Formulation Development of Medicated Dermastics for Skin Infections

FORMULATION DEVELOPMENT OF MEDICATED DERMASTICS FOR SKIN INFECTIONS

M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

BY ROLE SAGAR SANJAY

UNDER THE GUIDANCE OF

Dr.K.PURUSHOTHAM RAO M.PHARM, Ph.D

DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY H.K.E.S’s MATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES (H.K.E.S’s COLLEGE OF PHARMACY) SEDAM ROAD GULBARGA – 585105 2011-2012

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate (In block letters) ROLE SAGAR SANJAY

Permanent address H.NO.1/629, SHIVAJI NAGAR, LATUR- 413512, MAHARASHTRA

H.K.E.S’s MATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES 2. Name of the institution (H.K.E.S’s COLLEGE OF PHARMACY) SEDAM ROAD GULBARGA – 585105

3. Course of study and subjects M.PHARM (PHARMACEUTICAL TECHNOLOGY)

4. Date of admission to the course 12-07-2011

FORMULATION DEVELOPMENT OF 5. Title of the topic MEDICATED DERMASTICS FOR SKIN INFECTIONS

6. Brief resume of the intended work

6.1 Need for the study:  Dermatosis is the common term used for any skin diseases. Dermatosis may be of various types such as infectious, genetic, inflammatory and scaling type1.  A few common examples of fungal and bacterial infections such like ringworm, erythema multiforme, contact dermatitis, furuncle, impetigo.  There are many topical drug delivery systems available such as ointments, creams, lotions, solutions, etc.  The present topical formulation have certain disadvantages such as, a) Ointment and crams are greasy, due to viscosity the preparation spread also to healthy skin. Long term extra application increase the risk of skin atrophy. b) Requires applicators or hand. c) Chances of contamination due to application with hands. d) Inconvenient to carry2.  Therefore it was found essential to find an alternative, convenient to carry, equally effective in topical drug delivery. So, the present work is of pharmaceutical industry oriented one i.e.,Formulation containing medicaments in the form of medicated sticks.

6.2 Objectives of the study:  Design of new dosage form model.  To provide better patient compliance,  Convenience and comfortness.  To provide economical dosage form than  The present commercial form.  Self medication is possible.  To avoide contamination while applying.  Easy to store and transport. Medicated Stick

6.3 Review of Literature : A through literature survey has been carried out on

the proposed topic and most prominent reference found are:

 Evaluation of rosins as a cream base for topical ketoconazole prepration3.

 The role of salicylic acid in the treatment of psoriasis4.

 Formulation and evaluation of topical drug delivery system of fluconazole5.

 Treatment of seborrhoeic dermatitis of the scalp with miconazole- hydrocortisone6.

 Antifungal activity of commercial clotrimazole cream7.

7. Materials and Methods 7.1 Materials:

 It is planned to prepare and use around five, oil in water ointment bases reported in textbook of pharmaceutics8.  Model drug selected in the present study are: a) Mupirocin.( Calcium) Anti-bacterial, Antibiotic b) Terbinafine. ( Hydrochloride) Anti-fungal

7.2 Method: It is planned to follow the present methodology with minor modifications in reported oil in water bases.8

Phase –I : Preparation of medicated sticks:

It is planned to prepare medicated sticks by following heating and congealing process, by varying concentration of waxes present in the bases. Phase -II : Charatecterization of prepared medicated sticks: The prepared formulation will be subjected for various evaluation parameters like; a) Drug content estimation. b) Penetrometer test. c) Thickness. d) Weight variation. e) IR & DTA. f) TLC etc. Phase –III: In-vitro drug diffusion:

All the formulations prepared will be subjected for in-vitro drug release studies by diffusion method for a period of 3 hours using pre-hydrated cellophane membrane as drug barrier. At various time intervals a 10ml sample will be withdrawn and subjected for amount of drug diffused using UV spectrophotometer. Stability studies: It is planned to study for 6 months by estimation of drug content in sticks

every 15 days time intervals.

7.3 Does the study require any investigation or invervention to be conducted on patients or other humans or animals? If so please describe briefly

------Not under the plan of our work------

7.4 Has ethical clearance have been obtained from your institution in case of 7.4?

------Not applicable------

8 List of References

1. Harsh Mohan Text book of pathology. 4th edition. 2000: 167-76.

2. Lindahl A. Derma stick Thickened Ointment, Patent Co-operation Treaty application 2004.

3. Lakshmana Prabhu S, Shirwaikar Arun, Shirwaikar Annie and Kumar Aravind. Evaluation of rosin as a cream base for topical ketoconazole preparation. Journal of Pharmaceutical research 2009; 8(2): 89-92.

4. Mark Lebwohl MD. The role of salicylic acid in the treatment of psoriasis. International journal of dermatology 1999; 38: 16-24.

5. Kavitha K. Sivaramakrishnan M, Nalini C.N.and Nappinnai M. Formulation and evaluation of topical drug delivery systems of Fluconazole. INDIAN DRUGS 2003; 40 (12): 720-23.

6. Faergemann J. Seborrhoeic dermatitis and pityrosporum orbiculare: Treatment of seborrhoeic dermatitis of the scalp with miconazole- hydrocortisone, miconazole and hydrocortisone. British journal of dermatology 1986; 114: 695-700.

7. Prasad M.J etal. Invitro release and antifungal activity of commercial clotrimazole creams. Indian J. Pharm.Sci., 1993; 55(4): 119-23.

8. Cooper and Gunn’s. Dispensing for pharmaceutical students. 12th ed. New Delhi: CBS Publisher and Distributors; 2002: 192-211.

9. Signature of candidate ROLE SAGAR

10. Remarks of Guide College has all the facilities to work. Hence this work is feasible

11. Name and designation of (in block letters)

Dr. K.PURUSHOTHAM RAO 11.1 Guide M. Pharm., Ph.D PROFESSOR DEPT.OF PHARMCEUTICAL TECHNOLOGY H.K.E.S’s COLLEGE OF PHARMACY GULBARGA – 585105 11.2 Signature

SHANTVEER.V. SALGAR 11.3 Co-guide M. Pham. ASST. PROFESSOR DEPT.OF PHARMCEUTICAL TECHNOLOGY H.K.E.S’s COLLEGE OF PHARMACY GULBARGA – 585105 11.6 Signature

12 12.1 Remarks of Chairman and Principal

12.2 Signature