Advances in Mechanistic Understanding of Release Rate Control Mechanisms of extended-release Hydrophilic Matrix Tablets

Abstract

Approaches to characterizing and developing understanding around the mechanisms that control the release of drugs from hydrophilic matrix tablets are reviewed. While historical context is provided and direct physical characterization methods are described, recent advances including the role of percolation thresholds, the application on magnetic resonance and other spectroscopic imaging techniques are considered. The influence of polymer and dosage form characteristics are reviewed. The utility of mathematical modeling is described. Finally, how all the information derived from applying the developed mechanistic understanding from all of these tools can be brought together to develop a robust and reliable hydrophilic matrix extended-release tablet formulation is proposed.

Keywords:

• extended-release
• hydrophilic matrix tablets
• release-rate mechanisms

Financial & competing interests disclosure

At the time of writing the manuscript all the authors were salaried employees of Bristol-Myers Squibb, a research-based biopharmaceutical company. Medicines offered by Bristol-Myers Squibb include those based on hydrophilic matrix tablets. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.