EFFECT OF VARIOUS WOUND HEALING MODIFIERS ON TOPICAL GEL OF MOXIFLOXACIN
M. Pharm. Dissertation Protocol
Submitted to the
Rajiv Gandhi University of Health Sciences, Karnataka
Bangalore.
By
ASWAT AYSHA HANIF
B. Pharm.
Under the guidance of
M.A.SALEEM
M.Pharm.,(Ph.D.)
PG Dept. of Pharmaceutics
Luqman College of Pharmacy, Gulbarga
DEPARTMENT OF PHARMACEUTICS LUQMAN COLLEGE OF PHARMACY, GULBARGA
2013-14
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, KARNATAKA
BANGALORE
ANNEXURE – II
PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate and permanent address( in block letters) / ASWAT AYSHA HANIF
C/o LUQMAN COLLEGE OF PHARMACY POST BOX NO:86, BEHIND P&T COLONY , OLD JEWARGI ROAD,
GULBARGA-585102
2 / Name of the institution / LUQMAN COLLEGE OF PHARMACY,
BEHIND P&T COLONY, OLD JEWARGI ROAD, GULBARGA,
PIN-585102.
3 / Course of study and subject / M. PHARM (PHARMACEUTICS)
4 / Date of admission to the course / 28/06/2013
5 / Title of Topic / “EFFECT OF VARIOUS WOUND HEALING MODIFIERS ON TOPICAL GEL OF MOXIFLOXACIN”
6. Brief Resume of the intended work
6.1 Need for the study:
Topical products are important class of drug delivery systems and their uses in the therapy become more widespread. The purpose of topical dosage form is to conveniently deliver drugs to localized area of the skin.1 The topical route of administration has been utilized either to produce local effect for treating skin disorder or to produce systemic drug effects. Within the major group of semisolid preparations, the use of transparent gels has expanded both in cosmetics and in pharmaceutical preparations.2 The USP defines gel as a semisolid system consisting of dispersion made up of either small inorganic particles or large organic molecules enclosing an interpenetrated by liquid. The inorganic particles form a three dimensional structure. Gels consist of two phase system in which inorganic particles are not dissolved but merely dispersed throughout the continuous phase and large organic particles are dissolved into the continuous phase.3 A wound is disruption of normal anatomic structure and function. Wounds result from pathologic process beginning internally or externally to the involved organ(s).4 The delivery of antibiotics to local wound sites may be preferred option to systemic administration in order to deliver antibiotics to wound sites, reduce the risk of systemic toxicity and chances of bacterial resistance.5
Moxifloxacin is a fourth generation synthetic fluoroquinolone, with broad-spectrum antibiotic activity. It functions by inhibiting DNA gyrase, a type II topoisomerase, and topoisomerase IV, an enzyme necessary to separate bacterial DNA strands, thereby inhibiting cell division. Moxifloxacin was approved by the FDA in 1999 for intravenous therapy of severe and life-threatening bacterial infections, such as complicated skin and skin structure infections and complicated intra-abdominal infections6.
In the present work an attempt will be made to prepare and evaluate topical gel of Moxifloxacin for the effective management of different types of wounds.
6.2 Review of Literature
Extensive literature survey was carried out on the proposed research work by referring various scientific journals, internet and helinet facilities.
Ø Jacobsen F et al7 investigated topical application of moxifloxacin as gel formulation in comparison to mupirocin, linezolid, and gentamicin using a porcine wound infection and a rat burn infection model. Wound fluid, tissue, and blood samples were taken, and bacterial counts as well as the moxifloxacin concentration were determined for a 14-day follow-up. A histological comparison of the rat burn wound tissues was performed. Bacterial strains were susceptible to moxifloxacin and gentamicin. All antibiotics showed efficient reduction of bacterial counts. Additionally, moxifloxacin was observed to promote wound healing as determined by histologic analysis, while no induction of bacterial resistance was observed during the treatment period. Moxifloxacin is therefore an ideal candidate, due to its broad antibacterial spectrum, its high efficiency, and its potential to promote wound healing.
Ø Prakash K, Bahlul ZA, Chandu BR, Soad AM AND Tukriya OA8 designed and invitro evaluated controlled release cephalexin sublingual films using natural biodegradeable polymer and concluded local sublingual controlled delivery of antibiotics using biodegradeable polymer is of recent interest to the formulation scientist.
Ø Ramesh U and Madrias M 9 developed and evaluated the wound healing effect of chitosan in fresh water fish Cyprinus carpio L. and concluded that application of dietary supplementation of chitin/chitosan on to an open wound induces significant wound contraction and accelerates the wound closure and healing time.
Ø Vikesh S, Vasudha M, Vineet B, Masareddy RS and Manvi FV 10 prepared ornidazole gel using natural biodegradable polymers chitosan, xanthan gum and Locust bean gum in variable concentrations. The formulated gel was characterized for surface pH, viscosity, bioadhesion strength, in vitro drug release studies and antimicrobial susceptibility test. Best formulation in term of cumulative percent drug release along with bioadhesion was formulation f3 with 79.23% drug release for 7 days and fulfilled many requirements of once a week delivery system. Hence it was easy to fabricate, cost effective, high patient compliance and the zone of inhibition was also satisfactory for all the formulations.
