Drug Administration
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(12) United States Patent (10) Patent No.: US 6,515,007 B2 Murad (45) Date of Patent: Feb
USOO6515007B2 (12) United States Patent (10) Patent No.: US 6,515,007 B2 Murad (45) Date of Patent: Feb. 4, 2003 (54) METHODS FOR MANAGING SCALP OTHER PUBLICATIONS CONDITIONS WPIDS AN 1997-389337, JP 09 169638 A, Jun. 30, 1997, (76) Inventor: Howard Murad, 4265 Marina City Dr., bstract.* Penthouse 11, Marina del Rey, CA (US) MEDLINE 79172521, Orfanos et al, Hautarzt, Mar. 1979, 90292 30(3), 124–33, abstract.* * cited by examiner (*) Notice: patentSubject is to extended any disclaimer, or adjusted the term under of this 35 Primary Examiner Rebecca Cook U.S.C. 154(b) by 0 days. (74) Attorney, Agent, or Firm-Pennie & Edmonds LLP (57) ABSTRACT (21) Appl. No.: 09/920,729 ThisS applicationCO relatesCLCSO to a ph CCUCtical compositionCOOOSOO f (22) Filed: Aug. 3, 2001 the prevention, treatment, and management of Scalp O O conditions, Such as dandruff, Seborrheic dermatitis, (65) Prior Publication Data pSoriasis, folliculitis, and hair thinning including a thera US 2002/0009423 A1 Jan. 24, 2002 peutically effective amount of an acidic component of a hydroxyacid or tannic acid, or a pharmaceutically acceptable Related U.S. Application Data Salt thereof. A preferred anti-dandruff composition and - - - method of managing dandruff includes a therapeutically (62) Pisie of Epitol N: SE filed R Aug. 5. effective amount of the acid component, a vitamin A application, now Nolog23,484Pat. No. O.Z f 1,240,filedonii. which 27, is 1998,a division now Pat o OPO and an anti-growthi- agent. A preferred anti-hairi-hai No. 6,207,694. thinning composition and method of managing thinning hair 7 includes a therapeutically effective amount of the acidic (51) Int. -
Study Protocol and Statistical Analysis Plan
The University of Texas Southwestern Medical Center at Dallas Institutional Review Board PROJECT SUMMARY Study Title: Ultrasound-guided fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial Principal Investigator: Irina Gasanova, MD Sponsor/Funding Source: Department of Anesthesiology and Pain Management, UT Southwestern Medical School IRB Number: STU 122015-022 NCT Number: NCT02658240 Date of Document: 01 April 2016 Page 1 of 7 Purpose: In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty (THA). Background: Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated (1). Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression (2). Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects. Therefore, their use has been emphasized (3, 4, 5, 6). Fascia Iliaca compartment block (FICB) is a field block that blocks the nerves from the lumbar plexus supplying the thigh (i.e., lateral femoral cutaneous femoral and obturator nerves). The obturator nerve is sometimes involved in the FICB but probably plays little role in postoperative pain relief for most surgeries of the hip and proximal femur. -
Intravenous Therapy Procedure Manual
INTRAVENOUS THERAPY PROCEDURE MANUAL - 1 - LETTER OF ACCEPTANCE __________________________________________ hereby approves (Facility) the attached Reference Manual as of _____________________. (Date) The Intravenous Therapy Procedure Manual will be reviewed at least annually or more often when deemed appropriate. Revisions will be reviewed as they occur. Current copies of the Intravenous Therapy Procedure Manual shall be maintained at each appropriate nursing station. I have reviewed this manual and agree to its approval. __________________________ (Administrator) __________________________ (Director of Nursing) __________________________ (Medical Director) - 2 - TABLE OF CONTENTS TABLE OF CONTENTS INTRODUCTION A. Purpose 1 B. Local Standard of Practice 1 RESPONSIBILITIES A. Responsibilities: M Chest Pharmacy 1 B. Responsibilities: Administrator 1 C. Responsibilities: Director of Nursing Services (DON/DNS) 1 D. Skills Validation 2 AMENDMENTS GUIDELINES A. Resident Candidacy for IV Therapy 1 B. Excluded IV Medications and Therapies 1 C. Processing the IV Order 1 D. IV Solutions/Medications: Storage 2 E. IV Solutions/Medications: Handling 3 F. IV Solutions and Supplies: Destroying and Returning 4 G. IV Tubing 5 H. Peripheral IV Catheters and Needles 6 I. Central Venous Devices 7 J. Documentation and Monitoring 8 K. IV Medication Administration Times 9 L. Emergency IV Supplies 10 I TABLE OF CONTENTS PROTOCOLS A. IV Antibiotic 1 1. Purpose 2. Guidelines 3. Nursing Responsibilities B. IV Push 2 1. Purpose 2. Guidelines C. Anaphylaxis Allergic Reaction 4 1. Purpose 2. Guidelines 3. Nursing Responsibilities and Interventions 4. Signs and Symptoms of Anaphylaxis 5. Drugs Used to Treat Anaphylaxis 6. Physician Protocol PRACTICE GUIDELINES A. Purpose 1 B. Personnel 1 C. Competencies 1 D. -
