AR091155A1 - Composicion farmaceutica acuosa que contiene un agente terapeutico biologico y guanidina o un derivado de guanidina y una inyeccion que incluye la composicion - Google Patents
Composicion farmaceutica acuosa que contiene un agente terapeutico biologico y guanidina o un derivado de guanidina y una inyeccion que incluye la composicionInfo
- Publication number
- AR091155A1 AR091155A1 ARP130101819A AR091155A1 AR 091155 A1 AR091155 A1 AR 091155A1 AR P130101819 A ARP130101819 A AR P130101819A AR 091155 A1 AR091155 A1 AR 091155A1
- Authority
- AR
- Argentina
- Prior art keywords
- composition
- guanidine
- therapeutic agent
- injection
- viscosity
- Prior art date
Links
- ZRALSGWEFCBTJO-UHFFFAOYSA-N Guanidine Chemical compound NC(N)=N ZRALSGWEFCBTJO-UHFFFAOYSA-N 0.000 title abstract 10
- 239000000203 mixture Substances 0.000 title abstract 10
- 239000003814 drug Substances 0.000 title abstract 6
- 229940124597 therapeutic agent Drugs 0.000 title abstract 6
- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 title abstract 4
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 title abstract 4
- 238000002347 injection Methods 0.000 title abstract 4
- 239000007924 injection Substances 0.000 title abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 150000002357 guanidines Chemical class 0.000 abstract 4
- 239000000243 solution Substances 0.000 abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 2
- 101100454807 Caenorhabditis elegans lgg-1 gene Proteins 0.000 abstract 1
- 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
- 125000003636 chemical group Chemical group 0.000 abstract 1
- 235000018102 proteins Nutrition 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
Classifications
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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
-
- 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
- A61K31/13—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
- 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)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (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)
Abstract
Composición farmacéutica acuosa, particularmente una composición oftálmica acuosa, adecuada como una inyección, particularmente una inyección intravítrea. La composición incluye un agente terapéutico biológico (por ejemplo, un anticuerpo monoclonal aislado que específicamente se une a una proteína C5) que tiende a elevar la viscosidad de la composición y una guanidina y/o derivado de guanidina (por ej., L-arginina) que tiende a disminuir la viscosidad de la composición. Reivindicación 1: Una composición acuosa adecuada para inyección, que comprende: un agente terapéutico donde el agente terapéutico biológico, cuando se usa para formar una solución que tiene una concentración de 100 mm. del agente terapéutico biológico en agua, da como resultado la solución que tiene una viscosidad que es por lo menos 10 cp; guanidina y/o derivado de guanidina, el derivado de guanidina tiene la fórmula (1) donde: R¹ es cero, CH₃, CₙH₂ₙ₊₁, CₙH₂ₙ, o CₙH₂ₙ₋₁ (n = 1 - 10); y/o R² es cero o cualquier grupo químico que no reduce significativamente la capacidad del grupo guanidina de disminuir la viscosidad de la composición; y R¹ y R² nunca son cero al mismo tiempo; y donde la guanidina y/o derivado de guanidina está presente en la composición en una concentración de por lo menos 25 mm. pero no mayor de 100 mm.; y agua; donde la composición tiene una viscosidad que no es mayor de 10 centésimas de poise. Reivindicación 8: Una composición como en cualquiera de las reivindicaciones precedentes donde el agente terapéutico biológico es un anticuerpo isotipo lgG1/l.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261651588P | 2012-05-25 | 2012-05-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR091155A1 true AR091155A1 (es) | 2015-01-14 |
