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Chewability testing in the development of a chewable tablet for hyperphosphatemia.

Michael Lanz1, Jan Baldischweiler, Burkhard Kriwet

  • 1Institute of Pharmaceutical Technology, School of Life Sciences - FHNW, Gründenstrasse 40 , Muttenz , Switzerland .

Drug Development and Industrial Pharmacy
|September 10, 2013
PubMed
Summary

New in vitro tests effectively assess tablet chewability, simulating chewing action better than current methods. These tests are crucial for developing and characterizing chewable medications like the phosphate binder PA21.

Keywords:
Artificial salivaaxial breaking forcechewabilitychewable tabletshyperphosphatemiain-vitro testindentationradial breaking force

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Current pharmacopeial standards lack in vitro chewability tests for tablets.
  • Limited scientific literature exists on tablet chewability assessment.

Purpose of the Study:

  • To evaluate existing and develop novel in vitro test procedures for tablet chewability.
  • To characterize the chewability of a novel phosphate binder (PA21) against commercial products.
  • To establish reliable methods for assessing chewable tablet properties.

Main Methods:

  • Assessment of standard breaking force and strength testing.
  • Development of new procedures simulating chewing action.
  • Testing of PA21 formulations, lanthanum-based, and calcium-based chewable tablets.
  • Moistening tablets with artificial saliva during testing.

Main Results:

  • Radial/diametrical breaking force poorly assesses chewability; axial breaking force is a better indicator.
  • Tablet behavior under repeated loading, especially when moistened, best simulates chewing.
  • Developed tests demonstrate superior discriminating power for chewability compared to pharmacopeial methods.

Conclusions:

  • Novel in vitro tests provide a more suitable evaluation of tablet chewability.
  • These methods confirm optimal chewability for PA21 development while ensuring production robustness.
  • The developed tests align with ICHQ6 guidelines for chewable tablet specifications.