Download Materials and methods

PREPARATION AND IN VITRO EVALUATION OF
FLURBIPROFEN TOPICAL GEL
M. Pharm. Dissertation Protocol
Submitted to the
Rajiv Gandhi University of Health Sciences, Karnataka
Bangalore.
By
MOMIN SAUD IMTIYAZ
B. Pharm.
Under the guidance of
Dr. Satyanandam S
M.Pharm, Ph.D
Professor
Dept. of Pharmaceutics
Luqman College of Pharmacy, Gulbarga
DEPARTMENT OF PHARMACEUTICS
LUQMAN COLLEGE OF PHARMACY, GULBARGA
2013-2014
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
Name of the candidate and
permanent address ( in block
letters)
2.
Name of the institution
3.
Course of study and subject
MOMIN SAUD IMTIYAZ
C/o LUQMAN COLLEGE OF PHARMACY
POST BOX NO:86, BEHIND P&T COLONY ,
OLD JEWARGI ROAD,
GULBARGA-585102
LUQMAN COLLEGE OF PHARMACY, BEHIND P
&T COLONY, OLD JEWARGI ROAD, GULBARGA,
PIN-585102.
M. PHARM (PHARMACEUTICS)
4.
Date of admission to the course
07/01/2013
5.
Title of Topic
PREPARATION AND AND IN VITRO
EVALUATION OF FLURBIPROFEN TOPICAL GEL
6.
Brief Resume of the intended work
6.1 Need for the study:
Topical drug delivery is an attractive root for local treatment. Further more the drug
concentration in the skin resulting from single topical application is much higher than that
obtained after prolonged oral administration.1 Considering the fact that most inflammatory
disease occur locally and near the surface of the body. Topical application of NSAID on the
inflamed side can offer the advantage of delivery of drug directly to the diseased site and
producing it local effect. This occur by avoiding gastric irritation and also reduce adverse
systemic effect.2 Topical preparation avoid the GI irritation prevent the metabolism of drug in
the liver and increase the bioavailability of the drug. Topical preparation give its action directly
to the site of action.3 Gels are transparent or translucent semisolid formulations containing a
high ratio of solvent/gelling agent. When dispersed in an appropriate solvent, gelling agents
merge or entangle to form a three dimensional colloidal network structure, which limits fluid
flow by entrapment and immobilization of the solvent molecules. The network structure is also
responsible for gel resistance to deformation and hence, its viscoelastic properties.4
Flurbiprofen is a propionic acid derivative is a non steroidal NSAID agent with antipyretic and
analgesic activity. Oral formulation of flurbiprofen may used for the symptomatic treatment of
rheumatoid arthritis, osteo arthritis and anklylosinge spondylitis. 5
Hence, in the present work an attempt will be made to prepare the topical gel of
flurbiprofen and to study the effect of permeation enhancers on in vitro permeation of
flurbiprofen.
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.
 N.G. Raghavendra rao et al.,6 formulated, evaluated and determined the anti
inflammatory activity of topical etoricoxib gel and concluded that the etoricoxib gel
formulation F25 containig 2% HPMC with 20% lemon grss oil was suitable for
topical application and it shows compareable result with that of marketed product.
 Baksh Abrar et al.,7 formulated and invitro evaluated NSAID gel and concluded that
gel has wider prospectus to be used as topical drug delivery dosage form.
 Rhee YS, Park S et al.,8 Developed a Transdermal gel formulation for Ibuprofen
using experimental design technique to evaluate its pharmacokinetic properties. The
three factors chosn for factorial design were the concentration of drug where in the
levels of each factor were low, medium and high. Skin permeation rates and lag times
of Ibuprofen were evaluated using the Franz-type diffusion cell in order to optimize
the gel formulation. The pharmacokinetic properties of the optimized formulation
were compared with those of two marketed products in rats. It was concluded that a
transdermal Ibuprofen gel could be formulated using the technique of experimental
design.
 Amin et al.,9 reported the preparation and evaluation of ketorolac tromethamine gels
for ocular anti inflammatory effect in rabbits. They were prepared by using Carbopol
940, HPMC, Sodium CMC, etc. Carbopol gel showed the maximum in vitro release
rate. All gels exhibited no ocular irritation and good anti inflammatory effect.
