DK2895187T1 - Daptomycinformuleringer og anvendelser deraf - Google Patents
Daptomycinformuleringer og anvendelser deraf Download PDFInfo
- Publication number
- DK2895187T1 DK2895187T1 DK13837694.2T DK13837694T DK2895187T1 DK 2895187 T1 DK2895187 T1 DK 2895187T1 DK 13837694 T DK13837694 T DK 13837694T DK 2895187 T1 DK2895187 T1 DK 2895187T1
- Authority
- DK
- Denmark
- Prior art keywords
- pharmaceutically acceptable
- lyophilized daptomycin
- formulation
- daptomycin formulation
- lyophilized
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- 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
- A61K31/403—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 carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/14—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Claims (24)
1. Lyofiliseret daptomycinformulering, som omfatter et additiv, der er valgt fra gruppen bestående af farmaceutisk acceptable antioxidanter, farmaceutisk acceptable organiske syrer og farmaceutisk acceptable salte deraf, farmaceutisk acceptable glucose-derivater og farmaceutisk acceptable salte deraf og kombinationer deraf.
2. Lyofiliseret daptomycinformulering ifølge krav 1, hvor formuleringen omfatter fra ca. 200 mg til ca. 600 mg daptomycin.
3. Lyofiliseret daptomycinformulering ifølge krav 1, hvor formuleringen omfatter fra ca. 0,01 mM til ca. 500 mM af additivet.
4. Lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-3, hvor den farmaceutisk acceptable antioxidant er ascorbinsyre.
5. Lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-3, hvor den farmaceutisk acceptable organiske syre er valgt fra gruppen bestående af organiske monocarboxylsyrer, organiske dicarboxylsyrer, hydroxylsubstituerede organiske dicarboxylsyrer, organiske tricarboxylsyrer, hydroxylsubstituerede organiske tricarb-oxylsyrer, organiske tetracarboxylsyrer og kombinationer deraf.
6. Lyofiliseret daptomycinformulering ifølge krav 5, hvor den farmaceutisk acceptable organiske syre er en hydroxysubstitueret organisk tricarboxylsyre.
7. Lyofiliseret daptomycinformulering ifølge krav 6, hvor den hydroxysubstituerede organiske tricarboxylsyre er citronsyre.
8. Lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-3, hvor det farmaceutisk acceptable glucosederivat er acetylglucosamin.
9. Lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-8, hvor formuleringen rekonstitueres i en farmaceutisk acceptabel diluent for at opnå en rekonstitueret lyofiliseret daptomycinformulering.
10. Lyofiliseret daptomycinformulering ifølge krav 9, hvor formuleringen rekonstitueres i den farmaceutisk acceptable diluent i mindre end ca. 5 minutter.
11. Lyofiliseret daptomycinformulering ifølge krav 9, hvor koncentrationen af daptomy-cin i den rekonstituerede lyofiliserede daptomycinformulering er fra ca. 20 mg/ml til ca. 100 mg/ml.
12. Lyofiliseret daptomycinformulering ifølge krav 9, hvor koncentrationen af additivet i den rekonstituerede lyofiliserede daptomycinformulering er fra ca. 1 mM til ca. 500 mM.
13. Lyofiliseret daptomycinformulering ifølge krav 12, hvor koncentrationen af additivet i den rekonstituerede lyofiliserede daptomycinformulering er ca. 237,5 mM.
14. Lyofiliseret daptomycinformulering ifølge krav 12, hvor koncentrationen af additivet i den rekonstituerede lyofiliserede daptomycinformulering er ca. 300 mM.
15. Lyofiliseret daptomycinformulering ifølge krav 9, hvor koncentrationen af additivet i den rekonstituerede lyofiliserede daptomycinformulering er fra ca. 1 mg/ml til ca. 500 mg/ml.
16. Lyofiliseret daptomycinformulering ifølge krav 9, hvor pH af den rekonstituerede lyofiliserede daptomycinformulering er fra ca. 4,0 til ca. 5,0.
17. Lyofiliseret daptomycinformulering ifølge krav 16, hvor pH af den rekonstituerede lyofiliserede daptomycinformulering er ca. 4,7.
18. Lyofiliseret daptomycinformulering Ifølge krav 9, hvor diluenten er valgt fra gruppen bestående af sterilt vand til Injektion, bakterlostatisk vand til injektion, 0,45% natrlum-chloridopløsnlng til Injektion, 0,9% natriumchioridopløsning til Injektion, Ringers opløsning, Ringers laktatopløsning og kombinationer deraf.
19. Lyofiliseret daptomycinformulering ifølge krav 18, hvor diluenten er 0,9% steril natriumchioridopløsning til injektion.
