Method for reducing the reconstitution time of spray-dried protein formulations
AssigneeUcb Biopharma Srl
InventorsMaarten BATENS, Jan Ivo MASSANT
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Abstract
The present invention relates to the use of a combination of sugar and one or more amino acids for reducing the reconstitution time of a spray-dried protein formulation.
Claims19
A method for reducing reconstitution time of a spray-dried protein formulation, wherein the method comprises spray-drying a protein formulation comprising a protein in the presence of a sugar and one or more amino acids, wherein the sugar is a disaccharide and is present in an amount from 1.0 to 20% w/v and wherein the one or more amino acids is present in an amount from or from above 50 mM to 200 mM.
A process for reducing reconstitution time of a spray-dried protein formulation comprising:
- preparing a protein formulation comprising a protein, a sugar and one or more amino acids;
- b. spray-drying the protein formulation prepared in step a);
- c. recovering the spray-dried protein formulation of step b);
- and
- d. reconstituting the recovered spray-dried protein formulation within a reconstitution time RT1;
- wherein the reconstitution time RT1 is less than the reconstitution time of the same protein formulation prepared in the absence of a sugar and one or more amino acids, wherein the sugar is a disaccharide and is present in an amount from 1.0 to 20% w/v and wherein the one or more amino acids is present in an amount from or from above 50 mM to 200 mM.
Dependencies are inferred from the claim text.