Approaches to Rapid In Vivo Optimization of Hydrophilic Matrix Tablets

  • John McDermott
  • Peter Scholes
  • Wu Lin
  • Alyson Connor
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 16)

Abstract

The optimisation of hydrophilic matrix tablets to balance formulation, biopharmaceutical, and physiological variables to achieve a target product profile is a complex process. Traditionally this optimisation process has relied upon application of a series of in vitro, preclinical, and clinical experimentation which extend programme timelines and increase cost to the development programme.

The purpose of this chapter is to discuss the formulation and biopharmaceutical variables that can impact the optimisation of a hydrophilic matrix tablet and describe the limitations of in vitro and preclinical models. The chapter will present strategies to overcome these limitations by designing development programmes to accelerate the in vivo optimisation process using a clinical “make-test” paradigm, termed Translational Pharmaceutics, including case studies.

Keywords

Regional absorption Gamma scintigraphy Translational pharmaceutics RapidFACT Formulation development Clinical testing Formulation design space 

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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • John McDermott
    • 1
  • Peter Scholes
    • 2
  • Wu Lin
    • 2
  • Alyson Connor
    • 2
  1. 1.Drug Product OptimizationQuotient ClinicalNottinghamUK
  2. 2.Quotient ClinicalNottinghamUK

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