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Particle Engineering for Enabling a Formulation Platform Suitable for Manufacturing Low-Dose Tablets by Direct

Wei-Jhe Sun1, Aktham Aburub2, Changquan Calvin Sun1

  • 1Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 308 Harvard Street S.E., Minneapolis, Minnesota 55455.

Journal of Pharmaceutical Sciences
|March 22, 2017
PubMed
Summary

Developing low-dose oral tablets using direct compression (DC) is challenging. This study presents a particle engineering approach with a porous carrier to create uniform API-carrier composites, ensuring excellent content uniformity (CU) and quality for DC tablets.

Keywords:
Neusilincontent uniformityformulationmanufacturabilityparticle engineeringtableting

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Maintaining content uniformity (CU) in low-dose oral tablets, especially via direct compression (DC), presents significant manufacturing challenges.
  • Traditional methods often struggle with achieving consistent drug distribution in the final tablet dosage form.

Purpose of the Study:

  • To develop a versatile platform direct compression (DC) tablet formulation for low-dose active pharmaceutical ingredients (APIs).
  • To demonstrate the efficacy of particle engineering via API-carrier composites for achieving excellent content uniformity (CU).

Main Methods:

  • Utilized particle engineering by loading APIs into porous carriers to form uniform API-carrier composites.
  • Evaluated powder properties (flowability, tabletability) and tablet attributes (friability, disintegration) for six model APIs.
  • Assessed drug release profiles from the developed tablets.

Main Results:

  • The developed platform formulation demonstrated excellent content uniformity (CU) across six model active pharmaceutical ingredients (APIs).
  • Powder and tablet properties were consistently excellent and showed minimal variation, irrespective of API chemical structure or loading.
  • Tablets exhibited nearly 100% drug release in water, indicating good bioavailability potential.

Conclusions:

  • Particle engineering of API-carrier composites offers a robust solution for developing low-dose direct compression (DC) tablets with superior content uniformity (CU).
  • This approach ensures critical quality attributes are met, holding promise for broad applicability in pharmaceutical manufacturing.