Simulated, biorelevant, clinically relevant or physiologically relevant dissolution media: The hidden role of bicarbonate buffer.

Simulated, biorelevant, clinically relevant or physiologically relevant dissolution media: The hidden role of bicarbonate buffer. Eur J Pharm Biopharm. 2019 Jun 10;: Authors: Amaral Silva D, Al-Gousous J, Davies NM, Bou Chacra N, Webster GK, Lipka E, Amidon G, Löbenberg R Abstract In-vitro dissolution testing of pharmaceutical formulations has been used as a quality control test for many years. At early drug product development, in vivo predictive dissolution testing can be used for guidance in the rational selection of candidate formulations that best fit the desired in vivo dissolution characteristics. At present, the most widely applied dissolution media are phosphate-based buffers and, in some cases, the result of dissolution tests performed in such media have demonstrated reasonable/acceptable IVIVCs. However, the presence of phosphates in human GI luminal fluids is insignificant, which makes the use of such media poorly representative of the in vivo environment. The gastrointestinal lumen has long been shown to be buffered by bicarbonate. Hence, much interest in the development of suitable biorelevant in vitro dissolution media based on bicarbonate buffer systems has evolved. However, there are inherent difficulties associated with these buffers, such as maintaining the pH throughout the dissolution test, as CO2 tends to leave the system. Various mathematical models have been proposed to analyze bicarbonate buffers and they ar...
Source: European Journal of Pharmaceutics and Biopharmaceutics - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharm Biopharm Source Type: research