MX2013007537A - Formulacion farmaceutica que comprende una droga biofarmaceutica. - Google Patents
Formulacion farmaceutica que comprende una droga biofarmaceutica.Info
- Publication number
- MX2013007537A MX2013007537A MX2013007537A MX2013007537A MX2013007537A MX 2013007537 A MX2013007537 A MX 2013007537A MX 2013007537 A MX2013007537 A MX 2013007537A MX 2013007537 A MX2013007537 A MX 2013007537A MX 2013007537 A MX2013007537 A MX 2013007537A
- Authority
- MX
- Mexico
- Prior art keywords
- pharmaceutical formulation
- biopharmaceutical drug
- biopharmaceutical
- drug
- backbone
- Prior art date
Links
- 229960000074 biopharmaceutical Drugs 0.000 title abstract 2
- 229940079593 drug Drugs 0.000 title abstract 2
- 239000003814 drug Substances 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 abstract 1
- 125000004432 carbon atom Chemical group C* 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 150000002762 monocarboxylic acid derivatives Chemical class 0.000 abstract 1
- 150000003839 salts Chemical class 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Abstract
Una formulación farmacéutica que comprende una droga biofarmacéutica, donde dicha composición además comprende por lo menos un ácido mono- o dicarboxílico con un esqueleto principal de 2 - 6 átomos de C, o por lo menos una sal del mismo (Figura 4a).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10197122A EP2471554A1 (en) | 2010-12-28 | 2010-12-28 | Pharmaceutical formulation comprising a biopharmaceutical drug |
| PCT/EP2011/074181 WO2012089778A1 (en) | 2010-12-28 | 2011-12-28 | Pharmaceutical formulation comprising a biopharmaceutical drug |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2013007537A true MX2013007537A (es) | 2014-03-13 |
| MX352245B MX352245B (es) | 2017-10-31 |
Family
ID=43982272
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2013007537A MX352245B (es) | 2010-12-28 | 2011-12-28 | Formulacion farmaceutica que comprende una droga biofarmaceutica. |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9480743B2 (es) |
| EP (2) | EP2471554A1 (es) |
| JP (2) | JP5767340B2 (es) |
| KR (1) | KR101808367B1 (es) |
| CN (1) | CN103269718B (es) |
| AR (2) | AR084627A1 (es) |
| AU (1) | AU2011351414B2 (es) |
| BR (1) | BR112013016770A2 (es) |
| CA (1) | CA2822859C (es) |
| DK (1) | DK2658575T3 (es) |
| ES (1) | ES2659981T3 (es) |
| HR (1) | HRP20171931T1 (es) |
| HU (1) | HUE035707T2 (es) |
| MX (1) | MX352245B (es) |
| NO (1) | NO2658575T3 (es) |
| PL (1) | PL2658575T3 (es) |
| PT (1) | PT2658575T (es) |
| RU (1) | RU2587056C2 (es) |
| SI (1) | SI2658575T1 (es) |
| TW (1) | TWI530295B (es) |
| WO (1) | WO2012089778A1 (es) |
| ZA (2) | ZA201304446B (es) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| EP3412310B1 (en) | 2012-03-07 | 2022-09-07 | Cadila Healthcare Limited | Pharmaceutical formulations of tnf-alpha antibodies |
| US20130236505A1 (en) * | 2012-03-09 | 2013-09-12 | Basf Se | Production Of Pharmaceutical Protective Coatings With Good Resistance In A Neutral Environment |
| EP2863951A1 (en) * | 2012-06-12 | 2015-04-29 | Boehringer Ingelheim International GmbH | Pharmaceutical formulation for a therapeutic antibody |
| PE20150964A1 (es) | 2012-09-07 | 2015-07-25 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| JP6326066B2 (ja) * | 2012-12-20 | 2018-05-16 | メディミューン,エルエルシー | 凝集プロファイルが改善されている液状抗体製剤 |
| CN103446583B (zh) * | 2013-03-21 | 2015-11-18 | 百奥泰生物科技(广州)有限公司 | 一种治疗TNF-α相关疾病的人抗体制剂 |
