Formulation Development of Medicated

FORMULATION DEVELOPMENT OF MEDICATED

LOZENGES FOR PEDIATRICS

M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA.

BY MANDEPUDI SUDHEER KUMAR Under the guidance of Dr.K.PURUSHOTHAM RAO M.Pharm., Ph.D

DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY H.K.E.S’s MATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES SEDAM ROAD GULBARGA – 585105 2011-2012

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BENGALURU ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate (In block letters) MANDEPUDI SUDHEER KUMAR

Permanent address MANDEPUDI SUDHEER KUMAR S/O M.CHANDRA SHEKAR RAO H NO:5-5-280/38 POST: SAMBANI NAGAR,KHAMMAM DIST: KHAMMAM STATE: ANDHRAPREADSH. PIN CODE: 507001.

2. Name of the institution H.K.E.S’s MTRIPS,SEDAM ROAD GULBARGA – 585105

3. Course of study and subjects M.PHARM (PHARMACEUTICAL TECHNOLOGY)

4. Date of admission to the course 12-07-2011

FORMULATION DEVELOPMENT OF 5. Title of the topic MEDICATED LOZENGES FOR PEDIATRICS

6. Brief resume of the intended work

6.1 Need for the study1,2: Oral thrush is a disorder caused by infection of the mouth due to fungus Candida albicans. In babies it may be a severe infection sometime causing epidemics in school by cross infection. Chronic thrush may develop, affect the roof of mouth, pharynx. Candida, a yeast like fungus, is commonly part of the normal flora of the skin, mouth, Intestinal tract, and vagina and is present in the oral cavity in 40% to 60% of the population. Candida albicans is the most commonly isolated species and is the species most likely to cause disease in humans Other Candida species include Candida tropicalis, Candida krusei, Candida guilliermondii, and Candida parapsilosis (of limited

2 pathogenicity but particularly associated with infection of indwelling vascular access devices).

The present investigation is design to improve patient compliance.These preparations are commonly used for the purpose of local and systemic effect through the Buccal mucosa. Lozenges are solid preparations that are intended to dissolve slowly in mouth. They contain one or more medicaments usually flavoured sweetened base.The present work is aimed at to anti-fungal anti-biotics tablet lozenges for pediatric meant for systemic effects. Most of the drug will be absorbed from the Buccal cavity and less would be swallowed and lost in GI tract. Lozenges have the advantage of being easy to administer to pediatric medications

6.2 Review of Literature: A through literature survey has been carried out on the proposed topic and most prominent references found are:

 Zinc Gluconate lozenges for treating the common cold in children3.

 Delivery of antifungal agents to the oral cavity4.

 Development of bioadhesive lozenge containing a synergistic combination of antifungal agents5.

 Koflet lozenges in the treatment of sore throat6.

 The nicotine lozenge is a safe and effective new treatment for smoking cessation in low and high–dependence smokers7.

 To study the effect of acidic candies on saliva in unilaterally irradiated pharyngeal cancer patients8.

 Lidocaine lollipop as single agent anaesthesia in upper GI Endoscopy9.

 Formulation of bio-active throat soothing lozenges10.

 Design of candy based doxofylline tablet lozenges11.

 Design of candy based clotrimazole pediatric tablet lozenges12.

6.3 Objectives of the study:

3  To design the sweetened candy based medicated tablet lozenges for systemic action.

 To design attractive and alternative dosage form for children.

 To enhance the patient compliance and acceptance and desire to hold the tablet in the mouth until it is completely dissolved.

 To achieve maximum drug efficacy.

 To help the drug industry to take up for future studies and introduce into the market such dosage formulations.

 To design a dosage form that is more effective and acceptable than the existing marketed formulations for Pediatrics.

7. Materials and Methods:

7.1 Source of Data:

 Internet, www.rguhs.ac.in.

 M.R.Medical college library, Gulbarga.

 International pharmaceutical abstract.

 H.k.e.s’s college of pharmacy library, Gulbarga.

4 7.2 Methods of collection of data

Materials and Methods:

It is planned to use sucrose, citric acid, calcium carbonate, sodium bicarbonate, HPMC, HEC, and all other chemicals will be used of analytical grade. In the present price of research work Fluconazole, Nystatin etc. chosen as model drug.

PHASE-1:Preparation of medicated tablet lozenges:

Syrupy base will be prepared following established method by dissolving the sugar in purified water and heating up to 140O F (113O C) for a period of 1hr. Other excipents like acidulents will be added in geometrical ratio to the syrupy base on continues stirring. By dispersing in glycerine and warming up to 60O separately. Specially designed 4gms capacity stainless steel molds are planned to use during formulation of lozenges.

