CA2866232A1 - Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition - Google Patents
Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition Download PDFInfo
- Publication number
- CA2866232A1 CA2866232A1 CA2866232A CA2866232A CA2866232A1 CA 2866232 A1 CA2866232 A1 CA 2866232A1 CA 2866232 A CA2866232 A CA 2866232A CA 2866232 A CA2866232 A CA 2866232A CA 2866232 A1 CA2866232 A1 CA 2866232A1
- Authority
- CA
- Canada
- Prior art keywords
- guanidine
- composition
- therapeutic agent
- aqueous pharmaceutical
- pharmaceutical composition
- 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.)
- Abandoned
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- ZRALSGWEFCBTJO-UHFFFAOYSA-N Guanidine Chemical compound NC(N)=N ZRALSGWEFCBTJO-UHFFFAOYSA-N 0.000 title abstract 4
- 238000002347 injection Methods 0.000 title abstract 3
- 239000007924 injection Substances 0.000 title abstract 3
- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 title abstract 2
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 title abstract 2
- 239000003814 drug Substances 0.000 title abstract 2
- 150000002357 guanidines Chemical class 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 229940124597 therapeutic agent Drugs 0.000 title abstract 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 abstract 1
- 229930064664 L-arginine Natural products 0.000 abstract 1
- 235000014852 L-arginine Nutrition 0.000 abstract 1
- 235000018102 proteins Nutrition 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
Classifications
-
- 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
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
-
- 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]
-
- 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
-
- 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
- A61K47/06—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
-
- 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
- A61K47/20—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
- A61K47/26—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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61K9/0051—Ocular inserts, ocular implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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 (1)
| Publication Number | Publication Date |
|---|---|
| CA2866232A1 true CA2866232A1 (en) | 2013-11-28 |
Family
ID=48534372
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2866232A Abandoned CA2866232A1 (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 |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US10010513B2 (enExample) |
| EP (1) | EP2854760B1 (enExample) |
| JP (3) | JP6250646B2 (enExample) |
| KR (1) | KR20150024301A (enExample) |
| CN (1) | CN104220047B (enExample) |
| AR (1) | AR091155A1 (enExample) |
| AU (2) | AU2013265255B2 (enExample) |
| CA (1) | CA2866232A1 (enExample) |
| CL (1) | CL2014003148A1 (enExample) |
| CO (1) | CO7270463A2 (enExample) |
| ES (1) | ES2706059T3 (enExample) |
| MX (1) | MX2014014318A (enExample) |
| PH (1) | PH12014502352A1 (enExample) |
| RU (1) | RU2014152803A (enExample) |
| WO (1) | WO2013174936A1 (enExample) |
| ZA (1) | ZA201406403B (enExample) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| ES2765657T3 (es) * | 2009-12-21 | 2020-06-10 | Hoffmann La Roche | Formulación farmacéutica de bevacizumab |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
-
2013
- 2013-05-23 AU AU2013265255A patent/AU2013265255B2/en active Active
- 2013-05-23 EP EP13725348.0A patent/EP2854760B1/en active Active
- 2013-05-23 MX MX2014014318A patent/MX2014014318A/es unknown
- 2013-05-23 US US13/900,724 patent/US10010513B2/en active Active
- 2013-05-23 RU RU2014152803A patent/RU2014152803A/ru not_active Application Discontinuation
- 2013-05-23 CA CA2866232A patent/CA2866232A1/en not_active Abandoned
- 2013-05-23 JP JP2015513185A patent/JP6250646B2/ja active Active
- 2013-05-23 KR KR20147026263A patent/KR20150024301A/ko not_active Ceased
- 2013-05-23 WO PCT/EP2013/060649 patent/WO2013174936A1/en not_active Ceased
- 2013-05-23 CN CN201380020203.0A patent/CN104220047B/zh active Active
- 2013-05-23 ES ES13725348T patent/ES2706059T3/es active Active
- 2013-05-24 AR ARP130101819 patent/AR091155A1/es unknown
-
2014
- 2014-09-01 ZA ZA2014/06403A patent/ZA201406403B/en unknown
- 2014-10-21 PH PH12014502352A patent/PH12014502352A1/en unknown
- 2014-11-20 CL CL2014003148A patent/CL2014003148A1/es unknown
- 2014-11-27 CO CO14261585A patent/CO7270463A2/es unknown
-
2017
- 2017-03-31 JP JP2017071601A patent/JP6405406B2/ja not_active Expired - Fee Related
-
2018
- 2018-06-04 AU AU2018203929A patent/AU2018203929A1/en not_active Abandoned
- 2018-09-14 JP JP2018172328A patent/JP2018193406A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20130317457A1 (en) | 2013-11-28 |
| AU2013265255B2 (en) | 2018-03-29 |
| JP2018193406A (ja) | 2018-12-06 |
| PH12014502352A1 (en) | 2015-01-12 |
| CN104220047A (zh) | 2014-12-17 |
| CO7270463A2 (es) | 2015-05-19 |
| AU2013265255A1 (en) | 2014-09-25 |
| WO2013174936A1 (en) | 2013-11-28 |
| EP2854760A1 (en) | 2015-04-08 |
| 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 |
| RU2014152803A (ru) | 2016-07-20 |
| CN104220047B (zh) | 2019-11-15 |
| JP6250646B2 (ja) | 2017-12-20 |
| JP2017122123A (ja) | 2017-07-13 |
| JP2015517556A (ja) | 2015-06-22 |
| MX2014014318A (es) | 2015-02-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20180426 |
|
| FZDE | Dead |
Effective date: 20200831 |