A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/40 (2006.01) A61K 39/395 (2006.01) A61K 49/00 (2006.01) B01D 61/24 (2006.01)
Patent
CA 2742988
A method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions by the addition of certain cyclodextrins (CDs) is disclosed Also provided is a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule and pharmaceutical formulations for such administration Further provided are methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention Further provided is an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions
La présente invention concerne un procédé permettant de réduire l'agrégation et d'inhiber la floculation d'une macromolécule telle quune protéine dans des conditions physiologiques par l'addition de certaines cyclodextrines (CD). L'invention concerne également un procédé permettant de minimiser l'inflammation au site d'injection lors de l'administration sous-cutanée d'une macromolécule et des formulations pharmaceutiques pour une telle administration. En outre, l'invention concerne des procédés visant à traiter une maladie auto-immune ou un cancer CD20-positif, qui consistent à administrer un anticorps anti-CD20 humanisé dans une formulation pharmaceutique de l'invention. Linvention concerne également un procédé de dialyse in vitro permettant d'évaluer la capacité d'un excipient à réduire l'agrégation d'un anticorps ou d'une autre macromolécule dans des conditions physiologiques.
Lo Sabrina
Lobo Brian
Wang Yuchang John
Wong Rita
Genentech Inc.
Smart & Biggar
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