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The awarded Egis medicines can replace the concurrent administration of ezetimibe and rosuvastatin, or ezetimibe and atorvastatin, often taken simultaneously in the therapy of cardiovascular diseases.
The innovative fixed-dose combination drugs contain both active ingredients, allowing the patient to take just one medication instead of two.
Developing these drugs posed several special challenges for the professionals at Egis. The active substances in question behave differently in many respects, and enclosed in the same capsule they can react with each other, potentially affecting each other's dissolution and bioavailability.
By processing the active ingredients in separate platform elements and by significantly reducing the contact surface, the interaction between them was finally minimized.
"We are especially proud that the active ingredient rosuvastatin is the result of Egis' own generic development and is currently manufactured by our company - said Csaba Poroszlai at the award ceremony. - During its development, our researchers successfully identified the zinc salt of rosuvastatin which is beneficial from stability point of view, and its crystalline form, which has proven to be highly suitable to be developed as an active pharmaceutical ingredient."
Additionally, a non-infringing, robust, high-yielding, and scalable drug manufacturing process has been elaborated at Egis. It is based on an unconventional chemical step.
An effective solution to one of the cornerstones of formulation development has also been found, namely, to increase the solubility and bioavailability of the active ingredient ezetimibe. Eliminating the disadvantages of known methods, it provides the required particle size distribution to achieve the desired dissolution rate.
Csaba Poroszlai, CEO of Egis Pharmaceuticals PLC received the award from Dr. Csaba Hende, Deputy Speaker of the National Assembly and Dr. Eszter Vitályos, Deputy Minister of the Ministry of Culture and Innovation in the House of Parliament on March 26, 2024.