BR112015014853A2 - Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura - Google Patents
Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufaturaInfo
- Publication number
- BR112015014853A2 BR112015014853A2 BR112015014853A BR112015014853A BR112015014853A2 BR 112015014853 A2 BR112015014853 A2 BR 112015014853A2 BR 112015014853 A BR112015014853 A BR 112015014853A BR 112015014853 A BR112015014853 A BR 112015014853A BR 112015014853 A2 BR112015014853 A2 BR 112015014853A2
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical formulation
- article
- manufacture
- lyophilized
- formulation
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 7
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000008351 acetate buffer Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- 230000008961 swelling Effects 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/14—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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261745293P | 2012-12-21 | 2012-12-21 | |
| PCT/EP2013/077166 WO2014096051A1 (en) | 2012-12-21 | 2013-12-18 | Anti her2 antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112015014853A2 true BR112015014853A2 (pt) | 2017-08-22 |
Family
ID=49779926
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112015014853A BR112015014853A2 (pt) | 2012-12-21 | 2013-12-18 | Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20150343058A1 (enExample) |
| EP (1) | EP2934582B1 (enExample) |
| JP (2) | JP6400595B2 (enExample) |
| AU (1) | AU2013360812B2 (enExample) |
| BR (1) | BR112015014853A2 (enExample) |
| CA (1) | CA2895869C (enExample) |
| DK (1) | DK2934582T3 (enExample) |
| EA (1) | EA201391729A1 (enExample) |
| ES (1) | ES2773103T3 (enExample) |
| IL (1) | IL239509A0 (enExample) |
| MX (2) | MX367748B (enExample) |
| PL (1) | PL2934582T3 (enExample) |
| SG (1) | SG11201504897YA (enExample) |
| WO (1) | WO2014096051A1 (enExample) |
| ZA (1) | ZA201504564B (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| KR101776879B1 (ko) * | 2015-01-19 | 2017-09-08 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
| GB2542391A (en) * | 2015-09-17 | 2017-03-22 | Annexin Pharmaceuticals Ab | Process of manufacture |
| TWI865337B (zh) * | 2018-07-25 | 2024-12-01 | 日商第一三共股份有限公司 | 抗體-藥物結合物之有效的製造方法 |
| TWI846717B (zh) | 2018-07-27 | 2024-07-01 | 日商第一三共股份有限公司 | 辨識抗體-藥物結合物之藥物部位的蛋白質 |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| KR20210142694A (ko) * | 2019-03-22 | 2021-11-25 | 소마로직, 인크. | 생물학적 복합 매트릭스에서 샘플-간 피분석물 변동성 감소 |
| CN114040754A (zh) * | 2019-06-28 | 2022-02-11 | 基因泰克公司 | 用于稳定液体蛋白质制剂的组合物及方法 |
| US20220273796A1 (en) * | 2019-07-19 | 2022-09-01 | Ichnos Sciences SA | Lyophilized antibody formulation |
| WO2021174113A1 (en) | 2020-02-28 | 2021-09-02 | Regeneron Pharmaceuticals, Inc. | Bispecific antigen binding molecules that bind her2, and methods of use thereof |
| CN114504642A (zh) * | 2020-11-17 | 2022-05-17 | 江苏奥赛康药业有限公司 | 一种含抗cldn18.2抗体的液体药物组合物 |
| CN114762727A (zh) * | 2021-01-15 | 2022-07-19 | 海正生物制药有限公司 | 一种稳定的帕妥珠单抗的药物组合物 |
| MX2024005772A (es) * | 2021-11-12 | 2024-07-22 | Beckman Coulter Inc | Novedosa formulación para la tinción de anticuerpos conjugados con polímeros. |
| WO2023140807A1 (en) * | 2022-01-19 | 2023-07-27 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical compositions of trastuzumab |
| WO2023202685A1 (en) * | 2022-04-22 | 2023-10-26 | Eirgenix, Inc. | Pharmaceutical compositons containing anti-her2 antibody for subcutaneous administration |
| WO2025085781A1 (en) | 2023-10-19 | 2025-04-24 | Genentech, Inc. | Combinations of il15/il15r alpha heterodimeric fc-fusion proteins and her2xcd3 bispecific antibodies for the treatment of her2-positive cancers |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1989011297A1 (en) * | 1988-05-27 | 1989-11-30 | Centocor, Inc. | Freeze-dried formulation for antibody products |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| MX9800684A (es) * | 1995-07-27 | 1998-04-30 | Genentech Inc | Formulacion de proteinas liofilizadas isotonicas estables. |
| DK0999853T3 (da) * | 1997-06-13 | 2003-04-22 | Genentech Inc | Stabiliseret antostofformulering |
| WO2003062375A2 (en) * | 2001-12-19 | 2003-07-31 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
| CN1671741A (zh) * | 2002-06-21 | 2005-09-21 | 拜奥根Idec公司 | 浓缩抗体的缓冲剂制剂及其使用方法 |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| ES2424042T3 (es) * | 2005-06-07 | 2013-09-26 | Esbatech - A Novartis Company Llc | Anticuerpos estables y solubles que inhiben TNF± |
| EP1909831A4 (en) * | 2005-06-14 | 2013-02-20 | Amgen Inc | SELF-BUFFING PROTEIN FORMULATIONS |
| US9345661B2 (en) * | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
-
2013
- 2013-12-18 DK DK13808043.7T patent/DK2934582T3/da active
- 2013-12-18 SG SG11201504897YA patent/SG11201504897YA/en unknown
- 2013-12-18 ES ES13808043T patent/ES2773103T3/es active Active
- 2013-12-18 BR BR112015014853A patent/BR112015014853A2/pt not_active Application Discontinuation
