EP3328437A4 - PHARMACEUTICAL COMPOSITION WITH IMPROVED STORAGE STABILITY AND PROCESS FOR PREPARING THE SAME - Google Patents
PHARMACEUTICAL COMPOSITION WITH IMPROVED STORAGE STABILITY AND PROCESS FOR PREPARING THE SAME Download PDFInfo
- Publication number
- EP3328437A4 EP3328437A4 EP16830853.4A EP16830853A EP3328437A4 EP 3328437 A4 EP3328437 A4 EP 3328437A4 EP 16830853 A EP16830853 A EP 16830853A EP 3328437 A4 EP3328437 A4 EP 3328437A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- preparing
- pharmaceutical composition
- same
- storage stability
- improved storage
- 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.)
- Withdrawn
Links
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
Classifications
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20150106629 | 2015-07-28 | ||
| PCT/KR2016/008270 WO2017018820A1 (en) | 2015-07-28 | 2016-07-28 | Pharmaceutical composition with improved storage stability and method for preparing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP3328437A1 EP3328437A1 (en) | 2018-06-06 |
| EP3328437A4 true EP3328437A4 (en) | 2019-03-20 |
Family
ID=57884713
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP16830853.4A Withdrawn EP3328437A4 (en) | 2015-07-28 | 2016-07-28 | PHARMACEUTICAL COMPOSITION WITH IMPROVED STORAGE STABILITY AND PROCESS FOR PREPARING THE SAME |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP3328437A4 (en) |
| JP (1) | JP2018521105A (en) |
| KR (1) | KR101787453B1 (en) |
| CN (1) | CN107466231A (en) |
| AU (1) | AU2016299548A1 (en) |
| BR (1) | BR112018001737A2 (en) |
| CA (1) | CA2993928A1 (en) |
| HK (1) | HK1249441A1 (en) |
| IL (1) | IL257187A (en) |
| MX (1) | MX2018001223A (en) |
| RU (1) | RU2018107055A (en) |
| WO (1) | WO2017018820A1 (en) |
| ZA (1) | ZA201801187B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101787447B1 (en) * | 2015-07-28 | 2017-10-19 | 주식회사 삼양바이오팜 | Pharmaceutical composition with improved storage stability and method for preparing the same |
| KR101787451B1 (en) * | 2015-07-28 | 2017-10-19 | 주식회사 삼양바이오팜 | Pharmaceutical composition with improved storage stability and method for preparing the same |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001085216A1 (en) * | 2000-05-12 | 2001-11-15 | Samyang Corporation | Method for the preparation of polymeric micelle via phase separation of block copolymer |
| WO2001087345A1 (en) * | 2000-05-17 | 2001-11-22 | Samyang Corporation | Stable polymeric micelle-type drug composition and method for the preparation thereof |
| US20100280214A1 (en) * | 2007-12-31 | 2010-11-04 | Samyang Corporation | Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof |
| US20130345297A1 (en) * | 2007-12-31 | 2013-12-26 | Samyang Biopharmaceuticals Corporation | Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6020507A (en) | 1998-03-02 | 2000-02-01 | Bristol-Myers Squibb Company | Synthesis of paclitaxel from baccatin III by protection of the 7-hydroxyl of baccatin III using a strong base and an electrophile |
| US7879317B2 (en) * | 2001-10-18 | 2011-02-01 | Samyang Corporation | Polymeric micelle compositions with improved stability and methods of making thereof |
| WO2005037840A1 (en) | 2003-10-16 | 2005-04-28 | Mayne Pharma (Usa), Inc. | Method for inverting the c2’ hydroxyl group of taxane esters |
| KR101024742B1 (en) * | 2007-12-31 | 2011-03-24 | 주식회사 삼양사 | Taxane-containing amphiphilic block copolymer micelle composition and preparation method thereof |