PHASE-II: Characterization of prepared tablet lozenges:

The prepared tablet lozenges will be subjected to various physico-chemical parameters like hardness, size, shape, weight variation, and drug content estimation etc.. to check the drug excipients interactions if any. The prepared formulation will be subjected for IR, TLC, DSC, DTA studies.

PHASE-III: In vitro DRUG RELEASE STUDIES:

All the formulations prepared will be subjected for in vitro drug release using electro lab six-basket tablet systematically using USP XXIII dissolution apparatus in PH 6.7 MEDIA AT 37OC.

PHASE-IV

The entire prepared tablet Lozenges will be subjected for stability studies for a period of three months. The drug content estimation will be carried out on the sample taken at various time intervals for 15 days.

5 7.3 Does the study require any investigation or invervention to be conducted on patients or other humans or animals? If so please describe briefly

------Not in the study------

7.4 Has ethical clearance have been obtained from your institution in case of 7.4?

------Not applicable------

8 List of References

1. Joel BE, MSD, DMD, Bruce P, MD2. Oropharyngeal Candidiasis: A Review of Its Clinical Spectrum and Current therapies. Clin Ther. 1998; 20(1):40-57.

2. Glibert S, Banker, Anderson NR. Tablets. In: Lachman L, Lieberman HA, kanig JL, editors. The Theory and Practice of Industrial Pharmacy. Bombay: Varghese Publishing House;1987.p.333.

3. George AE, Davis DR, William WH. Reduction in Duration of Common Colds by Zinc Gluconate Lozenges in a Double-Blind Study. Antimicrob Agents Chemother. 1984; 25(1):20-4.

4. Samaranayake LP, Ferguson MM. Delivery of Antifungal Agents to the Oral Cavity. Adv Drug Deliv Rev. 1994; 13:161-79.

5. Codd JE, Deasy PB. Formulation Development and in vivo Evaluation of a Novel Bioadhesive Lozenge Containing a Synergistic Combination of Antifungal Agents. Int J Pharm. 1998;173:13-24.

6. Prakash T. Koflet Lozenges in the Treatment of Sore Throat. The Antiseptic. 2001; 98(4):124-7.

7. Shiffman S, Dresler CM, Hajek P, Gilburt SJA, Targett DA, Strahs KR. Efficacy of a Nicotine Lozenge for Smoking Cessation. Arch Intern Med. 2002; 162:1267-76.

8. Jensdottir T, Nauntofte B, Buchwald C, Hansen HS, Bardow A. Effects of Sucking Acidic Candies on Saliva in Unilaterally Irradiated Pharyngeal Cancer Patients. Oral Oncol. 2006; 42:317-22.

9. Ayoub C, Skoury A, Abdul-Baki H, Nasr V, Soweid A. Lidocaine Lollipop as Single-agent Anesthesia in Upper GI Endoscopy. 2007; 66(4):786-93.

6 10. Ahuja R, Jain RK, Nandane AS, Lakadawala M, Patel S, Katkoriya M. Optimization of the Formulation of Bio-active Throat Soothing Lozenges. 2009; 89:12-18.

11. Purushotham RK, Mohanta GP, Krantikumar S, Veerabhadrappa H, Shivanand B. Design of Candy Based Doxofylline Tablet Lozenges. Recent Trends Pharmac. Toxic. 2009; 6:43-50.

12. Purushotham RK, Shivappa NN, Zakaullah S, Zainab H, Arshiya S. Studies on Candy based Clotrimazole Pediatric Tablet lozenges. J Chem Pharm Res. 2010; 2(3):640-6.

9. Signature of candidate MANDEPUDI SUDHEER KUMAR

10. Remarks of Guide College has all the facilities to work .Hence this work is feasible.

11. Name and designation of (in block letters)

Dr. K.PURUSHOTHAM RAO 11.1 Guide M. Pharm.,Ph.D. PROFESSOR DEPT.OF PHARMCEUTICAL TECHNOLOGY H.K.E.S’s COLLEGE OF PHARMACY GULBARGA – 585105 11.2 Signature

Shantveer.v.salger 11.3 Co-guide M. Pharm. ASST. PROFESSOR DEPT.OF PHARMCEUTICAL TECHNOLOGY H.K.E.S’s COLLEGE OF PHARMACY GULBARGA – 585105 11.6 Signature

1 12.1 Remarks of Chairman 2 and Principal

12.2 Signature