AU2010315325B2 - Composition, method, and kit for alpha-1 proteinase inhibitor - Google Patents

Composition, method, and kit for alpha-1 proteinase inhibitor Download PDF

Info

Publication number
AU2010315325B2
AU2010315325B2 AU2010315325A AU2010315325A AU2010315325B2 AU 2010315325 B2 AU2010315325 B2 AU 2010315325B2 AU 2010315325 A AU2010315325 A AU 2010315325A AU 2010315325 A AU2010315325 A AU 2010315325A AU 2010315325 B2 AU2010315325 B2 AU 2010315325B2
Authority
AU
Australia
Prior art keywords
composition
api
amino acid
alanine
formulation
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
AU2010315325A
Other languages
English (en)
Other versions
AU2010315325A1 (en
Inventor
Deborah Barnette
Bret Coldren
Jianxin Guo
Anthony Klos
Mark Manning
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.)
Grifols Therapeutics LLC
Original Assignee
Grifols Therapeutics LLC
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43970713&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2010315325(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grifols Therapeutics LLC filed Critical Grifols Therapeutics LLC
Publication of AU2010315325A1 publication Critical patent/AU2010315325A1/en
Application granted granted Critical
Publication of AU2010315325B2 publication Critical patent/AU2010315325B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2010315325A 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor Active AU2010315325B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25771109P 2009-11-03 2009-11-03
US61/257,711 2009-11-03
PCT/US2010/055135 WO2011056793A2 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Publications (2)

Publication Number Publication Date
AU2010315325A1 AU2010315325A1 (en) 2012-06-07
AU2010315325B2 true AU2010315325B2 (en) 2014-11-27

Family

ID=43970713

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2010315325A Active AU2010315325B2 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Country Status (19)

Country Link
US (2) US20130131192A1 (enExample)
EP (1) EP2496246B1 (enExample)
JP (2) JP2013510158A (enExample)
KR (1) KR20120114235A (enExample)
CN (1) CN102655876B (enExample)
AU (1) AU2010315325B2 (enExample)
BR (1) BR112012010392B8 (enExample)
CA (1) CA2779369C (enExample)
CL (1) CL2012001159A1 (enExample)
ES (1) ES2679819T3 (enExample)
HU (1) HUE039240T2 (enExample)
IL (1) IL219485A (enExample)
MX (1) MX2012005132A (enExample)
NZ (1) NZ599783A (enExample)
PL (1) PL2496246T3 (enExample)
PT (1) PT2496246T (enExample)
RU (1) RU2555332C2 (enExample)
TR (1) TR201809898T4 (enExample)
WO (1) WO2011056793A2 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG2014012066A (en) * 2011-12-30 2014-09-26 Grifols Sa Alpha1-proteinase inhibitor for delaying the onset or progression of pulmonary exacerbations
IL267520B2 (en) * 2016-12-22 2023-09-01 Kamada Ltd Dry powder composition of alpha-1 antitrypsin
WO2018132874A1 (en) * 2017-01-19 2018-07-26 Csl Limited Method of preventing an immune response with alpha- 1 anti-trypsin
IL267923B2 (en) * 2018-08-02 2023-06-01 Grifols Worldwide Operations Ltd The composition containing the most concentrated alpha-1 type protein inhibitor and a method for obtaining it
EP3935062A1 (en) * 2019-03-04 2022-01-12 TAE Life Sciences, LLC Borylated amino acid compositions for use in boron neutron capture therapy and methods thereof
AU2021225310A1 (en) 2020-02-25 2022-10-06 Grifols Worldwide Operations Limited Method for obtaining Alpha-1 Proteinase Inhibitor

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4623717A (en) * 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
US20050013867A1 (en) * 2001-10-19 2005-01-20 Lehrman S. Russ Use of proton sequestering agents in drug formulations