| EP2201935B1 (en) * | 2008-12-26 | 2020-07-08 | Samyang Biopharmaceuticals Corporation | Polymeric micelle composition containing a poorly soluble drug and preparation method of the same |
-
2016
- 2016-07-27 KR KR1020160095415A patent/KR101787453B1/en active Active
- 2016-07-28 AU AU2016299548A patent/AU2016299548A1/en not_active Abandoned
- 2016-07-28 JP JP2018504263A patent/JP2018521105A/en active Pending
- 2016-07-28 BR BR112018001737A patent/BR112018001737A2/en not_active Application Discontinuation
- 2016-07-28 HK HK18109126.8A patent/HK1249441A1/en unknown
- 2016-07-28 MX MX2018001223A patent/MX2018001223A/en unknown
- 2016-07-28 WO PCT/KR2016/008270 patent/WO2017018820A1/en not_active Ceased
- 2016-07-28 EP EP16830853.4A patent/EP3328437A4/en not_active Withdrawn
- 2016-07-28 CN CN201680001947.1A patent/CN107466231A/en active Pending
- 2016-07-28 CA CA2993928A patent/CA2993928A1/en not_active Abandoned
- 2016-07-28 RU RU2018107055A patent/RU2018107055A/en unknown
-
2018
- 2018-01-28 IL IL257187A patent/IL257187A/en unknown
- 2018-02-21 ZA ZA2018/01187A patent/ZA201801187B/en unknown
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001085216A1 (en) * | 2000-05-12 | 2001-11-15 | Samyang Corporation | Method for the preparation of polymeric micelle via phase separation of block copolymer |
| WO2001087345A1 (en) * | 2000-05-17 | 2001-11-22 | Samyang Corporation | Stable polymeric micelle-type drug composition and method for the preparation thereof |
| US20100280214A1 (en) * | 2007-12-31 | 2010-11-04 | Samyang Corporation | Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof |
| US20130345297A1 (en) * | 2007-12-31 | 2013-12-26 | Samyang Biopharmaceuticals Corporation | Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug |
Non-Patent Citations (3)
| Title |
|---|
| KIM S C ET AL: "In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 72, no. 1-3, 14 May 2001 (2001-05-14), pages 191 - 202, XP027296131, ISSN: 0168-3659, [retrieved on 20010514] * |
| See also references of WO2017018820A1 * |
| ZHU K J ET AL: "PREPARATION, CHARACTERIZATION, AND PROPERTIES OF POLYLACTIDE (PLA)-POLY(ETHYLENE GLYCOL) (PEG) COLOYMERS: A POTENTIAL DRUG CARRIER", JOURNAL OF APPLIED POLYMER SCIENCE, JOHN WILEY & SONS, INC, US, vol. 39, no. 1, 1 January 1990 (1990-01-01), pages 1 - 09, XP000650366, ISSN: 0021-8995, DOI: 10.1002/APP.1990.070390101 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN107466231A (en) | 2017-12-12 |
| WO2017018820A1 (en) | 2017-02-02 |
| JP2018521105A (en) | 2018-08-02 |
| KR101787453B1 (en) | 2017-10-19 |
| EP3328437A1 (en) | 2018-06-06 |
| RU2018107055A (en) | 2019-08-28 |
| RU2018107055A3 (en) | 2019-08-28 |
| AU2016299548A1 (en) | 2018-02-22 |
| IL257187A (en) | 2018-03-29 |
| HK1249441A1 (en) | 2018-11-02 |
| ZA201801187B (en) | 2018-12-19 |
| BR112018001737A2 (en) | 2018-09-11 |
| MX2018001223A (en) | 2018-11-09 |
| CA2993928A1 (en) | 2017-02-02 |
| KR20170015200A (en) | 2017-02-08 |
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| A4 | Supplementary search report drawn up and despatched |
Effective date: 20190215 |
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| RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61K 9/107 20060101ALI20190211BHEP Ipc: A61K 31/122 20060101ALI20190211BHEP Ipc: A61K 47/34 20170101AFI20190211BHEP Ipc: A61K 9/19 20060101ALI20190211BHEP Ipc: A61K 31/337 20060101ALI20190211BHEP |
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| STAA | Information on the status of an ep patent application or granted ep patent |
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