BR112012010392B8 - composição e kit para o inibidor de alfa-1 proteinase - Google Patents
composição e kit para o inibidor de alfa-1 proteinaseInfo
- Publication number
- BR112012010392B8 BR112012010392B8 BR112012010392A BR112012010392A BR112012010392B8 BR 112012010392 B8 BR112012010392 B8 BR 112012010392B8 BR 112012010392 A BR112012010392 A BR 112012010392A BR 112012010392 A BR112012010392 A BR 112012010392A BR 112012010392 B8 BR112012010392 B8 BR 112012010392B8
- Authority
- BR
- Brazil
- Prior art keywords
- composition
- kit
- alpha
- proteinase inhibitor
- api
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 6
- 102000015395 alpha 1-Antitrypsin Human genes 0.000 title abstract 2
- 108010050122 alpha 1-Antitrypsin Proteins 0.000 title abstract 2
- 150000001413 amino acids Chemical class 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000007788 liquid Substances 0.000 abstract 1
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
- 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
- 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
- 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)
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 (3)
| Publication Number | Publication Date |
|---|---|
| BR112012010392A2 BR112012010392A2 (pt) | 2016-07-12 |
| BR112012010392B1 BR112012010392B1 (pt) | 2021-01-05 |
| BR112012010392B8 true BR112012010392B8 (pt) | 2021-05-25 |
Family
ID=43970713
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112012010392A BR112012010392B8 (pt) | 2009-11-03 | 2010-11-02 | composição e kit para o inibidor de alfa-1 proteinase |
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)
| 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 |
Family Cites Families (45)
| 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 |
| 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 |
| 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 |
| AU2002335046A1 (en) * | 2001-10-19 | 2003-05-06 | Inhale Therapeutic Systems, Inc. | The use of proton sequestering agents in drug formulations |
| 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 |
-
2010
- 2010-11-02 KR KR1020127013706A patent/KR20120114235A/ko not_active Ceased
- 2010-11-02 WO PCT/US2010/055135 patent/WO2011056793A2/en not_active Ceased
- 2010-11-02 RU RU2012122793/15A patent/RU2555332C2/ru active
- 2010-11-02 NZ NZ599783A patent/NZ599783A/xx unknown
- 2010-11-02 EP EP10828979.4A patent/EP2496246B1/en not_active Revoked
- 2010-11-02 ES ES10828979.4T patent/ES2679819T3/es active Active
- 2010-11-02 PT PT108289794T patent/PT2496246T/pt unknown
- 2010-11-02 CN CN201080054535.7A patent/CN102655876B/zh active Active
- 2010-11-02 JP JP2012537945A patent/JP2013510158A/ja not_active Withdrawn
- 2010-11-02 HU HUE10828979A patent/HUE039240T2/hu unknown
- 2010-11-02 MX MX2012005132A patent/MX2012005132A/es active IP Right Grant
- 2010-11-02 PL PL10828979T patent/PL2496246T3/pl unknown
- 2010-11-02 BR BR112012010392A patent/BR112012010392B8/pt active IP Right Grant
- 2010-11-02 TR TR2018/09898T patent/TR201809898T4/tr unknown
- 2010-11-02 US US13/504,783 patent/US20130131192A1/en not_active Abandoned
- 2010-11-02 AU AU2010315325A patent/AU2010315325B2/en active Active
- 2010-11-02 CA CA2779369A patent/CA2779369C/en active Active
-
2012
- 2012-04-30 IL IL219485A patent/IL219485A/en active IP Right Grant
- 2012-05-03 CL CL2012001159A patent/CL2012001159A1/es unknown
-
2015
- 2015-09-04 JP JP2015175001A patent/JP6030201B2/ja active Active
- 2015-10-29 US US14/926,450 patent/US9616126B2/en active Active
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] |
Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
|
| B06T | Formal requirements before examination [chapter 6.20 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 05/01/2021, OBSERVADAS AS CONDICOES LEGAIS. |
|
| B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/11/2010 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |