KR20150024301A - 생물학적 치료제 및 구아니딘 또는 구아니딘 유도체를 함유하는 수성 약제학적 조성물 및 당해 조성물을 포함하는 주사제 - Google Patents
생물학적 치료제 및 구아니딘 또는 구아니딘 유도체를 함유하는 수성 약제학적 조성물 및 당해 조성물을 포함하는 주사제 Download PDFInfo
- Publication number
- KR20150024301A KR20150024301A KR20147026263A KR20147026263A KR20150024301A KR 20150024301 A KR20150024301 A KR 20150024301A KR 20147026263 A KR20147026263 A KR 20147026263A KR 20147026263 A KR20147026263 A KR 20147026263A KR 20150024301 A KR20150024301 A KR 20150024301A
- Authority
- KR
- South Korea
- Prior art keywords
- composition
- guanidine
- viscosity
- therapeutic agent
- biological
- 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.)
- Ceased
Links
Images
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 or 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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], 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)
- Microbiology (AREA)
- Immunology (AREA)
- Ophthalmology & Optometry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (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)
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 |
|---|---|
| KR20150024301A true KR20150024301A (ko) | 2015-03-06 |
Family
ID=48534372
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR20147026263A Ceased KR20150024301A (ko) | 2012-05-25 | 2013-05-23 | 생물학적 치료제 및 구아니딘 또는 구아니딘 유도체를 함유하는 수성 약제학적 조성물 및 당해 조성물을 포함하는 주사제 |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US10010513B2 (https=) |
| EP (1) | EP2854760B1 (https=) |
| JP (3) | JP6250646B2 (https=) |
| KR (1) | KR20150024301A (https=) |
| CN (1) | CN104220047B (https=) |
| AR (1) | AR091155A1 (https=) |
| AU (2) | AU2013265255B2 (https=) |
| CA (1) | CA2866232A1 (https=) |
| CL (1) | CL2014003148A1 (https=) |
| CO (1) | CO7270463A2 (https=) |
| ES (1) | ES2706059T3 (https=) |
| MX (1) | MX2014014318A (https=) |
| PH (1) | PH12014502352A1 (https=) |
| RU (1) | RU2014152803A (https=) |
| WO (1) | WO2013174936A1 (https=) |
| ZA (1) | ZA201406403B (https=) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20180018393A (ko) * | 2016-08-10 | 2018-02-21 | (주)셀트리온 | 항-인플루엔자 바이러스 항체의 안정한 액체 약제학적 제제 |
| WO2019009661A1 (en) * | 2017-07-07 | 2019-01-10 | Cj Healthcare Corporation | Composition for injection |
Families Citing this family (9)
| 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 |
| CA2941232C (en) * | 2014-03-11 | 2020-08-25 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
| EP3200804A4 (en) * | 2014-10-01 | 2018-04-18 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| WO2016130478A1 (en) | 2015-02-09 | 2016-08-18 | University Of Louisville Research Foundation, Inc. | Ophthalmic compositions and methods for reducing oxidative damage to an eye lens |
| JP6560764B2 (ja) * | 2015-11-30 | 2019-08-14 | ロート製薬株式会社 | 眼科組成物 |
| ES2984352T3 (es) | 2016-06-14 | 2024-10-29 | Regeneron Pharma | Anticuerpos anti-C5 y usos de los mismos |
| GB201713660D0 (en) * | 2017-08-25 | 2017-10-11 | Kalvista Pharmaceuticals Ltd | Pharmaceutical compositions |
| MA51147A (fr) | 2017-12-13 | 2021-03-24 | Regeneron Pharma | Associations d'anticorps anti-c5 et utilisations associées |
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 |
| ATE547080T1 (de) | 2000-08-30 | 2012-03-15 | Univ Johns Hopkins | Vorrichtungen zur intraokularen arzneimittelabgabe |
| 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 |
| JP2010521194A (ja) * | 2007-03-22 | 2010-06-24 | ノバルティス アーゲー | C5抗原およびその使用 |
| PY09026846A (es) | 2008-08-05 | 2015-09-01 | Novartis Ag | Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5 |
| JP6214161B2 (ja) * | 2009-12-21 | 2017-10-18 | ジェネンテック, インコーポレイテッド | 抗体製剤 |
| BR112012021576A2 (pt) * | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
-
2013
- 2013-05-23 EP EP13725348.0A patent/EP2854760B1/en active Active
- 2013-05-23 JP JP2015513185A patent/JP6250646B2/ja active Active
- 2013-05-23 US US13/900,724 patent/US10010513B2/en active Active
