Claims for Patent: 9,616,126

Summary for Patent: 9,616,126

Title:	Composition, method, and kit for alpha-1 proteinase inhibitor
Abstract:	The present invention provides compositions comprising API and at least one amino acid, in particular a liquid API formulation comprising amino acids, and methods and kits related thereto. These amino acids when incorporated into the API composition afford stability to the API formulation.
Inventor(s):	Guo; Jianxin (Clayton, NC), Klos; Anthony (Raleigh, NC), Coldren; Bret (Research Triangle Park, NC), Barnette; Deborah (Cary, NC), Manning; Mark (Research Triangle Park, NC)
Assignee:	Grifols Therapeutics, Inc. (Research Triangle Park, NC)
Application Number:	14/926,450
Patent Claims:	1. A stable liquid pharmaceutical composition, suitable for administration by intravenous injection, subcutaneous injection, or inhalation without reconstitution, comprising: (a) an alpha-1 proteinase inhibitor (API); (b) about 0.1M to about 0.3M alanine; and (c) a pharmaceutically acceptable carrier, wherein the concentration of API in the composition is at least about 50 mg/ml; wherein the stable liquid pharmaceutical composition exhibits less than 5% aggregation and/or degradation after at least 24 months storage at a temperature between 5.degree. C. and 25.degree. C.; and wherein the percent aggregation and/or degradation is determined by size exclusion high performance liquid chromatography. 2. The composition of claim 1 wherein the pharmaceutically acceptable carrier comprises: (a) sterile water; and (b) optionally, one or more buffers or excipients. 3. The composition of claim 2 wherein the one or more buffers are selected from the group consisting of, monobasic sodium phosphate dibasic sodium phosphate, and mixtures thereof. 4. The composition of claim 2 wherein the one or more excipients are selected from the group consisting of sucrose, mannitol, glycerol, sorbitol, dextran, trehalose, hydroxyethyl starch, and 1,2-propanediol. 5. The composition of claim 3 wherein the phosphate is present in an amount to maintain the solution at a pH between 6.9 and 7.1. 6. A stable liquid pharmaceutical composition suitable for administration by intravenous injection, subcutaneous injection or inhalation without reconstitution, consisting essentially of: (a) an alpha-1 proteinase inhibitor (API); (b) about 0.1M to about 0.3M alanine; and (c) a pharmaceutically acceptable carrier; wherein the concentration of API in the composition is at least about 50 mg/ml; wherein the stable liquid pharmaceutical composition exhibits less than 5% aggregation and/or degradation after at least 24 months storage at a temperature between 5.degree. C. and 25.degree. C.; and wherein the percent aggregation and/or degradation is determined by size exclusion high performance liquid chromatography. 7. The composition of claim 6 wherein the pharmaceutically acceptable carrier consists of: (a) sterile water; and (b) a buffer. 8. The composition of claim 7 wherein the buffer is selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate, and mixtures thereof. 9. The composition of claim 8 wherein the phosphate is present in an amount to maintain the solution at a pH between 6.3 and 7.4. 10. The composition of claim 8 wherein the phosphate is present in an amount to maintain the solution at a pH between 6.9 and 7.1. 11. A kit comprising the composition of claim 6 suitable for intravenous or subcutaneous injection. 12. A stable liquid pharmaceutical composition, suitable for administration by intravenous injection, subcutaneous injection, or inhalation without reconstitution, consisting essentially of: (a) an alpha-1 proteinase inhibitor (API); and (b) about 0.1M to about 0.3M alanine; wherein the concentration of API in the composition is at least about 50 mg/ml; wherein the stable liquid pharmaceutical composition exhibits less than 5% aggregation and/or degradation after at least 24 months storage at a temperature between 5.degree. C. and 25.degree. C.; and wherein the percent aggregation and/or degradation is determined by size exclusion high performance liquid chromatography.

Details for Patent 9,616,126

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2029-11-03