COMPARATIVE QUALITY EVALUATION OF MARKETED FORMULATION OF DICLOFENAC DIETHYLAMINE GEL
Keywords:
Diclofenac diethylamine Gels, Viscosity, Texture profile analysis, Diffusion study, Comparative evaluationAbstract
Diclofenac diethylamine (DDA), a non-steroidal anti-inflammatory agent is frequently prescribed for the long term treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Three different marketed DDA gel formulations of different brands were evaluated to check their critical quality control parameters. Different brands of formulations were characterized for their drug diffusion study, texture analysis profile, viscosity, pH etc. The statistical methods like correlation coefficient, confidence interval (95% CI) were applied for their dosage form performance aspect in comparision with reference product.The results of all three brands revealed that Brand B is superior to Brand A and Brand C in terms of drug diffusion properties (96.8%, 50min) in comparision with reference product profile, texture analysis (TPA-450 and Compresion- 550) and viscosity (2300cP).
Downloads
References
Shah V.P. In-vitro release from semisolid form. In: Bronugh.L. ; maibach, H.I. (Eds.) percutaneous absorption. Boca Raton : Taylor and Francis group, 2005; p. 473-480
Ueda C.T. et al. A Topical and transdermal drug products, Pharm. Forum 2009;35(3):750-764
BRASIL. Resolution RDC n. 48, dated October 6, 2009. It provides for the realization of alteration, inclu-sion, suspension, reactivation, and post-registration, cancellation of medications and other measures. National agency for health surveillance, Brasilia, October 07 2009. Section 1, p.60-67
Shivhare U.D. et al. formulation development and evaluation of diclofenac sodium gel using water soluble polyacrylamide polymer, digest journal of nanomaterials and biostructure 2009;4:285-290
Ravindra R.P. et al. comparison of physical characteristics of vanishing cream base, cow ghee and shata dhauta ghrita as per pharmacopoeial standard, Int J pharm bio sci 2013 oct;4(4):14-21
Kaur L.P. et al. Development and evaluation of topical gel of minomidil from different polymer bases in application of alopecia. Int. J. pharmacy and pharm. Sci. 2010;2:43-47
Ashni verma et al. formulation, optimization and evaluation of clobetasol propionate gel, Int journal of pharmacy and pharmaceutics sci 2013; 5(4): 666-674
Bharat parashar et al. formulation and evaluation of gel containing miconazole nitrate an antifungal agent, Int journal of pharma research and review 2013;2(6):675-680
V.V. pande et al. fabrication and characterization of sertaconazole nitrate microsponge as a topical drug delivery system, Indian journal of pharmaceutical sci 2015;77(6):675-680
Damodar c goupale et al. evaluation of physical stability of oleogels containing diclofenac diethylamine. Research journal of pharmaceutical, biological and chemical sciences 2011;2(4):92-99
Baksh abrar et al. formulation and in-vitro evaluation of NSAIDs gel. International journal of current pharmaceutical research 2012;4(3):56-58
Karin goebel et al. In-vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug product in brazil. Brazillian journal of pharmaceutical science 2013;49(2)
Ganesh dinkarrao basarkar et . development of microsperes containing diclofenac diethylamine as sus-tained release topical formulation. Bulletin of pharmaceutical research 2013;3(1):14-22
Shah, V.P. et al. In vitro release: Comparative evaluation of vertical diffusion cell system and automated procedure. Pharm. Dev. Technol. 2003;8(1):97-102
Aulton, M.E. Design of pharmaceutical forms. 2nd ed. Porto Alegre: Artmed, 2005, 677
Bemvindo, C.S. comparative study of cutaneous clearance and penetration of miconazole nitrate from commercial topical emulsions. Rio de Janeiro, 2006. 110 p. [Master’s Degree Thesis, Federal University of Rio de Janeiro, Brazil]
Vishal pande et al. Design expert assisted formulation of topical bioadhesive gel of sertaconazole nitrate. Advance Pharmaceutical Bulletin 2014;4(2):121-130
Guy R.H et al. On the determination of drug release rates from topical dosage forms. Int. J. Pharm. 1990;60(2):R1-R3
Higuchi W.I. Analysis of data on the medicament release from ointments. J. Pharm. Sci. 1962;51(8):802-804.
Toscano C.: Development and validation of a system for evaluating the in-vitro release of benzoyl peroxide delivered in geysers. Rev. Bras. Cienc. Farm, 2001, 37(3) 341-346.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.
