Studies on Implantablegelatin Fibres for Dental Disorders

STUDIES ON IMPLANTABLEGELATIN FIBRES FOR DENTAL DISORDERS

M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

SHIVANAND S. HULMAJGE

Under the guidance of

Dr. K. PURUSHOTHAM RAO

M.PHARM, PhD

DEPARTMENT OF PHARMA.TECHNOLOGY

H.K.E.SOCIETY’SMATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES,MR MEDICAL COLLEGE CAMPUS, GULBARGA – 585105

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, KARNATAKA

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / Name of the Candidate
(In block letters) / SHIVANAND S. HULMAJGE
2 / Permanent Address / AT POST; MUDKANNA GALLI, MURUM TQ: OMERGA DIST: OSMANABAD 413 605
3 / Name of the Institution / H.K.E.SOCIETY’SMATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES,MR MEDICAL COLLEGE CAMPUS, GULBARGA – 585105
4 / Course of Study and Subjects / M.PHARM
(PHARMA.TECHNOLOGY)
5 / Date of Admission to the Course /
30-07-2013
6 / Title of the Topic / “STUDIES ON IMPLANTABLE GELATIN FIBRES FOR DENTAL DISORDERS
7 / Brief Resume of the work
7.1 / Need for Study1,2,3

In recent years extensive efforts have been made in various pharmaceutical research laboratories for the development of novel and targeted drug delivery systems, with an aim of improved patient convenience,better therapeutic efficacy, less side effects, and reduced dosage regimen with less toxicity for the treatment of many dental disorders.

Drug implants are useful in the field of dental care for effective treatment.
Though there are many drug dosage forms are available for the treatment, there is a need for implantable targeted drug delivery systems.

In recent years extensive efforts have being made in various pharmaceutical research laboratories for the development of novel and targeted drug delivery systems with an aim to improve patient compliance, better therapeutic efficacies, less side effects and reduced dosage regimen with less toxicity.
Keeping in view the present investigation has been aimed at designing some suitable biodegradable drug implants using gelatin which is non-toxic, biocompatible and biodegradable polysaccharide as a base dental implantation.

7.2 / Review of Literature
A thorough review of literature has been done and among them the prominent references pertaining to the present investigation are:

VS Mastiholimath, PM Dandagi, AP Gadad, MB Patil, FV Manvi, VK Chandur. Formulation and evaluation of ornidazole dental implants for periodontitis. Formulation V6 released 97.07% of drug at the end of 120 h and was considered as best formulation. In vitro antibacterial activity was carried out on Streptococcus mutans .
Sudeep Kothari, G. Gnanaranjan and Preeti Kothiyal. FORMULATION AND EVALUATION OF ERYTHROMYCIN DENTAL IMPLANTS FOR PERIODONTITIS. Implants were prepared by dissolving Ethyl cellulose alone and with copolymers (HPMC K4M, Sodium Alginate) in chloroform and dichloromethane (1:1) solution, using dibutyl phthalate and PEG‐400 as plasticizers. These formulated implants were then evaluated for different parameters like uniformity of thickness, uniformity of weight, tensile strength of the films, folding endurance and in vitro drug release.
B. Karunakar, K. Sabu, N. Udupa and B. R. R. Varma. Design and Evaluation of Tinidazole Dental Implants. Tinidazole dental implant was formulated, in vitro release, stability and in vivo therapeutic efficacy of these dental implants were evaluated. Tinidazole dental implant had efficient antibacterial activity with 400 times decreased dose.
B Karunakar, N Udupa. Design and evaluation of norfloxacin dental implants.
Attempt was made to formulate Norfloxacin as targeted sustained release dental implant which can be directly placed near the site of action in periodontitis and also to study various pharmaceutical parameters like physicochemical, stability and drug release characteristics.
R Nagaraju, N Udupa. Preparation And Evaluation Of Dental Implants Containing Doxycycline Hydrochloride And Tinidazole In Biodegradable Carrier. The formulations showed an initial burst release followed by more sustained release of the drugs throughout the period of study (42 days).
Vandekerckhove BN, Quirynen M, van Steenberghe D. The use of tetracycline-containing controlled-release fibers in the treatment of refractory periodontitis. The results of this study prove that tetracycline-impregnated fibers can reduce probing depth significantly for a period of 6 months in patients not responding to thorough and repeated classical periodontal treatment.
Minabe M, Takeuchi K, Tamura T, Hori T, Umemoto T. Subgingival administration of tetracycline on a collagen film. The purpose of this study was to evaluate the duration of therapeutic effect after administration of the collagen film immobilized tetracycline (TC film).
Sujatha Muchalambe, Dandagi PM, Yogesh HS, Ravindra R, Gopalakrishna B.Preparation and evaluation of Sparfloxacin Dental Implants for treatment of Periodontal diseases. Formulation F4 released 90.24% of drug at the end of 120 hr and was considered as best formulation. In vitro antibacterial activity was carried out on Streptococcus mutans.

