Investigation of Fluidized Bed Granulation Mechanism by Using an Online Particle Size Monitoring Device

Author:

Hayashi Kentaro12,Watano Satoru2

Affiliation:

1. Formulation Development, Production Technology Department, Manufacturing Division, SHIONOGI & CO., LTD.

2. Graduate School of Engineering, Osaka Prefecture University

Publisher

The Society of Powder Technology, Japan

Subject

Filtration and Separation,Fluid Flow and Transfer Processes,Process Chemistry and Technology,Catalysis

Reference22 articles.

1. [1] ICH Expert Working Group, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8, Revision 2, 2009.

2. [2] U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 2004.

3. [3] T. Mizuta, Seizo Risk to PAT Guidance oyobi PAT no Syuho, PDA J. GMP Val. Japan 7 (2005) 25–37.

4. [4] M. Fujiwara, W. Momose, K. Kuroda, T. Inatani, K. Yamashita, K. Sako, Proportional control of moisture content of granules by adjusting inlet air temperature in fluidized bed granulation using near-infrared spectroscopy, Adv. Powder Technol. 25 (2014) 704–709.

5. [5] H. Nakagawa, Y. Kikkawa, K. Matsuura, S. Tanabe, T. Watanabe, Implementation of enhanced QbD to drug product development, J. Japan Soc. Pharm. Mach. Eng. 24 (2015) 469–475.

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