Biorelevant Dissolution Testing

May Almukainzi, Na´dia Araci Bou-Chacra, Roderick B. Walker, Raimar Lo¨benberg

Research output: Chapter in Book/Report/Conference proceedingChapter

3 Citations (Scopus)

Abstract

This chapter reviews briefly the history of dissolution testing, types of apparatuses commonly used and discusses their routine use in quality control of oral dosage forms. The properties and usage of different available dissolution media to test oral dosage forms are highlighted and examples are given for their use and composition including biorelevant dissolution media. The challenges how to establish meaningful in vitro/in vivo correlations (IVIVC) in modern product development is discussed by looking into the mechanistic principles of the biopharmaceutical drug classification system (BCS) and how this can be used to develop a successful IVIVC strategy. Such approaches are especially important for quality by design environments. Finally, different studies utilizing computer simulations in combination with biorelevant dissolution protocols to establish IVIVC are shown. The chapter gives an overview of the possibilities and challenges in vitro dissolution testing offers to set biorelevant product specifications.

Original languageEnglish
Title of host publicationTherapeutic Delivery Solutions
PublisherWiley-Blackwell
Pages335-365
Number of pages31
ISBN (Electronic)9781118903681
ISBN (Print)9781118111260
DOIs
Publication statusPublished - 28 Jul 2014

Fingerprint

Dissolution
Testing
Product development
Quality control
Specifications
Computer simulation
Chemical analysis
Pharmaceutical Preparations

Keywords

  • Biopharmaceutical drug classification system
  • Biorelevant
  • Compartmental absorption and transit model
  • Dissolution
  • in vitro/in vivo correlation
  • Physiologically based pharmacokinetic model
  • Quality by design
  • USP

Cite this

Almukainzi, M., Bou-Chacra, N. A., Walker, R. B., & Lo¨benberg, R. (2014). Biorelevant Dissolution Testing. In Therapeutic Delivery Solutions (pp. 335-365). Wiley-Blackwell. https://doi.org/10.1002/9781118903681.ch12
Almukainzi, May ; Bou-Chacra, Na´dia Araci ; Walker, Roderick B. ; Lo¨benberg, Raimar. / Biorelevant Dissolution Testing. Therapeutic Delivery Solutions. Wiley-Blackwell, 2014. pp. 335-365
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Almukainzi, M, Bou-Chacra, NA, Walker, RB & Lo¨benberg, R 2014, Biorelevant Dissolution Testing. in Therapeutic Delivery Solutions. Wiley-Blackwell, pp. 335-365. https://doi.org/10.1002/9781118903681.ch12

Biorelevant Dissolution Testing. / Almukainzi, May; Bou-Chacra, Na´dia Araci; Walker, Roderick B.; Lo¨benberg, Raimar.

Therapeutic Delivery Solutions. Wiley-Blackwell, 2014. p. 335-365.

Research output: Chapter in Book/Report/Conference proceedingChapter

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Almukainzi M, Bou-Chacra NA, Walker RB, Lo¨benberg R. Biorelevant Dissolution Testing. In Therapeutic Delivery Solutions. Wiley-Blackwell. 2014. p. 335-365 https://doi.org/10.1002/9781118903681.ch12