CA2642324A1 - Stable pharmaceutical composition of taxanes - Google Patents
Stable pharmaceutical composition of taxanes Download PDFInfo
- Publication number
- CA2642324A1 CA2642324A1 CA002642324A CA2642324A CA2642324A1 CA 2642324 A1 CA2642324 A1 CA 2642324A1 CA 002642324 A CA002642324 A CA 002642324A CA 2642324 A CA2642324 A CA 2642324A CA 2642324 A1 CA2642324 A1 CA 2642324A1
- Authority
- CA
- Canada
- Prior art keywords
- solvent
- water
- ionic
- aqueous
- immiscible
- 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.)
- Granted
Links
Classifications
-
- 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
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
The present invention discloses a non-ionic solvent having a conductivity value of less than or equal to 5.0 micro semens, which is capable of providing a stabilized pharmaceutical composition comprising a taxane. The present invention relates to a stable pharmaceutical composition of taxanes and a method for preparation thereof.
Claims (10)
1. A process for preparation of a non-ionic solvent capable of providing a stabilized taxane pharmaceutical composition comprising the steps of :
a) dissolving the non-ionic solvent in an water-immiscible organic solvent;
b) adding an aqueous solvent to the solution of step(a) to form a biphasic system;
c) extracting the non-ionic-solvent into the organic phase;
d) allowing the two immiscible phases to stand;
e) separating the aqueous and organic phases;
f) optionally, washing the organic phase with the aqueous solvent once more or twice;
g) optionally, extracting the combined aqueous phase of step (e) and (f) with the water-immiscible organic solvent;
h) combining all the water-immiscible organic phases of steps (e), (f) and (g); and i) evaporating the organic solvent to obtain the non-ionic solvent.
a) dissolving the non-ionic solvent in an water-immiscible organic solvent;
b) adding an aqueous solvent to the solution of step(a) to form a biphasic system;
c) extracting the non-ionic-solvent into the organic phase;
d) allowing the two immiscible phases to stand;
e) separating the aqueous and organic phases;
f) optionally, washing the organic phase with the aqueous solvent once more or twice;
g) optionally, extracting the combined aqueous phase of step (e) and (f) with the water-immiscible organic solvent;
h) combining all the water-immiscible organic phases of steps (e), (f) and (g); and i) evaporating the organic solvent to obtain the non-ionic solvent.
2. A process for the preparation of a non-ionic solvent having conductivity value of less than or equal to 5.0, which is capable of providing a stabilized taxane pharmaceutical composition comprising the steps of:
a) dissolving the non-ionic solvent in an water-immiscible organic solvent;
b) adding an aqueous solvent to the solution of step (a) to form a biphasic system;
c) extracting the non-ionic solvent into the organic phase;
d) allowing the two immiscible phases to stand;
e) separating the aqueous and organic phases;
f) optionally, washing the organic phase with the aqueous solvent once more or twice;
g) optionally, extracting the combined aqueous phase of step (e) and (f) with the water-immiscible organic solvent;
h) combining all the water-immiscible organic phases of steps (e), (f) and (g); and i) evaporating the organic solvent to obtain the non-ionic solvent.
a) dissolving the non-ionic solvent in an water-immiscible organic solvent;
b) adding an aqueous solvent to the solution of step (a) to form a biphasic system;
c) extracting the non-ionic solvent into the organic phase;
d) allowing the two immiscible phases to stand;
e) separating the aqueous and organic phases;
f) optionally, washing the organic phase with the aqueous solvent once more or twice;
g) optionally, extracting the combined aqueous phase of step (e) and (f) with the water-immiscible organic solvent;
h) combining all the water-immiscible organic phases of steps (e), (f) and (g); and i) evaporating the organic solvent to obtain the non-ionic solvent.
3. The process as claimed in claim 10 or 11 wherein the water-immiscible organic solvent is a non-halogenated hydrocarbon or a halogenated hydrocarbon.
4. The process according to claim 12, wherein the non-halogenated hydrocarbon is cyclohexane, n-hexane or n-heptane.
5. The process according to claim 12, wherein the halogenated hydrocarbon is dichloromethane, carbon tetrachloride, chloroform or 1,2-dichloroethane.
6. The process as claimed in any one of claims 10 to 14, wherein the water-immiscible organic solvent is dichloromethane.
7. The process as claimed in any one of claims 10 to 15, wherein the aqueous solvent is water or Milli-Q water. 10 to 16, wherein the non-ionic solvent is polyethoxylated castor oil or polyoxyl-35-castor oil.
