ES2655215T3 - Mejoramiento de la formulación inyectable de daptomicina - Google Patents
Mejoramiento de la formulación inyectable de daptomicina Download PDFInfo
- Publication number
- ES2655215T3 ES2655215T3 ES13838871.5T ES13838871T ES2655215T3 ES 2655215 T3 ES2655215 T3 ES 2655215T3 ES 13838871 T ES13838871 T ES 13838871T ES 2655215 T3 ES2655215 T3 ES 2655215T3
- Authority
- ES
- Spain
- Prior art keywords
- daptomycin
- formulation
- solution
- tpm
- tocopheryl phosphate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 108010013198 Daptomycin Proteins 0.000 title claims abstract description 50
- 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 49
- 229960005484 daptomycin Drugs 0.000 title claims abstract description 40
- 239000007972 injectable composition Substances 0.000 title description 2
- 239000000203 mixture Substances 0.000 claims abstract description 47
- 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 21
- 239000003242 anti bacterial agent Substances 0.000 claims abstract description 6
- 238000007911 parenteral administration Methods 0.000 claims abstract description 4
- 239000012931 lyophilized formulation Substances 0.000 claims abstract 7
- 239000013543 active substance Substances 0.000 claims abstract 2
- 238000009472 formulation Methods 0.000 claims description 31
- 239000000243 solution Substances 0.000 claims description 31
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 11
- 239000008215 water for injection Substances 0.000 claims description 10
- 238000003756 stirring Methods 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 4
- 208000035143 Bacterial infection Diseases 0.000 claims description 3
- 208000022362 bacterial infectious disease Diseases 0.000 claims description 3
- 239000000047 product Substances 0.000 description 20
- 229940021392 cubicin Drugs 0.000 description 11
- 238000004090 dissolution Methods 0.000 description 6
- 238000007654 immersion Methods 0.000 description 6
- 239000012535 impurity Substances 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 6
- 229940032301 daptomycin injection Drugs 0.000 description 5
- 238000013019 agitation Methods 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- 239000000126 substance 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
- 238000004108 freeze drying Methods 0.000 description 3
- 229940090044 injection Drugs 0.000 description 3
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- 239000008354 sodium chloride injection Substances 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
- 239000008364 bulk solution Substances 0.000 description 2
- 229940032302 daptomycin 500 mg Drugs 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 230000007062 hydrolysis Effects 0.000 description 2
- 238000006460 hydrolysis reaction Methods 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 101100065878 Caenorhabditis elegans sec-10 gene Proteins 0.000 description 1
- 238000010268 HPLC based assay Methods 0.000 description 1
- 108010028921 Lipopeptides Proteins 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 241000958215 Streptomyces filamentosus Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229960003767 alanine Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000000855 fermentation Methods 0.000 description 1
- 230000004151 fermentation Effects 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 239000013022 formulation composition Substances 0.000 description 1
- 239000005414 inactive ingredient Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 150000002596 lactones Chemical class 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 206010040872 skin infection Diseases 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
