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Product‐centered processing: Pharmaceutical tablets and capsules
Author(s) -
Fung Ka Y.,
Ng Ka M.
Publication year - 2003
Publication title -
aiche journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.958
H-Index - 167
eISSN - 1547-5905
pISSN - 0001-1541
DOI - 10.1002/aic.690490512
Subject(s) - quality by design , product (mathematics) , process engineering , quality (philosophy) , process (computing) , process analytical technology , computer science , critical quality attributes , manufacturing process , heuristics , manufacturing engineering , antacid , biochemical engineering , new product development , engineering , mathematics , chemistry , materials science , work in process , business , operations management , marketing , philosophy , geometry , biochemistry , epistemology , composite material , operating system
A systematic procedure is presented for synthesizing and developing a manufacturing process for pharmaceutical tablets and capsules. The product quality factors—functional, physical and sensorial—are first identified. The dosage form and excipients are then selected, and the process flowsheet is synthesized along with the suitable equipment and operating conditions. Finally, the product and process are evaluated to ensure that the product possesses the desired quality factors. Design heuristics and physical models are provided to assist decision‐making. Examples involving Vitamin C, antacid, and ginseng are provided to illustrate the procedure.