DK2887953T3 - IMPROVED, INJECTABLE DAPTOMYCIN INFORMATION - Google Patents
IMPROVED, INJECTABLE DAPTOMYCIN INFORMATION Download PDFInfo
- Publication number
- DK2887953T3 DK2887953T3 DK13838871.5T DK13838871T DK2887953T3 DK 2887953 T3 DK2887953 T3 DK 2887953T3 DK 13838871 T DK13838871 T DK 13838871T DK 2887953 T3 DK2887953 T3 DK 2887953T3
- Authority
- DK
- Denmark
- Prior art keywords
- daptomycin
- lyophilized
- formulation
- stable
- solution
- Prior art date
Links
- 108010013198 Daptomycin Proteins 0.000 title claims abstract description 48
- DOAKLVKFURWEDJ-QCMAZARJSA-N daptomycin Chemical compound 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 title claims abstract description 48
- 229960005484 daptomycin Drugs 0.000 title claims abstract description 39
- 239000000203 mixture Substances 0.000 claims abstract description 36
- JUIUXBHZFNHITF-IEOSBIPESA-N [(2r)-2,5,7,8-tetramethyl-2-[(4r,8r)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] dihydrogen phosphate Chemical compound OP(=O)(O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C JUIUXBHZFNHITF-IEOSBIPESA-N 0.000 claims abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 13
- 239000003242 anti bacterial agent Substances 0.000 claims abstract description 7
- 239000000243 solution Substances 0.000 claims description 29
- 238000009472 formulation Methods 0.000 claims description 23
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 18
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 9
- 239000008215 water for injection Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 239000012931 lyophilized formulation Substances 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 4
- 238000007911 parenteral administration Methods 0.000 claims description 4
- 208000035143 Bacterial infection Diseases 0.000 claims description 3
- 208000022362 bacterial infectious disease Diseases 0.000 claims description 3
- 239000004480 active ingredient Substances 0.000 claims description 2
- 238000011049 filling Methods 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 239000003002 pH adjusting agent Substances 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 1
- 239000000413 hydrolysate Substances 0.000 abstract description 7
- 238000002360 preparation method Methods 0.000 abstract description 7
- 239000000126 substance Substances 0.000 abstract description 5
- 239000008194 pharmaceutical composition Substances 0.000 abstract description 4
- 108010028921 Lipopeptides Proteins 0.000 abstract description 2
- 241000958215 Streptomyces filamentosus Species 0.000 abstract description 2
- 125000004122 cyclic group Chemical group 0.000 abstract description 2
- 238000000855 fermentation Methods 0.000 abstract description 2
- 230000004151 fermentation Effects 0.000 abstract description 2
- 239000000047 product Substances 0.000 description 19
- 229940021392 cubicin Drugs 0.000 description 10
- 238000004090 dissolution Methods 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 6
- 229940032301 daptomycin injection Drugs 0.000 description 5
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- 206010040047 Sepsis Diseases 0.000 description 3
- 241000191967 Staphylococcus aureus Species 0.000 description 3
- 208000037815 bloodstream infection Diseases 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000002033 PVDF binder Substances 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 239000008364 bulk solution Substances 0.000 description 2
