title: Investigation of an active film coating to prepare new fixed-dose combination tablets for treatment of diabetes.
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.
authors.affiliation: School of Pharmacy, Sungkyunkwan University, Suwon 440-746, Republic of Korea.
authors.forename: Ju-Young
authors.initials: JY
authors.lastname: Kim
authors.forename: Dong-Wook
authors.initials: DW
authors.lastname: Kim
authors.forename: Yun-Mo
authors.initials: YM
authors.lastname: Kuk
authors.forename: Chun-Woong
authors.initials: CW
authors.lastname: Park
authors.forename: Yun-Seok
authors.initials: YS
authors.lastname: Rhee
authors.forename: Tack-Oon
authors.initials: TO
authors.lastname: Oh
authors.forename: Kwon-Yeon
authors.initials: KY
authors.lastname: Weon
authors.forename: Eun-Seok
authors.initials: ES
authors.lastname: Park
mesh_terms: D000328:Adult; D000465:Algorithms; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003920:Diabetes Mellitus / Q000188:drug therapy; D004338:Drug Combinations; D004339:Drug Compounding; D004345:Drug Industry / Q000379:methods; D004355:Drug Stability; D005079:Excipients; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D012995:Solubility; D019265:Spectroscopy, Near-Infrared; D013453:Sulfonylurea Compounds / Q000008:administration & dosage* / Q000493:pharmacokinetics; D013535:Suspensions; D013607:Tablets
chemical_list: D004338:Drug Combinations; D005079:Excipients; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D013535:Suspensions; D013607:Tablets; C057619:glimepiride; D008687:Metformin