HRP20181380T4 - Lipopeptidne kompozicije i s njima povezani postupci - Google Patents
Lipopeptidne kompozicije i s njima povezani postupci Download PDFInfo
- Publication number
- HRP20181380T4 HRP20181380T4 HRP20181380TT HRP20181380T HRP20181380T4 HR P20181380 T4 HRP20181380 T4 HR P20181380T4 HR P20181380T T HRP20181380T T HR P20181380TT HR P20181380 T HRP20181380 T HR P20181380T HR P20181380 T4 HRP20181380 T4 HR P20181380T4
- Authority
- HR
- Croatia
- Prior art keywords
- daptomycin
- solid composition
- molar ratio
- trehalose
- mannitol
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 2
- 108010028921 Lipopeptides Proteins 0.000 title 1
- 108010013198 Daptomycin Proteins 0.000 claims 27
- DOAKLVKFURWEDJ-QCMAZARJSA-N daptomycin Chemical group C([C@H]1C(=O)O[C@H](C)[C@@H](C(NCC(=O)N[C@@H](CCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H](C)C(=O)N[C@@H](CC(O)=O)C(=O)NCC(=O)N[C@H](CO)C(=O)N[C@H](C(=O)N1)[C@H](C)CC(O)=O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](CC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)CCCCCCCCC)C(=O)C1=CC=CC=C1N DOAKLVKFURWEDJ-QCMAZARJSA-N 0.000 claims 27
- 229960005484 daptomycin Drugs 0.000 claims 27
- 239000008247 solid mixture Substances 0.000 claims 15
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 3
- 239000006193 liquid solution Substances 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- 239000006172 buffering agent Substances 0.000 claims 1
- 229940061607 dibasic sodium phosphate Drugs 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 125000000647 trehalose group Chemical group 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
Classifications
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- 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
- 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
- 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
- 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
- A61P17/00—Drugs for dermatological disorders
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K11/00—Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K11/02—Depsipeptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof cyclic, e.g. valinomycins ; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (12)
1. Čvrsta kompozicija daptomicina, naznačena time što je navedena kompozicija pripremljena liofilizacijom tekuće vodene otopine daptomicina koja sadrži najmanje jedan ekscipijens koji je nereducirajući šećer, pri čemu tekuća vodena otopina daptomicina ima pH od 6.5 do 7.5.
2. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 1, naznačena time što molarni odnos daptomicina prema šećeru iznosi 1:1.12 do 1:21.32.
3. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 1 ili 2, naznačena time što je šećer odabran od trehaloze, saharoze i manitola.
4. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 1, naznačena time što čvrsta kompozicija daptomicina sadrži daptomicin i trehalozu.
5. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 4, naznačena time što molarni odnos daptomicina prema trehalozi iznosi 1:2.13 do 1:21.32.
6. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 1, naznačena time što čvrsta kompozicija daptomicina sadrži daptomicin i saharozu.
7. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 6, naznačena time što molarni odnos daptomicina prema saharozi iznosi 1:1.12 do 1:8.98.
8. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 1, naznačena time što čvrsta kompozicija daptomicina sadrži daptomicin i manitol.
9. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 8, naznačena time što molarni odnos daptomicina prema manitolu iznosi 1:2.52 do 1:5.04.
10. Čvrsta kompozicija daptomicina prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time što tekuća otopina daptomicina ima pH vrijednost od 7.0.
11. Čvrsta kompozicija daptomicina prema bilo kojem od patentnih zahtjeva 1 do 10, naznačena time što tekuća otopina daptomicina sadrži pufersko sredstvo natrijev fosfat.
12. Čvrsta kompozicija daptomicina prema patentnom zahtjevu 11, naznačena time što tekuća otopina daptomicina sadrži dibazni natrijev fosfat.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26378409P | 2009-11-23 | 2009-11-23 | |
| EP10832379.1A EP2504353B2 (en) | 2009-11-23 | 2010-11-23 | Lipopeptide compositions and related methods |
| PCT/US2010/057910 WO2011063419A2 (en) | 2009-11-23 | 2010-11-23 | Lipopeptide compositions and related methods |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20181380T1 HRP20181380T1 (hr) | 2018-10-19 |