An Overview On: Sublingual Route for Systemic Drug Delivery
International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701 __________________________________________Review Article An Overview on: Sublingual Route for Systemic Drug Delivery K. Patel Nibha1 and SS. Pancholi2* 1Department of Pharmaceutics, BITS Institute of Pharmacy, Gujarat Technological university, Varnama, Vadodara, Gujarat, India 2BITS Institute of Pharmacy, Gujarat Technological University, Varnama, Vadodara, Gujarat, India. __________________________________________________________________________________ ABSTRACT Oral mucosal drug delivery is an alternative and promising method of systemic drug delivery which offers several advantages. Sublingual literally meaning is ''under the tongue'', administrating substance via mouth in such a way that the substance is rapidly absorbed via blood vessels under tongue. Sublingual route offers advantages such as bypasses hepatic first pass metabolic process which gives better bioavailability, rapid onset of action, patient compliance , self-medicated. Dysphagia (difficulty in swallowing) is common among in all ages of people and more in pediatric, geriatric, psychiatric patients. In terms of permeability, sublingual area of oral cavity is more permeable than buccal area which is in turn is more permeable than palatal area. Different techniques are used to formulate the sublingual dosage forms. Sublingual drug administration is applied in field of cardiovascular drugs, steroids, enzymes and some barbiturates. This review highlights advantages, disadvantages, different sublingual formulation such as tablets and films, evaluation. Key Words: Sublingual delivery, techniques, improved bioavailability, evaluation. INTRODUCTION and direct access to systemic circulation, the oral Drugs have been applied to the mucosa for topical mucosal route is suitable for drugs, which are application for many years. However, recently susceptible to acid hydrolysis in the stomach or there has been interest in exploiting the oral cavity which are extensively metabolized in the liver. -
Vaccine Administration Joellen Wolicki, BSN, RN and Elaine Miller, RN, BSN, MPH
Vaccine Administration JoEllen Wolicki, BSN, RN and Elaine Miller, RN, BSN, MPH This chapter summarizes best practices related to vaccine administration, a key factor in ensuring vaccination is as safe NOTES and effective as possible. Administration involves a series of actions: assessing patient vaccination status and determining needed vaccines, screening for contraindications and precautions, educating patients, preparing and administering vaccines properly, and documenting the vaccines administered. Professional standards for medication administration, manufacturer instructions, and organizational policies and procedures should always be followed when applicable. 6 Staff Training and Education Policies should be in place to validate health care professionals’ knowledge of, and skills in, vaccine administration. All health care professionals should receive comprehensive, competency- based training before administering vaccines. Training, including an observation component, should be integrated into health care professionals’ education programs including orientation for new staff and annual continuing education requirements for all staff. In addition, health care professionals should receive educational updates as needed, such as when vaccine administration recommendations are updated or when new vaccines are added to the facility’s inventory. Training should also be offered to temporary staff who may be filling in on days when the facility is short-staffed or helping during peak periods of vaccine administration such as influenza season. Once initial training has been completed, accountability checks should be in place to ensure staff follow all vaccine administration policies and procedures. Before Administering Vaccine Health care professionals should be knowledgeable about appropriate techniques to prepare and care for patients when administering vaccines. Assess for Needed Vaccines The patient’s immunization status should be reviewed at every health care visit. -
