TY - JOUR AU - Sisinthy, Sreenivas Patro AU - Rao, Nalamolu Koteswara AU - Me, Bhanoji Rao PY - 2015/11/01 Y2 - 2024/03/29 TI - CONTROLLED RELEASE LAYERED MATRIX TABLETS OF ITOPRIDE HYDROCHLORIDE: IN VITRO AND IN VIVO EVALUATION JF - Asian Journal of Pharmaceutical and Clinical Research JA - Asian J Pharm Clin Res VL - 8 IS - 6 SE - Original Article(s) DO - UR - https://journals.innovareacademics.in/index.php/ajpcr/article/view/7871 SP - 130-135 AB - <p>Objectives: The tablets were prepared by wet granulation method using polyethylene oxide, which was used to prepare both the matrix core and<br />barrier layers. In vitro dissolution studies were carried out on the developed formulations. Based on the dissolution data, the best formulation was<br />chosen, and evaluated for its controlled release in healthy human volunteers.<br />Results: When the dissolution data was analyzed, IMP3L2 has shown the highest R<br /> value (0.9866) with at least 80% of the drug released in 12 hrs<br />among all the formulations. Hence, the formulation IMP3L2 was chosen as an ideal formulation and selected for in vivo studies in human volunteers.<br />Eight healthy volunteers participated in the study, and a two-way crossover design was followed. The serum concentration of itopride hydrochloride<br />was estimated by reverse-phase high-performance liquid chromatography. The pharmacokinetic parameters were calculated from the serum<br />concentration of itopride hydrochloride versus time data. The delayed T<br />max<br />2<br />, decreased K<br />a<br />, unaltered bioavailability, and prolonged t<br />, indicated a slow<br />and prolonged release of itopride hydrochloride from polyethylene oxide layered matrix tablets in comparison with the plain matrix tablet.<br />Conclusion: Based on the results of in vitro and in vivo studies, it was concluded that polyethylene oxide based layered matrix tablets provided oral<br />controlled release of itopride hydrochloride.<br />Objective: In this study, layered matrix tablets of itopride hydrochloride were formulated using polyethylene oxide as release retardant to achieve<br />a zero order drug release. The objective of the study was to develop a formulation which will release at least 80% of the drug in 12 hrs and show a<br />correlation coefficient (R<br />2<br />) value of at least 0.95.<br />Keywords: Layered matrix tablets, Itopride hydrochloride, Polyethylene oxide, High-performance liquid chromatography, Serum.</p> ER -