Physicochemical properties of buffers used in simulated biological fluids with potential application for in vitro dissolution testing: A mini-review

Abstract

This literature review focuses on the physicochemical properties of buffers used in biorelevant media for in vitro dissolution testing. Because biorelevant dissolution systems have been previously reviewed, this review is primarily related to the buffers used in biorelevant media and not the media, per se. It is based on a survey of the literature in areas including analytical chemistry; biochemistry; clinical, solution, and physical chemistry; dissolution science and technology; pharmaceutical sciences; simulated biological fluids; and buffer-related articles from the National Institute of Standards and Technology with the intent of identifying challenges in formulating buffered biorelevant dissolution media and also identifying general attributes that are useful in selecting a buffer for a particular dissolution application. Other topics include: (1) key physicochemical properties of buffers that affect experimental conditions and dissolution results; (2) buffer compatibility with a diverse array of ingredients found in biorelevant media; and (3) the potential to supplement the library of traditional buffers used for in vitro dissolution testing with zwitterionic buffers that were designed for biological application.