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Development of memantine orodispersible tablets and their in vitro description and biopharmaceutical performance

机译:美金刚胺orodispersible平板电脑的发展及其在体外和描述生物制药的性能

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摘要

Aim: New approaches are required to improve compliance in older patients with problems in swallowing traditional formulations. A novel memantine orodispersible tablet (ODT) was formulated, and its bioavail-ability and taste acceptability were evaluated. Materials & methods: In vitro characterization of ODT comprised dispersion in simulated saliva prior to dissolution assay in a limited volume of biorelevant media. A single oral dose of 20-mg memantine ODT exhibits similar bioavailability to that of an immediate release 20-mg tablet in a healthy population under fasting conditions. Results: 90% confidence interval for C_(max) was of 96.78-106.52% and 98.27-104.78% for AUC_(0-72). An applied palatability survey showed exceptional acceptance of the formulation. Conclusion: Memantine microspheres prepared by a solid-dispersion technique results in ODT with adequate biopharmaceutical performance.
机译:目的:新方法需要改进合规在老年患者中存在的问题吞咽传统配方。美金刚胺orodispersible平板(ODT)制定,其bioavail-ability和口感可接受性进行评估。方法:体外ODT的表征由分散在模拟唾液之前解散有限体积的测定biorelevant媒体。美金刚胺ODT展示类似的生物利用度立即发布20毫克的平板电脑在禁食条件下健康人群。结果:90%置信区间为C_ (max)96.78 -106.52%和98.27 -104.78%AUC_(0 - 72)。特殊配方的验收。结论:美金刚胺微球的准备结果在ODT固体分散技术足够的生物制药的性能。

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  • 1. ORODISPERSIBLE TABLET [P] . 外国专利: US2022202722A1 . 2022-06-30

    机译:ORODISPERSIBLE TABLET

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