# US 11,439,691 B2 · Aqueous solution of burlulipase comprising calciumions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,691 B2 - Document ID: US11439691B2 - Status: Granted - Kind: B2 - Application number: 16/490,550 - Filed: 2018-03-05 - Published: 2020-01-09 - Granted: 2022-09-13 - Earliest claimed: 2017-03-03 - Assignees: Nordmark Pharma GmbH - Applicants: Nordmark Pharma GmbH - Inventors: Richard Fuhrherr; Annika Müller-Lucks; Katharina Rützel; Jan Lüdemann; Martin Werner - Web page: https://patentgrep.com/patent/US11439691B2 ## CPC - A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} - A61K 47/02: Inorganic compounds - A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes - C12N 9/18: Carboxylic ester hydrolases {(3.1.1)} - C12N 9/96: Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates - C12Y 301/01003: Triacylglycerol lipase (3.1.1.3) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - C12Y: ENZYMES ## Abstract The present invention relates to an aqueous solution comprising burlulipase which is characterized in that it contains calcium ions. In particular, it also relates to corresponding pharmaceuticals. Such pharmaceuticals are suitable for the treatment of exocrine pancreatic insufficiency. These pharmaceuticals are particularly suitable for treating patients having cystic fibrosis and in pediatrics. Another aspect of the present invention relates to container-packaged solutions and pharmaceuticals as mentioned above, which are containers produced by the blow-fill-seal method, and to methods for producing such packaged solutions and pharmaceuticals. ## Claims ### Claim 1 An active pharmaceutical grade lipase product, comprising: an aqueous shelf-stable, pharmaceutical grade solution comprising burlulipase stabilized by solubilized calcium ions, and at least one of 6-deoxy-talane, lipids, and rhamnolipids. ### Claim 2 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the solution comprises calcium chloride. ### Claim 3 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the concentration of burlulipase in the aqueous solution is 0.1 to 35 mg per ml. ### Claim 4 (depends on 3) The active pharmaceutical grade lipase product according to claim 3, wherein the concentration of burlulipase in the aqueous solution is 0.5 to 30 mg per ml. ### Claim 5 (depends on 4) The active pharmaceutical grade lipase product according to claim 4, wherein: the concentration of calcium ions in the aqueous solution is 0.1 to 200 mmol/l; or the solution comprises calcium chloride in a concentration of 0.1 to 200 mmol/l. ### Claim 6 (depends on 5) The active pharmaceutical grade lipase product according to claim 5, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.2 to 100 mmol/l. ### Claim 7 (depends on 6) The active pharmaceutical grade lipase product according to claim 6, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.5 to 50 mmol/l. ### Claim 8 (depends on 3) The active pharmaceutical grade lipase product according to claim 3, wherein the concentration of burlulipase in the aqueous solution is 1 to 25 mg per ml. ### Claim 9 (depends on 8) The active pharmaceutical grade lipase product according to claim 8, wherein: the concentration of calcium ions in the aqueous solution is 0.1 to 200 mmol/l; or the solution comprises calcium chloride in a concentration of 0.1 to 200 mmol/l. ### Claim 10 (depends on 9) The active pharmaceutical grade lipase product according to claim 9, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.2 to 100 mmol/l. ### Claim 11 (depends on 10) The active pharmaceutical grade lipase product according to claim 10, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.5 to 50 mmol/l. ### Claim 12 (depends on 3) The active pharmaceutical grade lipase product according to claim 3, wherein the concentration of burlulipase in the aqueous solution is 3 to 20 mg per ml. ### Claim 13 (depends on 12) The active pharmaceutical grade lipase product according to claim 12, wherein: the concentration of calcium ions in the aqueous solution is 0.1 to 200 mmol/l; or the solution comprises calcium chloride in a concentration of 0.1 to 200 mmol/l. ### Claim 14 (depends on 13) The active pharmaceutical grade lipase product according to claim 13, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.2 to 100 mmol/l. ### Claim 15 (depends on 14) The active pharmaceutical grade lipase product according to claim 14, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.5 to 50 mmol/l. ### Claim 16 (depends on 12) The active pharmaceutical grade lipase product according to claim 12, wherein the pH of the solution is 7.3 to 7.7. ### Claim 17 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein: the concentration of calcium ions in the aqueous solution is 0.1 to 200 mmol/l; or the solution comprises calcium chloride in a concentration of 0.1 to 200 mmol/l. ### Claim 18 (depends on 17) The active pharmaceutical grade lipase product according to claim 17, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.2 to 100 mmol/l. ### Claim 19 (depends on 18) The active pharmaceutical grade lipase product according to claim 18, wherein the concentration of calcium ions or calcium chloride in the aqueous solution is 0.5 to 50 mmol/l. ### Claim 20 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the aqueous solution has a pH of 4 to 9. ### Claim 21 (depends on 20) The active pharmaceutical grade lipase product according to claim 20, wherein the pH of the solution is 6 to 8. ### Claim 22 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the aqueous solution further comprises tris(hydroxymethyl)aminomethane. ### Claim 23 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the solution is packaged in a container produced by a blow-fill-seal process. ### Claim 24 (depends on 1) The active pharmaceutical grade lipase product according to claim 1, wherein the aqueous solution further comprises one or more pharmaceutically acceptable excipients. ### Claim 25 A product comprising: a shelf-stable, pharmaceutical grade aqueous solution of burlulipase stabilized by solubilized calcium ions, and at least one of 6-deoxy-talane, lipids, and rhamnolipids. ### Claim 26 (depends on 25) The product of claim 25 wherein the aqueous solution is packaged in a container produced by a blow-fill-seal process.