Related Experiment Video
Updated: Apr 22, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Determination of critical parameters of drug substance influencing dissolution: a case study
Erika Bojnanska1, Michal Kalina2, Ladislav Parizek2
1Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackeho 1/3, 612 42 Brno, Czech Republic.
Abstract:
The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.
Related Concept Videos
Drug Dissolution: Requirements and Profile Comparison
Factors Influencing Drug Absorption: Drug Dissolution
Factors Influencing Drug Absorption: Pharmaceutical Parameters
Factors Affecting Dissolution: Particle Size and Effective Surface Area
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH
A drug's pKa and the pH of the gastrointestinal (GI) tract play crucial roles...