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5029005B2 (enExample) * 1972-05-08 1975-09-19
JPS51118819A (en) * 1975-04-08 1976-10-19 Green Cross Corp:The A process for preparing heat stable antitrypsin
JPS597693B2 (ja) 1978-01-07 1984-02-20 株式会社ミドリ十字 抗トロンビン製剤及びその製法
US4337242A (en) 1980-02-05 1982-06-29 Merck & Co., Inc. Vaccine stabilizer containing L-glutamic acid and L-arginine
DE3262575D1 (en) 1981-12-23 1985-04-18 Schering Corp Stabilised interferon formulations and their preparation
US4517294A (en) 1982-03-03 1985-05-14 Genentech, Inc. Human antithrombin III
US4632981A (en) 1982-07-30 1986-12-30 Genentech, Inc. Human antithrombin III
US5218091A (en) 1982-08-13 1993-06-08 Zymogenetics, Inc. Glycolytic promoters for regulated protein expression: protease inhibitor
US4711848A (en) 1984-03-14 1987-12-08 Zymogenetics, Inc. Site specific mutagenesis in alpha-1-antitrypsin
US4931373A (en) 1984-05-25 1990-06-05 Zymogenetics, Inc. Stable DNA constructs for expression of α-1 antitrypsin
US4732973A (en) 1984-06-14 1988-03-22 Chiron Corporation Active site modified protease α-1-antitrypsin inhibitors
JP2599585B2 (ja) 1984-06-19 1997-04-09 トランスジ−ン ソシエテ アノニム ヒトα▲下１▼−アンチトリプシン誘導体及びその製造法
US5366894A (en) 1986-06-30 1994-11-22 Pharmaceutical Proteins Limited Peptide production
US4873316A (en) 1987-06-23 1989-10-10 Biogen, Inc. Isolation of exogenous recombinant proteins from the milk of transgenic mammals
DE3901917A1 (de) 1989-01-24 1990-07-26 Behringwerke Ag Mutanten von humanem antithrombin iii
GB8913183D0 (en) 1989-06-08 1989-07-26 Central Blood Lab Authority Chemical products
US5079336A (en) 1989-06-23 1992-01-07 The Trustees Of The University Of Pennsylvania α-1-antichymotrypsin, analogues and methods of production
US5032405A (en) 1989-09-27 1991-07-16 Warner-Lambert Company Oral pharmaceutical composition for acid sensitive proteinaceous agents
US5134119A (en) 1990-10-16 1992-07-28 Lezdey John Treatment of inflammation using 358 substituted alpha-antitrypsin
JP3479539B2 (ja) 1992-04-10 2003-12-15 エーザイ株式会社 ヒトアンチトロンビンｉｉｉ変異体
US6051256A (en) * 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
US5561115A (en) 1994-08-10 1996-10-01 Bayer Corporation Low temperature albumin fractionation using sodium caprylate as a partitioning agent
US5843705A (en) 1995-02-21 1998-12-01 Genzyme Transgenic Corporation Transgenically produced antithrombin III
AT407114B (de) 1997-06-10 2000-12-27 Immuno Ag Alpha 1-antitrypsin-präparation sowie verfahren zu deren herstellung
AU4186899A (en) 1998-05-12 1999-11-29 Susan C. Bock Human antithrombin iiis and methods related thereto
EP2193809B1 (en) 1999-02-22 2015-04-08 University of Connecticut Albumin-free factor VIII formulations
WO2000051624A2 (en) * 1999-03-05 2000-09-08 The Trustees Of University Technology Corporation Methods and compositions useful in inhibiting apoptosis
US20040157911A1 (en) 1999-08-31 2004-08-12 Spiridon Spireas Storage-stable and bio-stable formulations of ace inhibitors, and methods for preparation thereof
DE10022092A1 (de) 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung
US20030170813A1 (en) 2000-07-05 2003-09-11 Kenichi Suga Process for producing glycoprotein
AU2003223497A1 (en) 2002-04-05 2003-10-27 Centocor, Inc. Asthma-related anti-il-13 immunoglobulin derived proteins, compositions, methods and uses
NZ536796A (en) * 2002-04-25 2007-03-30 Scripps Research Inst Treatment and prevention of pulmonary conditions comprising at least one lung surfactant polypeptide and at least one protease inhibitor, lipase inhibitor or an anti-oxidant
US7777006B2 (en) * 2002-12-31 2010-08-17 Csl Behring L.L.C. Method for purification of alpha-1-antitrypsin
DK1664123T4 (da) 2003-09-22 2012-03-05 Kamada Ltd Storskalafremstilling af alfa-1-proteinaseinhibitor og anvendelse deraf
US7691810B2 (en) 2003-10-09 2010-04-06 Kyowa Hakko Kirin Co., Ltd Method of producing recombinant antithrombin III composition
WO2005049801A2 (en) 2003-11-14 2005-06-02 Arriva Pharmaceuticals, Inc. Dry protein formulation
ES2375706T3 (es) 2003-11-14 2012-03-05 Baxter International Inc. Composiciones de alfa 1-antitripsina y métodos de tratamiento que usan tales composiciones.
CA2554018A1 (en) 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization
US20070105768A1 (en) * 2004-11-10 2007-05-10 Rajiv Nayar Dry recombinant human alpha 1-antitrypsin formulation
US20070237758A1 (en) 2005-11-22 2007-10-11 Anthony Barry Immunoglobulin fusion protein formulations
MX2008010172A (es) 2006-02-09 2009-09-07 Pari Gmbh Suministro pulmonar de inhibidor de proteinasa alafa-i.
RU2540480C2 (ru) 2009-11-24 2015-02-10 Грифольс Терапьютикс Инк. Способы, композиции и наборы для лиофилизации

