Method and formulation for reducing aggregation of a...

Details Method and formulation for reducing aggregation of a... Method and formulation for reducing aggregation of a...

A - Human Necessities

61

K

A61K 47/30 (2006.01) A61K 39/395 (2006.01) A61P 35/00 (2006.01) A61P 37/06 (2006.01) B01D 61/24 (2006.01)

Patent

CA 2742990

The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and 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. The invention further provides 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 5 % à 20 % de polyvinylpyrrolidone (PVP) avec une gamme de poids moléculaire de 2000 à 54 000 Da. L'invention concerne également un procédé permettant de minimiser l'inflammation au site d'injection lors de l'administration sous-cutanée d'une macromolécule. Sous dautres aspects, l'invention concerne des formulations pharmaceutiques pour administration sous-cutanée d'une macromolécule, et 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 en outre 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.

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