FORMULATION AND EVALUATION OF TRANSDERMAL FILM CONTAINING OXYBUTYNIN.

M. Pharm Dissertation Protocol Submitted to

Rajiv Gandhi University of Health Sciences, Karnataka Bangalore 560 041 By

Mr. PRAVEEN KUMAR.Y B.Pharm

Under the Guidance of

Mr. SHIVANAND KALYANAPPA M. Pharm

Professor.

Department of Pharmaceutics, Acharya & B.M. Reddy College of Pharmacy,

Soldevanahalli, Chikkabanavara (Post), Hesaraghatta Main Road, Bangalore 560 090. 2007-2009

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE. ANNEXURE II

Name of the candidate and address

Mr. PRAVEEN KUMAR.Y

#553-1,NEHRUNAGAR, SHANKARAPURAMPOST,KADAPA, PIN:516002,ANDHRAPRADESH

Name of the Institution

ACHARYA & B.M. REDDY COLLEGE OF PHARMACY, Chikkabanavara Post , Hesaraghatta Main Road, Soldevanahalli, Bangalore-560 090. M. Pharmacy (Pharmaceutics) June - 2007

Course of the study and subject Date of admission

TITLE OF THE PROJECT:-

FORMULATION AND EVALUATION OF TRANSDERMAL FILM CONTAINING OXYBUTYNIN

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BRIEF RESUME OF INTENDED WORK:NEED FOR THE STUDY:Transdermal therapeutic systems are defined as self-contained, discrete dosage forms which, when applied to the intact skin, delivery the drug , though the skin, at controlled rate to the systemic circulation.13 Advantages of Transdermal medication:The concept of delivering drugs through the skin for systemic treatment of disease is gaining increasingly great important due to its numerous advantages like bypassing hepatic first pass metabolism, enhancement of therapeutic efficiency, prolonged duration of action of drugs with short half life and maintenance of steady plasma level of drug. The simplified medication regimen leads to improved patient compliance and reduced inter and intra-patient variability. Self administration is possible with these systems. The drug input can be terminated at any point of time by removing transdermal patch. Oxybutynin is an anticholinergic medication used to relieve urinary and bladder difficulties, including frequent urination and inability to control urination (urge incontinence), Oxybutynin is used extensively in the treatment of patients with overactive bladder. Overactive bladder is a common condition characterized by urinary frequency and urgency, with or without incontinence and nocturia. The drug acts by decreasing muscle spasms of the bladder. It competitively antagonizes the M1, M2, and M3 subtypes of the muscarinic acetylcholine receptor. It also has direct spasmolytic effects on bladder smooth muscle as a calcium antagonist and local anesthetic. The half life of oxybutynin is opproximatly 13.82.9hrs12, and The absolute bioavailability of oxybutynin is reported to be about 6% (range 1.6 to 10.9%) for the tablet. Oral administration of oxybutynin drug releases only 6%, the remaining amount of drug passes its fist pass metabolism, and also produces a high incidence of anti cholinergic adverse events, such as dry mouth, constipation, dizziness, nausea, etc. This is due to the high serum concentration of the active metabolite Ndesethyloxybutynin that follows hepatic first pass metabolism in gut and liver.

LIST OF REFERENCES:1) Kulkarni RV, Mutalik S, Effect of plasticizers on the permeability and mechanical properties of Eudragit films for transdermal application. Ind. J. Pharm. Sci., 2002, 64(1): 28-31. 2) Manvi FV, Dandagi PM., Formulation of transdermal drug delivery system of ketotifen fumarate. Ind. J. Pharm. Sci., 2003, 65(3): 239-243. 3) K.E.V. Nagoji, Release studies of Nimesulide using EC alone and a combination of HPMC and EC matrices. Ind. J. Pharm. Sci., 2000, 67(5): 482-484. 4) Kulkarni VH, Keshavayya J, Transdermal Delivery of an Anti-asthmatic Drug through modified chitosan membrane. Ind. J. Pharm. Sci., 2005, 67(5): 544-547. 5) Sadhana P, Gupta, Jain SK, Effective and Controlled Transdermal Delivery of Metaprolol Tartarate, Ind. J. Pharm. Sci., 2005, 67(3): 346-350. 6) Jain NK, Bhadra D, a novel vesicular carrier for Enhanced Transdermal Delivery of an AntiHIV Agent, Ind. J. Pharm. Sci., 2004, 66(1): 72-81. 7) Kusumdevi V, saisivam S, Design and Evaluation of matrix diffusion controlled Transdermal patches, Drug Development and industrial pharmacy. 2003, 29(5): 495503 8) Sankar V, Benito D, Design and evalution of Nifedipine transdermal patches, Ind. J. Pharm. Sci., 2003, 65(5): 346-350. 9) Siddaramaihah, Manjula, Chitosan/ HPMC blends for developing transdermal drug delivery systems, Google.com page 1 of 1. 10) Udupa N, Pandey S, Formulate and Evaluation of Nimesulide Transdermal Drug Delivery Systems, Ind. J. Pharm. Sci., 2000, 62(5) 376-379. 11) Andersson, K.E., 2004. Antimuscarinics for treatment of overactive bladder. Lancet Neurol. 3, 4653. 12) Goodman&Gilmans, The pharmacological basis of therapeutics, Editors, Joel G. Hardman, Lee E.Limbird, 2001,1992-1993. 13) Controlled and novel drug delivary, Edited by,N.K.Jain, 1997,2002, 101-102

Signature of the candidate:

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Remarks of the Guide: Name and Designation of:

Recommended

11. 1 11. 2 11. 3 11. 4 11. 5

Institutional Guide:

Mr. Shivanand Kalyanappa Asst. Professor.

Signature:

Co-Guide: Signature:

Mr. Venkatesh D.P

Head of the Department:

Dr. ROOPA KARKI Professor & HOD (Department of pharmaceutics)

11. 6 12 12. 1 12. 2

Signature

Remarks of the Principal

Recommended.

Signature

PRINCIPAL Prof. GOLI DIVAKAR ACHARYA & B. M.REDDY COLLEGE OF PHARMACY, SOLDEVANAHALLI, HESARAGHATTA MAIN ROAD, BANGALORE-90.