Characterization and Quality Control of Pharmaceutical Cocrystals

Author:

Izutsu Ken-ichi1,Koide Tatsuo1,Takata Noriyuki2,Ikeda Yukihiro3,Ono Makoto4,Inoue Motoki5,Fukami Toshiro5,Yonemochi Etsuo6

Affiliation:

1. Division of Drugs, National Institute of Health Sciences

2. Research Division, Chugai Pharmaceutical Co., Ltd.

3. Analytical Development Laboratories, CMC Center, Takeda Pharmaceutical Co., Ltd.

4. Analytical & Quality Evaluation Research Laboratories, Daiichi-Sankyo Co., Ltd.

5. Department of Molecular Pharmaceutics, Meiji Pharmaceutical University

6. School of Pharmacy and Pharmaceutical Sciences, Hoshi University

Publisher

Pharmaceutical Society of Japan

Subject

Drug Discovery,General Chemistry,General Medicine

Reference106 articles.

1. 1) Thakuria R., Delori A., Jones W., Lipert M. P., Roy L., Rodríguez-Hornedo N., Int. J. Pharm., 453, 101–125 (2013).

2. 2) Brittain H. G., J. Pharm. Sci., 102, 311–317 (2013).

3. 3) “Guidance for industry: Regulatory classification of pharmaceutical co-crystals,” Food and Drug Administration (2013).

4. 4) “Reflection paper on the use of cocrystals of active substances in medicinal products,” European Medicines Agency (2015).

5. 5) Shan N., Perry M. L., Weyna D. R., Zaworotko M. J., Expert Opin. Drug Metab. Toxicol., 10, 1255–1271 (2014).

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