- 2013-12-18 JP JP2015548495A patent/JP6400595B2/ja not_active Expired - Fee Related
- 2013-12-18 WO PCT/EP2013/077166 patent/WO2014096051A1/en not_active Ceased
- 2013-12-18 AU AU2013360812A patent/AU2013360812B2/en not_active Ceased
- 2013-12-18 MX MX2015008194A patent/MX367748B/es active IP Right Grant
- 2013-12-18 CA CA2895869A patent/CA2895869C/en active Active
- 2013-12-18 PL PL13808043T patent/PL2934582T3/pl unknown
- 2013-12-18 EP EP13808043.7A patent/EP2934582B1/en active Active
- 2013-12-18 US US14/654,096 patent/US20150343058A1/en not_active Abandoned
- 2013-12-19 EA EA201391729A patent/EA201391729A1/ru unknown
-
2015
- 2015-06-18 IL IL239509A patent/IL239509A0/en unknown
- 2015-06-22 MX MX2019010479A patent/MX2019010479A/es unknown
- 2015-06-24 ZA ZA2015/04564A patent/ZA201504564B/en unknown
-
2018
- 2018-09-05 JP JP2018165536A patent/JP2018199720A/ja active Pending
-
2019
- 2019-07-08 US US16/504,411 patent/US20200061190A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU2013360812A1 (en) | 2015-07-09 |
| HK1215796A1 (en) | 2016-09-15 |
| JP6400595B2 (ja) | 2018-10-03 |
| EA201391729A1 (ru) | 2014-09-30 |
| US20200061190A1 (en) | 2020-02-27 |
| MX2015008194A (es) | 2016-02-05 |
| CA2895869C (en) | 2020-09-22 |
| JP2018199720A (ja) | 2018-12-20 |
| PL2934582T3 (pl) | 2020-08-10 |
| ZA201504564B (en) | 2016-11-30 |
| EP2934582A1 (en) | 2015-10-28 |
| CA2895869A1 (en) | 2014-06-26 |
| IL239509A0 (en) | 2015-08-31 |
| DK2934582T3 (da) | 2020-02-24 |
| US20150343058A1 (en) | 2015-12-03 |
| ES2773103T3 (es) | 2020-07-09 |
| EP2934582B1 (en) | 2019-11-27 |
| WO2014096051A1 (en) | 2014-06-26 |
| JP2016508973A (ja) | 2016-03-24 |
| AU2013360812B2 (en) | 2018-11-08 |
| MX2019010479A (es) | 2019-10-15 |
| SG11201504897YA (en) | 2015-07-30 |
| WO2014096051A9 (en) | 2014-10-02 |
| MX367748B (es) | 2019-09-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| BR112015014853A2 (pt) | Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura | |
| AU2018256640A1 (en) | Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives | |
| CR20140365A (es) | Compuestos de carbamato y preparación y uso de los mismos | |
| CL2016001547A1 (es) | Composiciones para el cuidado oral | |
| CL2015003801A1 (es) | Formulaciones de anticuerpos y metodos | |
| UA110103C2 (uk) | Модифікований туберкульозний антиген | |
| MX2016005395A (es) | Formulacion estable de insulina glulisina. | |
| CR20150455A (es) | Imidazopiridazinas sustituidas | |
| MX373309B (es) | Composiciones antibióticas de ceftolozano. | |
| BR112013014189A8 (pt) | composição farmacêutica, uso de um agente de potencialização e uso de uma composição | |
| CL2015001342A1 (es) | Compuestos derivados de pirrolo[3,2-d]pirimidina; composicion farmaceutica y de vacuna que los comprende y el uso en el tratamiento de enfermedades alergicas y otras enfermedades inflamatorias, infecciosas y cancer. | |
| EA201591830A1 (ru) | Фармацевтические композиции, включающие эверолимус | |
| WO2014153009A3 (en) | Thiosaccharide mucolytic agents | |
| UA117833C2 (uk) | Склад з відстроченим вивільненням, що містить гранули цистеаміну, і способи його одержання та застосування | |
| BR112016014870A2 (pt) | Formulação de selante líquido compreendendo monômeros de fibrina e um peptídeo de gprp, seu método de fabricação, recipiente e kit | |
| UY35848A (es) | Tienopirimidinas | |
| BR112013032870A2 (pt) | composição cosmética compreendendo pelo menos um polímero anfotérico particular e pelo menos um agente condicionante particular | |
| MX2015016410A (es) | Esteres de acidos oligo-hidroxicarboxilicos y uso de los mismos. | |
| BR112015027436A2 (en) | Topical composition and carrier for administration of pharmaceutically or cosmetically active ingredients | |
| BR112013019924A2 (pt) | composições para cuidado oral | |
| BR112014025416A2 (pt) | AGENTES ANTIMALÁRICOS, COMPOSIÇÃO FARMACEUTICA COMPREENDENDO-OS E USO Dos MESMOS. | |
| CL2012003265A1 (es) | Polisacarido de semillas de tamarindo para usarse en el tratamiento de enfermedades infecciosas; composicion farmacéutica y/o dermocosmética antiinflamatoria que contiene dicho polisacárido; uso de un polisacárido de semilla de tamarindo. | |
| CL2015001748A1 (es) | Formulaciones antiparasitarias transdermicas | |
| BR112015033065A8 (pt) | nanopartícula de lipídio; composição farmacêutica; e uso da nanopartícula de lipídio | |
| BR112014016804A2 (pt) | composições, métodos de uso e métodos de tratamento |
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] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06I | Publication of requirement cancelled [chapter 6.9 patent gazette] |
Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B25D | Requested change of name of applicant approved |
Owner name: ICHNOS SCIENCES SA (CH) |
|
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B11B | Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements |