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1. 发明申请

US20160331687A1 ORALLY DISINTEGRATING DOSAGE FORM FOR ADMINISTRATION OF AVANAFIL, AND ASSOCIATED METHODS OF MANUFACTURE AND USE 审中-公开
标题翻译： ORA用于治疗AVANAFIL的剂型及相关制造和使用方法
公开(公告)号：US20160331687A1
公开(公告)日：2016-11-17
申请号：US14714028
申请日：2015-05-15
申请人： Vivus, Inc.
发明人： Calvin Theodore Broman , Eric Sheu
IPC分类号： A61K9/20 , A61K31/506
CPC分类号： A61K9/2031 , A61K9/0056 , A61K9/2018 , A61K9/2095 , A61K31/506
摘要： 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.
摘要翻译：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。

2. 发明授权

US10028916B2 Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use 有权
公开(公告)号：US10028916B2
公开(公告)日：2018-07-24
申请号：US14714028
申请日：2015-05-15
申请人： Vivus, Inc.
发明人： Calvin Theodore Broman , Eric Sheu
IPC分类号： A61K31/506 , A61K9/20 , A61K9/00
摘要： 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.

3. 发明申请

US20150328246A1 ORALLY ADMINISTRATABLE FORMULATIONS FOR THE CONTROLLED RELEASE OF A PHARMACOLOGICALLY ACTIVE AGENT 审中-公开
标题翻译：用于控制释放药物活性剂的ORALM管理配方
公开(公告)号：US20150328246A1
公开(公告)日：2015-11-19
申请号：US14713938
申请日：2015-05-15
申请人： Vivus, Inc.
发明人： Calvin Theodore Broman , Eric Sheu
IPC分类号： A61K31/7048 , B29C43/00 , A61K9/24 , A61K45/06 , A61K9/20
CPC分类号： A61K31/7048 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/209 , A61K9/2095 , A61K31/137 , A61K45/06 , B29C43/006 , B29L2031/753 , A61K2300/00
摘要： Drug tablets that include a controlled release layer of a moisture-sensitive active agent are prepared with a lipidic matrix forming excipient, a water-soluble, channel forming excipient and a filler, each being non-hygroscipic. The tablets are formed in a process where the components are blended in the absence of moisture and in particulate form.
摘要翻译：包含湿敏性活性剂的控制释放层的药物片剂是用形成脂质基质的赋形剂，水溶性通道形成赋形剂和填充剂制备的，每种不吸湿。片剂是以不含水分和颗粒形式混合组分的方法形成的。

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