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1. (WO2017151571) ABUSE DETERRENT SOFT CHEWABLE DRUG FORMULATIONS

Pub. No.:    WO/2017/151571    International Application No.:    PCT/US2017/019869
Publication Date: Sat Sep 09 01:59:59 CEST 2017 International Filing Date: Wed Mar 01 00:59:59 CET 2017
IPC: A61K 9/20
A61K 31/485
Applicants: FIRST TIME US GENERICS LLC
DIXIT, Manesh
Inventors: DIXIT, Manesh
PEWAR, Vaibhav
PATEL, Rushi
PATEL, Mineshkumar
Title: ABUSE DETERRENT SOFT CHEWABLE DRUG FORMULATIONS
Abstract:
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.