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Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing.

Hayato Ishimoto1, Manabu Kano2, Hirokazu Sugiyama3

  • 1Formulation Research, Pharmaceutical Science & Technology Core Function Unit, Medicine Development Center, Eisai Co., Ltd.

Chemical & Pharmaceutical Bulletin
|December 10, 2020
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Summary
This summary is machine-generated.

This document outlines a control strategy for continuous manufacturing of oral solid dosage forms, adapting existing batch manufacturing methods. It highlights differences in process development for continuous versus batch manufacturing.

Keywords:
Quality by Design (QbD)continuous manufacturingcontrol strategyregulatory sciencesolid drug productstate of control

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Control

Background:

  • Continuous manufacturing is an emerging paradigm in pharmaceutical production.
  • Established batch manufacturing principles offer a foundation for continuous processes.
  • Adapting existing methodologies is crucial for successful implementation.

Purpose of the Study:

  • To present an approach for establishing a control strategy for continuous manufacturing of oral solid dosage forms.
  • To identify similarities and differences between batch and continuous manufacturing processes.
  • To provide a framework for developing control strategies in pharmaceutical manufacturing.

Main Methods:

  • Leveraging existing drug development, technology transfer, process control, and quality control methods.
  • Analyzing process development differences between continuous and batch manufacturing.
  • Illustrating a thought process for control strategy establishment.

Main Results:

  • Existing batch manufacturing methods are largely applicable to continuous manufacturing.
  • Process development requires specific considerations for continuous manufacturing.
  • A structured approach to control strategy is feasible.

Conclusions:

  • A robust control strategy can be developed for continuous manufacturing by adapting current practices.
  • Understanding process development nuances is key to successful continuous manufacturing implementation.
  • This work provides a foundational approach for the pharmaceutical industry.