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Last Updated: December 12, 2025

Claims for Patent: 8,642,760

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Summary for Patent: 8,642,760

Title:	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Abstract:	The present invention provides low hygroscopic forms of aripiprazole and processes for the preparation thereof which will not convert to a hydrate or lose their original solubility even when a medicinal preparation containing the anhydrous Aripiprazole crystals is stored for an extended period.
Inventor(s):	Takuji Bando, Satoshi Aoki, Junichi Kawasaki, Makoto Ishigami, Youichi Taniguchi, Tsuyoshi Yabuuchi, Kiyoshi Fujimoto, Yoshihiro Nishioka, Noriyuki Kobayashi, Tsutomu Fujimura, Masanori Takahashi, Kaoru Abe, Tomonori Nakagawa, Koichi Shinhama, Naoto Utsumi, Michiaki Tominaga, Yoshihiro Ooi, Shohei Yamada, Kenji Tomikawa
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US13/067,750
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,642,760
Patent Claims:	1. Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.40% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60° C. and a humidity level of 100%. 2. Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.10% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60° C. and a humidity level of 100%. 1. Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.40% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60.degree. C. and a humidity level of 100%. 2. Aripiprazole drug substance of low hygroscopicity wherein said low hygroscopicity is defined as a moisture content of 0.10% or less after placing said drug substance for 24 hours in a dessicator maintained at a temperature of 60.degree. C. and a humidity level of 100%.

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