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4623717A (en) * 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
US20050013867A1 (en) * 2001-10-19 2005-01-20 Lehrman S. Russ Use of proton sequestering agents in drug formulations

Also Published As

Publication number Publication date
CN102655876A (zh) 2012-09-05
RU2555332C2 (ru) 2015-07-10
US9616126B2 (en) 2017-04-11
KR20120114235A (ko) 2012-10-16
CA2779369A1 (en) 2011-05-12
IL219485A (en) 2017-06-29
WO2011056793A3 (en) 2011-09-29
IL219485A0 (en) 2012-06-28
EP2496246A4 (en) 2013-03-27
CL2012001159A1 (es) 2012-09-14
RU2012122793A (ru) 2013-12-10
TR201809898T4 (tr) 2018-07-23
ES2679819T3 (es) 2018-08-31
WO2011056793A2 (en) 2011-05-12
BR112012010392A2 (pt) 2016-07-12
MX2012005132A (es) 2012-07-25
JP2013510158A (ja) 2013-03-21
JP2015221835A (ja) 2015-12-10
US20130131192A1 (en) 2013-05-23
NZ599783A (en) 2013-10-25
BR112012010392B8 (pt) 2021-05-25
CA2779369C (en) 2018-06-19
CN102655876B (zh) 2015-07-15
HUE039240T2 (hu) 2018-12-28
US20160106843A1 (en) 2016-04-21
PL2496246T3 (pl) 2018-09-28
JP6030201B2 (ja) 2016-11-24
EP2496246A2 (en) 2012-09-12
EP2496246B1 (en) 2018-06-27
BR112012010392B1 (pt) 2021-01-05
PT2496246T (pt) 2018-07-31
AU2010315325A1 (en) 2012-06-07
ES2679819T8 (es) 2019-01-22

Similar Documents

Publication Publication Date Title
US9616126B2 (en) Composition, method, and kit for alpha-1 proteinase inhibitor
ES2758827T3 (es) Formulaciones para enzimas lisosómicas
JP4635340B2 (ja) Ｈｇｆ凍結乾燥製剤
JP4119407B2 (ja) 凍結乾燥されたアルブミン非含有の組換え人血液凝固第８因子製剤
WO1997002832A1 (fr) Preparations lyophilisees de hgf
CN107249622A (zh) 包含纤溶酶原的药物组合物和其用途
PT2720710E (pt) Formulações liofilizadas de fgf-18
CN106687126B (zh) 因子viii制剂
US12144849B2 (en) Composition comprising highly-concentrated Alpha1 proteinase inhibitor and method for obtaining thereof
EP4065161A1 (en) High concentration formulations of anti-csf1 and anti-csf1r antibodies
AU2020311050B2 (en) Stable formulations of recombinant proteins
RU2813136C1 (ru) Композиция, содержащая высококонцентрированный ингибитор альфа-1-протеиназы, и способ ее приготовления
RU2776108C2 (ru) Лиофилизированный состав на основе hgf
JP2025522991A (ja) 修飾カベオリン－１ペプチド製剤ならびにその製造方法及び使用方法
HK40026929A (en) Composition comprising highly-concentrated alpha-1 proteinase inhibitor and method for obtaining thereof

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)