US20130131192A1 - Composition, method, and kit for alpha-1 proteinase inhibitor - Google Patents

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

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Publication number
US20130131192A1
US20130131192A1 US13/504,783 US201013504783A US2013131192A1 US 20130131192 A1 US20130131192 A1 US 20130131192A1 US 201013504783 A US201013504783 A US 201013504783A US 2013131192 A1 US2013131192 A1 US 2013131192A1
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US
United States
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.)
Abandoned
Application number
US13/504,783
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English (en)
Inventor
Jianxin Guo
Anthony Klos
Bret Coldren
Deborah Barnette
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
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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.)
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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=US20130131192(A1) "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
Priority to US13/504,783 priority Critical patent/US20130131192A1/en
Publication of US20130131192A1 publication Critical patent/US20130131192A1/en
Assigned to DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT reassignment DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT SECURITY AGREEMENT Assignors: GRIFOLS INC., Grifols Therapeutics Inc., GRIFOLS-CHIRON DIAGNOSTICS CORP.
Assigned to GRIFOLS, S.A., TALECRIS BIOTHERAPEUTICS, INC., GRIFOLS INC. reassignment GRIFOLS, S.A. RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 26390/0193 Assignors: DEUTSCHE BANK AG NEW YORK BRANCH
Assigned to Grifols Therapeutics Inc., GRIFOLS DIAGNOSTIC SOLUTIONS INC., GRIFOLS SHARED SERVICES NORTH AMERICA INC. reassignment Grifols Therapeutics Inc. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: DEUTSCHE BANK AG NEW YORK BRANK
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
US13/504,783 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor Abandoned US20130131192A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US13/504,783 US20130131192A1 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25771109P 2009-11-03 2009-11-03
PCT/US2010/055135 WO2011056793A2 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor
US13/504,783 US20130131192A1 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/055135 A-371-Of-International WO2011056793A2 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/926,450 Continuation US9616126B2 (en) 2009-11-03 2015-10-29 Composition, method, and kit for alpha-1 proteinase inhibitor

Publications (1)

Publication Number Publication Date
US20130131192A1 true US20130131192A1 (en) 2013-05-23

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ID=43970713

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US13/504,783 Abandoned US20130131192A1 (en) 2009-11-03 2010-11-02 Composition, method, and kit for alpha-1 proteinase inhibitor
US14/926,450 Active US9616126B2 (en) 2009-11-03 2015-10-29 Composition, method, and kit for alpha-1 proteinase inhibitor

Family Applications After (1)

Application Number Title Priority Date Filing Date
US14/926,450 Active US9616126B2 (en) 2009-11-03 2015-10-29 Composition, method, and kit for alpha-1 proteinase inhibitor

Country Status (19)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11566031B2 (en) * 2019-03-04 2023-01-31 Tae Life Sciences, Llc Borylated amino acid compositions for use in boron neutron capture therapy and methods thereof

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20140108516A (ko) * 2011-12-30 2014-09-11 그리폴스, 에스.에이. 폐 악화의 발현 또는 진행을 지연시키기 위한 알파1-프로테이나제 억제제
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
BR112022016234A2 (pt) 2020-02-25 2022-10-11 Grifols Worldwide Operations Ltd Método para obtenção de inibidor de proteinase alfa-1

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US20070020199A1 (en) * 1994-03-07 2007-01-25 Platz Robert M Dispersible macromolecule compositions and methods for their preparation and use
US20080261868A1 (en) * 1999-03-05 2008-10-23 Leland Shapiro Methods and Compositions for Treating Diabetes

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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
US4623717A (en) 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
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
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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
WO1986000337A1 (fr) 1984-06-19 1986-01-16 Transgene S.A. DERIVES DE L'alpha1-ANTITRYPSINE HUMAINE ET PROCEDE POUR LEUR PREPARATION
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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
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US3940480A (en) * 1972-05-08 1976-02-24 Eisai Co., Ltd. Process for production of stabilized powdery secretin preparation by lyophilization
US20070020199A1 (en) * 1994-03-07 2007-01-25 Platz Robert M Dispersible macromolecule compositions and methods for their preparation and use
US20080261868A1 (en) * 1999-03-05 2008-10-23 Leland Shapiro Methods and Compositions for Treating Diabetes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11566031B2 (en) * 2019-03-04 2023-01-31 Tae Life Sciences, Llc Borylated amino acid compositions for use in boron neutron capture therapy and methods thereof

Also Published As

Publication number Publication date
EP2496246B1 (en) 2018-06-27
AU2010315325B2 (en) 2014-11-27
AU2010315325A1 (en) 2012-06-07
ES2679819T8 (es) 2019-01-22
WO2011056793A3 (en) 2011-09-29
CN102655876B (zh) 2015-07-15
BR112012010392B1 (pt) 2021-01-05
JP2015221835A (ja) 2015-12-10
WO2011056793A2 (en) 2011-05-12
CA2779369A1 (en) 2011-05-12
NZ599783A (en) 2013-10-25
RU2555332C2 (ru) 2015-07-10
CA2779369C (en) 2018-06-19
IL219485A0 (en) 2012-06-28
IL219485A (en) 2017-06-29
MX2012005132A (es) 2012-07-25
KR20120114235A (ko) 2012-10-16
EP2496246A4 (en) 2013-03-27
BR112012010392B8 (pt) 2021-05-25
JP6030201B2 (ja) 2016-11-24
CL2012001159A1 (es) 2012-09-14
CN102655876A (zh) 2012-09-05
US9616126B2 (en) 2017-04-11
JP2013510158A (ja) 2013-03-21
RU2012122793A (ru) 2013-12-10
TR201809898T4 (tr) 2018-07-23
PT2496246T (pt) 2018-07-31
US20160106843A1 (en) 2016-04-21
EP2496246A2 (en) 2012-09-12
PL2496246T3 (pl) 2018-09-28
HUE039240T2 (hu) 2018-12-28
ES2679819T3 (es) 2018-08-31
BR112012010392A2 (pt) 2016-07-12

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