8. The process as claimed in any one of claims 10 to 15 wherein the non-ionic solvent is cremophor.
9. The process as claimed in any one of claims 10 to 15, wherein the proportion of non-ionic solvent to water-immiscible organic solvent is 1:1.
10. The process as claimed in any one of claims 10 to 18 wherein the proportion of water-immiscible organic solvent and aqueous solvent is 1:1.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN473DE2006 | 2006-02-21 | ||
| IN473/DEL/2006 | 2006-02-21 | ||
| PCT/IN2007/000052 WO2007096900A1 (en) | 2006-02-21 | 2007-02-07 | Stable pharmaceutical composition of taxanes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2642324A1 true CA2642324A1 (en) | 2007-08-30 |
| CA2642324C CA2642324C (en) | 2011-03-29 |
Family
ID=38191277
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2642324A Expired - Fee Related CA2642324C (en) | 2006-02-21 | 2007-02-07 | Stable pharmaceutical composition of taxanes |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP1998808A1 (en) |
| AR (1) | AR059452A1 (en) |
| AU (1) | AU2007219104B2 (en) |
| CA (1) | CA2642324C (en) |
| WO (1) | WO2007096900A1 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101291658B (en) | 2005-08-31 | 2014-04-16 | 阿布拉科斯生物科学有限公司 | Compositions and methods for preparation of poorly water soluble drugs with increased stability |
| RU2433818C2 (en) | 2005-08-31 | 2011-11-20 | АБРАКСИС БАЙОСАЙЕНС, ЭлЭлСи | Compositions, including poorly soluble in water pharmaceutic substances and antimicrobial substances |
| BR112012028037A2 (en) | 2010-05-03 | 2016-08-02 | Teikoku Pharma Usa Inc | non-aqueous taxane liquid proemulsion formulation, methods for administering a taxane to a patient and for manufacturing a taxane proemulsion formulation, taxane emulsion composition, and kit |
| JO3685B1 (en) | 2012-10-01 | 2020-08-27 | Teikoku Pharma Usa Inc | Non-aqueous taxane nanodispersion formulations and methods of using the same |
| CN107929750B (en) * | 2017-12-20 | 2021-06-08 | 江苏九旭药业有限公司 | Anti-tumor pharmaceutical composition and preparation method and application thereof |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2561330A (en) * | 1948-03-25 | 1951-07-24 | Phillips Petroleum Co | Process for refining soybean oil |
| FR2601675B1 (en) | 1986-07-17 | 1988-09-23 | Rhone Poulenc Sante | TAXOL DERIVATIVES, THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM |
| US5925776A (en) * | 1997-12-24 | 1999-07-20 | Schein Pharmacetical, Inc. | Polyethoxylated castor oil, process of making the same and formulations thereof |
| AU1214400A (en) * | 1998-10-20 | 2000-05-08 | Ben Venue Laboratories, Inc. | Process for purification of solvents useful in the preparation of pharmaceuticalcompositions |
| WO2004100994A2 (en) * | 2003-05-19 | 2004-11-25 | Ebewe Pharma Ges.M.B.H. Nfg.Kg | Method for the production of a stable injectable formulation made of difficult to dissolve antineoplastic active substances |
| US20050016926A1 (en) * | 2003-07-24 | 2005-01-27 | Dabur Research Foundation | Stabilized formulation |
| EP1690551A3 (en) * | 2005-02-10 | 2006-10-18 | Sindan Pharma Srl | Method of purifying a surfactant by ultrafiltration |
-
2007
- 2007-02-07 EP EP07706195A patent/EP1998808A1/en not_active Withdrawn
- 2007-02-07 AU AU2007219104A patent/AU2007219104B2/en not_active Ceased
- 2007-02-07 CA CA2642324A patent/CA2642324C/en not_active Expired - Fee Related
- 2007-02-07 WO PCT/IN2007/000052 patent/WO2007096900A1/en active Application Filing
- 2007-02-14 AR ARP070100637A patent/AR059452A1/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| AU2007219104A1 (en) | 2007-08-30 |
| AU2007219104B2 (en) | 2010-07-01 |
| AR059452A1 (en) | 2008-04-09 |
| WO2007096900A1 (en) | 2007-08-30 |
| CA2642324C (en) | 2011-03-29 |
| EP1998808A1 (en) | 2008-12-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20130207 |