| HRP20181380T4 true HRP20181380T4 (hr) | 2023-11-10 |
Family
ID=44060422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181380TT HRP20181380T4 (hr) | 2009-11-23 | 2010-11-23 | Lipopeptidne kompozicije i s njima povezani postupci |
Country Status (33)
| Country | Link |
|---|---|
| US (3) | US8835382B2 (hr) |
| EP (2) | EP2504353B2 (hr) |
| JP (3) | JP6041673B2 (hr) |
| CN (3) | CN108785654A (hr) |
| AR (2) | AR079127A1 (hr) |
| AU (1) | AU2010321531C1 (hr) |
| BR (1) | BR112012012406B1 (hr) |
| CA (1) | CA2781666C (hr) |
| CL (2) | CL2012001336A1 (hr) |
| CO (1) | CO6541585A2 (hr) |
| CR (1) | CR20120271A (hr) |
| CY (1) | CY1120854T1 (hr) |
| DK (1) | DK2504353T4 (hr) |
| DO (1) | DOP2012000140A (hr) |
| EC (1) | ECSP12011939A (hr) |
| ES (1) | ES2686331T5 (hr) |
| FI (1) | FI2504353T4 (hr) |
| HR (1) | HRP20181380T4 (hr) |
| HU (1) | HUE039967T2 (hr) |
| IL (1) | IL219891B (hr) |
| LT (1) | LT2504353T (hr) |
| MX (1) | MX2012005993A (hr) |
| NZ (1) | NZ600118A (hr) |
| PE (2) | PE20151717A1 (hr) |
| PL (1) | PL2504353T5 (hr) |
| PT (1) | PT2504353T (hr) |
| RS (1) | RS57566B2 (hr) |
| RU (1) | RU2607526C2 (hr) |
| SG (1) | SG10201407724YA (hr) |
| SI (1) | SI2504353T2 (hr) |
| TR (1) | TR201812823T4 (hr) |
| TW (2) | TWI606838B (hr) |
| WO (1) | WO2011063419A2 (hr) |
Families Citing this family (24)
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| US6696412B1 (en) | 2000-01-20 | 2004-02-24 | Cubist Pharmaceuticals, Inc. | High purity lipopeptides, Lipopeptide micelles and processes for preparing same |
| US20060014674A1 (en) * | 2000-12-18 | 2006-01-19 | Dennis Keith | Methods for preparing purified lipopeptides |
| MX2012005993A (es) | 2009-11-23 | 2012-11-23 | Cubist Pharm Inc | Composiciones de lipopeptido y metodos relacionados. |
| US8709310B2 (en) | 2011-01-05 | 2014-04-29 | Hospira, Inc. | Spray drying vancomycin |
| EP2714012A1 (en) * | 2011-05-26 | 2014-04-09 | Cubist Pharmaceuticals, Inc. | Cb-183,315 compositions and related methods |
| AU2013201937B8 (en) * | 2012-01-12 | 2015-08-20 | Celgene Corporation | Romidepsin formulations and uses thereof |
| ES2655215T3 (es) * | 2012-08-23 | 2018-02-19 | Mylan Laboratories Ltd. | Mejoramiento de la formulación inyectable de daptomicina |
| WO2014041425A1 (en) | 2012-09-11 | 2014-03-20 | Hospira Australia Pty Ltd. | Daptomycin formulations and uses thereof |
| CN104027791B (zh) * | 2013-03-06 | 2016-08-10 | 浙江海正药业股份有限公司 | 药物组合物 |
| CN104511011A (zh) * | 2013-09-29 | 2015-04-15 | 山东新时代药业有限公司 | 一种达托霉素无菌粉末及其制备方法 |
| US10647746B2 (en) | 2016-04-08 | 2020-05-12 | Versitech Limited | Antibacterial cyclic lipopeptides |
| US11667674B2 (en) | 2016-04-08 | 2023-06-06 | Versitech Limited | Antibacterial cyclic lipopeptides |
| EP3528786B1 (en) | 2016-10-21 | 2023-04-05 | Xellia Pharmaceuticals ApS | Liquid formulations of daptomycin |
| CA3070660A1 (en) | 2017-08-31 | 2019-03-07 | Xellia Pharmaceuticals Aps | Daptomycin formulations |
| CN110339341A (zh) * | 2018-04-03 | 2019-10-18 | 江苏恒瑞医药股份有限公司 | 一种达托霉素或其盐的组合物 |
| CN110548130A (zh) * | 2018-06-04 | 2019-12-10 | 浙江医药股份有限公司新昌制药厂 | 含达托霉素的喷雾干粉及其工业化制备方法 |
| US11058745B1 (en) | 2018-10-04 | 2021-07-13 | Good Health, Llc | Stable liquid pharmaceutical compositions of daptomycin |
| CN111840511A (zh) * | 2019-04-30 | 2020-10-30 | 江苏恒瑞医药股份有限公司 | 一种含有精氨酸的达托霉素或其盐的组合物 |
| JPWO2021131314A1 (hr) * | 2019-12-26 | 2021-07-01 | ||
| WO2021170807A1 (en) | 2020-02-28 | 2021-09-02 | Xellia Pharmaceuticals Aps | Daptomycin formulation |
| WO2021183752A1 (en) * | 2020-03-12 | 2021-09-16 | Baxter International Inc. | Daptomycin formulations containing a combination of sorbitol and mannitol |
| US11362190B2 (en) | 2020-05-22 | 2022-06-14 | Raytheon Company | Depletion mode high electron mobility field effect transistor (HEMT) semiconductor device having beryllium doped Schottky contact layers |
| KR102218688B1 (ko) * | 2020-06-25 | 2021-02-22 | 주식회사 클린텍 | 무선제어기능을 구비한 고압세척기 |
| RU2770481C1 (ru) * | 2021-06-25 | 2022-04-18 | федеральное государственное автономное образовательное учреждение высшего образования «Казанский (Приволжский) федеральный университет» (ФГАОУ ВО КФУ) | Способ получения суммарной фракции липопептидов бактерий Bacillus subtilis MG-8 ВКПМ В-12476 и его использование в качестве профилактического средства от болезней сельскохозяйственных птиц |
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