Scale-Up of Solid Dosage Forms

Authored by: Jiahui Hu , Colleen E. Ruegger , Mangesh Bordawekar , Robert F. Wagner , Stephen J. Valazza , Mark R. Mecadon , Alan E. Royce , Natrajan Kumaraperumal , Matthew J. Mollan

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v4-52

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Abstract

The development of new drug products goes through many stages. Very early clinical studies may require less than 100 unit doses for proof-of-concept studies. Powder in a bottle and hand-filled capsule, manual-type approaches, can be acceptable at these early stages of development. As the product advances through the various phases of clinical trials, so does the scale of manufacture to produce the increasing supplies needed for clinical studies with larger patient populations. This requires development of processes on equipment with outputs in the thousands to millions, depending on the indication and patient population that will be treated.

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