Comparative Study of Natural and Synthetic Superdisintegrants in Fast Dissolving Tablets s1

“DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL WAFERS OF PROCHLORPERAZINE MALEATE”

MASTER OF PHARMACY DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE.

BY MAYANK K. KAMANI M.PHARM – I

Under The Guidance of

Mr. VIRESH K. CHANDUR M. Pharm

DEPARTMENT OF PHARMACEUTICS.

SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE – 574143

2012-2014

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the Candidate and Mr. MAYANK K. KAMANI Address: 1stYEAR M. PHARM. DEPT. OF PHARMACEUTICS, SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE-574143.

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

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

4. Date of Admission: 25/06/2012

5. Title of the Project:

“ DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL WAFERS OF PROCHLORPERAZINE MALEATE” 6. BRIEF RESUME OF THE INTENDED WORK:

6.1 Need of the study:

Among the delivery routes, oral route is the most preferred route for the delivery of the drug till date due to easy of ingestion, pain avoidance and versatility (to accommodate various types of drug candidates).

Fast-dissolving drug-delivery systems were first developed in the late 1970s as an alternative to tablets, capsules and syrups for paediatric and geriatric patients who experience difficulties swallowing traditional oral solid-dosage forms. The novel technology for oral fast dispersing dosage forms is known as fast dissolve, rapid dissolve, rapid melt and quick disintegrating tablets1.

Fast dissolving oral films (FDOFs) or Wafers are the most advanced form of oral solid dosage form due to more flexibility and comfort. It improve the efficiency of APIs by dissolving within minute in oral cavity after the contact with saliva without chewing and no need of water for administration. It gives quick absorption and instant bioavailability of drugs due to high blood flow and permeability of oral mucosa is 4-1000 times greater than that of skin. FDOFs are useful in patients, such as paediatric, geriatric, bedridden, emetic patients, diarrhoea, sudden episode of allergic attacks, or coughing for those who have an active life style. It is also useful whether local action desired such as local anaesthetic for toothaches, oral ulcers, cold sores or teething2.

Film is prepared using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation via dissolution when contact with liquid is made3.

Oral dissolving films are intended to disintegrates or dissolve within seconds. They offer advantages such as administration without water, rapid onset of action and convenience of dosing4.

Prochlorperazine maleate (PCZM) is a phenothiazine antipsychotic, 9. Signature of the candidate (MAYANK K. KAMANI)

The work, which is assigned to 10. Remarks of the Guide Mr. MAYANK K. KAMANI is under my guidance.

11. 11.1 Name and Designation of the Mr. VIRESH K. CHANDUR M.Pharm, Guide Asst. Professor Department of Pharmaceutics 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. A. R. SHABARAYA M.Pharm., Ph.D. HOD and Principal Department of Pharmaceutics, Srinivas College of Pharmacy, Valachil, Mangalore- 574143

11.6 Signature

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

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