公开(公告)号：WO2017106812A1

公开(公告)日：2017-06-22

申请号：PCT/US2016/067443

申请日：2016-12-19

申请人： DIXIT, Manesh A. ,  FIRST TIME US GENERICS LLC

发明人： DIXIT, Manesh A. ,  PAWAR, Viabhav ,  PATEL, Rushi ,  SOMWANSHI, Amol ,  PATEL, Mineshkumar

IPC分类号： A61K9/00 ,  A61K47/12

CPC分类号： A61K9/0056 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2059 ,  A61K9/2095 ,  A61K31/00 ,  A61K31/405 ,  A61K31/496 ,  A61K31/501 ,  A61K31/546 ,  A61K31/635

摘要： A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about 2 kilopond and friability of less than about 1% at 300 rotations (per USP). The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.

摘要翻译： 制造用于将药物活性成分或营养剂递送至动物或人类受试者的可食用软咀嚼剂型的产品和方法，通过适当混合形成粒状软咀嚼物并且 筛分步骤，并用压机成型片剂。 这种软咀嚼剂型在300转（每USP）下具有小于约2千克的硬度和小于约1％的脆碎度。 制造这种压缩软咀嚼片的方法使用压片（压片）压制设备来生产具有一致重量和质地的软咀嚼片。

公开(公告)号：WO2017151571A1

公开(公告)日：2017-09-08

申请号：PCT/US2017/019869

申请日：2017-02-28

申请人： FIRST TIME US GENERICS LLC ,  DIXIT, Manesh

发明人： DIXIT, Manesh ,  PEWAR, Vaibhav ,  PATEL, Rushi ,  PATEL, Mineshkumar

IPC分类号： A61K9/20 ,  A61K31/485

CPC分类号： A61K9/2095 ,  A61K9/0056 ,  A61K9/2013 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2059 ,  A61K9/2077 ,  A61K31/137 ,  A61K31/222 ,  A61K31/445 ,  A61K31/4468 ,  A61K31/485 ,  A61K31/522 ,  A61P25/30

摘要： The present disclosure relates to oral, abuse deterrent, edible soft chewable dosage forms for delivery of drugs that are susceptible to abuse to a human or animal subject. The dosage forms are provided as chewable tablets manufactured using a compression (tablet) press. The edible soft chew dosage forms can be administered to subjects that are unable to swallow conventional tablets or capsules whole. One or more abuse deterrent measures in the dosage forms prevent the conversion of the dosage form into a residue or extract suitable for non-oral administration, such as intranasal or intravenous abuse. The present disclosure also relates to processes of preparing the dosage form. Such soft chew dosage forms have hardness less than 2 kilopond, preferably less than 1 kilopond, more preferably no measurable hardness when measured with tablet hardness tester and friability less than 1%, preferably less than 0.5 %, more preferably less than 0.1% for 100 rotations (per USP); 200 rotations or 300 rotations.

摘要翻译： 本公开涉及用于将易于滥用的药物递送至人类或动物受试者的口服，滥用威慑，可食用软咀嚼剂型。 提供的剂型是作为使用压片机（压片机）制造的咀嚼片。 可食用的软咀嚼剂型可以给予不能吞服常规片剂或胶囊整体的受试者。 剂型中的一种或多种滥用威慑措施防止剂型转化为适合非口服给药的残留物或提取物，例如鼻内或静脉内滥用。 本公开还涉及制备该剂型的方法。 这样的软咀嚼剂型具有小于2千克的硬度，优选小于1千克的硬度，更优选当用片剂硬度测试仪测量时不具有可测量的硬度，并且脆碎度小于1％，优选小于0.5％，更优选小于0.1％ 轮换（每USP）; 200转或300转。