Stable liquid interferon beta formulations
First Claim
1. A liquid formulation comprising:
- (i) an interferon-beta, and (ii) a stabilizing agent at between about 0.3% and 5% by weight, wherein said stabilizing agent is L-glutamic acid, wherein the formulation does not comprise serum albumin, and wherein the formulation has not been previously lyophilized.
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Accused Products
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 contract 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
24 Claims
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1. A liquid formulation comprising:
- (i) an interferon-beta, and (ii) a stabilizing agent at between about 0.3% and 5% by weight, wherein said stabilizing agent is L-glutamic acid, 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)
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12. 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 between about 0.3% and 5% by weight L-glutamic acid;
- 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 (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- wherein the liquid formulation has not been reconstituted from lyophilized interferon;
Specification