- 239000013022 formulation composition Substances 0.000 description 2
- 229940090044 injection Drugs 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 2
- 238000002791 soaking Methods 0.000 description 2
- 239000008354 sodium chloride injection Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 1
- 108010009736 Protein Hydrolysates Proteins 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 239000005414 inactive ingredient Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 150000002596 lactones Chemical class 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- 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
- A61K38/15—Depsipeptides; Derivatives 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2452MU2012 | 2012-08-23 | ||
| PCT/IN2013/000511 WO2014045296A2 (en) | 2012-08-23 | 2013-08-22 | Improved daptomycin injectable formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2887953T3 true DK2887953T3 (en) | 2018-01-15 |
Family
ID=54187094
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13838871.5T DK2887953T3 (en) | 2012-08-23 | 2013-08-22 | IMPROVED, INJECTABLE DAPTOMYCIN INFORMATION |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20150216928A1 (https=) |
| EP (2) | EP3287138A1 (https=) |
| JP (1) | JP2015526463A (https=) |
| AU (2) | AU2013319737B2 (https=) |
| BR (1) | BR112015003198A2 (https=) |
| CA (1) | CA2881121A1 (https=) |
| DK (1) | DK2887953T3 (https=) |
| ES (1) | ES2655215T3 (https=) |
| NO (1) | NO2887953T3 (https=) |
| PT (1) | PT2887953T (https=) |
| SI (1) | SI2887953T1 (https=) |
| WO (1) | WO2014045296A2 (https=) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HK1207006A1 (en) | 2012-09-11 | 2016-01-22 | Hospira Australia Pty Ltd | Daptomycin formulations and uses thereof |
| US10933019B2 (en) | 2016-10-21 | 2021-03-02 | Xellia Pharmaceuticals Aps | Liquid formulations of daptomycin |
| CN118766886A (zh) | 2017-08-31 | 2024-10-15 | 埃克斯利亚制药有限公司 | 达托霉素制剂 |
| AU2021233893A1 (en) | 2020-03-12 | 2022-08-25 | Baxter Healthcare Sa | Daptomycin formulations containing a combination of sorbitol and mannitol |
| CN112684043A (zh) * | 2020-12-16 | 2021-04-20 | 南京健友生化制药股份有限公司 | 一种达托霉素有关物质的检测方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4537717A (en) | 1982-05-21 | 1985-08-27 | Eli Lilly And Company | Derivatives of A-21978C cyclic peptides |
| FR2657526B1 (fr) * | 1990-01-31 | 1994-10-28 | Lvmh Rech | Utilisation d'un phosphate d'alpha-tocopherol, ou de l'un de ses derives, pour la preparation de compositions cosmetiques, dermatologiques, ou pharmaceutiques; compositions ainsi obtenues. |
| WO1997014705A1 (fr) * | 1995-10-17 | 1997-04-24 | Showa Denko K.K. | Phosphates de tocopherol tres purs, procedes de preparation, techniques d'analyse et produits cosmetiques correspondants |
| JP4088597B2 (ja) * | 2004-01-06 | 2008-05-21 | 樹男 飯田 | 内服および注射用組成物とその製法 |
| CA2564180A1 (en) * | 2004-04-22 | 2005-11-03 | Dainippon Sumitomo Pharma Co., Ltd. | Pharmaceutical preparation containing bacterial cell wall skeleton component |
| NZ565049A (en) * | 2005-06-17 | 2012-02-24 | Vital Health Sciences Pty Ltd | A carrier comprising one or more DI and/or mono-(electron transfer agent) phosphate derivatives or complexes thereof |
| CA2772660A1 (en) * | 2009-09-01 | 2011-03-10 | Northwestern University | Delivery of therapeutic agents using oligonucleotide-modified nanoparticles as carriers |
