Most drug candidates in pharmaceutical development are highly pure and in a thermodynamically stable crystalline state.
However, upon initial isolation the active may be obtained in a fully or partially amorphous state, which possesses physical properties different from their corresponding crystalline state. Solid state modification from crystalline to amorphous can be a viable approach for enhancing drug dissolution and thus bioavailability. However, the high internal energy and specific volume of amorphous state relative to crystalline means that during processing or storage the amorphous state may undergo devitrification. Hence, amorphous solids require stabilization, it is common practice to prepare a dispersion in a pharmaceutically-acceptable polymer in order to achieve a stable form. Typically, amorphous forms are prepared via melt extrusion or spray drying.
Hot Melt Extrusion Technologies
Hot melt extrusion (HME) processing represents an excellent technique to prepare amorphous API formulations for pharmaceutical products with an increased active dissolution rate leading to enhanced bioavailability. In general, HME involves preparing a molecular dispersion of the active in a polymer matrix Scientists at CPES can extrude combinations of drugs, polymers and additives (plasticisers) into a variety of finished forms to obtain a drug product with the desired Critical Quality Attributes (CQA’s). CPES are experts in HME with many years experience in developing new pharmaceutical formulations and have a large range of laboratory scale equipment and a clean room facility. We also have relationships with CMO’s and can transfer processes for clinical manufacture.
Professor Anant Paradkar - Director
Dr Jason Jones - Business Development
T: +44-1274- 236193