FORMULATION AND EVALUATION OF DUAL DRUG DELIVERY OF IRBESARTAN AND HYDROCHLOROTHIAZIDE WITH PH INDEPENDENT SYSTEM
P. Tanuja*, R. Shireesh Kiran, A. Pratyusha, V. Uma Maheswara Rao
ABSTRACT
The main objective of the present study was to formulate and evaluate Dual drug tablets of Irbesartan and Hydrochlorothiazide with pH independent system by direct compression technique. Irbesartan is an angiotensin receptor and Hydrochlorothiazide is a diuretic with short half-life (3-4 hrs & 6-14hrs respectively) with a bioavailability of 70-90% orally. The drugs identity were confirmed by UV spectroscopy. The polymers used to sustain the drug release are Guar gum, Xanthan gum, HPMC and ethyl cellulose. The compatibility studies between the drug and the polymer were studied using the FT-IR spectroscopy and were found to be compatible. Preformulation parameters like tapped density, bulk density, Carr’s index, Hausner’s ratio, compressibility index, angle of repose were studied and the results were found to be
within the limits. Using the above polymers, formulations F1 to F7 were manufactured by direct compression technique and the tablets were evaluated for their thickness, hardness, friability, weight variation and content uniformity test. The in vitro drug release studies were performed in Phosphate buffer of pH 1.2 and 6.8 using USP type-II dissolution apparatus. From the dissolution studies it was found that F6 formulation was best since it release minimum amount of drug (6.8%) initially and maximum drug (100%) at the end of 9hrs.The F6 formulation was subjected to stability studies for about 3months as per ICH guidelines and found to be stable.
Keywords: Angiotensin receptor; Diuretics; Irbesartan; Hydrochlorothiazide, pH independent, Dual drug action.
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