Family
ID=48534372
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP130101819 AR091155A1 (es) | 2012-05-25 | 2013-05-24 | Composicion farmaceutica acuosa que contiene un agente terapeutico biologico y guanidina o un derivado de guanidina y una inyeccion que incluye la composicion |
Country Status (16)
Country | Link |
---|---|
US (1) | US10010513B2 (es) |
EP (1) | EP2854760B1 (es) |
JP (3) | JP6250646B2 (es) |
KR (1) | KR20150024301A (es) |
CN (1) | CN104220047B (es) |
AR (1) | AR091155A1 (es) |
AU (2) | AU2013265255B2 (es) |
CA (1) | CA2866232A1 (es) |
CL (1) | CL2014003148A1 (es) |
CO (1) | CO7270463A2 (es) |
ES (1) | ES2706059T3 (es) |
MX (1) | MX2014014318A (es) |
PH (1) | PH12014502352A1 (es) |
RU (1) | RU2014152803A (es) |
WO (1) | WO2013174936A1 (es) |
ZA (1) | ZA201406403B (es) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2923859C (en) | 2013-09-11 | 2021-11-23 | Arsia Therapeutics, Inc. | Liquid protein formulations containing viscosity-lowering agents |
EP3118210B1 (en) * | 2014-03-11 | 2019-11-13 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
SG10201902915VA (en) * | 2014-10-01 | 2019-04-29 | 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 |
WO2017094507A1 (ja) * | 2015-11-30 | 2017-06-08 | ロート製薬株式会社 | 眼科組成物 |
CN116751293A (zh) | 2016-06-14 | 2023-09-15 | 瑞泽恩制药公司 | 抗c5抗体及其用途 |
WO2018030777A1 (ko) * | 2016-08-10 | 2018-02-15 | ㈜셀트리온 | 항-인플루엔자 바이러스 항체의 안정한 액체 약제학적 제제 |
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 |
EP3724226A1 (en) | 2017-12-13 | 2020-10-21 | Regeneron Pharmaceuticals, Inc. | Anti-c5 antibody combinations and uses thereof |
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 |
AU7141701A (en) | 2000-08-30 | 2002-03-13 | Univ Johns Hopkins | 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 |
AR072897A1 (es) | 2008-08-05 | 2010-09-29 | Novartis Ag | Composiciones y metodos para anticuerpos que se dirigen a la proteina de complemento c5 |
CN102770158B (zh) | 2009-12-21 | 2016-10-19 | 霍夫曼-拉罗奇有限公司 | 抗体配制剂 |
KR20120130757A (ko) * | 2010-02-26 | 2012-12-03 | 노보 노르디스크 에이/에스 | 안정한 항체 함유 조성물 |
-
2013
- 2013-05-23 ES ES13725348T patent/ES2706059T3/es active Active
- 2013-05-23 EP EP13725348.0A patent/EP2854760B1/en active Active
- 2013-05-23 US US13/900,724 patent/US10010513B2/en active Active
- 2013-05-23 KR KR20147026263A patent/KR20150024301A/ko not_active Application Discontinuation
- 2013-05-23 JP JP2015513185A patent/JP6250646B2/ja active Active
- 2013-05-23 AU AU2013265255A patent/AU2013265255B2/en active Active
- 2013-05-23 CA CA2866232A patent/CA2866232A1/en not_active Abandoned
- 2013-05-23 CN CN201380020203.0A patent/CN104220047B/zh active Active
- 2013-05-23 MX MX2014014318A patent/MX2014014318A/es unknown
- 2013-05-23 RU RU2014152803A patent/RU2014152803A/ru not_active Application Discontinuation
- 2013-05-23 WO PCT/EP2013/060649 patent/WO2013174936A1/en active Application Filing
- 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 |
JP6405406B2 (ja) | 2018-10-17 |
JP2018193406A (ja) | 2018-12-06 |
JP2017122123A (ja) | 2017-07-13 |
ES2706059T3 (es) | 2019-03-27 |
CN104220047B (zh) | 2019-11-15 |
US10010513B2 (en) | 2018-07-03 |
JP2015517556A (ja) | 2015-06-22 |
EP2854760B1 (en) | 2018-10-17 |
CN104220047A (zh) | 2014-12-17 |
CL2014003148A1 (es) | 2015-02-27 |
KR20150024301A (ko) | 2015-03-06 |
ZA201406403B (en) | 2019-01-30 |
WO2013174936A1 (en) | 2013-11-28 |
MX2014014318A (es) | 2015-02-12 |
EP2854760A1 (en) | 2015-04-08 |
CA2866232A1 (en) | 2013-11-28 |
JP6250646B2 (ja) | 2017-12-20 |
PH12014502352A1 (en) | 2015-01-12 |
RU2014152803A (ru) | 2016-07-20 |
CO7270463A2 (es) | 2015-05-19 |
AU2013265255A1 (en) | 2014-09-25 |
AU2013265255B2 (en) | 2018-03-29 |
AU2018203929A1 (en) | 2018-06-21 |
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