Stable liquid interferon-beta formulations
First Claim
1. A liquid formulation comprising:
- (i) an interferon-beta, and (ii) between about 0.3% and 5% by weight of an amino acid selected from the group consisting of acidic amino acids, arginine and glycine, wherein the formulation does not comprise serum albumin and;
wherein the formulation has not been previously lyophilized.
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Abstract
Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contact with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.
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Citations
29 Claims
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1. A liquid formulation comprising:
- (i) an interferon-beta, and (ii) between about 0.3% and 5% by weight of an amino acid selected from the group consisting of acidic amino acids, arginine and glycine, wherein the formulation does not comprise serum albumin and;
wherein the formulation has not been previously lyophilized. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
- (i) an interferon-beta, and (ii) between about 0.3% and 5% by weight of an amino acid selected from the group consisting of acidic amino acids, arginine and glycine, wherein the formulation does not comprise serum albumin and;
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14. A liquid formulation comprising:
- (i) an interferon-beta present at between 6 MIU/ml and 50 MIU/ml and (ii) between about 0.3% and 5% by weight of arginine-HCl, wherein the formulation does not comprise serum albumin, wherein the formulation has not been previously lyophilized, wherein the formulation has a pH of between 4.8 and 5.2, wherein the formulation further comprises an acetate or acetate salt present at 20 mM and;
wherein the formulation further comprises a surfactant, and;
wherein the formulation has a dissolved oxygen level that is less than or equal to 10% of atmospheric equilibrium levels.
- (i) an interferon-beta present at between 6 MIU/ml and 50 MIU/ml and (ii) between about 0.3% and 5% by weight of arginine-HCl, wherein the formulation does not comprise serum albumin, wherein the formulation has not been previously lyophilized, wherein the formulation has a pH of between 4.8 and 5.2, wherein the formulation further comprises an acetate or acetate salt present at 20 mM and;
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15. A packaged kit for parenteral administration of an interferon-beta, the kit containing a syringe pre-filled with a liquid formulation comprising the interferon-beta and an acidic amino acid stabilizing agent selected from the group consisting of acidic amino acids, arginine and glycine;
- wherein the amino acid stabilizing agent is present at between 0.3% and 5% w/v;
wherein the liquid formulation has not been reconstituted from lyophilized interferon;
wherein the liquid formulation is not further lyophilized, wherein the liquid formulation does not comprise serum albumin, and wherein the syringe has a head space flushed with an inert gas. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
- wherein the amino acid stabilizing agent is present at between 0.3% and 5% w/v;
Specification