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Formulation and Bioequivalence Evaluation of Extended Release Solid Drug Delivery System for Metronidazole Using Eudragit NM30D and Methocel Premium K4M as Retardant Material

Md. Abdullah-Al-Mamun, Md. Rashidur Rahman, Sujit Biswas, Sukalyan Kumar Kundu and Johir Rayhan

A conventional dosage form of Metronidazole produce a drug blood level time profile which does not maintain within the therapeutic range for extended period of time. In the present study, an attempt was made to develop an extended release Metronidazole composition that will be capable of delivering acceptable bioavailability for up to 24 hours. Extended release formulations of Metronidazole were prepared using various proportions of Eudragit NM30D and Methocel Premium K4M, separately through wet granulation. Eudragit NM30D and Methocel Premium K4M were used as retardant material. Three formulations (U-1 to U-3) were developed using Eudragit NM30D and while another five (M-1 to M-5) using Methocel Premium K4M. The granules for tabletting were evaluated for moisture content, compressibility index and angle of repose etc. Tablets were subjected to thickness, hardness, friability and in vitro release studies. Dissolution study of the formulated tablet matrices were carried out in 0.1 N Hydrochloric acidfor 24 hours period. Dissolution profiles were then compared with innovator’s drug Flagyl ER in term of difference factor (f1) and similarity factor (f2). It was observed that, formulation U-1, U-2, M-2, M-3, M-4 meet the specification of bioequibalance with Flagyl ER. Among them, M-3 showed the highest similarity and lowest difference factor. It is evident from the study that, formulation M-3 posses all the required characteristics to provide an extended release Metronidazole composition that will be stable enough and capable of delivering acceptable bioavailability for up to 24 hours.

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