Formulation and Evaluation Of

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE.

ANNEXURE I

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

Mr. Goutam S. Inchal Name of the Candidate and Address 1 PERMANENT ADDRESS Room no. 22, Anuja Boys Hostel, Behind M. P. Mirji College, Near Pai Hotel, Nehru Nagar, Belgaum – 590 010.

Name of the Institution 2 R. R. K. Samiti College of Pharmacy. Naubad, Bidar – 585 402, Karnataka.

3 Course of the Study and Subject MASTER OF PHARMACY PHARMACEUTICS

4 Date of Admission DECEMBER 2012

5 TITLE OF THE PROJECT:- “DESIGN, FORMULATION AND EVALUATION OF TRANSDERMAL PATCHES FOR ANTI- HYPERTENSIVE DRUG”

6 BRIEF RESUME OF INTENDED WORK:-

6.1 NEED FOR THE STUDY:-

Transdermal drug delivery is a technique that is used to deliver a drug into systemic circulation across the skin. This mechanism of drug delivery route has many advantages, including steady drug plasma concentration, improved patient compliance, elimination of hepatic first pass, and degradation in the gastrointestinal tract, controlled release over extended period besides providing a convenient non- invasive and easily terminable means for systemic as well as topical drug delivery. The successful development of transdermal drug delivery system depends on the choice of drug. Conventional oral dosage forms such as tablets and capsules provide specific drug concentration in systemic circulation without offering any control over drug fluctuation in plasma levels. Administration of drug normally distributes throughout the body and interacts not only with target cells but also with the normal healthy cells which often results in toxic effect. In transdermal drug delivery because of high drug loading capacity we can provide higher concentration gradient thus increasing the driving force across the skin. Hence this enhances the vehicle skin drug transfer. They have been used to improve the bioavailability of various poorly soluble drugs. Conventional therapy requires frequent administration of the therapeutic agent to the patient which reduces compliance. Systemic administration of the drug often requires high concentration to maintain therapeutic effect because of dilution effect. Hence transdermal device are used to avoid this type of toxic effect. The antihypertensives are a class of drugs that are used to treat hypertension (high blood pressure). Evidence suggests that reduction of the blood pressure by 5 mmHg can decrease the risk of stroke by 34%, ischaemic heart disease by 21%, and reduce the likelihood of dementia, heart failure and mortality from cardiovascular disease. Current work of formulating transdermal drug delivery systems by using an anti hypertensive drug with shorter half life, low bio availability, short duration of action when given through oral route. Administration of drug via transdermal drug delivery system that provides controlled drug delivery without pre systemic metabolism, reduce toxic effects and enhances the bioavailability.

REVIEW OF LITERATURE:- 6.2

2 6.3 OBJECTIVE OF THE STUDY:- The objectives of the study is as follows: 1) The current study is to develop an ideal transdermal drug delivery system.

2) Formulation of transdermal patches by suitable method.

3) Evaluation of transdermal patches for their physicochemical studies.

4) Stability studies for selected formulations.

7.0 MATERIALS & METHODS:-

7.1 SOURCE OF DATA:-

• Review of literature from: Journals such as: • Indian Journal of Pharmaceutical Sciences • Journal of applied pharmaceutical science • Journal of Controlled Release • International Journal of Pharmaceutics • European journal of pharmaceutics and biopharmacetics • Journal of applied pharmaceutical science Web sites : • Word wide web. • J-Gate@Helinet • Science Direct

3 7.2 Materials:

Anti hypertensive drug and polymers will be procured from Pharma grade suitable manufacturer.

Other reagents will be of Analytical grade.

7.3 Methods:

1) Preparation of Transdermal films by Solvent Casting Technique 2) Evaluation a) Film Thickness

b) Weight Variation

c) Drug Content

d) Percentage Moisture Absorption

e) Percentage Moisture Loss

f) Folding Endurance

g)Drug release studies

3) Stability studies as per ICH guidelines

7.4 Method of collection of data (including sampling procedures if any): The data will be collected from prepared formulations subjected to different evaluation techniques, scale-up techniques and stability studies obtained from ICH guidelines.

7.5 Does the study require any investigation or interventions to be conducted on patients or other humans or animals?

7.6 - NOT APPLICABLE-

Has ethical clearance been obtained from your institution in case of 7.5? -NOT APPLICABLE-

4 8.0 LIST OF REFERENCE:

1. Nirvaseth, Rajan B Mistry. Formulation and evaluation of transdermal patches and to study

permeation enhancement effect of eugenol. J App Pharm Sci.2011;01(03):96-101

2. Manvi FV, Dandagi PM. Formulation of transdermal drug delivery system of ketotifen

fumarate. Ind J Pharm Sci.2003;65(3):239-243.

3.Klimes J, Sochor J, Dolezal P, Korner J. HPLC evaluation of diclofenac in transdermal therapeutic

preparation. Int J Pharm. 2001;217:153-160

4. Mi-Kyeong kim, Hong Zhano, Chi-Ho lei, Dae-Duk kim. Formulation of a reservoir-type

testosterone transdermal delivery system. Int J Pharm. 2001;219:51-59

5.Changshun Ren,Liang fang, Qiang Wang,Shiai Liu, Li Gang Zhao,Zhonggui Hc. Design and

Evaluation of a indapamide transdermal patch. Int J Pharm Sci:2009;370:129-135

6. Eva Gutschke, Stefen Bracht, Stefen Nagel, Werner Weitscheies. Adhesion testing of transdermal

matrix patches with probe tack test –in vitro and in vivo evaluation. Eur J Pharm and Bio

pharm.2010;75:399-404

7. Anna M.Wokovich, Suneela Produturi, William H.Doub,Azaj S.Hussain, Weinda F.Busche. Transdermal drug delivery system adhesion as a critical,safety,efficacy and quality attributes Eur J Pharm and Biopharm.2006;64:1-8

8. Agarwal S.S, Munjal P. Permeation studies of atenolol and metaprolol tartrate from three different polymers for transdermal delivery. Ind J pharm Sci.2007;64(4):535-539

9. Amit Misra, Pramod Upadhyay. Apparatus for preparing adhesive-dispersion transdermal patches on laboratory scale.Int J pharm.1996;132:267-270

10. Hanan M.El- Laithy.Novel transdermal delivery of timolol maleate using sugar ester: pre-clinical and clinical studies. Eur J Pharm and biopharm.2009;72:239-245.

5 9.0 SIGNATURE OF THE

CANDIDATE:

10 REMARKS OF THE GUIDE:

The above information and literature has been extensively investigated, verified and was found to be correct. The present study will be carried out under my supervision and guidance. 11 NAME AND

DESIGNATION OF

11.1 GUIDE: Dr. K. Shrinivas Rao M.pharm, Ph.D.

Head of Pharmaceutics Department,

R. R. K. Samiti College of Pharmacy.

Naubad,

Bidar – 585 402.

Section I.1 SIGNATURE:

Section I.2 HEAD OF THE Dr. K. Shrinivas Rao M.pharm, Ph.D. DEPARTMENT: Head of Pharmaceutics Department,

Naubad,

Bidar – 585 402.

Section I.3 SIGNATURE:

12 12.1 REMARKS OF THE The above-mentioned information is correct and I PRINCIPAL: recommend the same for approval.

6 12.2 PRINCIPAL: Dr. K. Shrinivas Rao M.pharm, Ph.D.

Principal,

Naubad,

Bidar – 585 402.

12.3 SIGNATURE: