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      저자 : Shivakumar Mantri (검색결과 1 건)
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        Establishing postprandial bio-equivalency and IVIVC for generic metformin sustained release small sized tablets

        Chandramohan Eaga,Shivakumar Mantri,Rajkumar Malayandi,Phani Krishna Kondamudi,Sumon Chakraborty,S. V. N. Raju,Deepika Aggarwal 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.3

        The objective of current study was to developmetformin hydrochloride modified release small sizedtablets, and to evaluate its bioequivalence when comparedwith the reference product (Glucophage SR). The physicochemicalproperties of the formulated and referencetablets were determined and compared. The in vitro dissolutionprofiles of formulated tablets were obtained usingbio-relevant media and IVIVC was established. Bioequivalenceinvestigation was carried out in 32 healthy malevolunteers who received a single dose 1,000 mg of bothtest and reference products in a randomized two-waycrossover design in postprandial conditions. After dosing,serial blood samples were collected for a period of 48 h. Metformin concentration was assayed by using a validatedLC–MS/MS method. The log-transformed Cmax and AUCwere statistically compared by analysis of variance, and the 90 % confidence intervals (CI) of the ratio of the logtransformedCmax and AUC between the most promisingdeveloped formulation and the reference product weredetermined. It was deduced that the dissolution rate profileof the formulated modified release small sized tablets wassimilar to the reference product employed in the study. Their similarity and difference factors were found to bewell within the established limits. In the bioequivalencestudy, the difference in Cmax, AUClast and AUCinf betweenthe test and reference product was not statistically significant,with the 90 % CI of 100.73–116.20, 86.16–97.37 and87.12–96.99 %, respectively. The results suggested that themetformin small tablets formulated with reduced quantityof controlled release polymer were found to be bioequivalentin the postprandial state. For these small tablets,pH 5.5 acetate buffer as a bio-relevant dissolution mediafor the development of IVIVC.

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