alexa Abstract | Fabrication and comparative bioavailability of modified gum microspheres loaded with disopyramide phosphate

Journal of Chemical and Pharmaceutical Research
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Abstract

The present study aims to develop a controlled release formulation of Disopyramide Phosphate (DSP) loaded into natural and modified gum microspheres, using water-in-oil emulsification solvent evaporation technique utilizing wetting agent. Effect of different process variables such as drug and gums ratio (1:1: 0.75 % w/v), stirring speed and time ( 1800 rpm & 210 min ), addition of surfactant (0.5 % w/v), effect of oily phase ( 200 ml), temperature of the emulsified phase (800 C), effect of cross-linker (0.5 % w/v) and effect of encapsulating agent (1.2 % w/v) on drug loading during the preparation of microspheres were optimized to produce microspheres. Sieve analysis data indicated that the prepared microspheres were in the range of 106 to500 μm. Prepared microspheres were spherical in shape as shown by SEM photomicrographs. Encapsulated drug in the prepared formulations was stable as confirmed by FTIR & DSC studies. A single dose randomized two period cross over study was conducted to compare the pharmacokinetics and bioavailability of test formulation DXML1 (product B –150 mg of DP loaded in MLBG) with standard formulation (Product A - Norpace® CR- 150 mg capsule). The observed mean values Tmax, Cmax, AUC0 -∞, Ka, t 1/2 and Kel for products A & B does not show any significant statistical difference. From the dissolution point and in vivo bio availability for products A & B could be considered bio equivalent. The drug release performance was greatly affected by the materials used in the microsphere preparation which allows maximum absorption in the intestine

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Author(s): Anjana John Zeinul Hukuman N H and D V Gowda

Keywords

Gum microspheres, Controlled release, Disopyramide phosphate, Release kinetics, bio availability, bioavailability

 
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