MX356212B - Composciones acuosas estabilizadas de agentes de bloqueo neuromuscular. - Google Patents
Composciones acuosas estabilizadas de agentes de bloqueo neuromuscular.Info
- Publication number
- MX356212B MX356212B MX2015004056A MX2015004056A MX356212B MX 356212 B MX356212 B MX 356212B MX 2015004056 A MX2015004056 A MX 2015004056A MX 2015004056 A MX2015004056 A MX 2015004056A MX 356212 B MX356212 B MX 356212B
- Authority
- MX
- Mexico
- Prior art keywords
- neuromuscular blocking
- aqueous composition
- quaternary ammonium
- blocking agent
- present
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 11
- 239000000842 neuromuscular blocking agent Substances 0.000 title abstract 6
- 229920001273 Polyhydroxy acid Polymers 0.000 abstract 5
- 125000001453 quaternary ammonium group Chemical group 0.000 abstract 5
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 4
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 abstract 3
- 150000002596 lactones Chemical class 0.000 abstract 3
- 239000007788 liquid Substances 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 150000001732 carboxylic acid derivatives Chemical class 0.000 abstract 1
- 230000001419 dependent effect Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/08—Solutions
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
- A61P23/02—Local anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Anesthesiology (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Abstract
La presente invención se refiere a una composición acuosa que comprende: (i) un agente de bloque neuromuscular de amonio cuaternario; y (ii) un excipiente seleccionado de un ácido polihidroxi de la siguiente fórmula: HO-CH2-[CH(OH)]n-COOH, en donde n es un entero de 1 a 8, una lactona intramolecular de dicho ácido polihidroxi o una mezcla de los mismos. Adicionalmente, la presente invención se refiere a una composición farmacéutica liquida que comprende o consiste de dicha composición acuosa y un método para producir dicha composición acuosa comprendiendo los pasos de: a) proporcionar un agente de bloque neuromuscular de amonio cuaternario, en donde dicho agente de bloque neuromuscular de amonio cuaternario es opcionalmente secado por congelación, b) proporcionar un excipiente seleccionado de un ácido polihidroxi de la siguiente fórmula: HO-CH2-[CH(OH)]n-COOH, en donde n es un entero de 1 a 8, una lactona iritramolecular de dicho ácido polihidroxi o una mezcla de los mismos, en donde dicho excipiente es opcionalmente secado por congelación, c) mezclar el agente de bloque neuromuscular de amonio cuaternario de paso a) y el excipiente de paso b) en agua para dar una composición acuosa. Además, la presente invención se refiere al uso de un ácido polihidroxi carboxílico de la siguiente fórmula: HO-CH2-[CH(OH)]n-COOH, en donde n es un entero de 1 a 8, una lactona intramolecular de dicho ácido polihidroxi o una mezcla de los mismos para estabilizar una composición acuosa que comprende un agente de bloque neuromuscular de amonio cuaternario. La presente invención también se refiere a un recipiente que contiene la composición acuosa o la composición farmacéutica líquido de la presente invención. Adicionalmente, se refiere a un kit que comprende dichas composiciones. Las modalidades preferidas son evidentes a partir de las reivindicaciones dependientes.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12186393.0A EP2712611A1 (en) | 2012-09-27 | 2012-09-27 | Stabilized aqueous compositions of neuromuscular blocking agents |
