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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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QbD approach to downstream processing of spray-dried amorphous solid dispersions - a case study.

João Henriques1, Jorge Moreira1, Slavomíra Doktorovová1

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Pharmaceutical Development and Technology
|December 16, 2020
PubMed
Summary

Roller compaction (RC) improves spray-dried amorphous solid dispersion powder flow for tablet manufacturing. Optimal RC parameters enhance powder flow and tablet quality without compromising compressibility.

Keywords:
DoERoller compactionamorphous solid dispersionsloss of compactabilitytablets manufacture

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Spray-dried amorphous solid dispersions (ASDs) are crucial for enhancing drug solubility and bioavailability.
  • Direct compression of spray-dried powders is often hindered by poor flow properties, necessitating alternative processing methods.
  • Roller compaction (RC) is a viable technique for improving the processability of ASD powders for tablet manufacturing.

Purpose of the Study:

  • To develop a structured approach for optimizing roller compaction (RC) parameters for spray-dried amorphous solid dispersions (ASDs).
  • To identify RC process conditions that improve powder flowability while maintaining tablet quality (robustness and compressibility).

Main Methods:

  • Utilized a structured experimental design to systematically vary RC process parameters (compaction force, gap, mesh aperture).
  • Compacted ten different powder blends using the defined RC parameters.
  • Compressed the resulting granules into tablets and analyzed granule and tablet properties.

Main Results:

  • Compaction force, gap, and mesh aperture significantly influence RC outcomes.
  • A combination of a large gap and low compaction force was identified as optimal.
  • This optimal condition improved powder flow, ensuring low tablet weight variation and preserving blend compressibility.

Conclusions:

  • The study successfully demonstrates a structured methodology for downstream process development of spray-dried ASDs using RC.
  • Optimized RC parameters are critical for achieving desirable powder flow and robust tablet characteristics.
  • The findings provide valuable insights for pharmaceutical manufacturers aiming to improve the tableting of spray-dried ASDs.