Chapter 1 Controlling Drug Delivery
chapter 1 Controlling drug delivery Overview In this chapter we will: & differentiate drug delivery systems according to their physical state & differentiate drug delivery systems according to their route of administration & differentiate drug delivery systems according to their type of drug release & discuss drug transport across epithelial barriers. Introduction KeyPoints & Continued developments in Pharmacotherapy can be defined as the treatment chemistry, molecular biology and prevention of illness and disease by means of and genomics support the drugs of chemical or biological origin. It ranks discovery and developments among the most important methods of medical of new drugs and new drug treatment, together with surgery, physical targets. & treatment, radiation and psychotherapy. There The drug delivery system are many success stories concerning the use of employed can control the pharmacological action of a drugs and vaccines in the treatment, prevention drug, influencing its and in some cases even eradication of diseases pharmacokinetic and (e.g. smallpox, which is currently the only subsequent therapeutic human infectious disease completely profile. eradicated). Although it is almost impossible to estimate the exact extent of the impact of pharmacotherapy on human health, there can be no doubt that pharmacotherapy, together with improved sanitation, better diet and better housing, has improved people’s health, life expectancy and quality of life. Tip Unprecedented developments in genomics Combinatorial chemistry is a way to and molecular biology today offer a plethora of build a variety of structurally related new drug targets. The use of modern chemical drug compounds rapidly and synthetic methods (such as combinatorial systematically. These are assembled chemistry) enables the syntheses of a large from a range of molecular entities number of new drug candidates in shorter times which are put together in different ‘ ’ than ever before. -
Delivery of Orally Administered Digestible Antibodies Using Nanoparticles
International Journal of Molecular Sciences Review Delivery of Orally Administered Digestible Antibodies Using Nanoparticles Toshihiko Tashima Tashima Laboratories of Arts and Sciences, 1239-5 Toriyama-cho, Kohoku-ku, Yokohama, Kanagawa 222-0035, Japan; [email protected] Abstract: Oral administration of medications is highly preferred in healthcare owing to its simplicity and convenience; however, problems of drug membrane permeability can arise with any administra- tion method in drug discovery and development. In particular, commonly used monoclonal antibody (mAb) drugs are directly injected through intravenous or subcutaneous routes across physical barri- ers such as the cell membrane, including the epithelium and endothelium. However, intravenous administration has disadvantages such as pain, discomfort, and stress. Oral administration is an ideal route for mAbs. Nonetheless, proteolysis and denaturation, in addition to membrane impermeability, pose serious challenges in delivering peroral mAbs to the systemic circulation, biologically, through enzymatic and acidic blocks and, physically, through the small intestinal epithelium barrier. A num- ber of clinical trials have been performed using oral mAbs for the local treatment of gastrointestinal diseases, some of which have adopted capsules or tablets as formulations. Surprisingly, no oral mAbs have been approved clinically. An enteric nanodelivery system can protect cargos from proteolysis and denaturation. Moreover, mAb cargos released in the small intestine may be delivered to the systemic circulation across the intestinal epithelium through receptor-mediated transcytosis. Oral Abs in milk are transported by neonatal Fc receptors to the systemic circulation in neonates. Thus, well-designed approaches can establish oral mAb delivery. In this review, I will introduce the imple- mentation and possibility of delivering orally administered mAbs with or without nanoparticles not Citation: Tashima, T. -
