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Approaches to Rapid In Vivo Optimization of Hydrophilic Matrix Tablets

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Hydrophilic Matrix Tablets for Oral Controlled Release

Part of the book series: AAPS Advances in the Pharmaceutical Sciences 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.

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Author information

Authors and Affiliations

  1. Drug Product Optimization, Quotient Clinical, Mere Way, Ruddington Fields, Nottingham, NG11 6JS, UK

    John McDermott Ph.D. (Director)

  2. Quotient Clinical, Nottingham, UK

    Peter Scholes Ph.D., Wu Lin Ph.D. & Alyson Connor Ph.D.

Authors
  1. John McDermott Ph.D.
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  2. Peter Scholes Ph.D.
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  3. Wu Lin Ph.D.
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  4. Alyson Connor Ph.D.
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Corresponding author

Correspondence to John McDermott Ph.D. .

Editor information

Editors and Affiliations

  1. Drug Product Science and Technology, Bristol-Myers Squibb, Moreton, Merseyside, United Kingdom

    Peter Timmins

  2. Commercial Trade Channels, Merck, Sharp and Dohme, Hoddesdon, Hertfordshire, United Kingdom

    Samuel R. Pygall

  3. School of Pharmacy, University of Nottingham, Notthingham, Nottinghamshire, United Kingdom

    Colin D. Melia

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McDermott, J., Scholes, P., Lin, W., Connor, A. (2014). Approaches to Rapid In Vivo Optimization of Hydrophilic Matrix Tablets. In: Timmins, P., Pygall, S., Melia, C. (eds) Hydrophilic Matrix Tablets for Oral Controlled Release. AAPS Advances in the Pharmaceutical Sciences Series, vol 16. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1519-4_9

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