DK3272361T3 - Fremgangsmåde til fremstilling af en frysetørret farmaceutisk sammensætning med indhold af mitomycin c - Google Patents
Fremgangsmåde til fremstilling af en frysetørret farmaceutisk sammensætning med indhold af mitomycin c Download PDFInfo
- Publication number
- DK3272361T3 DK3272361T3 DK17188743.3T DK17188743T DK3272361T3 DK 3272361 T3 DK3272361 T3 DK 3272361T3 DK 17188743 T DK17188743 T DK 17188743T DK 3272361 T3 DK3272361 T3 DK 3272361T3
- Authority
- DK
- Denmark
- Prior art keywords
- mitomycin
- preparing
- contents
- procedure
- pharmaceutical composition
- Prior art date
Links
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/26—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
- A61K9/08—Solutions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17188743.3A EP3272361B1 (de) | 2013-10-22 | 2013-10-22 | Verfahren zur herstellung einer gefriergetrockneten pharmazeutischen zusammensetzung mit gehalt an mitomycin c |
| EP13189775.3A EP2865391B1 (de) | 2013-10-22 | 2013-10-22 | Verfahren zur Herstellung einer gefriergetrockneten pharmazeutischen Zusammensetzung mit Gehalt an Mitomycin C |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3272361T3 true DK3272361T3 (da) | 2020-01-27 |
Family
ID=49515194
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17188743.3T DK3272361T3 (da) | 2013-10-22 | 2013-10-22 | Fremgangsmåde til fremstilling af en frysetørret farmaceutisk sammensætning med indhold af mitomycin c |
| DK13189775.3T DK2865391T3 (da) | 2013-10-22 | 2013-10-22 | Fremgangsmåde til fremstilling af en frysetørret farmaceutisk sammensætning indeholdende mitomycin C |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13189775.3T DK2865391T3 (da) | 2013-10-22 | 2013-10-22 | Fremgangsmåde til fremstilling af en frysetørret farmaceutisk sammensætning indeholdende mitomycin C |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10688049B2 (da) |
| EP (2) | EP2865391B1 (da) |
| JP (2) | JP6461945B2 (da) |
| CN (1) | CN105744957B (da) |
| DK (2) | DK3272361T3 (da) |
| EA (1) | EA036982B1 (da) |
| ES (2) | ES2771227T3 (da) |
| HK (1) | HK1208351A1 (da) |
| LT (2) | LT2865391T (da) |
| NO (1) | NO2865391T3 (da) |
| PL (2) | PL2865391T3 (da) |
| PT (2) | PT3272361T (da) |
| WO (1) | WO2015059023A1 (da) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20200141446A (ko) * | 2018-04-05 | 2020-12-18 | 타베다 세라퓨틱스, 인코포레이티드 | 감소된 3급-부탄올 수준을 갖는 약제학적 조성물 |
| US20220202773A1 (en) * | 2020-12-11 | 2022-06-30 | Urogen Pharma Ltd. | Material and method for treating cancer |
| CN113197870B (zh) * | 2021-04-14 | 2022-07-01 | 健进制药有限公司 | 一种注射用丝裂霉素冻干制剂及其制备方法 |
| CA3229273A1 (en) * | 2021-09-17 | 2023-03-23 | Intas Pharmaceuticals Ltd. | A stable ready to dilute injectable pharmaceutical formulation of mitomycin |
| CN114557970B (zh) | 2022-03-17 | 2023-03-31 | 浙江长典药物技术开发有限公司 | 一种眼用丝裂霉素冻干粉及其制备方法 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB830874A (en) | 1957-04-06 | 1960-03-23 | Kyowa Hakko Kogyo Kk | A new antibiotic mitomycin c and its production by fermentation |
| ZA86308B (en) * | 1985-02-25 | 1986-11-26 | Bristol Myers Co | In-vial deposition of 7-(dimethylaminomethylene)amino-9a-methoxy-mitosane |
| US5216011A (en) | 1989-09-01 | 1993-06-01 | Bristol-Myers Squibb Co. | Stable solutions of mitomycin c |