20. Lyofiliseret daptomycinformulering ifølge krav 18, hvor diluenten er sterilt vand til injektion.
21. Fremgangsmåde til behandling afen bakterieinfektion i et individ, omfattende administration til et individ, som har behov derfor, af en effektiv mængde af en lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-20.
22. Fremgangsmåde til behandling eller forebyggelse af en biofilm, hvilken fremgangsmåde omfatter, at en overflade af en indretning udsættes for en opløsning af en effektiv mængde af en lyofiliseret daptomycinformulering ifølge et hvilket som helst af kravene 1-20.
23. Fremgangsmåde til fremstilling af en lyofiliseret daptomycinformulering, hvor fremgangsmåden omfatter, at: (a) der dannes en vandig opløsning af daptomycin og et additiv, som er valgt fra gruppen bestående af farmaceutisk acceptable antioxidanter, farmaceutisk acceptable organiske syrer og farmaceutisk acceptable salte deraf, farmaceutisk acceptable glucosederivater og farmaceutisk acceptable salte deraf og kombinationer deraf; (b) pH indstilles til ca. 4,0 til ca. 5,0; og (c) opløsningen lyofiliseres til opnåelse af et lyofilisat.
24. Fremgangsmåde til fremstilling af en lyofiliseret daptomycinformulering, hvor fremgangsmåden omfatter, at: (a) der dannes en vandig opløsning af daptomycin ved en pH på 4,0 til 5,0; (b) et additiv, som er valgt fra gruppen bestående af farmaceutisk acceptable antioxidanter, farmaceutisk acceptable organiske syrer og farmaceutisk acceptable salte deraf, farmaceutisk acceptable glucosederivater og farmaceutisk acceptable salte deraf, opløses i den vandige opløsning af daptomycin; (c) pH indstilles til ca. 4,0 til ca. 5,0; og (d) opløsningen lyofiliseres til opnåelse af et pulver.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261699570P | 2012-09-11 | 2012-09-11 | |
| US201361839699P | 2013-06-26 | 2013-06-26 | |
| PCT/IB2013/002191 WO2014041425A1 (en) | 2012-09-11 | 2013-09-11 | Daptomycin formulations and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2895187T1 true DK2895187T1 (da) | 2015-11-16 |
Family
ID=50277707
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13837694.2T DK2895187T1 (da) | 2012-09-11 | 2013-09-11 | Daptomycinformuleringer og anvendelser deraf |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US9655946B2 (da) |
| EP (2) | EP2895187A4 (da) |
| AU (2) | AU2013316779A1 (da) |
| BR (1) | BR112015005400B1 (da) |
| CA (1) | CA2884484C (da) |
| CL (1) | CL2015000608A1 (da) |
| CY (1) | CY2200004T2 (da) |
| DE (1) | DE13837694T1 (da) |
| DK (1) | DK2895187T1 (da) |
| ES (1) | ES2552754T1 (da) |
| HK (1) | HK1207006A1 (da) |
| HU (1) | HUE13837694T1 (da) |
| IL (1) | IL237652B (da) |
| MX (1) | MX366122B (da) |
| NZ (3) | NZ706286A (da) |
| SA (1) | SA515360129B1 (da) |
| SG (1) | SG11201506113WA (da) |
| TN (1) | TN2015000090A1 (da) |
| WO (1) | WO2014041425A1 (da) |
| ZA (1) | ZA201502310B (da) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA37975B2 (fr) | 2012-09-11 | 2021-03-31 | Genzyme Corp | Inhibiteurs de synthase de glucosylcéramide |
| EP2895187A4 (en) * | 2012-09-11 | 2015-12-02 | Hospira Australia Pty Ltd | DAPTOMYCIN FORMULATIONS AND USES THEREOF |
| EP3528786B1 (en) | 2016-10-21 | 2023-04-05 | Xellia Pharmaceuticals ApS | Liquid formulations of daptomycin |
| MX2020001885A (es) | 2017-08-31 | 2020-09-07 | Xellia Pharmaceuticals Aps | Formulaciones de daptomicina. |
| CN110339342A (zh) * | 2018-04-03 | 2019-10-18 | 江苏恒瑞医药股份有限公司 | 一种达托霉素的盐或含盐的组合物及其制备方法 |
| US11058745B1 (en) | 2018-10-04 | 2021-07-13 | Good Health, Llc | Stable liquid pharmaceutical compositions of daptomycin |
