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Abstract

IN-VIVO PHARMACOKINETIC EVALUATION OF DEVELOPED TRANSDERMAL PATCH OF ACECLOFENAC AND THIOCOLCHICOSIDE IN TREATMENT OF GOUT

Devang Tandel*1, Hitesh Raval1, Nirmala Sonchhatra1, Lalji Baldania2, Bhumi Raval2, Tejal Gandhi3

1 Department of Quality assurance, Anand Pharmacy College, Anand. 
2 Department of Pharmaceutics, Anand Pharmacy College, Anand. 
3 Department of Pharmacology, Anand Pharmacy College, Anand.

ABSTRACT

In present work, transdermal drug delivery systems (TDDS) was developed to overcome the drawback of oral formulation comprised of Aceclofenac and Thiocolchicoside in the symptomatic treatment of gout. Aceclofenac has major side effect on stomach walls which is peptic ulcer, while thiocolchicoside has lower bioavailability in oral route due to extensive first pass metabolism, therefore, it was thought of interest to developed long acting transdermal patch of Aceclofenac and Thiocolchicoside. The bioanalytical method was developed using Phenomenex Luna-C18 (250 x 4.60 mm, 5 μm) column as stationary phase. The mobile phase used for HPLC method was 15 mM potassium di-hydrogen orthophosphate buffer (pH=3.11) and acetonitrile in gradient mode. Sample preparation was done using protein precipitation technique Bioanalytical method was validated according to Guidance for Industry: Bioanalytical Method Validation of U.S. Department of Health and Human Services. The optimized mobile phase gave peak of Aceclofenac, Thiocolchicoside and ISTD at Rt= 5.17 ± 0.04, 14.60 ± 0.07 and 9.2 ±0.03 min respectively at 260 nm. Pharmacokinetic data of developed transdermal patch showed better Area under curve (AUC), elimination half-life (t1/2), Mean residence time (MRT) as compared to marketed formulation, therefore, the developed transdermal patch is able to surmounting drawbacks of oral marketed formulation of title drugs.

Keywords: Bioanalytical method, transdermal drug delivery system, aceclofenac, thiocolchicoside.


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