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Understanding the Delamination Risk of a Trilayer Tablet Using Minipiloting Tools.

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  • 1Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey 08901.

Journal of Pharmaceutical Sciences
|July 20, 2017
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Summary
This summary is machine-generated.

Tooling design significantly impacts multilayer tablet strength. Round flat-faced tooling yields stronger interfaces than typical commercial tablet shapes, crucial for assessing risks in formulation development.

Keywords:
compressionpowderprocessingsolid dosage formunit operations

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Multilayer tablets are essential for formulating incompatible drugs.
  • Current feasibility studies often use round flat-faced tooling, but its link to tablet performance is unclear.

Purpose of the Study:

  • To investigate tooling design's impact on multilayer tablet interfacial strength.
  • To evaluate scale-up/down effects using tablet weight and dimensions.
  • To assess how tablet shape, cup depth, and embossing size influence interfacial defects.

Main Methods:

  • Utilized a prototype trilayer tablet for small-scale studies.
  • Evaluated various tooling designs, including round flat-faced and typical commercial shapes.
  • Analyzed the influence of tablet weight, dimensions, and specific tooling parameters.

Main Results:

  • Tablet weight and dimensions significantly affect interfacial strength due to compression and ejection forces.
  • Round flat-faced tooling produced trilayer tablets with superior interfacial strength compared to oval, concave commercial designs.
  • Tooling design is a critical factor in multilayer tablet interfacial integrity.

Conclusions:

  • Round flat-faced tooling provides a robust method for assessing multilayer tablet interface risks.
  • Considerations for tooling selection are vital for accurate feasibility studies and scale-up predictions.
  • Findings guide the selection of appropriate tooling for evaluating multilayer tablet formulation stability.