| AU2014291970B2 (en) * | 2013-07-19 | 2017-09-28 | Hexal Ag | Methods and formulations which allow the modulation of immune responses related to the administration of a biopharmaceutical drug |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| ES2572919T3 (es) | 2014-05-23 | 2016-06-03 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946765B1 (en) | 2014-05-23 | 2016-08-31 | Ares Trading S.A. | Liquid pharmaceutical composition |
| HUP1400510A1 (hu) | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| JP2026501288A (ja) | 2022-12-21 | 2026-01-14 | フォーマイコン アーゲー | 抗pd1抗体の製剤 |
| WO2025149960A1 (en) * | 2024-01-11 | 2025-07-17 | Lupin Limited | Pharmaceutical formulation of anti-il-5 antibody |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US6548640B1 (en) | 1986-03-27 | 2003-04-15 | Btg International Limited | Altered antibodies |
| US5223409A (en) | 1988-09-02 | 1993-06-29 | Protein Engineering Corp. | Directed evolution of novel binding proteins |
| WO1990005144A1 (en) | 1988-11-11 | 1990-05-17 | Medical Research Council | Single domain ligands, receptors comprising said ligands, methods for their production, and use of said ligands and receptors |
| US5859205A (en) | 1989-12-21 | 1999-01-12 | Celltech Limited | Humanised antibodies |
| JP3179538B2 (ja) * | 1990-12-11 | 2001-06-25 | ノバルティス アクチエンゲゼルシャフト | 安定なヒトカルシトニンの水性溶液 |
| US20040120952A1 (en) * | 2000-08-07 | 2004-06-24 | Centocor, Inc | Anti-TNF antibodies and peptides of human tumor necrosis factor |
| US5264142A (en) | 1991-11-25 | 1993-11-23 | Lever Brothers Company, Division Of Conopco, Inc. | Stabilization of peroxygen bleach in enzyme-containing heavy duty liquids |
| DK1143006T3 (da) | 1995-08-18 | 2008-07-14 | Morphosys Ip Gmbh | Vektorer/DNA-sekvenser fra humane kombinatoriske antistofbiblioteker |
| AU2440197A (en) * | 1996-04-18 | 1997-11-07 | Baxter International Inc. | Stabilization of therapeutic hemoglobin compositions |
| US6309663B1 (en) * | 1999-08-17 | 2001-10-30 | Lipocine Inc. | Triglyceride-free compositions and methods for enhanced absorption of hydrophilic therapeutic agents |
| CN100518819C (zh) * | 2000-06-30 | 2009-07-29 | 阿斯比奥制药株式会社 | 含有人甲状旁腺激素的药物成分及含有该成分的用于鼻内给药的药物组合物 |
| UA81743C2 (uk) | 2000-08-07 | 2008-02-11 | Центокор, Инк. | МОНОКЛОНАЛЬНЕ АНТИТІЛО ЛЮДИНИ, ЩО СПЕЦИФІЧНО ЗВ'ЯЗУЄТЬСЯ З ФАКТОРОМ НЕКРОЗУ ПУХЛИН АЛЬФА (ФНПα), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ЙОГО МІСТИТЬ, ТА СПОСІБ ЛІКУВАННЯ РЕВМАТОЇДНОГО АРТРИТУ |
| NZ532896A (en) * | 2001-11-08 | 2007-08-31 | Pdl Biopharma Inc | Stable liquid pharmaceutical formulation of IGG antibodies including daclizumab and fontolizumab |
| JP2005515180A (ja) * | 2001-11-13 | 2005-05-26 | ザ プロクター アンド ギャンブル カンパニー | 阻害物質で安定化させた酵素を含有する局所適用組成物 |
| ATE306810T1 (de) | 2002-03-05 | 2005-11-15 | Artemis Pharmaceuticals Gmbh | Durch inzucht erzeugte von embryonalen stammzellen abgeleitete mäuse |
| US20030204861A1 (en) | 2002-04-30 | 2003-10-30 | Madaiah Puttaraju | Transgenic animal model for spliceosome-mediated RNA trans-splicing |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| WO2004019861A2 (en) * | 2002-08-28 | 2004-03-11 | Pharmacia Corporation | Stable ph optimized formulation of a modified antibody |
| AU2003301761A1 (en) * | 2002-10-29 | 2004-05-25 | Medical Nutrition Usa, Inc. | Method for treating wounds to promote healing |
| US20040101939A1 (en) * | 2002-11-22 | 2004-05-27 | Santora Ling C. | Method for reducing or preventing modification of a polypeptide in solution |
