RH-EPO NASAL FORMULATIONS WITH LOW SIALIC ACID CONCENTRATIONFOR THE TREATMENT OF DISEASES OF THE CENTRAL NERVOUS SYSTEM

摘要

The invention relates to the biopharmaceutical industry and, in particular, to the development of a medicament which is intended for the treatment of cerebrovascular, neurodegenerative and psychiatric diseases and which contains, by way of active principle, recombinant human erythropoietin (rh- Epo) with a low sialic acid concentration. During rh-Epo production, the glycoprotein is obtained with a different sialic acid concentration when les s than 40 % of the molecule thereof is protected with (basic) sialic acid, in which case it is not biologically active by systemic route and is inactivate d by hepatic enzymes. Surprisingly, it was found that nasally-administered bas ic rh-Epo has greater therapeutic benefits than the acid. The inventive basic r h- Epo nasal formulations include bioadhesive polymers which increase the residence time in the nasal cavity, thereby enhancing the therapeutic effect thereof. Said formulations also include other auxiliary substances, such as preservative substances, surfactants, pH regulators, isotonising agents and protein stabilisers.