Traditional (USP) dissolution tests have been used in the pharmaceutical industry to perform quality control of manufacturing process for drug products, and also to compare performance of different drug product formulations during the late stage of the drug development process. It has been a subject of multiple debates if differences in the dissolution profile would be biorelevant, i.e. would lead to the significant changes in the in vivo absorption properties of active pharmaceutical ingredients (API). The goal of this study was to develop a method enabling simultaneous monitoring of dissolution of the drug product in the compendial apparatus at the same time providing the means to assess kinetic of API penetration into the absorption chamber separated from the dissolution vessel by a lipophilic membrane.

New and Improved Features in Pion DissoPRO Software Version 3.5

Pion Scissor is a new instrument designed to simulate the physiological conditions of the hypodermis, to be used as an in vitro model of the physical behaviour of biopharmaceutical formulations undergoing subcutaneous (SC) injection. Often biopharmaceuticals are formulated under non-physiological conditions with the aim of improving stability and prolonging shelf-life. Biopharmaceuticals intended for SC injection are typically formulated at low pH to mitigate decomposition, and in the presence of various stabilising agents and excipients