The aim of the current study was the development of Nicorandil mucoadhesive matrix tablets using direct compression. Mucoadhesive formulations were developed using various blends of mucoadhesive polymers. A 32 randomized factorial design was adopted to control both the adhesion properties and the release rate of the drug from the delivery system. In this study 2 factors were evaluated, each at 3 levels. The amount of HPMC K100M: Sod Alginate (X1) and Carbopol 974P (X2) were selected as independent variables and the mucoadhesive strength (f), times required for 50% of drug release (t50%), amount of drug release at 12 h (Rel 12 h) and release exponent (n) were selected as dependent variables. Prepared tablets were evaluated for their Physico-chemical parameter, swelling index, ex-vivo bioadhesion, in-vitro drug release and in-vivo γ- scintigraphy experiments in humans. Data obtained in these studies demonstrated that optimized formulation MF3, containing (3:1 ratio of HPMC K100M: Sodium Alginate, 100mg and Carbopol 974P, 45mg,) showed Mucoadhesion force (f) as 146.61 dynes/cm2, time to release 50% of drug (t50%) as 4.8 h, release of drug at 12h (Rel 12 h) as 99.93% and release exponent (n) as 0.709 confirming non-Fickian diffusion. In-vivo γ- scintigraphy studies revealed that mucoadhesive matrix tablet was retained in the human stomach for more than 6h.
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