Comparative Study of Natural and Synthetic Superdisintegrants in Fast Dissolving Tablets

“ DESIGN AND IN-VITRO EVALUATION OF GASTRO RETENTIVE FLOATING MARTIX TABLETS OF NIZATIDINE BY USING NATURAL AND SYNTHETIC POLYMERS”

MASTER OF PHARMACY DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,BANGALORE, KARNATAKA.

BY MODI MEDHA ANILKUMAR M.PHARM – I

Under The Guidance of

Dr. HARISH.N.M.M. Pharm., Ph.D. ASSOCIATE PROFESSOR

DEPARTMENT OF INDUSTRIAL PHARMACY.

SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE – 574143

2011-2013

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION MODI MEDHA ANILKUMAR 1. Name of the Candidate and 1stYEARM.PHARM, Address: DEPT. OF INDUSTRIAL PHARMACY, SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE-574143.

2. Name of the Institution: SRINIVAS COLLEGE OF PHARMACY VALACHIL, FARANGIPETE POST, MANGALORE-574143.

3. Course of Study and Subject: MASTER OF PHARMACY (INDUSTRIAL PHARMACY)

4. Date of Admission: 31/10/2011

5. Title of the Project:

‟DESIGN AND IN-VITRO EVALUATION OF GASTRO RETENTIVE FLOATING MATRIX TABLETS OF NIZATIDINE BY USING NATURAL AND SYNTHETIC POLYMERS” Brief Resume of the intended work:

6.1 Need of the study:

Oral delivery of drug is by far the most preferable route of drug delivery due to the ease of administration, patient compliance and flexibility in the formulation. Numerous oral delivery systems have been developed to act as drug reservoirs from which the active substances can be released over a defined period of time at a predetermined and controlled rate. Drug absorption is unsatisfactory and highly variable among and between individuals, despite excellent in vitro release patterns.1

Gastric emptying of dosage forms is an extremely variable process. The ability to prolong and control the emptying time is a valuable asset for dosage forms which reside in the stomach for a longer period than conventional dosage forms. Drug absorption from the gastro intestinal tract (GIT) is a complex procedure and is subject to many variables.2

The small intestinal transit time is an important parameter for drugs that are incompletely absorbed. Gastroretentive systems can remain in the gastric region for several hours and hence significantly prolong the gastric residence time of drugs. Prolonged gastric retention improves bioavailability, reduces drug waste and improves solubility for drugs that are less soluble in a high pH environment. It has applications also for local drug delivery to the stomach and proximal small intestine.3

Floating drug delivery systems have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting the gastro residence time (GRT) for a prolonged period of time. This results in an increased GRT and a better control of fluctuations in plasma drug concentration. Based on the mechanism of buoyancy two distinctly different technologies, i.e. non-effervescent fast dissolving drug delivery system and effervescent FDDS. Effervescent FDDS when reached to the stomach, CO2 is liberated by the acidity of gastric contents and is entrapped in the jellified hydrocolloid. The CO2 generating components such as sodium bicarbonate,

1 calcium carbonate, citric acid and tartaric acid mixtures may be used. 9. Signature of the candidate (MODI MEDHA ANILKUMAR)

The work, which is assigned to 10. Remarks of the Guide MODI MEDHA ANILKUMAR is under my guidance.

Dr. HARISH.N.M.M.Pharm., Ph.D. 11. 11.1 Name and Designation of the Associate Professor, Guide Department of Industrial Pharmacy Srinivas College Of Pharmacy, Valachil, Mangalore-574143

11.2 Signature

11.3 Name and Designation of the Co-Guide ------

11.4 Signature ------

11.5 Head of the Department Dr. HARISH.N.M.M.Pharm., Ph.D. Associate Professor, Department of Industrial Pharmacy Srinivas College Of Pharmacy, Valachil, Mangalore-574143

11.6 Signature

Recommended and forwarded for 12. 12.1 Remarks of the Principal favourable consideration.

12.2 Signature

Dr. A. R. SHABARAYA M.Pharm., Ph.D. Principal and Director, Srinivas College of Pharmacy, Valachil, Mangalore- 574143