CN104220047B - 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 - Google Patents
含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 Download PDFInfo
- Publication number
- CN104220047B CN104220047B CN201380020203.0A CN201380020203A CN104220047B CN 104220047 B CN104220047 B CN 104220047B CN 201380020203 A CN201380020203 A CN 201380020203A CN 104220047 B CN104220047 B CN 104220047B
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- China
- Prior art keywords
- composition
- viscosity
- biopharmaceuticals
- arginine
- concentration
- 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.)
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- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 title abstract description 37
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 title abstract description 37
- 229940083094 guanine derivative acting on arteriolar smooth muscle Drugs 0.000 title abstract description 36
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- 239000003795 chemical substances by application Substances 0.000 claims abstract 2
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- 239000004475 Arginine Substances 0.000 claims description 23
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- 235000009697 arginine Nutrition 0.000 claims description 23
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 10
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- 125000002059 L-arginyl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])C([H])([H])C([H])([H])N([H])C(=N[H])N([H])[H] 0.000 claims 1
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
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- 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
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
- A61K9/0048—Eye, e.g. artificial tears
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- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Ophthalmology & Optometry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261651588P | 2012-05-25 | 2012-05-25 | |
| US61/651,588 | 2012-05-25 | ||
| PCT/EP2013/060649 WO2013174936A1 (en) | 2012-05-25 | 2013-05-23 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104220047A CN104220047A (zh) | 2014-12-17 |
| CN104220047B true CN104220047B (zh) | 2019-11-15 |
Family
ID=48534372
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380020203.0A Active CN104220047B (zh) | 2012-05-25 | 2013-05-23 | 含有生物治疗剂和胍或胍衍生物的水性药物组合物以及包含所述组合物的注射剂 |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US10010513B2 (enExample) |
| EP (1) | EP2854760B1 (enExample) |
| JP (3) | JP6250646B2 (enExample) |
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| CN105164204A (zh) | 2012-11-21 | 2015-12-16 | 路易斯维尔大学研究基金会 | 用于降低氧化损伤的组合物和方法 |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| ES2769783T3 (es) * | 2014-03-11 | 2020-06-29 | Green Cross Holdings Corp | Procedimiento de purificación de inmunoglobulina |
| AU2015325055B2 (en) * | 2014-10-01 | 2021-02-25 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| EP3256136A4 (en) | 2015-02-09 | 2018-11-21 | University Of Louisville Research Foundation, Inc. | Ophthalmic compositions and methods for reducing oxidative damage to an eye lens |
| TW201722437A (zh) * | 2015-11-30 | 2017-07-01 | Rohto Pharma | 眼科組成物 |
| MY191668A (en) | 2016-06-14 | 2022-07-06 | Regeneron Pharma | Anti-c5 antibodies and uses thereof |
| ES2968923T3 (es) | 2016-08-10 | 2024-05-14 | Celltrion Inc | Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe |
| KR102262743B1 (ko) | 2017-07-07 | 2021-06-09 | 에이치케이이노엔 주식회사 | 주사용 조성물 |
| GB201713660D0 (en) * | 2017-08-25 | 2017-10-11 | Kalvista Pharmaceuticals Ltd | Pharmaceutical compositions |
| JP2021506241A (ja) | 2017-12-13 | 2021-02-22 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 抗ｃ５抗体組み合わせ物およびその使用 |
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| US5364884A (en) * | 1993-01-21 | 1994-11-15 | Baylor College Of Medicine | Arginine compounds as ocular hypotensive agents |
| US5658948A (en) * | 1994-03-02 | 1997-08-19 | Allergan | Enhancement of benzalkonium chloride preservative activity in formulations containing an incompatible drug using amino acids having net positive charge |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6462071B1 (en) * | 2000-03-02 | 2002-10-08 | Vitreo-Retinal Technologies, Inc. | Agents for intravitreal administration to treat or prevent disorders of the eye |
| AU2001271417B2 (en) | 2000-08-30 | 2006-10-05 | Johns Hopkins University | Devices for intraocular drug delivery |
| AU2003293543A1 (en) * | 2002-12-13 | 2004-07-09 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| US20060182783A1 (en) * | 2004-04-30 | 2006-08-17 | Allergan, Inc. | Sustained release intraocular drug delivery systems |
| EP2129681A2 (en) * | 2007-03-22 | 2009-12-09 | Novartis Ag | C5 antigens and uses thereof |
| WO2010015608A1 (en) | 2008-08-05 | 2010-02-11 | Novartis Ag | Compositions and methods for antibodies targeting complement protein c5 |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
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| WO2011084750A1 (en) * | 2009-12-21 | 2011-07-14 | Genentech, Inc. | Antibody formulation |
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| AU2013265255B2 (en) | 2018-03-29 |
| JP2018193406A (ja) | 2018-12-06 |
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| CN104220047A (zh) | 2014-12-17 |
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| WO2013174936A1 (en) | 2013-11-28 |
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| ES2706059T3 (es) | 2019-03-27 |
| KR20150024301A (ko) | 2015-03-06 |
| ZA201406403B (en) | 2019-01-30 |
| JP6405406B2 (ja) | 2018-10-17 |
| EP2854760B1 (en) | 2018-10-17 |
| AU2018203929A1 (en) | 2018-06-21 |
| AR091155A1 (es) | 2015-01-14 |
| US10010513B2 (en) | 2018-07-03 |
| CL2014003148A1 (es) | 2015-02-27 |
| CA2866232A1 (en) | 2013-11-28 |
| RU2014152803A (ru) | 2016-07-20 |
| JP6250646B2 (ja) | 2017-12-20 |
| JP2017122123A (ja) | 2017-07-13 |
| JP2015517556A (ja) | 2015-06-22 |
| MX2014014318A (es) | 2015-02-12 |
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