ISSN: 2249–9504
CAS CODEN: IJPCDX

FORMULATION, DEVELOPMENT AND OPTIMIZATION OF ALPRAZOLAM 0.5 MG SUSTAINED RELEASE TABLET WITH 12 HOURS RELEASE PROFILE

Abstract

Author(s): Ayon Dutta1* and Jayanta Chattapadhyay

Alprazolam is a Benzodiazepine derivative drug used as an antianxiety drug. Alprazolam 0.5 mg sustained release tablet already available in market but most manufacturers have not reported release profile of their formulation . So, basically marketed Alprazolam 0.5 mg sustained release follows 8 hours release profile. As per comparison of release profile of marketed tablet here developed Alprazolam 0.5 mg sustained release tablet with 12 hours release profile. Total six formulations are developed by using some different rate controlling polymers HPMC (Methocel) K 15 and K 100, PVP K 30, Sodium carboxy methyl cellulose, Acrypol 912G and 971G and other some excepients like lactose , microcrystalline cellulose, dicalcium phosphate, magnesium stearate. Formulations are developed and optimized by changed the ratio of rate controlling polymer. Here mentioned the best two formulation from all formulations. First formulation of best of two follows 8 hours release profile and depending on this profile developed the final formulation by changing ratio of polymers which formulation followed the 12 hours release profile. This 12 hours release profile alprazolam 0.5 mg sustained release tablet not available in market. All formulations are prepared by wet garanulation method. After compression the finished tablet release profile were done by using USP type 1 rotating basket type dissolution apparatus and dissolution medium Phosphate buffer 6.4. Plotted all dissolution kinetic models and swelling index study also done of this tablet. Morphology study of tablets done by using scaning electron microscopy (SEM). Total formulations were prepared according to I.P and follows 3 point assay of I.P.

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