dissolutionprofil

Dissolutionprofil, typically referred to in English as the dissolution profile, is the data set that describes the rate and extent to which a drug dissolves from a dosage form in a defined dissolution medium under standardized conditions. It is usually expressed as the percentage of drug dissolved over time and can be represented as a curve plotted against time.

The dissolutionprofil is generated through in vitro dissolution testing, most commonly using standardized apparatuses such as USP apparatus II (paddle) or apparatus I (basket) at a controlled temperature of 37°C. Samples are taken at predefined intervals and analyzed to determine how much drug has dissolved. Profiles are constructed for each batch and formulation and can vary for immediate-release and modified-release products.

Applications of the dissolutionprofil include quality control and batch release, stability assessment, and formulation development. It also plays a central role in establishing in vitro–in vivo correlations (IVIVC), which link dissolution behavior to expected in vivo performance. Comparison of dissolution profiles between products or batches is often performed using similarity metrics such as the f2 factor, with higher values indicating greater similarity.

Several factors can influence a dissolutionprofil, including the physicochemical properties of the active pharmaceutical ingredient (solubility, particle size, polymorphism), excipient composition, dosage form design, and test conditions (pH, ionic strength, agitation, media volume). Regulatory guidance from authorities such as the USP and ICH governs the generation, interpretation, and reporting of dissolution profiles as part of quality assurance and regulatory submissions.