- 2013-05-23 CN CN201380020203.0A patent/CN104220047B/zh active Active
- 2013-05-23 MX MX2014014318A patent/MX2014014318A/es unknown
- 2013-05-23 ES ES13725348T patent/ES2706059T3/es active Active
- 2013-05-23 RU RU2014152803A patent/RU2014152803A/ru not_active Application Discontinuation
- 2013-05-23 AU AU2013265255A patent/AU2013265255B2/en active Active
- 2013-05-23 KR KR20147026263A patent/KR20150024301A/ko not_active Ceased
- 2013-05-23 CA CA2866232A patent/CA2866232A1/en not_active Abandoned
- 2013-05-23 WO PCT/EP2013/060649 patent/WO2013174936A1/en not_active Ceased
- 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
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20180018393A (ko) * | 2016-08-10 | 2018-02-21 | (주)셀트리온 | 항-인플루엔자 바이러스 항체의 안정한 액체 약제학적 제제 |
| US12065482B2 (en) | 2016-08-10 | 2024-08-20 | Celltrion Inc. | Stable liquid pharmaceutical formulation of anti-influenza virus antibody |
| WO2019009661A1 (en) * | 2017-07-07 | 2019-01-10 | Cj Healthcare Corporation | Composition for injection |
| JP2020525516A (ja) * | 2017-07-07 | 2020-08-27 | エイチケー イノ.エヌ コーポレーション | 注射用組成物 |
| US10828253B2 (en) | 2017-07-07 | 2020-11-10 | Hk Inno.N Corporation | Composition for injection |
Also Published As
| Publication number | Publication date |
|---|---|
| CL2014003148A1 (es) | 2015-02-27 |
| CO7270463A2 (es) | 2015-05-19 |
| PH12014502352A1 (en) | 2015-01-12 |
| MX2014014318A (es) | 2015-02-12 |
| JP6250646B2 (ja) | 2017-12-20 |
| JP2017122123A (ja) | 2017-07-13 |
| EP2854760B1 (en) | 2018-10-17 |
| AU2013265255B2 (en) | 2018-03-29 |
| ZA201406403B (en) | 2019-01-30 |
| JP2015517556A (ja) | 2015-06-22 |
| WO2013174936A1 (en) | 2013-11-28 |
| JP6405406B2 (ja) | 2018-10-17 |
| US20130317457A1 (en) | 2013-11-28 |
| CN104220047B (zh) | 2019-11-15 |
| CN104220047A (zh) | 2014-12-17 |
| US10010513B2 (en) | 2018-07-03 |
| AR091155A1 (es) | 2015-01-14 |
| EP2854760A1 (en) | 2015-04-08 |
| CA2866232A1 (en) | 2013-11-28 |
| AU2013265255A1 (en) | 2014-09-25 |
| AU2018203929A1 (en) | 2018-06-21 |
| RU2014152803A (ru) | 2016-07-20 |
| ES2706059T3 (es) | 2019-03-27 |
| JP2018193406A (ja) | 2018-12-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| KR20150024301A (ko) | 생물학적 치료제 및 구아니딘 또는 구아니딘 유도체를 함유하는 수성 약제학적 조성물 및 당해 조성물을 포함하는 주사제 | |
| AU2020244614B2 (en) | Stable protein solution formulation containing high concentration of an anti-VEGF antibody | |
| CA2918419C (en) | Stabilized antibody compositions | |
| AU2004277466C1 (en) | Method of stabilizing antibody and stabilized solution-type antibody preparation | |
| US10568951B2 (en) | Pharmaceutical composition of an anti-VEGF antibody | |
| US20240182554A1 (en) | Protein solution formulation containing high concentration of an anti-vegf antibody | |
| CA3152838A1 (en) | Novel formulation of highly concentrated pharmacologically active antibody | |
| CN119095618B (zh) | 用于治疗巨噬细胞活化综合征的组合物和方法 | |
| CA2966758C (en) | Stable protein solution formulation containing high concentration of an anti-vegf antibody | |
| EA042435B1 (ru) | Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0105 | International application |
Patent event date: 20140919 Patent event code: PA01051R01D Comment text: International Patent Application |
|
| PG1501 | Laying open of application | ||
| A201 | Request for examination | ||
| PA0201 | Request for examination |
Patent event code: PA02012R01D Patent event date: 20180426 Comment text: Request for Examination of Application |
|
| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
Comment text: Notification of reason for refusal Patent event date: 20190902 Patent event code: PE09021S01D |
|
| E601 | Decision to refuse application | ||
| PE0601 | Decision on rejection of patent |
Patent event date: 20191108 Comment text: Decision to Refuse Application Patent event code: PE06012S01D Patent event date: 20190902 Comment text: Notification of reason for refusal Patent event code: PE06011S01I |