RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

Annexure-ll

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME AND ADDRESS OF THE CANDIDATE
(IN BLOCK LETTERS) / RITESH KUMAR GUPTA
J.S.S. COLLEGE OF PHARAMACY,
S.S. NAGAR, MYSORE-15.
2. /

NAME OF THE INSTITUTION

/ J.S.S.COLLEGE OF PHARMACY.
3. /

COURSE OF STUDY AND

SUBJECT

/ MASTER OF PHARMACY
IN INDUSTRIAL PHARMACY.
4. / DATE OF ADMISSION OF
COURSE / 04-06-2007
5. /

TITLE

/ FORMULATION AND EVALUATION OF BIOADHESIVE FILMS FOR LOCAL DELIVERY OF ANTIFUNGAL DRUGS
6. / BRIEF RESUME OF THE
INTENDED WORK
6.1 Need for the study
6.2 Review of the literature
6.3 Objectives of the study / ----- Enclosed-----
----- Enclosed-----
----- Enclosed-----
7 /

MATERIALS AND METHODS

7.1 Source of data
Laboratory based study
7.2 Method of collection of data
(Including sampling procedure,
If any)
Laboratory investigations
7.3 Does study require any
Investigations or interventions
to be conducted on patients or
Other human or animal? If so,
Please describe briefly
7.4 Has ethical clearance been
Obtained from your institution
In case of 7.3? / ----- Enclosed-----
----- Enclosed-----
-----NO-----
----N.A----
8 / LIST OF REFERENCES / ----- Enclosed-----
9 / Signature of Candidate
10 / Remarks of Guide
11 / Name and Designation of
11.1 Guide
11.2 Signature
11.3 Head of Department
11.4 Signature / Mr. R.Sudeendra Bhat
Assistant Professor
Department of Pharmaceutics,
J.S.S College of Pharmacy,
S.S. Nagar, Mysore-15.
Dr. H.G.SHIVAKUMAR
PRINCIPAL,
Professor and Head
Department of Pharmaceutics,
J.S.S College of Pharmacy,
S.S. Nagar, Mysore-15
12 / 12.1 Remarks of the Principal
12.2 Signature


TITLE:

FORMULATION AND EVALUATION OF BIOADHESIVE FILMS FOR LOCAL DELIVERY OF ANTIFUNGAL DRUGS

6.0  BRIEF RESUME OF THE NEEDED WORK:

6.1  NEED FOR THE STUDY:

The efficacy of conventional dosage forms for use in the oral cavity is limited by the short residence time of the formulation. Conventional formulations for local oral delivery are principally lozenges, mouthwashes, oral gels, pastes and suspensions. Release of drugs from these preparations involves an initial burst of activity, whose level rapidly declines to sub therapeutic concentration. To achieve the desired action from the conventional dosage form, frequent administration is needed.

However a number of advancements have been made recently in the development of new technique for drug delivery, which could provide one or more of the following benefits:

1.  Ability to increase the contact time of the drug with biological substrate, thus increasing absorption or localization of the drug.

2.  Mucoadhesive system can also adhere to specific sites of the body leading to greater bioavailability.

3.  It provides rapid onset of action, high blood level.

4.  Avoidance of first pass effect, and degradation of the drug in the GIT.

5.  Controlled and desirable rate of drug release.

6.  Reduction of side effects.

7.  Enhancement of patient compliance.

8.  Minimization of the needs for frequent dose intake.

Retentive buccal mucoadhesive formulation may prove to be a viable alternative to the conventional oral medication as they can be readily attached to the buccal cavity, retained for a longer period of time and removed at any time.

Buccal patches are highly flexible and thus much more readily tolerated by the patients than tablets. Patches also ensure more accurate dosing of the drug compared to gels and ointments.

The present work is aimed at preparing and evaluating the mucoadhesive antifungal film using carbomer as polymer.

6.2 REVIEW OF LITERATURE:

Senel et al 1 developed chitosan films and hydrogels of chlorhexidine gluconate for oral mucosal delivery. The antifungal activity of chlorhexidine increased with increase in concentration of chitosan in the gels. The highest antifungal activity was obtained with 2% chitosan gel containing 0.1%chlorhexidine.

Llabot JM et al 2 developed novel antifungal mucoadhesive films of nystatin. The incorporation of plasticizer (PEG 400) and surfactant (ASC 16) in the formulation of mucoadhesive film produced a significant improvement in the physical – mechanical properties and the nystatin release behaviour.

Nafee NA et al 3 studied invitro/invivo performance and effect of ageing on mucoadhesive buccal patches of miconazole nitrate. The patches were prepared with ionic polymers sodium carboxy methylcellulose and chitosan or non-ionic polymers polyvinyl alcohol, hydroxy ethyl cellulose and hydroxy propyl methylcellulose. Convenient bioadhesion, acceptable elasticity swelling and surface ph were obtained. PVA patches showed improved, uniform and effective miconazole levels .In vitro and in vivo (>5 hrs) without being drastically influenced by ageing.

Yoo JW et al 4 studied the physicodynamic properties of mucoadhesive polymeric films, which were developed as female controlled drug delivery system. An increase in carbopol content in the film elevated tensile strength but decreased erosion rate. HPMC influenced the erosion rate and SDS release rate from the film. A combination of the polymers was integral to maintain mucoadhesiveness and optimal release rate profile of SDS.