| US7642230B2 (en) * | 2003-05-01 | 2010-01-05 | Ltt Bio-Pharma Co., Ltd. | Zinc-containing sustained-release composition, its preparation, and method for producing the same |
| EP1688432B1 (en) * | 2003-10-09 | 2011-08-03 | Chugai Seiyaku Kabushiki Kaisha | Igm high concentration stabilized solution |
| US20070184050A1 (en) * | 2003-12-25 | 2007-08-09 | Kirin Beer Kabushiki Kaisha | Stable water-based medicinal preparation containing antibody |
| US20080090753A1 (en) * | 2004-03-12 | 2008-04-17 | Biodel, Inc. | Rapid Acting Injectable Insulin Compositions |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| GT200600031A (es) * | 2005-01-28 | 2006-08-29 | Formulacion anticuerpo anti a beta | |
| CN101111264A (zh) * | 2005-01-28 | 2008-01-23 | 惠氏公司 | 稳定化的液体多肽制剂 |
| GB0503337D0 (en) * | 2005-02-17 | 2005-03-23 | Glaxosmithkline Biolog Sa | Compositions |
| WO2006112838A1 (en) | 2005-04-18 | 2006-10-26 | Xtl Biopharmaceuticals Ltd. | Stabilized anti-hepatitis b (hbv) antibody formulations |
| GB0707938D0 (en) * | 2007-04-25 | 2007-05-30 | Univ Strathclyde | Precipitation stabilising compositions |
| JP2009153392A (ja) * | 2007-12-25 | 2009-07-16 | Lion Corp | 液体経口用組成物 |
| NZ621174A (en) * | 2008-01-15 | 2015-09-25 | Abbvie Deutschland | Powdered protein compositions and methods of making same |
| CN102076716A (zh) * | 2008-06-25 | 2011-05-25 | 艾斯巴技术,爱尔康生物医药研究装置有限责任公司 | 抑制TNFα的稳定和可溶的抗体 |
| GB0818228D0 (en) * | 2008-10-06 | 2008-11-12 | Avecia Biolog Ltd | Purification process |
| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
-
2010
- 2010-12-28 EP EP10197122A patent/EP2471554A1/en not_active Withdrawn
-
2011
- 2011-12-28 RU RU2013133953/15A patent/RU2587056C2/ru active
- 2011-12-28 AR ARP110104977A patent/AR084627A1/es not_active Application Discontinuation
- 2011-12-28 DK DK11807947.4T patent/DK2658575T3/en active
- 2011-12-28 CN CN201180062372.1A patent/CN103269718B/zh not_active Expired - Fee Related
- 2011-12-28 SI SI201131399T patent/SI2658575T1/en unknown
- 2011-12-28 HU HUE11807947A patent/HUE035707T2/en unknown
- 2011-12-28 HR HRP20171931TT patent/HRP20171931T1/hr unknown
- 2011-12-28 KR KR1020137016504A patent/KR101808367B1/ko not_active Expired - Fee Related
- 2011-12-28 US US13/995,556 patent/US9480743B2/en active Active
- 2011-12-28 PL PL11807947T patent/PL2658575T3/pl unknown
- 2011-12-28 AU AU2011351414A patent/AU2011351414B2/en not_active Ceased
- 2011-12-28 ES ES11807947.4T patent/ES2659981T3/es active Active
- 2011-12-28 EP EP11807947.4A patent/EP2658575B1/en active Active
- 2011-12-28 NO NO11807947A patent/NO2658575T3/no unknown
- 2011-12-28 PT PT118079474T patent/PT2658575T/pt unknown
- 2011-12-28 MX MX2013007537A patent/MX352245B/es active IP Right Grant
- 2011-12-28 CA CA2822859A patent/CA2822859C/en not_active Expired - Fee Related
- 2011-12-28 WO PCT/EP2011/074181 patent/WO2012089778A1/en not_active Ceased
- 2011-12-28 JP JP2013546703A patent/JP5767340B2/ja active Active
- 2011-12-28 TW TW100149158A patent/TWI530295B/zh active
- 2011-12-28 BR BR112013016770A patent/BR112013016770A2/pt not_active Application Discontinuation
-
2013
- 2013-06-06 ZA ZA2013/04446A patent/ZA201304446B/en unknown
- 2013-11-25 ZA ZA2013/08841A patent/ZA201308841B/en unknown
-
2015
- 2015-03-09 JP JP2015045482A patent/JP2015131832A/ja not_active Abandoned
-
2022
- 2022-01-18 AR ARP220100101A patent/AR124676A2/es unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |