专利名称:SODIUM CHLORIDE SOLUTION FOR DRUG
RECONSTITUTION OR DILUTION
发明人:WEBB, Chandra A.,ZERFAS, Julie申请号:EP17166616.7申请日:20061027公开号:EP3225233A1公开日:20171004
专利附图:
摘要:The invention provides methods for preparing pharmaceutical formulations forinjection such that upon injection the formulation does not cause erythrocyteagglutination, hemolysis, and/or cell shrinkage. To prevent agglutination, a
pharmaceutical formulation ready for injection needs to have a sufficient ionic strength.To prevent hemolysis or cell shrinkage, a pharmaceutical formulation ready for injectionneeds to be about isotonic with respect to plasma. The invention provides methods thatprepare pharmaceutical formulations for injection that have both the sufficient ionicstrength to prevent agglutination and the requisite tonicity to prevent significanthemolysis or cell dehydration or shrinkage. The present methods involve the use ofsodium chloride solutions that are about 25 mM to about 150 mM for reconstitutinglyophilized cakes (or other non-liquid pharmaceutical formulations) into solution or fordiluting pharmaceutical formulation solutions.
申请人:Wyeth LLC
地址:235 East 42nd Street New York, NY 10017-5755 US
国籍:US
代理机构:Pfizer
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