Ø Japan Patel, Brijesh Patel, Hardeepsingh Banwait, Kaushal Parmar and Manish Patel11 formulated and evaluated topical aceclofenac gel using different gelling agents’ carbopol, HPMC, CMC and sodium alginate and concluded that carbopol gel shows superior drug release. The drug release decreases with increase in carbopol concentration.
Ø Patel NA, Patel M and Patel PR12 formulated and evaluated polyherbal gel for wound healing and cocluded that wound contraction increases on increasing the concentration of herbal extract.
6.3 Objectives of the Study
The work is planned with the following objectives;
Ø To prepare the topical gels of Moxifloxacin for better evaluation of wound healing activity on albino rats.
Ø To prepare the topical gel by using different gel forming polymers along with chitosan.
Ø To enhance the efficacy of the gel using turmeric/ serratiopeptidase against different types of wounds.
Ø Evaluate the prepared gels for drug content, pH, rheological properties.
Ø To study the invitro antimicrobial activity.
7. MATERIALS AND METHODS
7.1 Material :
The materials to be used in the present studies include,
Drug : Moxifloxacin
Polymer : Chitosan, guar gum, sodium alginate etc
Other additives: Neem, Vitamin C, Turmeric etc
Animals used : Albino Wister rats
Equipments :
a) UV/ visible spectrophotometer (shimadzu 1700)
b) IR-spectrophotometer-JASCO FT/IR 5300
c) Single pan electronic balance (Dhona equipment Pvt. Ltd Kolkata)
d) Digital balance (shimadzu corporation BL-2204)
e) Digital type pH meter (elico LT-122)
7.2 Methods
1) UV/visible spectroscopic estimation of Moxifloxacin .
2) The topical gels will be prepared by will be soaking method.
3) The gels will be characterized by using FTIR.
4) The gel will be evaluated for rheological properties like viscosity, extrudability, spreadability etc.
5) The wound healing activity will be done by using albino rats by incision method.
7.3 Does the study require any investigation or intervention to be conducted on patients or animals? If yes please describe briefly.
--- Yes it is under the plan of work --
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
--- Yes obtained--
8. LIST OF REFERENCES:
1) EL-Badry M, Hussein N.A. Formulation and evaluation of Econazol hydrochloride topical gels. Bull Pharm Sci. 2005, 28(2): 283-289.
2) Doaa AH et al. Formulation and evaluation of fluconazole topical gel. Int J Pharmacy Pharm Sci. 2012, 4(5): 176-183.
3) Bharat Parashar, Atul Kabra, Ajay Chandel. Formulation and Evaluation of Gel Containing Miconazole Nitrate an Antifungal Agent. Int J Pharma Res and Review. 2013, 2(6): 18-28.
4) Lazarus GS, Cooper DM, Knighton DR, Margolis DJ. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol.1994, 130: 489-493.
5) Boateng JS, Matthews KH, Stevens HN, Eccleston GM. Wound Healing Dressings and Drug Delivery Systems: A Review. J. Pharm Sci. 2008, 97(8): 2892-2923.
6) Stass H, Dalhoff A, Kubitza D, Schühly U. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrobial Agents and Chemotherapy, 1998, 42(8): 2060–2065.
7) Jacobsen F et al. Efficacy of Topically Delivered Moxifloxacin against Wound Infection by Pseudomonas aeruginosa and Methicillin-Resistant Staphylococcus aureus. Antimicrobial Agents and Chemotherapy. 2011, 55(5): 2325-2334
8) Prakash K, Bahlul ZA, Chandu BR, Soad AM, Tukriya OA. Design and in vitro evaluation of controlled release cephalexin sublingual films using natural biodegradeable polymer. Recent Res Sci Tec. 2010, 2(4): 6-11.
9) Ramesh U and Madrias M. Wound healing effect of chitosan in fresh water fish Cyprinus carpio L. Int J Biological Tech. 2010, 1(1): 99-102.
10) Vikesh S, Vasudha M, Vineet B, Masareddy RS, Manvi FV. Preparation and evaluation of periodontal gel of ornidazole using natural polymers, Der Pharmacia Letter, 2010, 2(1): 61-69.
11) Japan Patel, Brijesh Patel, Hardeepsingh Banwait, Kaushal Parmar, Manish Patel. Formulation and evaluation of topical aceclofenac gel using different gelling agents. Int J Drug Dev and research. 2011, 3(1):156-164.
12) Patel NA, Patel M, Patel PR. Formulation and evaluation of poly herbal gel for Wound Healing. Int Res J Pharm. 2011, 1(1):1-6.
9 / Signature of Candidate / (ASWAT AYSHA HANIF)
10 / Remarks of guide / The proposed work is a simple method of preparing topical gels using combined antimicrobial and wound modifiers which will be effective for management of all types of wounds. Hence recommended for registration.
11 / Name and designation of the
11.1 Guide / M.A. SALEEM
ASST. PROFESSOR
DEPARTMENT OF PHARMACEUTICS. LUQMAN COLLEGE OF PHARMACY, GULBARGA.
11.2 Signature of Guide
11.3 Co-guide / --
11.4 Signature of Co-guide / --
12 / 12.1 Remarks of the Chairman and Principal / We will provide all the necessary facilities required for the proposed research work.
So, recommended for registration.
12.2 Signature