Jae-Soon Ahn et al 5 studied the release of Triamcinolone acetonide from mucoadhesive polymer composed of chitosan and poly acrylic acid .A novel mucoadhesive polymer prepared by template polymerization of acrylic acid in the presence of chitosan showed strong adhesive force and limited aqueous solubility, which was essential requirement for developing transmucosal drug delivery system.

Sudarat et al 6 studied retention and transit of intestinal mucoadhesive films in rat small intestine. Four layered film preparation had a dissolution site specific mucoadhesion in rat small intestine and the adhesive layer has a function of mucoadhesiveness to the small intestinal wall though depend on the dissolution rate, the duration of the adhesion was approximately 2 hrs in rats, the result support the usefulness of gastrointestinal mucoadhesive film preparation for the oral delivery of macromolecules.

Eovani et al 7 reported the in vitro comparative study of buccal mucoadhesive performance of different polymeric films. The measurements indicated that hydrogel of carbopol 9719 has the highest elastic property and its polymeric film presents the lowest degree of hydration capacity followed by polycarbophil and caerageenan.

Nicoli et al 8 studied invitro permeation of bioadhesive film containing oxybutynin across rabbit ear skin. From the results obtained in the work it can be concluded that the bioadhesive film can be promising and innovative therapeutic system for the transdermal administration of oxybutynin. When the films were applied in occlusive condition, the release profile was much higher than in non-occlusive condition, reaching 50% of drug permeation after 24 hrs.

Praveen KM et al 9 studied characterization of hot melt extruded drug delivery system for onchomycosis. Drug loaded films containing upto 20 % ketoconazole were successfully prepared by hot melt extrusion process.

6.3 OBJECTIVES OF THE STUDY:

1.  To formulate Bioadhesive films for local delivery of antifungal drugs.

2.  To evaluate the prepared bioadhesive film for drug and polymer compatibility by FTIR, DSC and surface morphology by SEM.

3.  To carry out in vitro release studies.

4.  To carry out the stability studies of the prepared formulation.

7.0 MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

A. Journals and publications.

B. Internet and Helinet

C. Laboratory based study

METHOD:

Carbomer 934 p and Sodium carboxy methylcellulose based bioadhesive films for local delivery of antifungal drugs will be prepared by Solvent casting method in different ratios. The prepared film will be evaluated for different parameters.

DRUG TO BE USED IN THE FORMULATION

One of the antifungal drugs will be selected from the mentioned list-

Chlorhexidine, Nystatin, Ketoconazole, Miconazole etc.

MATERIALS

Carbomer 934 p

Sodium carboxy methylcellulose

Polyethylene glycol 400

Ascorbyl palmitate 16

7.2 EVALUATION

1. Drug polymer compatibility studies by FTIR.

2. Surface morphology by SEM.

3. Water absorption capacity.

4. In vitro release studies.

5. Film thickness and viscosity.

7.3 Does the study require any investigations or interventions to be conducted on patients or other human or animals? If so, please describe briefly.

NO

7.4 Has ethical clearance been obtained from your institution in case 7.3?

NOT APPLICABLE

REFERENCE

1.  Senel S, Ikinci G, Kas S, Yousefi-Rad A, Sargon MF, Hincal AA. Chitosan films and hydrogels of Chlorhexidine Gluconate for oral mucosal delivery, Int. J Pharm.2000; 193:197-203.

2.  Llabot JM, Palma SD, Mnazo RH, Allemandi DA. Design of novel antifungal mucoadhesive films. Formulation and in vitro biopharmaceutical evaluation, Int. J Pharm. 2007; 336:263-8.

3.  Nafee AN, Fatma A. Ismail, Boraie NN, Mortada LM. Mucoadhesive buccal patches of Miconazole Nitrate: in vitro/in vivo performance and effect of ageing. Int. J Pharm. 2003; 264:1-14.

4.  Jin-WY, Dharmala K, .Lee CH. The physicodynamic properties of mucoadhesive polymeric films developed as female controlled drug delivery system. Int. J Pharm. 2006; 309:139-45.

5.  Ahn JS, Choi HK, Chun MK, Ryu JM, Jung JH, Kim YU, Cho CS. Release of Triamcinolone acetonide from mucoadhesive polymer composed of chitosan and poly (acrylic acid) in vitro. Biomaterials 2002; 23:1411-6

6.  Eaimtrakarn S, Itoh Y, Kishimoto JI, Yoshikawa Y, Shibata N, Takada K. Retention and transit of intestinal mucoadhesive films in rat small intestine. Int. J Pharm. 2001; 224(1-2): 61-7

7.  Eouani C, Piccerelle P, Prinderre P, Bourette E. In vitro comparative study of buccal mucoadhesive performance of different polymeric films. Eur J Pharm Biopharm.2001; 52:45-55.

8.  Nicoli S, Penna E, Padula C, Colombo P, Santi P. New transdermal bioadhesive film containing oxybutynin: in vitro permeation across rabbit ear skin. Int. J Pharm. 2006; 325(1-2): 2-7.

9.  Mididoddi PK, Repka MA, Prodduturi S, Munjal M and Stodghill SP. Characterization of hot melt extruded drug delivery system for onchomychosis. Eur J Pharm Biopharm.2007; 66(1): 95-105.