 Jagtap et al.,10 evaluated the efficacy, safety and tolerability of Valdecoxib (1%) gel
in adult patients with painful inflammatory joint disease. They found that Valdecoxib
gel is effective in reducing the inflammation satisfactorily. The laboratory values
were found with in normal limits. There were no reports of any hypersensitivity
reactions.
 Gendy AEL et al.,11 formulated and evaluated different gel and ointment
formulations of flurbiprofen using carbopol 934P (CAB), poloxamer 407 (POL), and
eudragit S100 (EUD) as gel bases, while emulsion (EML) and polyethylene glycol
(PEG) ointments were employed. It has been reported that the CAB and POL gels
could be the vehicles of choice for rapid release and onset of flurbiprofen after
topical application.
6.3 Objectives of the Study
The work is planned with the following objectives;
 To prepare the topical gel by using gel forming agent.
 Evaluate the prepared gels for drug content, pH, rheological properties.
 To study the effect of permeation enhancers on in vitro release.
7.
MATERIALS AND METHODS
7.1 Material :
The materials to be used in the present studies include,
Drug
:
Flurbiprofen
Polymer
:
Carbopol, HPMC, MC etc.
Other additives:
Menthol, Camphor.
Other chemicals will be use of analytical grade.
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 flubiprofen.
2) The topical gels will be prepared by 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) In vitro release study will be perform by using Keshry-Chin Cell
7.3
Does the Study require any investigation or intervention to be conducted on
patients or other human or animals? If so please describe briefly.
7.4
--- Yes it is under the plan of work --Has ethical clearance been obtained from your institution in case of 7.3?
--- Yes obtained ---
8.
LIST OF REFERENCES:
1) Mahmoud A A et al., Preparation and evaluation of hydrogels as a vehicle for of
lornoxicam. Int J Drug Formulation and Res. 2011-2(5):254-273.
2) MA. Saleem and Sumanji Bala. Formulation and evaluation of meloxicam solid
dispersion incorporated topical gels. Int J Pharm Bio Sci. 2010-1(3):1-9.
3) Loveleen Preet Kaur, Tarun Kumar Gulleri. Topical gel: A recent approach for novel
drug delivery. Asian J Bio Pharm Sci. 2013-3(17):1-5.
4) Lalit kumar and Ruchi Verma. In vitro evaluation of prepared topical gel of Nimesulide.
J Chem Pharm Res. 2010-2(1):273-279.
5) http://www.drug bank. ca/drug/DB00712.
6) NG. Raghavendra rao, P Ravi prakash and Chowdary soujanya. Formulation and
evaluation, anti inflammatory activity of topical etoricoxib gel. 2010-3(2):126-129.
7) Baksh Abrar, Shaikh Anis, Bhargav Tanu, Sameer Singh. Formulation and in vitro
evaluation of NSAID’s gel. 2012-4(3):56-58.
8) Rhee YS, Chang S, Park E. Optimization of Ibuprofen gel formulation using
experimental design technique for enhanced transdermal penetration. Int J Pharm 2008;
364:14-20.
9) Amin PD, Tayade PT, Davse VV. Evaluation of Keterolac tromethamine gels for ocular
anti-inflammatory activity in rabbits. The Eastern Pharmacist 1998; 12: 127-130.
10) Jagtap SA, Chincholi S, Taneja PK, Ismail ND, Ram S, Sarvagad SB, Dongre N, Desai
A. Evaluation, efficacy, safety and tolerability of Valdecoxib gel (1%) in adult patients
with painful inflammatory joint disease. J Indian Med Assoc. 2003; 101(12): 764, 766,
727.
11) Gendy AME, Jun HW, Kassem AA. In vitro release studies of Flurbiprofen from
different topical formulations. Drug Dev Ind Pharm. 2002; 28: 823-831.
9.
Signature of Candidate
10
Remarks of guide
11.
Name and designation of the
11.1 Guide
MOMIN SAUD IMTIYAZ
The proposed work is a simple method of preparing
topical gels of flurbiprofen using gel forming agent and
to study the effect of permeation enhancers on in vitro
permeation of flurbiprofen.
DR. SATYANANDAM S
M.PHARM, PH.D
PROFESSOR
DEPT. OF PHARMACEUTICS
Luqman College of Pharmacy, Gulbarga
11.2 Signature of Guide
12.
11.3
Co-guide
11.4
Signature of Co-guide
12.1 Remarks of the Chairman
and Principal
12.2 Signature
We will provide all the necessary facilities required for
the proposed research work.
So, recommended for registration.