BR112021012675A2 - Formulação, formulação liofilizada, formulação reconstituída e kit - Google Patents

Formulação, formulação liofilizada, formulação reconstituída e kit Download PDF

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Publication number
BR112021012675A2
BR112021012675A2 BR112021012675-9A BR112021012675A BR112021012675A2 BR 112021012675 A2 BR112021012675 A2 BR 112021012675A2 BR 112021012675 A BR112021012675 A BR 112021012675A BR 112021012675 A2 BR112021012675 A2 BR 112021012675A2
Authority
BR
Brazil
Prior art keywords
formulation
collagenase
lyophilized
mannitol
lyophilized formulation
Prior art date
Application number
BR112021012675-9A
Other languages
English (en)
Portuguese (pt)
Inventor
Karunakar Sukuru
Original Assignee
Endo Global Aesthetics Limited
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 Limited filed Critical Endo Global Aesthetics Limited
Publication of BR112021012675A2 publication Critical patent/BR112021012675A2/pt

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Classifications

    • 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
    • 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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
BR112021012675-9A 2019-01-06 2020-01-03 Formulação, formulação liofilizada, formulação reconstituída e kit BR112021012675A2 (pt)

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

Publications (1)

Publication Number Publication Date
BR112021012675A2 true BR112021012675A2 (pt) 2021-09-28

Family

ID=69845512

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021012675-9A BR112021012675A2 (pt) 2019-01-06 2020-01-03 Formulação, formulação liofilizada, formulação reconstituída e kit

Country Status (10)

Country Link
US (3) US20220305094A1 (https=)
EP (1) EP3906014A1 (https=)
JP (2) JP7565280B2 (https=)
KR (1) KR20210113271A (https=)
CN (1) CN113382714A (https=)
AU (2) AU2020204922B2 (https=)
BR (1) BR112021012675A2 (https=)
IL (2) IL321891A (https=)
MX (1) MX2021008017A (https=)
WO (1) WO2020142701A1 (https=)

Families Citing this family (5)

* 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
AU2023232693A1 (en) * 2022-03-08 2024-09-19 Connext Co.,Ltd. Composition comprising collagenase, calcium, histidine, and glycine, and method for stabilizing collagenase
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

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2921180B1 (en) * 1999-02-22 2019-08-14 University of Connecticut 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
CN101312744A (zh) 2005-11-22 2008-11-26 惠氏公司 免疫球蛋白融合蛋白制剂
US7811560B2 (en) 2006-01-30 2010-10-12 Auxilium Us Holdings, Llc Compositions and methods for treating collagen-mediated diseases
ES2388219T3 (es) * 2008-06-02 2012-10-10 F. Hoffmann-La Roche Ag Purificación mejorada de colagenasas a partir de un cultivo líquido de Clostridium histolyticum
WO2012125948A1 (en) 2011-03-16 2012-09-20 Biospecifics Technologies Corp. Compositions and methods for producing clostridial collagenases
JP2014530873A (ja) * 2011-10-21 2014-11-20 オーキシリウム インターナショナル ホールディングス，インコーポレイテッド Ｅｆｐの治療または低減方法
PT2802652T (pt) 2012-01-12 2019-09-10 Endo Global Ventures Enzimas de clostridium histolyticum
EP3834840B8 (en) 2013-03-15 2025-09-17 Endo Biologics Limited 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
CA3039655A1 (en) * 2016-10-07 2018-04-12 Regeneron Pharmaceuticals, Inc. Room temperature stable lyophilized protein
EP4591945A3 (en) * 2017-03-01 2026-04-15 Endo Operations Limited Apparatus and method for assessing and treating cellulite

Also Published As

Publication number Publication date
JP2022516569A (ja) 2022-02-28
IL321891A (en) 2025-09-01
AU2025204915A1 (en) 2025-07-24
AU2020204922B2 (en) 2025-04-24
IL284270A (en) 2021-08-31
JP7565280B2 (ja) 2024-10-10
MX2021008017A (es) 2021-08-05
CN113382714A (zh) 2021-09-10
JP2025016453A (ja) 2025-02-04
CA3125007A1 (en) 2020-07-09
US20250249080A1 (en) 2025-08-07
WO2020142701A1 (en) 2020-07-09
US20240041993A1 (en) 2024-02-08
US20220305094A1 (en) 2022-09-29
IL284270B1 (en) 2025-08-01
US12303557B2 (en) 2025-05-20
KR20210113271A (ko) 2021-09-15
AU2020204922A1 (en) 2021-07-01
EP3906014A1 (en) 2021-11-10
IL284270B2 (en) 2025-12-01

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B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]