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Systematical approach of formulation and process development using roller compaction.

Yue Teng1, Zhihui Qiu, Hong Wen

  • 1Pharmaceutical Development Unit, Novartis Pharmaceuticals Corporation, East Hanovor, NJ 07446, USA.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|May 2, 2009
PubMed
Summary
This summary is machine-generated.

This review covers roller compaction, a key pharmaceutical dry granulation technique. It details excipients, equipment, process parameters, and quality attribute impacts for optimized drug product development.

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Area of Science:

  • Pharmaceutical technology
  • Chemical engineering
  • Materials science

Background:

  • Roller compaction is increasingly vital for pharmaceutical dry granulation.
  • Understanding excipient and equipment roles is crucial for process success.

Purpose of the Study:

  • To review common excipients and equipment in roller compaction.
  • To discuss process parameters and their effect on critical quality attributes.
  • To outline evaluation methods for roller compaction products.

Main Methods:

  • Literature review of roller compaction processes.
  • Analysis of excipient and equipment selection criteria.
  • Discussion of process parameter optimization and quality control.

Main Results:

  • Identification of commonly used excipients and machinery for dry granulation.
  • Elucidation of the relationship between process parameters and critical quality attributes.
  • Presentation of various analytical techniques for evaluating roller compacted products.

Conclusions:

  • A systematic approach to formulation and process development is essential.
  • Excipient selection, critical process parameter identification, and testing are key components.
  • Optimized roller compaction leads to improved pharmaceutical product quality.