DOI: 10.5176/2345-783X_PHARMA13.24

Authors: Sreenivas Patro Sisinthy, Koteswara Rao Nalamolu, Satpal Singh Bisht, Bhanoji Rao

Abstract:

Polyethylene oxide based plain and layered matrix tablets were developed for the oral controlled release of itopride hydrochloride. Matrix core and barrier layers were prepared by wet granulation method using polyethylene oxide as the release retardant. In vitro dissolution studies were carried out on the developed formulations. The objective of the study was to develop a formulation which will release at least 80{6e6090cdd558c53a8bc18225ef4499fead9160abd3419ad4f137e902b483c465} of the drug in 12 hours and show a R2 value of at least 0.95. When the dissolution data was analyzed, IMP3L2 has shown the highest R2 value (0.9866) with at least 80{6e6090cdd558c53a8bc18225ef4499fead9160abd3419ad4f137e902b483c465} of the drug released in 12 hours among all the formulations. Hence, the formulation IMP3L2 was chosen as an ideal formulation and selected for in vivo studies in human volunteers. Eight healthy volunteers participated in the study and a two-way crossover design was followed. The serum concentration of itopride hydrochloride was estimated by reverse-phase HPLC. The pharmacokinetic parameters were calculated from the serum concentration of itopride hydrochloride versus time data. The delayed Tmax, decreased Ka, unaltered bioavailability and prolonged t1/2, indicated a slow and prolonged release of itopride hydrochloride from polyethylene oxide layered matrix tablets in comparison with the plain matrix tablet. Based on the results of in vitro and in vivo studies it was concluded that that polyethylene oxide based layered matrix tablets provided oral controlled release of itopride hydrochloride.

Keywords: Layered matrix tablets, itopride hydrochloride, polyethylene oxide, HPLC, serum

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