Teneligliptin hydrobromide hydrate mouth dissolving strip: Formulation and evaluation

S.M. Attar, S. Ghurghure, Sumit
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Abstract

Oral route is considered as one of the most convenient route for administration of various pharmaceutical dosage form like tablet, capsule, syrup, suspension and emulsion. Fast Dissolving Drug Delivery systems have developed various fast disintegrating preparations like Oral disintegrating film, ODF. Oral disintegrating film is the solid oral drug delivery system, in which water soluble polymer involve to disintegrate film into mouth fastly. Oral disintegrating film is superior as compare to orally disintegrating tablet as the cost of production is low. The present research was undertaken to develop oral disintegrating film of tteneligliptin hydrobromide hydrate to have rapid onset of action. of tteneligliptin hydrobromide hydrate which is an anti-diabetic. The mechanism action of Teneligliptin is to increase incretin levels (GLP-1 and GIP), which inhibit glucagon release, which in turn increases insulin secretion, decreases gastric emptying, and decreases blood glucose levels.The concept of formulating fast disintegrating film Teneligliptin containing offers a suitable and practical approach in serving desired objective of faster disintegration and dissolution characteristics with increased bioavailability. ODF of Teneligliptin were prepared by solvent casting method and evaluated physicochemical parameters like thickness, weight variation, moisture content, folding endurance, drug content, etc. All the formulations of Teneligliptin ODF displayed optimum folding endurance, which indicates the formulation prepared can withstand handling and transportation. From the results obtained, it was concluded that the formulation of oral disintegrating film has better physical chemical properties with good disintegration property.
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氢溴酸替尼列汀水合物口腔溶解条:配方与评估
口服途径被认为是片剂、胶囊、糖浆、混悬剂和乳剂等各种药物剂型最方便的给药途径之一。快速溶解给药系统开发了各种快速崩解制剂,如口腔崩解膜(ODF)。口腔崩解膜是一种固体口服给药系统,其中的水溶性聚合物可使药物在口腔中快速崩解。与口腔崩解片相比,口腔崩解膜具有生产成本低的优点。本研究旨在开发氢溴酸替奈利汀水合物口腔崩解片,使其快速起效。替尼列汀的作用机制是提高增量素(GLP-1 和 GIP)水平,从而抑制胰高血糖素的释放,进而增加胰岛素分泌,减少胃排空,降低血糖水平。我们采用溶剂浇铸法制备了替尼列汀的 ODF,并对其厚度、重量变化、含水量、耐折度、药物含量等理化参数进行了评估。所有替格列汀 ODF 制剂都显示出最佳的耐折性,这表明所制备的制剂能够经受处理和运输。从所得结果可以得出结论,口腔崩解片制剂具有较好的物理化学特性和良好的崩解性能。
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