IMMUNOGLOBULIN FORMULATION AND METHOD OF PREPARATION THEREOF

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which m...

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Bibliographic Details
Main Authors CALLOWAY, JAMES, LEHRMAN, SHERWOOD, RUSS, BUCKLEY, SHAUN, E, BURKE, DAVID, J, O'CONNOR, BARBARA, HORSEY
Format Patent
LanguageEnglish
French
Published 26.08.2004
Edition7
Subjects
CHEMISTRY
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary:A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight. L'invention a trait à une préparation pharmaceutique aqueuse stable, qui contient une dose thérapeutiquement efficace d'un anticorps, du polysorbate 80, un tampon qui inhibe l'oxydation du polysorbate, ainsi qu'à des procédés de production de ladite préparation. L'invention concerne également des préparations contenant une concentration d'anticorps élevée, qui conservent un volume fixe et qui peuvent être utilisées sur des patients de poids variable.
Bibliography:Application Number: WO2004US03873