The nanotechnology company Capsulution NanoScience AG (Berlin, Germany) has begun with pre-clinical in-vivo tests of innovative formulations of a hormone compound for tumor therapy. In collaboration with the “Forschungseinrichtung für Experimentelle Medizin” (FEM) at the Charité in Berlin, these tests investigate new kinds of depot formulations, which were developed on the basis of Capsulution’s technology platform in cooperation with an unnamed American company. By demonstrating this new kind of depot formulations Capsulution makes another important step establishing its patented technology in the field of pharmaceutical development. At the same time, the results of already generated in-vitro tests have served as the foundation for a contract development of yet another innovative hormone formulation.
Dr. Volker Fehring, Project Director at Capsulution, comments, “The in-vivo studies allow the efficient investigation of these new kinds of depot formulations on the pharmacokinetic, pharmacodynamic and histological levels. In combination with appropriate bioequivalence tests, Capsulution will get a deeper insight into the complex release and effective mechanisms and thus make it possible to fine-tune these depot formulations in a targeted manner.”
Upon successful conclusion of the tests, Capsulution and its partner are planning to further develop the product as fast as possible. Few contingency risks are expected on the way to regulatory approval of the finished formulations on the market. In contrast to the development of new chemical entities (NCE), the development of these formulations are based on active and excipient agents that have already been approved.
Dr. Volker Fehring, Project Director at Capsulution, comments, “The in-vivo studies allow the efficient investigation of these new kinds of depot formulations on the pharmacokinetic, pharmacodynamic and histological levels. In combination with appropriate bioequivalence tests, Capsulution will get a deeper insight into the complex release and effective mechanisms and thus make it possible to fine-tune these depot formulations in a targeted manner.”
Upon successful conclusion of the tests, Capsulution and its partner are planning to further develop the product as fast as possible. Few contingency risks are expected on the way to regulatory approval of the finished formulations on the market. In contrast to the development of new chemical entities (NCE), the development of these formulations are based on active and excipient agents that have already been approved.
