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• W2031293048 abstract "The aim of the present study was to formulate new fixed-dose combination tablets (FCTs) by coating a glimepiride (GLM) immediate-release (IR) layer on a metformin hydrochloride (MTF) extended-release (ER) core tablet using perforated film coating equipment. Composition of GLM-IR coating suspension for homogeneity was studied and application of near-infrared spectroscopy (NIR) to determine the end-point of the coating process was also investigated. The final product was administered to healthy male volunteers and its pharmacokinetic parameters were analyzed. GLM-IR coating suspension was prepared with a ratio of SLS to GLM at 0.75 for homogeneity. An inert mid-layer was introduced to prevent contact between MTF-ER core tablet and GLM-IR layer, which led to an increased release rate of GLM in pH 7.8 medium. The proportional correlation was confirmed between analytical results of GLM determined by NIRS and those by HPLC-UV. Thus, the end-point of the GLM coating process was determined by NIRS, the fast and non-destructive method. New FCTs were confirmed to be bioequivalent to the marketed product." @default.
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• W2031293048 date "2012-05-01" @default.
• W2031293048 modified "2023-09-26" @default.
• W2031293048 title "Investigation of an active film coating to prepare new fixed-dose combination tablets for treatment of diabetes" @default.
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• W2031293048 doi "https://doi.org/10.1016/j.ijpharm.2012.01.057" @default.
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