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Control strategy and methods for continuous direct compression processes.

Yasuhiro Suzuki1, Hirokazu Sugiyama2, Manabu Kano3

  • 1Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Kanagawa 254-0014, Japan.

Asian Journal of Pharmaceutical Sciences
|May 17, 2021
PubMed
Summary
This summary is machine-generated.

This study introduces a new control strategy for continuous direct compression tablet manufacturing. It highlights the importance of controlling component ratios and powder content using the Residence Time Distribution (RTD) model for Loss in Weight feeders.

Keywords:
Continuous manufacturingLoss in weight feederProcess controlRegulatory scienceResidence time distributionSolid drug products

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Control

Background:

  • Traditional batch manufacturing for tablets has limitations.
  • Continuous manufacturing offers potential advantages in efficiency and quality.
  • A specific control strategy is needed for continuous direct compression processes.

Purpose of the Study:

  • To present a novel control strategy for tablet manufacturing via continuous direct compression.
  • To identify critical control points specific to continuous manufacturing.
  • To establish a foundation for implementing advanced process control in pharmaceutical production.

Main Methods:

  • Collaboration between pharmaceutical industry experts, machine suppliers, academia, and regulatory authorities.
  • Identification of component ratio and blended powder content as key control parameters.
  • Application of the Residence Time Distribution (RTD) model for feeder control.

Main Results:

  • The Loss in Weight (LIW) feeder control was identified as crucial for continuous manufacturing.
  • The RTD model proved effective for setting control ranges and managing LIW feeders.
  • A conceptual framework for process control using RTD was developed.

Conclusions:

  • The proposed control strategy, centered on RTD modeling, is effective for continuous direct compression.
  • This approach provides a robust foundation for adopting new control methods in pharmaceutical manufacturing.
  • The findings are applicable to both Japanese and international markets.