| AU2021233893A1 (en) | 2020-03-12 | 2022-08-25 | Baxter Healthcare Sa | Daptomycin formulations containing a combination of sorbitol and mannitol |
| IL300090A (en) | 2020-07-24 | 2023-03-01 | Genzyme Corp | Pharmaceutical preparations containing VENGLUSTAT |
| CN115590825B (zh) * | 2022-10-20 | 2024-02-02 | 安士制药（中山）有限公司 | 一种注射用达托霉素及其制备方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5560906A (en) * | 1995-03-27 | 1996-10-01 | Oral Technology Laboratories, Inc. | Non-alcoholic antimicrobial mouthwash for removal of dental plaque |
| ATE322280T1 (de) * | 1998-09-25 | 2006-04-15 | Cubist Pharm Inc | Verwendung von daptomycin |
| US6696412B1 (en) | 2000-01-20 | 2004-02-24 | Cubist Pharmaceuticals, Inc. | High purity lipopeptides, Lipopeptide micelles and processes for preparing same |
| WO2002059145A1 (en) | 2000-12-18 | 2002-08-01 | Cubist Pharmaceuticals, Inc. | Methods for preparing purified lipopeptides |
| US7468428B2 (en) * | 2004-03-17 | 2008-12-23 | App Pharmaceuticals, Llc | Lyophilized azithromycin formulation |
| CN1616083A (zh) * | 2004-09-01 | 2005-05-18 | 魏雪纹 | 注射用达托霉素冻干制剂及制备方法 |
| CA2610716A1 (en) * | 2005-05-31 | 2006-12-07 | Cubist Pharmaceuticals, Inc. | Daptomycin for the treatment of biofilm and catheter salvage |
| NZ600118A (en) | 2009-11-23 | 2014-08-29 | Cubist Pharm Inc | Lipopeptide compositions and related methods |
| JP2013511522A (ja) * | 2009-11-23 | 2013-04-04 | イーグル・ファーマシューティカルズ・インコーポレーテッド | ダプトマイシン製剤 |
| CA2881121A1 (en) * | 2012-08-23 | 2014-03-27 | Agila Specialties Private Limited | Improved daptomycin injectable formulation |
| EP2895187A4 (en) * | 2012-09-11 | 2015-12-02 | Hospira Australia Pty Ltd | DAPTOMYCIN FORMULATIONS AND USES THEREOF |
-
2013
- 2013-09-11 EP EP13837694.2A patent/EP2895187A4/en not_active Withdrawn
- 2013-09-11 BR BR112015005400-5A patent/BR112015005400B1/pt active IP Right Grant
- 2013-09-11 NZ NZ706286A patent/NZ706286A/en unknown
- 2013-09-11 AU AU2013316779A patent/AU2013316779A1/en not_active Abandoned
- 2013-09-11 EP EP22169277.5A patent/EP4066849A1/en active Pending
- 2013-09-11 NZ NZ742241A patent/NZ742241A/en unknown
- 2013-09-11 US US14/427,618 patent/US9655946B2/en active Active
- 2013-09-11 SG SG11201506113WA patent/SG11201506113WA/en unknown
- 2013-09-11 ES ES13837694.2T patent/ES2552754T1/es active Pending
- 2013-09-11 MX MX2015003164A patent/MX366122B/es active IP Right Grant
- 2013-09-11 CA CA2884484A patent/CA2884484C/en active Active
- 2013-09-11 WO PCT/IB2013/002191 patent/WO2014041425A1/en active Application Filing
- 2013-09-11 DE DE13837694.2T patent/DE13837694T1/de active Pending
- 2013-09-11 DK DK13837694.2T patent/DK2895187T1/da unknown
- 2013-09-11 NZ NZ74134213A patent/NZ741342A/en unknown
-
2015
- 2015-03-10 IL IL237652A patent/IL237652B/en active IP Right Grant
- 2015-03-10 TN TNP2015000090A patent/TN2015000090A1/fr unknown
- 2015-03-11 SA SA515360129A patent/SA515360129B1/ar unknown
- 2015-03-11 CL CL2015000608A patent/CL2015000608A1/es unknown
- 2015-04-07 ZA ZA2015/02310A patent/ZA201502310B/en unknown
- 2015-08-12 HK HK15107795.5A patent/HK1207006A1/xx unknown
- 2015-11-11 HU HUE13837694A patent/HUE13837694T1/hu unknown
- 2015-11-20 CY CY20152200004T patent/CY2200004T2/el unknown
-
2017
- 2017-04-20 US US15/492,111 patent/US20170216396A1/en not_active Abandoned
-
2018
- 2018-02-23 US US15/903,764 patent/US10357535B2/en active Active
- 2018-08-17 AU AU2018217322A patent/AU2018217322B2/en active Active
-
2020
- 2020-04-15 US US16/849,387 patent/US20200237858A1/en not_active Abandoned
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