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RH-EPO NASAL FORMULATIONS WITH LOW SIALIC ACID CONCENTRATION FOR THE TREATMENT OF DISEASES OF THE CENTRAL NERVOUS SYSTEM
专利权人:
CENTRO DE INVESTIG Y DESARROLLO DE MEDICAMENTOS CIDEM
发明人:
申请号:
EP06761631.8
公开号:
EP1997483B1
申请日:
2006.07.27
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
The present invention is related to the biopharmaceutical industry and in particular to the development of a medication for the treatment of cerebrovascular, neurodegenerative and psychiatric diseases. Its active principle is recombinant human erythropoietin (rhEPO) with low content of sialic acid. During the production of rhEPO, this glycoprotein is obtained with different contents of sialic acid if less than 40% of the molecule is protected with (basic) sialic acid, it is not biologically active in the systemic way, as it is then inactivated by hepatic enzymes. Surprisingly, we have found that intranasal administration of basic rhEPO has enhanced therapeutic activity in comparison with acid rhEPO. The nasal formulations of basic rhEPO herein presented incorporate bioadhesive polymers which increase the residence time in the nasal cavity, thereby enhancing their therapeutic effect. They also include other auxiliary substances such as preservatives, tensioactive agents, pH regulators, isotonic agents and protein stabilizers.
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