Evaluation of Drug Adsorption to Membrane Filters under Biowaiver Test Conditions

Abstract

Media The media used for the filtration experiments were pH 1.2 Simulated Gastric Fluid without pepsin (SGFsp), a pH 4.5 acetate buffer (50 mM), and pH 6.8 Simulated Intestinal Fluid without pancreatin (SIFsp), which are all USP Test Solutions (4). Stock solutions of the model drugs were prepared in each buffer solution; the concentrations are displayed in Table 2. Concentrations were chosen to simulate the 100% dissolution rate from the lowest standard dosage forms (100 mg acetylsalicylic acid and 5 mg prednisolone) in their compendial dissolution volumes (500 mL for acetylsalicylic acid and 900 mL for prednisolone) (4).