Soft Gelatin Capsules)
ERGOCALCIFEROL- ergocalciferol capsule Blenheim Pharmacal, Inc. ---------- VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units) Rx Only DESCRIPTION Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU. Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2 ,is 9, 10-secoergosta-5, 7,10(19),22-tetraen-3-ol,(3β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients: D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil. CLINICAL PHARMACOLOGY The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxy- vitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. -
A Survey of Cannabis Consumption and Implications of an Experimental Policy Manipulation Among Young Adults
Virginia Commonwealth University VCU Scholars Compass Theses and Dissertations Graduate School 2018 A SURVEY OF CANNABIS CONSUMPTION AND IMPLICATIONS OF AN EXPERIMENTAL POLICY MANIPULATION AMONG YOUNG ADULTS Alyssa K. Rudy Virginia Commonwealth University Follow this and additional works at: https://scholarscompass.vcu.edu/etd © The Author Downloaded from https://scholarscompass.vcu.edu/etd/5297 This Thesis is brought to you for free and open access by the Graduate School at VCU Scholars Compass. It has been accepted for inclusion in Theses and Dissertations by an authorized administrator of VCU Scholars Compass. For more information, please contact [email protected]. A SURVEY OF CANNABIS CONSUMPTION AND IMPLICATIONS OF AN EXPERIMENTAL POLICY MANIPULATION AMONG YOUNG ADULTS A thesis proposal submitted in partial fulfillment of the requirements for the degree of Master of Science at Virginia Commonwealth University. by Alyssa Rudy B.S., University of Wisconsin - Whitewater, 2014 Director: Dr. Caroline Cobb Assistant Professor Department of Psychology Virginia Commonwealth University Richmond, Virginia January, 2018 ii Acknowledgement I would like to first acknowledge Dr. Caroline Cobb for your guidance and support on this project. Thank you for allowing me to explore my passions. I am thankful for your willingness to jump into an unfamiliar area of research with me, and thank you for constantly pushing me to be a better writer, researcher, and person. I would also like to acknowledge the other members of my thesis committee, Drs. Eric Benotsch and Andrew Barnes for their support and expertise on this project. I would also like to thank my family for always supporting my desire to pursue my educational and personal goals. -
Inhalation Therapy - Approaches and Challenges
Online - 2455-3891 Vol 11, Issue 4, 2018 Print - 0974-2441 Review Article INHALATION THERAPY - APPROACHES AND CHALLENGES SAYANI BHATTACHARYYA*, BHARANI S SOGALI Department of Pharmaceutics, Krupanidhi College of Pharmacy, No: 12/1 Carmelaram Road, Chikka Bellandur, Varthur, Hobli, Carmelaram Post, Bengaluru – 560 035, Karnataka, India. Email:[email protected] Received: 05 December 2017, Revised and Accepted: 02 January 2018 ABSTRACT Inhalation therapy is an effective way for local and systemic delivery of miscellaneous drugs for pulmonary and non-pulmonary diseases. The inhalation therapy aims to target specific cells or regions of the lung, bypassing the lung’s clearance mechanisms and thereby providing high retention of the drug for longer periods. It helps in improved penetration of intravenously administered antibiotics into lung parenchymal tissue and bronchial secretions, and as a result, their potential systemic toxicity is reduced when given over prolonged periods of time. The advancement in device technology supports the development of more efficient therapy in the form of delivering finer particles into the lung in large doses. Therefore, meticulous daily management of lung disease, together with prompt, aggressive treatment of exacerbations can be achieved through inhalation to preserve lung function. This review summarizes the features of inhalation delivery devices, their advantages and limitations, challenges in formulation and brief description of novel technologies currently marketed. Keywords: Lung, Inhalation, Target, Local delivery, Systemic delivery, Novel technologies. © 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2018.v11i4.24117 INTRODUCTION while drug localized at the upper airways are removed by ciliated cells in the epithelial region. -
Oral Films: a Comprehensive Review
Mahboob et al., International Current Pharmaceutical Journal, November 2016, 5(12): 111-117 International Current http://www.icpjonline.com/documents/Vol5Issue12/03.pdf Pharmaceutical Journal REVIEW ARTICLE OPEN ACCESS Oral Films: A Comprehensive Review *Muhammad Bilal Hassan Mahboob1,2, Tehseen Riaz1,2, Muhammad Jamshaid1, Irfan Bashir1,2 and Saqiba Zulfiqar1,2,3 1Faculty of Pharmacy, University of Central Punjab Lahore, Pakistan 2Foundation for Young Researchers, Pakistan 3Shoukat Khanum Memorial Cancer Hospital & Research Centre, Lahore, Pakistan ABSTRACT In the late 1970s, rapid disintegrating drug delivery system was developed as an alternative to capsules, tablets and syrups for geriatric and pediatric patients having problems in swallowing. To overcome the need, number of orally disintegrating tablets which disinte- grate within one minute in mouth without chewing or drinking water were commercialized. Then later, oral drug delivery technology had been improved from conventional dosage form to modified release dosage form and developed recently rapid disintegrating films rather than oral disintegrating tablets. Oral disintegrating film or strips containing water dissolving polymer retain the dosage form to be quickly hydrated by saliva, adhere to mucosa, and disintegrate within a few seconds, dissolve and releases medication for oro- mucosal absorption when placed in mouth. Oral film technology is the alternative route with first pass metabolism. This review give a comprehensive detail of materials used in ODF, manufacturing process, evaluation tests and marketed products. Key Words: Oral disintegrating film, oral strip, pediatric and geriatric patients. INTRODUCTIONINTRODUCTION An oral film or strips are manufactured as a large Oral administration is the most preferred route due to re- sheet and then cut into individual dosage unit for packag- lieve of ingestion, pain reduction, to accommodate various ing (Desai et al., 2012). -
An Update on Pharmaceutical Strategies for Oral Delivery of Therapeutic Peptides and Proteins in Adults and Pediatrics
children Review An Update on Pharmaceutical Strategies for Oral Delivery of Therapeutic Peptides and Proteins in Adults and Pediatrics Nirnoy Dan, Kamalika Samanta and Hassan Almoazen * Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, Memphis, TN 38163, USA; [email protected] (N.D.); [email protected] (K.S.) * Correspondence: [email protected]; Tel.: +1-(901)-448-2239 Received: 28 October 2020; Accepted: 16 December 2020; Published: 19 December 2020 Abstract: While each route of therapeutic drug delivery has its own advantages and limitations, oral delivery is often favored because it offers convenient painless administration, sustained delivery, prolonged shelf life, and often lower manufacturing cost. Its limitations include mucus and epithelial cell barriers in the gastrointestinal (GI) tract that can block access of larger molecules including Therapeutic protein or peptide-based drugs (TPPs), resulting in reduced bioavailability. This review describes these barriers and discusses different strategies used to modify TPPs to enhance their oral bioavailability and/or to increase their absorption. Some seek to stabilize the TTPs to prevent their degradation by proteolytic enzymes in the GI tract by administering them together with protease inhibitors, while others modify TPPs with mucoadhesive polymers like polyethylene glycol (PEG) to allow them to interact with the mucus layer, thereby delaying their clearance. The further barrier provided by the epithelial cell membrane can be overcome by the addition of a cell-penetrating peptide (CPP) and the use of a carrier molecule such as a liposome, microsphere, or nanosphere to transport the TPP-CPP chimera. Enteric coatings have also been used to help TPPs reach the small intestine.