- 238000012360 testing method 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)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (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 (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2452MU2012 | 2012-08-23 | ||
| 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 |
|---|---|
| ES2655215T3 true ES2655215T3 (es) | 2018-02-19 |
Family
ID=54187094
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES13838871.5T Active ES2655215T3 (es) | 2012-08-23 | 2013-08-22 | Mejoramiento de la formulación inyectable de daptomicina |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20150216928A1 (enExample) |
| EP (2) | EP3287138A1 (enExample) |
| JP (1) | JP2015526463A (enExample) |
| AU (2) | AU2013319737B2 (enExample) |
| BR (1) | BR112015003198A2 (enExample) |
| CA (1) | CA2881121A1 (enExample) |
| DK (1) | DK2887953T3 (enExample) |
| ES (1) | ES2655215T3 (enExample) |
| NO (1) | NO2887953T3 (enExample) |
| PT (1) | PT2887953T (enExample) |
| SI (1) | SI2887953T1 (enExample) |
| WO (1) | WO2014045296A2 (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE13837694T1 (de) | 2012-09-11 | 2015-12-31 | Hospira Australia Pty Ltd. | Daptomycinformulierungen und Verwendungen davon |
| WO2018073269A1 (en) | 2016-10-21 | 2018-04-26 | Xellia Pharmaceuticals Aps | Liquid formulations of daptomycin |
| MX2020001885A (es) | 2017-08-31 | 2020-09-07 | Xellia Pharmaceuticals Aps | Formulaciones de daptomicina. |
| CA3170514A1 (en) | 2020-03-12 | 2021-09-16 | Baxter International Inc. | 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 |
| US20080032384A1 (en) * | 2004-04-22 | 2008-02-07 | Takehiko Nomura | Pharmaceutical Preparation Containing Bacterial Cell Wall Skeleton |
| CA2611831C (en) * | 2005-06-17 | 2014-09-16 | 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 |
| BR112012012406B1 (pt) * | 2009-11-23 | 2021-11-16 | Cubist Pharmaceuticals Llc | Composições farmacêuticas sólidas de daptomicina, seu produto farmacêutico e seus métodos de fabricação |
| AU2011213557B2 (en) * | 2010-02-05 | 2015-05-07 | Phosphagenics Limited | Carrier comprising non-neutralised tocopheryl phosphate |
| CA2752784A1 (en) * | 2010-09-21 | 2012-03-21 | Xellia Pharmaceuticals Aps | Daptomycin formulation |
-
2013
- 2013-08-22 CA CA2881121A patent/CA2881121A1/en not_active Abandoned
- 2013-08-22 EP EP17194652.8A patent/EP3287138A1/en not_active Withdrawn
- 2013-08-22 JP JP2015528010A patent/JP2015526463A/ja active Pending
- 2013-08-22 AU AU2013319737A patent/AU2013319737B2/en not_active Ceased
- 2013-08-22 SI SI201330908T patent/SI2887953T1/en unknown
- 2013-08-22 US US14/431,170 patent/US20150216928A1/en not_active Abandoned
- 2013-08-22 BR BR112015003198A patent/BR112015003198A2/pt not_active Application Discontinuation
- 2013-08-22 WO PCT/IN2013/000511 patent/WO2014045296A2/en not_active Ceased
- 2013-08-22 ES ES13838871.5T patent/ES2655215T3/es active Active
- 2013-08-22 PT PT138388715T patent/PT2887953T/pt unknown
- 2013-08-22 EP EP13838871.5A patent/EP2887953B1/en not_active Not-in-force
- 2013-08-22 DK DK13838871.5T patent/DK2887953T3/en active
- 2013-08-22 NO NO13838871A patent/NO2887953T3/no unknown
-
2018
- 2018-06-18 AU AU2018204334A patent/AU2018204334A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| BR112015003198A2 (pt) | 2017-10-10 |
| DK2887953T3 (en) | 2018-01-15 |
| WO2014045296A2 (en) | 2014-03-27 |
| WO2014045296A3 (en) | 2014-10-23 |
| AU2018204334A1 (en) | 2018-07-05 |
| AU2013319737B2 (en) | 2018-08-02 |
| EP3287138A1 (en) | 2018-02-28 |
| PT2887953T (pt) | 2018-01-10 |
| JP2015526463A (ja) | 2015-09-10 |
| CA2881121A1 (en) | 2014-03-27 |
| NO2887953T3 (enExample) | 2018-03-10 |
| EP2887953A4 (en) | 2016-05-25 |
| SI2887953T1 (en) | 2018-02-28 |
| EP2887953B1 (en) | 2017-10-11 |
| AU2013319737A1 (en) | 2015-02-05 |
| US20150216928A1 (en) | 2015-08-06 |
| EP2887953A2 (en) | 2015-07-01 |
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