Solubility vs Dissolution in Physiological Bicarbonate Buffer.

ABSTRACT:

Background

Phosphate buffer is often used as a replacement for the physiological bicarbonate buffer in pharmaceutical dissolution testing, although there are some discrepancies in their properties making it complicated to extrapolate dissolution results in phosphate to the in vivo situation. This study aims to characterize these discrepancies regarding solubility and dissolution behavior of ionizable compounds.

Methods

The dissolution of an ibuprofen powder with a known particle size distribution was simulated in silico and verified experimentally in vitro at two different doses and in two different buffers (5 mM pH 6.8 bicarbonate and phosphate).

Results

The results showed that there is a solubility vs. dissolution mismatch in the two buffers. This was accurately pre

SUBMITTER: Claussen F 

PROVIDER: S-EPMC11116206 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature