[go: up one dir, main page]

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
Application number
MX2013007537A
Other languages
English (en)
Other versions
MX352245B (es
Inventor
Martina Danek-Bulius
Britta Deutel
Sabine Fürtinger
Bernt Pragl
Drago Kuzman
Original Assignee
Hexal Ag
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
Application filed by Hexal Ag filed Critical Hexal Ag
Publication of MX2013007537A publication Critical patent/MX2013007537A/es
Publication of MX352245B publication Critical patent/MX352245B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist 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).
MX2013007537A 2010-12-28 2011-12-28 Formulacion farmaceutica que comprende una droga biofarmaceutica. MX352245B (es)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
US20130336968A1 (en) 2013-12-19
TWI530295B (zh) 2016-04-21
CN103269718B (zh) 2016-02-10
RU2587056C2 (ru) 2016-06-10
EP2658575B1 (en) 2017-11-15
CA2822859C (en) 2016-11-08
AR084627A1 (es) 2013-05-29
JP2015131832A (ja) 2015-07-23
HRP20171931T1 (hr) 2018-02-23
JP2014505682A (ja) 2014-03-06
WO2012089778A1 (en) 2012-07-05
ZA201304446B (en) 2014-02-26
BR112013016770A2 (pt) 2016-10-11
CA2822859A1 (en) 2012-07-05
KR20130137653A (ko) 2013-12-17
PL2658575T3 (pl) 2018-04-30
EP2471554A1 (en) 2012-07-04
ZA201308841B (en) 2015-02-25
CN103269718A (zh) 2013-08-28
KR101808367B1 (ko) 2018-01-18
SI2658575T1 (en) 2018-02-28
ES2659981T3 (es) 2018-03-20
RU2013133953A (ru) 2015-02-10
JP5767340B2 (ja) 2015-08-19
PT2658575T (pt) 2018-02-22
EP2658575A1 (en) 2013-11-06
HUE035707T2 (en) 2018-05-28
TW201302223A (zh) 2013-01-16
DK2658575T3 (en) 2018-01-22
AU2011351414A1 (en) 2013-07-04
AR124676A2 (es) 2023-04-26
US9480743B2 (en) 2016-11-01
MX352245B (es) 2017-10-31
NO2658575T3 (es) 2018-04-14
AU2011351414B2 (en) 2017-01-19

Similar Documents

Publication Publication Date Title
MX2013007537A (es) Formulacion farmaceutica que comprende una droga biofarmaceutica.
JOP20180103A1 (ar) مركب صيدلاني
MY156938A (en) Hexafluoroisopropyl carbamate derivatives, their preparation and their therapeutic application
MX2022007264A (es) Mejoramiento de autofagia o incremento de longevidad por administracion de urolitinas o precursores de las mismas.
CL2012003722A1 (es) Compuestos derivados del acido naf-2-ilacetico; composicion farmaceutica; y uso para el tratamiento del sida.
UA109010C2 (en) Morpholino pyrividines and their use in therapy
MY183312A (en) Pharmaceutical formulation
IN2015KN00262A (es)
EP3699176A3 (en) Antiviral compounds
ZA201206254B (en) Novel salts for the manufacture of pharmaceutical compositions
EP2546330A4 (en) MILKY ACID BACTERIA CONTAINING PREPARATION
MX2013002422A (es) Sales de lorcaserina con acidos opticamente activos.
MA33948B1 (fr) Dérivés d'acide 3-hétéroaroylamino-propionique substitues par oxygène et leur utilisation en tant qu'agents pharmaceutiques.
MX2014010698A (es) Polimeros cationicos con base en glucogeno.
IN2015DN03998A (es)
EP3228311A3 (en) Pharmaceutical and nutraceutical compositions of abscisic acid
MX347919B (es) Composiciones de tetraciclina.
WO2012049307A3 (en) Novel n-terminally modified insulin derivatives
WO2010118291A3 (en) Biphenyl-3-carboxylic acid modulators of beta-3-adrenoreceptor
MX344846B (es) Combinacion de granulos cargados activos con activos adicionales.
MX2014010433A (es) Nueva forma cristalina de sulfato de sitagliptina.
IN2014DN10449A (es)
MX2014004210A (es) Derivados de 2-oxo-piperidinilo.
EP2641594A3 (en) Enteric coated solid pharmaceutical compositions for proton pump inhibitors
HUE040484T2 (hu) Eljárás (3S,3S')4,4'-diszulfándiilbisz(3-aminobután-1-szulfonsav) elõállítására

Legal Events

Date Code Title Description
FG Grant or registration