# US 10,246,755 B2 · Crystallized oxalate decarboxylase and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,246,755 B2 - Document ID: US10246755B2 - Status: Granted - Kind: B2 - Application number: 15/630,978 - Filed: 2017-06-23 - Published: 2018-03-29 - Granted: 2019-04-02 - Earliest claimed: 2013-01-18 - Assignees: Allena Pharmaceuticals, Inc. - Applicants: Allena Pharmaceuticals, Inc. - Inventors: Jack Greene; Richard Johnson; Dennis Krushinskie; Bhami Shenoy - Web page: https://patentgrep.com/patent/US10246755B2 ## CPC - C12N 9/88: Lyases (4.) - A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules} - A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 9/1647: {Polyesters, e.g. poly(lactide-co-glycolide)} - A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)} - A61K 38/51: Lyases (4) - C12Y 401/01002: Oxalate decarboxylase (4.1.1.2) - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - 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) - C12Y: ENZYMES ## Abstract Pharmaceutical compositions comprising spray-dried oxalate decarboxylase crystals are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using compositions comprising spray-dried oxalate decarboxylase crystals are also disclosed. ## Claims ### Claim 1 A pharmaceutical composition comprising a capsule containing crystals of spray-dried oxalate decarboxylase comprising the amino acid sequence of SEQ ID NO:1 where the thiol moiety at Cys383 is protected by a reaction with a thiol protecting group, wherein the crystals have a Hausner ratio of about 1.00 to about 1.59. ### Claim 2 (depends on 1) The pharmaceutical composition of claim 1, further comprising an excipient. ### Claim 3 (depends on 2) The pharmaceutical composition of claim 2, wherein the excipient is a sugar. ### Claim 4 (depends on 3) The pharmaceutical composition of claim 3, wherein the sugar is a disaccharide or a monosaccharide. ### Claim 5 (depends on 4) The pharmaceutical composition of claim 4, wherein the sugar is selected from trehalose, sucrose, and glucose. ### Claim 6 (depends on 5) The pharmaceutical composition of claim 5, wherein the sugar is trehalose. ### Claim 7 (depends on 1) The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio of about 1.00 to about 1.34. ### Claim 8 (depends on 7) The pharmaceutical composition of claim 7, wherein the crystals have a Hausner ratio of about 1.00 to about 1.25. ### Claim 9 (depends on 8) The pharmaceutical composition of claim 8, wherein the crystals have a Hausner ratio of about 1.00 to about 1.18. ### Claim 10 (depends on 9) The pharmaceutical composition of claim 9, wherein the crystals have a Hausner ratio of about 1.12 to about 1.18. ### Claim 11 (depends on 8) The pharmaceutical composition of claim 8, wherein the crystals have a Hausner ratio of about 1.19 to about 1.25. ### Claim 12 (depends on 7) The pharmaceutical composition of claim 7, wherein the crystals have a Hausner ratio of about 1.26 to about 1.34. ### Claim 13 (depends on 1) The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio of about 1.34. ### Claim 14 (depends on 1) The pharmaceutical composition of claim 1, wherein the crystals have a Hausner ratio less than 1.34. ### Claim 15 (depends on 1) The pharmaceutical composition of claim 1, wherein the capsule is a size 0 capsule and comprises at least 5,000 U of oxalate decarboxylase crystals. ### Claim 16 (depends on 1) The pharmaceutical composition of claim 1, wherein the capsule is a size 1 capsule and comprises at least 3,000 U of oxalate decarboxylase crystals. ### Claim 17 (depends on 16) The pharmaceutical composition of claim 16, wherein the capsule comprises at least 6,000 U of oxalate decarboxylase crystals. ### Claim 18 (depends on 16) The pharmaceutical composition of claim 16, wherein the capsule comprises between 6,000 U and 21,000 U of oxalate decarboxylase crystals. ### Claim 19 (depends on 1) A method of treating a disorder associated with elevated oxalate concentration in a mammal, the method comprising administering the pharmaceutical composition of claim 1 comprising a capsule containing crystals of spray-dried oxalate decarboxylase to the mammal in an amount sufficient to reduce one or more symptoms associated with the disorder. ### Claim 20 (depends on 19) The method of claim 19, wherein the disorder is related to a kidney or a liver function. ### Claim 21 (depends on 19) The method of claim 19, wherein the disorder is selected from primary hyperoxaluria, enteric hyperoxaluria, idiopathic hyperoxaluria, ethylene glycol poisoning, cystic fibrosis, inflammatory bowel disease, urolithiasis, nephrolithiasis, chronic kidney disease, hemodialysis, gastrointestinal bypass, and kidney stones. ### Claim 22 (depends on 19) The method of claim 19, wherein the pharmaceutical composition further comprises an excipient. ### Claim 23 (depends on 22) The method of claim 22, wherein the excipient is a sugar. ### Claim 24 (depends on 23) The method of claim 23, wherein the sugar is a disaccharide or a monosaccharide. ### Claim 25 (depends on 24) The method of claim 24, wherein the sugar is selected from trehalose, sucrose, and glucose. ### Claim 26 (depends on 25) The method of claim 25, wherein the sugar is trehalose. ### Claim 27 (depends on 19) The method of claim 19, wherein the crystals have a Hausner ratio of about 1.00 to about 1.34. ### Claim 28 (depends on 27) The method of claim 27, wherein the crystals have a Hausner ratio of about 1.00 to about 1.25. ### Claim 29 (depends on 28) The method of claim 28, wherein the crystals have a Hausner ratio of about 1.00 to about 1.18. ### Claim 30 (depends on 29) The method of claim 29, wherein the crystals have a Hausner ratio of about 1.12 to about 1.18. ### Claim 31 (depends on 28) The method of claim 28, wherein the crystals have a Hausner ratio of about 1.19 to about 1.25. ### Claim 32 (depends on 27) The method of claim 27, wherein the crystals have a Hausner ratio of about 1.26 to about 1.34. ### Claim 33 (depends on 19) The method of claim 19, wherein the crystals have a Hausner ratio of about 1.34. ### Claim 34 (depends on 19) The method of claim 19, wherein the crystals have a Hausner ratio less than 1.34. ### Claim 35 (depends on 19) The method of claim 19, wherein the capsule is a size 0 capsule and comprises at least 5,000 U of oxalate decarboxylase crystals. ### Claim 36 (depends on 19) The method of claim 19, wherein the capsule is a size 1 capsule and comprises at least 3,000 U of oxalate decarboxylase crystals. ### Claim 37 (depends on 36) The pharmaceutical composition of claim 36, wherein the capsule comprises at least 6,000 U of oxalate decarboxylase crystals. ### Claim 38 (depends on 36) The pharmaceutical composition of claim 36, wherein the capsule comprises between 6,000 U and 21,000 U of oxalate decarboxylase crystals.