Development of new pharmaceutical compounds and dosage forms often requires in vitro dissolution testing with the closest similarity to the human gastrointestinal (GI) tract. To create such conditions, one needs a suitable dissolution apparatus and the appropriate data on the human GI physiology. This review discusses technological approaches applicable in biorelevant dissolutions as well as the physiology of stomach and small intestine in both fasted and fed state, that is, volumes of contents, transit times for water/food and various solid oral dosage forms, pH, osmolality, surface tension, buffer capacity, and concentrations of bile salts, phospholipids, enzymes, and Ca(2+) ions. The information is aimed to provide clear suggestions on how these conditions should be set in a dynamic biorelevant dissolution test.

University of Veterinary and Pharmaceutical Sciences Brno Brno 612 42 Czech Republic

Citace poskytuje Crossref.org

Anticancer Applications of Essential Oils Formulated into Lipid-Based Delivery Nanosystems

Chronic Inflammatory Diseases, Anti-Inflammatory Agents and Their Delivery Nanosystems

Optimization of Dissolution Compartments in a Biorelevant Dissolution Apparatus Golem v2, Supported by Multivariate Analysis

Preparation of Hydrochlorothiazide Nanoparticles for Solubility Enhancement

Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem": A Novel Apparatus