JP7565280B2 - コラゲナーゼ製剤およびその製造方法 - Google Patents

コラゲナーゼ製剤およびその製造方法 Download PDF

Info

Publication number
JP7565280B2
JP7565280B2 JP2021539410A JP2021539410A JP7565280B2 JP 7565280 B2 JP7565280 B2 JP 7565280B2 JP 2021539410 A JP2021539410 A JP 2021539410A JP 2021539410 A JP2021539410 A JP 2021539410A JP 7565280 B2 JP7565280 B2 JP 7565280B2
Authority
JP
Japan
Prior art keywords
formulation
collagenase
lyophilized
mannitol
freeze
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
JP2021539410A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022516569A (ja
JPWO2020142701A5 (https=
JP2022516569A5 (https=
Inventor
スクル、カルナカル
Original Assignee
エンド グローバル エステティックス リミテッド
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 エンド グローバル エステティックス リミテッド filed Critical エンド グローバル エステティックス リミテッド
Publication of JP2022516569A publication Critical patent/JP2022516569A/ja
Publication of JPWO2020142701A5 publication Critical patent/JPWO2020142701A5/ja
Publication of JP2022516569A5 publication Critical patent/JP2022516569A5/ja
Priority to JP2024169863A priority Critical patent/JP2025016453A/ja
Application granted granted Critical
Publication of JP7565280B2 publication Critical patent/JP7565280B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K47/06—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)
  • 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)
JP2021539410A 2019-01-06 2020-01-03 コラゲナーゼ製剤およびその製造方法 Active JP7565280B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024169863A JP2025016453A (ja) 2019-01-06 2024-09-30 コラゲナーゼ製剤およびその製造方法

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
JP2024169863A Division JP2025016453A (ja) 2019-01-06 2024-09-30 コラゲナーゼ製剤およびその製造方法

Publications (4)

Publication Number Publication Date
JP2022516569A JP2022516569A (ja) 2022-02-28
JPWO2020142701A5 JPWO2020142701A5 (https=) 2022-12-19
JP2022516569A5 JP2022516569A5 (https=) 2022-12-19
JP7565280B2 true JP7565280B2 (ja) 2024-10-10

Family

ID=69845512

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021539410A Active JP7565280B2 (ja) 2019-01-06 2020-01-03 コラゲナーゼ製剤およびその製造方法
JP2024169863A Pending JP2025016453A (ja) 2019-01-06 2024-09-30 コラゲナーゼ製剤およびその製造方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024169863A Pending JP2025016453A (ja) 2019-01-06 2024-09-30 コラゲナーゼ製剤およびその製造方法

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

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003510369A (ja) 1999-10-01 2003-03-18 アムジエン・インコーポレーテツド フィブリン溶解剤の薬剤組成物
JP2003520764A (ja) 1999-02-22 2003-07-08 バクスター・インターナショナル・インコーポレイテッド 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物
JP2009516692A (ja) 2005-11-22 2009-04-23 ワイス 免疫グロブリン融合タンパク質製剤
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
US20170333536A1 (en) 2016-05-18 2017-11-23 Hyalo Technologies, LLC Composition and method of preparation of protease microparticulate slow release preparation
US20180099049A1 (en) 2016-10-07 2018-04-12 Regeneron Pharmaceuticals, Inc. Room Temperature Stable Lyophilized Protein

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070224184A1 (en) * 2006-02-22 2007-09-27 The Research Foundation Of The State University Of New York Method for treating cellulite
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
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
EP4591945A3 (en) * 2017-03-01 2026-04-15 Endo Operations Limited Apparatus and method for assessing and treating cellulite

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003520764A (ja) 1999-02-22 2003-07-08 バクスター・インターナショナル・インコーポレイテッド 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物
JP2003510369A (ja) 1999-10-01 2003-03-18 アムジエン・インコーポレーテツド フィブリン溶解剤の薬剤組成物
JP2009516692A (ja) 2005-11-22 2009-04-23 ワイス 免疫グロブリン融合タンパク質製剤
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
US20170333536A1 (en) 2016-05-18 2017-11-23 Hyalo Technologies, LLC Composition and method of preparation of protease microparticulate slow release preparation
US20180099049A1 (en) 2016-10-07 2018-04-12 Regeneron Pharmaceuticals, Inc. Room Temperature Stable Lyophilized Protein

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
MX2021008017A (es) 2021-08-05
CN113382714A (zh) 2021-09-10
JP2025016453A (ja) 2025-02-04
BR112021012675A2 (pt) 2021-09-28
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

Similar Documents

Publication Publication Date Title
JP7565280B2 (ja) コラゲナーゼ製剤およびその製造方法
AU2021250949A1 (en) Liquid Pharmaceutical Composition
Zhang et al. Development of a stable lyophilized adeno-associated virus gene therapy formulation
Sane et al. Reconstitution of highly concentrated lyophilized proteins: part 1 amorphous formulations
CN108379561B (zh) 一种聚乙二醇化尿酸氧化酶冻干粉剂及其制备方法
JP2015078177A (ja) 室温保存用凍結乾燥製剤
CN112004522A (zh) 使用葡甲胺盐稳定包含蛋白的制剂的方法
CN121335712A (zh) 用于产生包含多克隆IgM的冻干组合物的方法及获得的组合物
KR20260051486A (ko) 콜라게나제 제형 및 이의 제조 방법
Vargas et al. Formulation development and feasibility of AAV5 as a lyophilized drug product
Bjelošević et al. Effects of monoclonal antibody concentration and type of bulking agent on critical quality attributes of lyophilisates
HK40053714A (en) Collagenase formulations and methods of producing the same
Gao et al. Formulation Factors Affecting the Formation of Visible-Bubbles During the Reconstitution Process of Freeze-Dried Etanercept Formulations: Protein Concentration, Stabilizers, and Surfactants
CA3125007C (en) Collagenase formulations and methods of producing the same
FR3158432A1 (fr) Compositions de neurotoxine de clostridium botulinum de sérotype A et processus de séchage ameliorés
HK40087140A (zh) 组织纤溶酶原激活剂制剂
KR20230047124A (ko) 조직 플라스미노겐 활성인자 제형
JP2023526024A (ja) Ｉｌ－２融合ポリペプチド組成物ならびにその作製及び使用方法
Jiang Stabilization of freeze dried protein formulations
Nandhakumar et al. Lyophillization formulation development with novel excipients for Pegylated therapeutic proteins: A case study

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221209

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20221209

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230926

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230927

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231226

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240319

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240619

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20240903

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240930

R150 Certificate of patent or registration of utility model

Ref document number: 7565280

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150