AU2020204922B2 - Collagenase formulations and methods of producing the same - Google Patents

Collagenase formulations and methods of producing the same Download PDF

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Publication number
AU2020204922B2
AU2020204922B2 AU2020204922A AU2020204922A AU2020204922B2 AU 2020204922 B2 AU2020204922 B2 AU 2020204922B2 AU 2020204922 A AU2020204922 A AU 2020204922A AU 2020204922 A AU2020204922 A AU 2020204922A AU 2020204922 B2 AU2020204922 B2 AU 2020204922B2
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AU
Australia
Prior art keywords
collagenase
formulation
mannitol
formulations
lyophilization
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2020204922A
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English (en)
Other versions
AU2020204922A1 (en
Inventor
Karunakar Sukuru
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Endo Global Aesthetics Ltd
Original Assignee
Endo Global Aesthetics Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Endo Global Aesthetics Ltd filed Critical Endo Global Aesthetics Ltd
Publication of AU2020204922A1 publication Critical patent/AU2020204922A1/en
Application granted granted Critical
Publication of AU2020204922B2 publication Critical patent/AU2020204922B2/en
Priority to AU2025204915A priority Critical patent/AU2025204915A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24003—Microbial collagenase (3.4.24.3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24007—Interstitial collagenase (3.4.24.7), i.e. matrix metalloprotease 1 or MMP1

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
AU2020204922A 2019-01-06 2020-01-03 Collagenase formulations and methods of producing the same Active AU2020204922B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025204915A AU2025204915A1 (en) 2019-01-06 2025-06-30 Collagenase formulations and methods of producing the same

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962788916P 2019-01-06 2019-01-06
US62/788,916 2019-01-06
PCT/US2020/012202 WO2020142701A1 (en) 2019-01-06 2020-01-03 Collagenase formulations and methods of producing the same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025204915A Division AU2025204915A1 (en) 2019-01-06 2025-06-30 Collagenase formulations and methods of producing the same

Publications (2)

Publication Number Publication Date
AU2020204922A1 AU2020204922A1 (en) 2021-07-01
AU2020204922B2 true AU2020204922B2 (en) 2025-04-24

Family

ID=69845512

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2020204922A Active AU2020204922B2 (en) 2019-01-06 2020-01-03 Collagenase formulations and methods of producing the same
AU2025204915A Pending AU2025204915A1 (en) 2019-01-06 2025-06-30 Collagenase formulations and methods of producing the same

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025204915A Pending AU2025204915A1 (en) 2019-01-06 2025-06-30 Collagenase formulations and methods of producing the same

Country Status (10)

Country Link
US (3) US20220305094A1 (cg-RX-API-DMAC10.html)
EP (1) EP3906014A1 (cg-RX-API-DMAC10.html)
JP (2) JP7565280B2 (cg-RX-API-DMAC10.html)
KR (2) KR20210113271A (cg-RX-API-DMAC10.html)
CN (1) CN113382714A (cg-RX-API-DMAC10.html)
AU (2) AU2020204922B2 (cg-RX-API-DMAC10.html)
BR (1) BR112021012675A2 (cg-RX-API-DMAC10.html)
IL (2) IL321891A (cg-RX-API-DMAC10.html)
MX (1) MX2021008017A (cg-RX-API-DMAC10.html)
WO (1) WO2020142701A1 (cg-RX-API-DMAC10.html)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113025599B (zh) * 2021-04-02 2023-09-12 重庆科润生物医药研发有限公司 一种重组溶组织梭菌i型胶原酶及其制备方法和应用
CN112941058B (zh) * 2021-04-02 2023-12-05 重庆科润生物医药研发有限公司 一种重组溶组织梭菌ii型胶原酶及其制备方法和应用
CN114264633B (zh) * 2022-02-10 2022-09-06 上海蓝长科技集团有限公司 一种福尔马肼聚合物冻干粉及制备方法
CN118829726A (zh) * 2022-03-08 2024-10-22 科纳斯特股份有限公司 包含胶原酶、钙、组氨酸及甘氨酸的组合物及胶原酶的稳定化方法
WO2026094005A1 (en) * 2024-11-04 2026-05-07 Endo Biologics Limited Compositions comprising collagenase for use in treatment of plantar fasciitis
CN119656117B (zh) * 2024-12-18 2025-08-29 远大生命科学(鞍山)有限公司 一种药物组合物及其制备方法和用途

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013059619A1 (en) * 2011-10-21 2013-04-25 Auxilium Pharmaceuticals, Inc. Method of treating or reducing efp

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EP1820516B1 (en) 1999-02-22 2013-07-24 University of Connecticut Novel albumin-free factor VIII formulations
US6440414B1 (en) 1999-10-01 2002-08-27 Amgen Inc. Pharmaceutical compositions of fibrinolytic agent
US20070224184A1 (en) * 2006-02-22 2007-09-27 The Research Foundation Of The State University Of New York Method for treating cellulite
KR20080071192A (ko) * 2005-11-22 2008-08-01 와이어쓰 면역글로불린 융합 단백질 제형
US7811560B2 (en) 2006-01-30 2010-10-12 Auxilium Us Holdings, Llc Compositions and methods for treating collagen-mediated diseases
EP2130551B1 (en) * 2008-06-02 2012-06-06 Roche Diagnostics GmbH Improved purification of collagenases from clostridium histolyticum liquid culture
US10119131B2 (en) 2011-03-16 2018-11-06 Biospecifics Technologies Corp. Compositions and methods for producing clostridial collagenases
EP4772625A2 (en) 2012-01-12 2026-07-08 Endo Biologics Limited Clostridium histolyticum enzyme
WO2014144859A1 (en) 2013-03-15 2014-09-18 Biospecifics Technologies Corporation Treatment method and product for uterine fibroids using purified collagenase
US10137179B2 (en) * 2016-05-18 2018-11-27 Hyalo Technologies, LLC Composition and method of preparation of protease microparticulate slow release preparation
CN110022855B (zh) * 2016-10-07 2024-07-16 瑞泽恩制药公司 室温稳定的冻干蛋白质
DK3589204T3 (da) * 2017-03-01 2025-06-30 Endo Operations Ltd Apparat og fremgangsmåde til vurdering og behandling af cellulitis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013059619A1 (en) * 2011-10-21 2013-04-25 Auxilium Pharmaceuticals, Inc. Method of treating or reducing efp
US20140335072A1 (en) * 2011-10-21 2014-11-13 Auxilium Pharmaceuticals, Inc. Method of Treating or Reducing EFP

Also Published As

Publication number Publication date
IL284270A (en) 2021-08-31
EP3906014A1 (en) 2021-11-10
JP7855655B2 (ja) 2026-05-08
US20240041993A1 (en) 2024-02-08
AU2020204922A1 (en) 2021-07-01
US12303557B2 (en) 2025-05-20
IL284270B2 (en) 2025-12-01
JP2022516569A (ja) 2022-02-28
AU2025204915A1 (en) 2025-07-24
CA3125007A1 (en) 2020-07-09
KR20260051486A (ko) 2026-04-16
US20250249080A1 (en) 2025-08-07
JP7565280B2 (ja) 2024-10-10
CN113382714A (zh) 2021-09-10
US20220305094A1 (en) 2022-09-29
KR20210113271A (ko) 2021-09-15
MX2021008017A (es) 2021-08-05
IL284270B1 (en) 2025-08-01
BR112021012675A2 (pt) 2021-09-28
IL321891A (en) 2025-09-01
JP2025016453A (ja) 2025-02-04
WO2020142701A1 (en) 2020-07-09

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