant data, Regulatory rule.
PCG 06 PHARMACOGNOSTIC PROFILING OF POGOSTEMON AURICULARIS L. Hussk AND DEVELOPMENT OF NOVEL TOPICAL ANTI INFLAMMATORY GEL WITH ITS QUALITY CHECK Maheshwari Kinara*, Jat Rakesh, Shah Biren, Ishwar, Pushpa T. John college of pharmacy Expectedly a quarter of current prescription medications are derived from plant sources ex. aspirin. In ancient time herbal medicine in different-different forms incorporating plant extracts or powders of crude drugs for medicinal purposes. It is the creation’s most ancient form of soothing. Considerably this age-old knowledge is still useful and gives effective results in modern clinical testing. Our ancestors had profusive familiarity towards herbs and their curing ability. Contrary to that they had modest information about active chemical constituents of primary and secondary metabolites. Conventional COX inhibitors come with deleterious effects like, Risk of hemorrhage, renal insufficiency, alteration of hepatic enzymes, bone marrow depression etc. where herbs produce laser side effects and comparable effectiveness. Pogostemon auricularis L. Hussk belonging to the family Lamiaceae. It is habitat to Bellary, Mysore, Chikamagalur, Assam, south India, Kodagu, Maharashtra, west Bengal and fully-fledged naturally in wastelands.
Methodology: Pogostemon auricularis L. Hussk was evaluated for Macroscopical, Anatomical features. Physical, chemical make-up was investigated along with TLC study as supportive parameter towards confirmation of findings. From the findings of primary secondary metabolites further pharmacological study was conducted. Anti-inflammatory study of methanolic extract was checked using Plethysmometer. Carrageenan induced paw oedema model was executed under standard lab condition. Novel pharmaceutical formulation, poly herbal gel was developed and standardized for its quality check.
47 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh Pharmacovigilance: Current Scenario and Emerging Trends
Results: Pogostemon auricularis leaves found covered with hairs on both the plane and lathery feel. It is dorsiventral leaf with presence of dicytic epidermal openings, cuticle layer to the epidermis, uniseriate covering trichomes, spongy parenchyma, vascular bundle at the midrib and most distinguish character cystoliths in epidermis. Chemical analysis depicted presence of alkaloids, cardiac & saponin glycoside, tannins, phenols, steroids and flavonoids presence. Pulverized leaves showed 17 % w/w extractives with methanol. So, the same extracts used for further pharmacological study and poly herbal gel preparation. Methanolic extract exhibited 73 % reduction in rat paw oedema volume compared to standard treatment Diclofenac which is 79 %. Gel preparation passed thee quality tests which are pH, viscosity, Spreadability, irritability, swelling ability, drug content, in-vitro drug diffusion and drug release kinetic model study.
48 Organized by Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh