Dry powder formulation of interferon beta and method for preparing same
AssigneeAbion Inc.
InventorsHong Seok CHOI, Na Young KIM, Jun Young CHOI
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Abstract
The present invention relates to a dry powder formulation of interferon beta and a method for preparing same and, more specifically, to a dry powder formulation of interferon beta in the form of spherical particles having a high degree of morphological perfection, prepared by spray-drying a liquid composition containing interferon beta, and a method for preparing the dry powder formulation of interferon beta.
Claims14
A dry powder formulation of interferon-beta prepared by spray drying a liquid composition, wherein the liquid composition comprises:
- (a) interferon beta or a variant thereof;
- (b) an acetate buffer at a concentration of 5 to 100 mM;
- (c) arginine at a concentration of 10 to 150 mM;
- (d) poloxamer 188 at a concentration of 0.1 to 10 mg/mL;
- (e) methionine at a concentration of 0.5 to 5 mM;
- and
- (f) 5 to 30% (w/v) of a hydrophobic amino acid.
A method for preparing a dry powder formulation of interferon-beta, comprising spray drying a liquid composition at an inlet temperature of 90 to 130° C. and an outlet temperature of 40 to 80° C., wherein the liquid composition comprises:
- (a) interferon beta or a variant thereof;
- (b) an acetate buffer at a concentration of 5 to 100 mM;
- (c) arginine at a concentration of 10 to 150 mM;
- (d) poloxamer 188 at a concentration of 0.1 to 10 mg/mL;
- (e) methionine at a concentration of 0.5 to 5 mM;
- and
- (f) 5 to 30% (w/v) of a hydrophobic amino acid.
Dependencies are inferred from the claim text.