| PCT/EP2013/069507 WO2014048836A1 (en) | 2012-09-27 | 2013-09-19 | Stabilized aqueous compositions of neuromuscular blocking agents |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2015004056A MX2015004056A (es) | 2015-07-06 |
| MX356212B true MX356212B (es) | 2018-05-18 |
Family
ID=47046351
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2015004056A MX356212B (es) | 2012-09-27 | 2013-09-19 | Composciones acuosas estabilizadas de agentes de bloqueo neuromuscular. |
Country Status (20)
| Country | Link |
|---|---|
| US (2) | US20150216979A1 (es) |
| EP (2) | EP2712611A1 (es) |
| JP (1) | JP6347784B2 (es) |
| KR (1) | KR102138392B1 (es) |
| CN (1) | CN104519872B (es) |
| AU (1) | AU2013322897B2 (es) |
| BR (1) | BR112015000688B1 (es) |
| CA (1) | CA2878714C (es) |
| CY (1) | CY1119086T1 (es) |
| ES (1) | ES2628076T3 (es) |
| HK (1) | HK1205694A1 (es) |
| IL (1) | IL236042A (es) |
| MX (1) | MX356212B (es) |
| PL (1) | PL2900216T3 (es) |
| PT (1) | PT2900216T (es) |
| RS (1) | RS56060B1 (es) |
| RU (1) | RU2695226C2 (es) |
| TW (1) | TWI595876B (es) |
| WO (1) | WO2014048836A1 (es) |
| ZA (1) | ZA201408945B (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2016016148A (es) * | 2014-06-26 | 2017-04-25 | Maruishi Pharma | Preparacion de rocuronio con estabilidad mejorada. |
| JP2016121073A (ja) * | 2014-12-24 | 2016-07-07 | ニプロ株式会社 | 注射剤用医薬組成物の製造方法 |
| WO2022078483A1 (zh) * | 2020-10-15 | 2022-04-21 | 江苏恩华络康药物研发有限公司 | 甾体季铵化合物及其制备方法、制剂和用途 |
| US20230014293A1 (en) | 2021-07-02 | 2023-01-19 | Fresenius Kabi Austria Gmbh | Aqueous, room-temperature stable rocuronium composition |
| EP4371553A1 (en) * | 2022-11-16 | 2024-05-22 | B. Braun Melsungen AG | Composition comprising rocuronium |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2681863B1 (fr) * | 1991-09-27 | 1995-02-03 | Rhone Dpc Europ | Solution de sparfloxacine sa preparation et sel la constituant. |
| IT1271031B (it) | 1994-10-21 | 1997-05-26 | Poli Ind Chimica Spa | Composizioni farmaceutiche miorilassanti |
| AU4428900A (en) * | 1999-01-28 | 2000-08-18 | Shshikant Prabhudas Kurani | Novel injectable muscle relaxant formulations |
| US20060229258A1 (en) * | 2003-07-30 | 2006-10-12 | Daniela Serikaku | Steroidal compositions containing hydroxycarboxylic acids and methods of using the same |
| DE10337710A1 (de) * | 2003-08-16 | 2005-03-10 | Supramol Parenteral Colloids | Amiodaron enthaltende Infusions- und Injektionslösungen |
| MY141763A (en) * | 2003-09-18 | 2010-06-30 | Novartis Ag | Pharmaceutical products comprising bisphosphonates |
| US20060148841A1 (en) * | 2004-02-26 | 2006-07-06 | Lundeen James E | Pharmaceutical composition comprising combination of non-alkaloid and alkaloid-based component for treating skeletal muscle spasm |
| US20060275331A1 (en) * | 2004-08-31 | 2006-12-07 | Borek Zaludek | Pharmaceutical composition, method of manufacturing and therapeutic use thereof |
| JP2008536864A (ja) * | 2005-04-15 | 2008-09-11 | リオトロピック セラピュティックス アイエヌシー． | 第四級アンモニウム神経筋遮断剤 |
| CN1864667B (zh) * | 2006-06-02 | 2010-10-06 | 重庆医药工业研究院有限责任公司 | 一种稳定的罗库溴铵冻干制剂及其制备方法 |
| KR101403105B1 (ko) | 2006-10-31 | 2014-06-09 | 엘지전자 주식회사 | 귀환 데이터 전송 방법, 귀환 데이터 생성 방법 및 데이터스케줄링 방법 |
| WO2008065142A1 (en) | 2006-11-29 | 2008-06-05 | N.V. Organon | Stabilized solution of rocuronium comprising a sulfoalkyl-ether-beta-cyclodextrin derivative |