| US8431539B2 (en) * | 2009-09-17 | 2013-04-30 | Eagle Pharmaceuticals, Inc. | Formulations of daptomycin |
| SG10201407724YA (en) * | 2009-11-23 | 2014-12-30 | Cubist Pharm Inc | Daptomycin compositions and related methods |
| ES2999020T3 (en) * | 2010-02-05 | 2025-02-24 | Phosphagenics Ltd | Carrier comprising non-neutralised tocopheryl phosphate |
| CA2752784A1 (en) * | 2010-09-21 | 2012-03-21 | Xellia Pharmaceuticals Aps | Daptomycin formulation |
-
2013
- 2013-08-22 NO NO13838871A patent/NO2887953T3/no unknown
- 2013-08-22 EP EP17194652.8A patent/EP3287138A1/en not_active Withdrawn
- 2013-08-22 AU AU2013319737A patent/AU2013319737B2/en not_active Ceased
- 2013-08-22 DK DK13838871.5T patent/DK2887953T3/en active
- 2013-08-22 BR BR112015003198A patent/BR112015003198A2/pt not_active Application Discontinuation
- 2013-08-22 JP JP2015528010A patent/JP2015526463A/ja active Pending
- 2013-08-22 EP EP13838871.5A patent/EP2887953B1/en not_active Not-in-force
- 2013-08-22 WO PCT/IN2013/000511 patent/WO2014045296A2/en not_active Ceased
- 2013-08-22 CA CA2881121A patent/CA2881121A1/en not_active Abandoned
- 2013-08-22 SI SI201330908T patent/SI2887953T1/en unknown
- 2013-08-22 ES ES13838871.5T patent/ES2655215T3/es active Active
- 2013-08-22 US US14/431,170 patent/US20150216928A1/en not_active Abandoned
- 2013-08-22 PT PT138388715T patent/PT2887953T/pt unknown
-
2018
- 2018-06-18 AU AU2018204334A patent/AU2018204334A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| SI2887953T1 (en) | 2018-02-28 |
| US20150216928A1 (en) | 2015-08-06 |
| EP2887953A2 (en) | 2015-07-01 |
| AU2013319737A1 (en) | 2015-02-05 |
| ES2655215T3 (es) | 2018-02-19 |
| AU2018204334A1 (en) | 2018-07-05 |
| EP2887953A4 (en) | 2016-05-25 |
| JP2015526463A (ja) | 2015-09-10 |
| NO2887953T3 (https=) | 2018-03-10 |
| WO2014045296A2 (en) | 2014-03-27 |
| PT2887953T (pt) | 2018-01-10 |
| CA2881121A1 (en) | 2014-03-27 |
| WO2014045296A3 (en) | 2014-10-23 |
| EP2887953B1 (en) | 2017-10-11 |
| BR112015003198A2 (pt) | 2017-10-10 |
| EP3287138A1 (en) | 2018-02-28 |
| AU2013319737B2 (en) | 2018-08-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| DK2887953T3 (en) | IMPROVED, INJECTABLE DAPTOMYCIN INFORMATION | |
| DK2618814T3 (en) | Caspofunginsammensætning | |
| JP5723030B2 (ja) | エキノカンジン系抗真菌剤であるミカファンギンを含む薬用組成物およびその製造方法と用途 | |
| CN102526700A (zh) | 一种注射用醋酸奥曲肽冻干组合物及其制备方法 | |
| WO2022129264A1 (en) | Aqueous solution | |
| CN102462684B (zh) | 头孢曲松钠和舒巴坦钠的药物组合物及其制备方法 | |
| WO2016098009A1 (en) | Lyophilized injectable compositions of daptomycin | |
| WO2022129263A1 (en) | Aqueous solution | |
| DK2922530T3 (en) | Caspofunginacetatformuleringer | |
| CN101961311A (zh) | 一种5α-雄甾(烷)-3β,5,6β-三醇注射剂及其制备方法 | |
| CN103494780B (zh) | 一种注射用加米霉素组合物冻干粉及制备方法 | |
| CN112402371B (zh) | 一种瑞德西韦注射液及其制备方法 | |
| US5972912A (en) | Method for lyophilizing ifosfamide | |
| CN117881392A (zh) | 室温下稳定的水性罗库溴铵组合物 | |
| CN114828873A (zh) | 含有达托霉素的稳定的冷冻干燥制剂 | |
| CN111465389B (zh) | 多西他赛共缀物的药物组合物及制备方法 | |
| CN101125125A (zh) | 马来酸甲麦角新碱粉针剂及其制备方法 | |
| CN101554368B (zh) | 一种室温稳定的注射用替曲朵辛组合物制剂 | |
| CN103330933A (zh) | 含有米卡芬净或其盐的药物组合物 | |
| JP3956654B2 (ja) | Ｎ−［ｏ−（ｐ−ピバロイルオキシベンゼンスルホニルアミノ）ベンゾイル］グリシン・モノナトリウム塩・４水和物含有溶液および製剤 | |
| WO2021170807A1 (en) | Daptomycin formulation | |
| CN106176626B (zh) | L-丙氨酸-(14-冬凌草甲素)酯胃肠外用药物组合物 | |
| CN120154577B (zh) | 一种注射用伏立康唑冻干粉针及其制备方法 | |
| CN103735522A (zh) | 一种炎琥宁冻干粉针及其制备方法 | |
| CN103330932B (zh) | 一种米卡芬净或其盐的药物组合物 |