| US5756552A (en) * | 1994-10-13 | 1998-05-26 | Wakamoto Pharmaceutical Co., Ltd. | Lyophilized pharmaceutical preparations capable of providing aqueous drug composition having property of reversible thermosetting gelation |
| DE19957371A1 (de) | 1999-11-29 | 2001-06-13 | Medac Klinische Spezialpraep | Mitomycin C-Lösung |
| PL205936B1 (pl) * | 2002-02-22 | 2010-06-30 | Schering Corp | Farmaceutyczny preparat zawierający termozolomid oraz sposób jego wytwarzania |
| CN1712014A (zh) | 2004-06-14 | 2005-12-28 | 马文·F·刘 | 甘草甜素的新用途 |
| CN101204382A (zh) | 2007-12-13 | 2008-06-25 | 厦门大学 | 植入型抗肿瘤药丝裂霉素双重缓释膜剂及其制备方法 |
| US8168224B2 (en) * | 2007-12-19 | 2012-05-01 | Beijing Shengyiyao Science & Technology Development Co., Ltd. | Sodium alginate microsphere vascular embolus containing water-soluble drug and preparation and application thereof |
-
2013
- 2013-10-22 DK DK17188743.3T patent/DK3272361T3/da active
- 2013-10-22 EP EP13189775.3A patent/EP2865391B1/de active Active
- 2013-10-22 EP EP17188743.3A patent/EP3272361B1/de active Active
- 2013-10-22 LT LTEP13189775.3T patent/LT2865391T/lt unknown
- 2013-10-22 PT PT171887433T patent/PT3272361T/pt unknown
- 2013-10-22 PT PT131897753T patent/PT2865391T/pt unknown
- 2013-10-22 LT LTEP17188743.3T patent/LT3272361T/lt unknown
- 2013-10-22 ES ES17188743T patent/ES2771227T3/es active Active
- 2013-10-22 ES ES13189775.3T patent/ES2648367T3/es active Active
- 2013-10-22 NO NO13189775A patent/NO2865391T3/no unknown
- 2013-10-22 PL PL13189775T patent/PL2865391T3/pl unknown
- 2013-10-22 PL PL17188743T patent/PL3272361T3/pl unknown
- 2013-10-22 DK DK13189775.3T patent/DK2865391T3/da active
-
2014
- 2014-10-16 JP JP2016525064A patent/JP6461945B2/ja active Active
- 2014-10-16 EA EA201690793A patent/EA036982B1/ru unknown
- 2014-10-16 WO PCT/EP2014/072201 patent/WO2015059023A1/de active Application Filing
- 2014-10-16 CN CN201480057080.2A patent/CN105744957B/zh active Active
- 2014-10-16 US US15/031,519 patent/US10688049B2/en active Active
-
2015
- 2015-09-14 HK HK15108977.3A patent/HK1208351A1/xx unknown
-
2018
- 2018-12-26 JP JP2018242147A patent/JP6869941B2/ja active Active
-
2020
- 2020-05-18 US US16/876,505 patent/US11766405B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US10688049B2 (en) | 2020-06-23 |
| EP3272361A1 (de) | 2018-01-24 |
| EP2865391A1 (de) | 2015-04-29 |
| EP3272361B1 (de) | 2019-11-20 |
| ES2648367T3 (es) | 2018-01-02 |
| CN105744957A (zh) | 2016-07-06 |
| JP2016534060A (ja) | 2016-11-04 |
| ES2771227T3 (es) | 2020-07-06 |
| US11766405B2 (en) | 2023-09-26 |
| PL2865391T3 (pl) | 2018-01-31 |
| EP2865391B1 (de) | 2017-09-20 |
| CN105744957B (zh) | 2019-07-02 |
| PT3272361T (pt) | 2020-01-21 |
| JP6869941B2 (ja) | 2021-05-12 |
| NO2865391T3 (da) | 2018-02-17 |
| LT2865391T (lt) | 2017-11-27 |
| PL3272361T3 (pl) | 2020-04-30 |
| EA201690793A1 (ru) | 2016-08-31 |
| US20160256391A1 (en) | 2016-09-08 |
| DK2865391T3 (da) | 2017-11-20 |
| EA036982B1 (ru) | 2021-01-22 |
| WO2015059023A1 (de) | 2015-04-30 |
| JP6461945B2 (ja) | 2019-01-30 |
| US20200276128A1 (en) | 2020-09-03 |
| JP2019043969A (ja) | 2019-03-22 |
| HK1208351A1 (en) | 2016-03-04 |
| PT2865391T (pt) | 2017-12-22 |
| LT3272361T (lt) | 2020-01-10 |
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