7.3 / Objectives of the study
In the present proposed investigation, the use of gelatin has been explored to prepare drug implantable discs. The nature of such implant:

Should facilitate and minimize patient compliance for effective treatment.
Should be capable of releasing drug and minimize side effect.
Should be easily implantable without major surgery and medical complications.
Should be helpful in minimizing oral consumption of medications.
Should be more site specific for effective treatment.
Should be helpful in minimizing the dose requirement.
Should be helpful in speedy recovery of patient.

8 / Materials and Methods
8.1 / In the proposed work the basic material required are:
Gelatin, Glycerine, Dibutylpthalate, formaldehyde and glutaraldehyde; etc.
It has been planned to study some antibiotics like amoxicillin HCl etc. A well designed and suitable implantable rod shaped (fibres) gelatin discs have been planned to prepare and characterize systematically in several phases.
Phase-1:
Preparation of 1mm thickness and 10mm length implants are planned to prepare using specially designing glass moulds in several batches with varying parameters like:
a) Concentrations of gelatin.
b)Influence of plasticizers.
c) Influence of cross-linking agents like formaldehyde and glutaraldehyde solutions.
Phase-2:
Characterization of prepared implants:
The implants will be subjected for various physico-chemical properties like size, shape, thickness, drug content uniformity etc.,
Phase-3:
In-vitro drug dissolution studies will be carried out in vial method fromtheimplant at pH 6.4 as dissolution media using incubator shaker. 10ml sample have to be pipette out at definite interval of time periods and analyzed for drug contentestimation using UV/ Visible spectrophotometer.
8.2 / Does the study require any investigation or interventions to be conducted on patient or other humans or animals? If so, please describe briefly
------not under the plan of work------
8.3 / Has ethical clearance been obtained from your institution in case of 7.3
------not applicable------
9 / List of References

Segal-S et al. New delivery systems for contraceptives steroids. Am. J.Obg. Gynecol.1987; Oct. 1090-1092.
Haluk Yetkin, Alpaslan Senkoylo et al. Biodegradable implants in orthopaedics and traumatology. Turk J Med sci. 2000; 30: 297-301.
Vijay Mathur et al. Formulation and evaluation of controlled release antibiotic biodegradable implants for post-operative site delivery. Acta Pharm. 2010; 60: 111-117.
VS Mastiholimath, PM Dandagi, AP Gadad, MB Patil, FV Manvi, VK Chandur. Formulation and evaluation of ornidazole dental implants for periodontitis. Indian journal of pharmaceutical sciences, 2006;68(1):68-71
Sudeep Kothari, G. Gnanaranjan and Preeti Kothiyal. FORMULATION AND EVALUATION OF ERYTHROMYCIN DENTAL IMPLANTS FOR PERIODONTITIS. Int. J. Drug Res. Tech. 2012, 2(5), 407-410
B. Karunakar, K. Sabu, N. Udupa and B. R. R. Varma. Design and Evaluation of Tinidazole Dental Implants. informa healthcare, 1994, Vol. 20, No. 3 , Pages 409-416
B. Karunakar, K. Sabu, N. Udupa and B. R. R. Varma. Design and Evaluation of Tinidazole Dental Implants. informa healthcare, 1994, Vol. 20, No. 3 , Pages 409-416
B Karunakar, N Udupa. Design and evaluation of norfloxacin dental implants. International journal of pharmaceutical science.1993;55(2):68-69
R Nagaraju, N Udupa. Preparation And Evaluation Of Dental Implants Containing Doxycycline Hydrochloride And Tinidazole In Biodegradable Carrier. International journal of pharmaceutical sciences.1998;60(6): 405-406.
Vandekerckhove BN, Quirynen M, van Steenberghe D. The use of tetracycline-containing controlled-release fibers in the treatment of refractory periodontitis. pubmed. 1997 Apr;68(4):353-61.
Minabe M, Takeuchi K, Tamura T, Hori T, Umemoto T. Subgingival administration of tetracycline on a collagen film. pubmed1989 Oct;60(10):552-6.
Sujatha Muchalambe, Dandagi PM, Yogesh HS, Ravindra R, Gopalakrishna B.Preparation and evaluation of Sparfloxacin Dental Implants for treatment of Periodontal diseases.Int.j.ph.sci.,may-aug.2010;2(2):606-611.

10 / Signature of the candidate
11 / Remarks of the Guide
12 / Name and Designation in block letters
12.1 / Guide
PROF. & HOD / Dr. K. PURUSHOTHAM RAOM.Pharm. Ph.D
DEPT.OF PHARMA.TECHNOLOGY
H.K.E.S’S COLLEGE OF PHARMACY,
SEDAM ROAD,GULBARGA – 585105
12.2 / Signature
13 / 13.1 / Remarks of the Chairman
and Principal
13.2 / Signature