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    • 1. 发明申请
    • ORALLY DISINTEGRATING DOSAGE FORM FOR ADMINISTRATION OF AVANAFIL, AND ASSOCIATED METHODS OF MANUFACTURE AND USE
    • ORA用于治疗AVANAFIL的剂型及相关制造和使用方法
    • US20160331687A1
    • 2016-11-17
    • US14714028
    • 2015-05-15
    • Vivus, Inc.
    • Calvin Theodore BromanEric Sheu
    • A61K9/20A61K31/506
    • A61K9/2031A61K9/0056A61K9/2018A61K9/2095A61K31/506
    • Formulations are provided for the oral administration of avanafil, a Type V phosphodiesterase inhibitor (“PDE V inhibitor”), and analogs thereof. The formulations are orally disintegrating tablets (ODTs) that rapidly dissolve or disintegrate in the oral cavity. The tablets contain an absorption enhancing composition that increases the duodenal absorption of the active agent, following transfer from the low pH environment of the stomach to the more basic pH of the duodenum. Methods for administering the active agent using the dosage forms are provided. The invention also encompasses a method of selecting components and compositions to incorporate in the formulations which will facilitate increased absorption of the active agent in the duodenum and thus serve as “absorption enhancing compositions” herein. Also provided are methods for manufacturing orally disintegrating tablets to optimize the physical properties of the dosage forms, particularly hardness and disintegration time.
    • 提供了用于口服给予阿伐他非,V型磷酸二酯酶抑制剂(“PDE V抑制剂”)及其类似物的制剂。 制剂是在口腔中快速溶解或分解的口腔崩解片(ODT)。 在从胃的低pH环境转移到十二指肠的更基本的pH之后,片剂含有增加活性剂的十二指肠吸收的吸收促进组合物。 提供了使用剂型给药活性剂的方法。 本发明还包括选择组合物和组合物以掺入制剂中的方法,其将促进活性剂在十二指肠中的增加的吸收,因此用作本文的“吸收增强组合物”。 还提供了制备口腔崩解片以优化剂型的物理性质,特别是硬度和崩解时间的方法。