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Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

By Wahlich, John

Published on

Abstract

Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.

Journal

Pharmaceutics. Volume 13, 2021, 1311

DOI

10.3390/pharmaceutics13081311

Type of publication

Peer-reviewed journal

Affiliations

  • Academy of Pharmaceutical Sciences

Article Classification

Review article

Classification Areas

  • PAT
  • Oral solid dose

Tags