| CZ300664B6 (cs) * | 2007-01-22 | 2009-07-15 | Pliva-Lachema A. S. | Sterilní kapalná farmaceutická kompozice a zpusob její výroby |
| US20100093849A1 (en) * | 2007-01-22 | 2010-04-15 | Borek Zaludek | Oxaliplatin pharmaceutical composition with alcoholic sugar-based buffer |
| KR101024742B1 (ko) | 2007-12-31 | 2011-03-24 | 주식회사 삼양사 | 탁산 함유 양친성 블록 공중합체 미셀 조성물 및 그 제조방법 |
| US20100082749A1 (en) | 2008-09-26 | 2010-04-01 | Yahoo! Inc | Retrospective spam filtering |
| CN101653412B (zh) * | 2009-09-15 | 2014-06-25 | 尹双保 | 一种稳定的罗库溴铵注射液 |
| JP6076740B2 (ja) | 2010-01-07 | 2017-02-08 | アルカーメス ファーマ アイルランド リミテッド | 第四級アンモニウム塩プロドラッグ |
| EP2462913A1 (en) * | 2010-12-10 | 2012-06-13 | Fresenius Medical Care Deutschland GmbH | Insert and vial for the infusion of liquids |
-
2012
- 2012-09-27 EP EP12186393.0A patent/EP2712611A1/en not_active Withdrawn
-
2013
- 2013-09-19 WO PCT/EP2013/069507 patent/WO2014048836A1/en active Application Filing
- 2013-09-19 MX MX2015004056A patent/MX356212B/es active IP Right Grant
- 2013-09-19 CA CA2878714A patent/CA2878714C/en active Active
- 2013-09-19 CN CN201380042469.5A patent/CN104519872B/zh active Active
- 2013-09-19 AU AU2013322897A patent/AU2013322897B2/en active Active
- 2013-09-19 ES ES13766501.4T patent/ES2628076T3/es active Active
- 2013-09-19 PT PT137665014T patent/PT2900216T/pt unknown
- 2013-09-19 RS RS20170581A patent/RS56060B1/sr unknown
- 2013-09-19 JP JP2015533539A patent/JP6347784B2/ja active Active
- 2013-09-19 KR KR1020157007764A patent/KR102138392B1/ko active IP Right Grant
- 2013-09-19 US US14/420,684 patent/US20150216979A1/en not_active Abandoned
- 2013-09-19 RU RU2015115430A patent/RU2695226C2/ru active
- 2013-09-19 EP EP13766501.4A patent/EP2900216B1/en active Active
- 2013-09-19 PL PL13766501T patent/PL2900216T3/pl unknown
- 2013-09-19 BR BR112015000688-4A patent/BR112015000688B1/pt active IP Right Grant
- 2013-09-25 TW TW102134492A patent/TWI595876B/zh active
-
2014
- 2014-12-03 IL IL236042A patent/IL236042A/en active IP Right Grant
- 2014-12-05 ZA ZA2014/08945A patent/ZA201408945B/en unknown
-
2015
- 2015-07-03 HK HK15106344.3A patent/HK1205694A1/xx unknown
-
2017
- 2017-06-02 CY CY20171100585T patent/CY1119086T1/el unknown
-
2019
- 2019-07-18 US US16/515,653 patent/US11998605B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US20200000925A1 (en) | 2020-01-02 |
| ES2628076T3 (es) | 2017-08-01 |
| KR20150058259A (ko) | 2015-05-28 |
| CA2878714C (en) | 2021-04-27 |
| PT2900216T (pt) | 2017-06-23 |
| IL236042A0 (en) | 2015-01-29 |
| BR112015000688B1 (pt) | 2022-02-15 |
| BR112015000688A2 (pt) | 2017-06-27 |
| KR102138392B1 (ko) | 2020-07-28 |
| RU2015115430A (ru) | 2016-11-20 |
| MX2015004056A (es) | 2015-07-06 |
| US20150216979A1 (en) | 2015-08-06 |
| JP2015531359A (ja) | 2015-11-02 |
| CN104519872A (zh) | 2015-04-15 |
| US11998605B2 (en) | 2024-06-04 |
| RS56060B1 (sr) | 2017-10-31 |
| TWI595876B (zh) | 2017-08-21 |
| WO2014048836A1 (en) | 2014-04-03 |
| EP2900216B1 (en) | 2017-04-26 |
| AU2013322897A1 (en) | 2015-01-29 |
| HK1205694A1 (en) | 2015-12-24 |
| EP2900216A1 (en) | 2015-08-05 |
| JP6347784B2 (ja) | 2018-06-27 |
| CA2878714A1 (en) | 2014-04-03 |
| AU2013322897B2 (en) | 2017-07-27 |
| TW201412317A (zh) | 2014-04-01 |
| PL2900216T3 (pl) | 2017-10-31 |
| EP2712611A1 (en) | 2014-04-02 |
| RU2695226C2 (ru) | 2019-07-22 |
| IL236042A (en) | 2017-06-29 |
| CY1119086T1 (el) | 2018-01-10 |
| ZA201408945B (en) | 2015-11-25 |
| CN104519872B (zh) | 2017-12-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |