US5972992A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Injectable composition
Assignee: Mayne Pharma USA Inc
•
Filing: 1998-02-24
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Granted: 1999-10-26
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Expires: 2018-02-24
Abstract
Abstract A pharmaceutical formulation of taxol and polyethoxylated castor oil is disclosed to be stabilized by reducing its pH to less than 8.1 and preferably within a pH range of 5 to 7, inclusively. Ethanol is optionally included in the formulation which is adapted for use in a body for the treatment of cancer. A formulation method is disclosed and includes the step of reducing the pH of a carrier material, such as polyethoxylated castor oil, to form a carrier solution after which taxol is added in an amount such that the resulting pH is less than 8.1 and preferably in a pH range of 5 to 7. Ethanol may optionally be slurried with the taxol before mixing with the carrier solution.
Inventors
- 👤 David Carver
- 👤 Timothy Prout
- 👤 Hernita Ewald
- 👤 Robyn Elliott
- 👤 Paul Handreck
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 13:41
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K31/00; A61K31/33; A61K31/335; A61K31/337; A61K47/00; A61K47/06; A61K47/08; A61K47/10; A61K47/12; A61K47/14; A61K47/44
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
24 words
A pharmaceutical taxol composition comprising taxol and a pharmaceutically-acceptable carrier wherein said pharmaceutical taxol composition has a pH less than or equal to 7.0.
Claim 2
Dependent Claim
24 words
A pharmaceutical taxol composition comprising taxol and a pharmaceutically-acceptable carrier wherein said pharmaceutical taxol composition has a pH less than or equal to 7.0.
Claim 3
Dependent Claim
15 words
The pharmaceutical taxol composition of claim 1 having a pH between 5 and 7, inclusive.
Claim 4
Dependent Claim
14 words
The pharmaceutical taxol composition of claim 1 further comprising ethanol as a constituent thereof.
Claim 5
Dependent Claim
16 words
The pharmaceutical taxol composition of claim 3 having a pH of between 5 and 7, inclusive.
Claim 6
Dependent Claim
15 words
The pharmaceutical taxol composition of claim 1, wherein said pharmaceutically-acceptable carrier is polyethoxylated castor oil.
Claim 7
Dependent Claim
12 words
The pharmaceutical taxol composition of claim 6, wherein said composition is anhydrous.
Claim 8
Dependent Claim
72 words
An improved method of formulating a pharmaceutical taxol solution, such that the taxol does not readily degrade, comprising the following steps: mixing taxol with a carrier material to form a taxol solution; and reducing the pH of said taxol solution to a level whereby the taxol solution is stabilized such that at least 95% of the taxol potency is retained when the composition is stored at 40° C. for seven (7) days.
Claim 9
Dependent Claim
72 words
An improved method of formulating a pharmaceutical taxol solution, such that the taxol does not readily degrade, comprising the following steps: mixing taxol with a carrier material to form a taxol solution; and reducing the pH of said taxol solution to a level whereby the taxol solution is stabilized such that at least 95% of the taxol potency is retained when the composition is stored at 40° C. for seven (7) days.
Claim 10
Dependent Claim
13 words
The method of claim 7, wherein said carrier material is polyethoxylated castor oil.
Claim 11
Dependent Claim
23 words
The method of claim 7 further comprising the step of slurrying said taxol in alcohol before mixing said taxol with the carrier material.
Claim 12
Dependent Claim
34 words
An article of manufacture comprising a container and a pharmaceutical formulation contained therein, said pharmaceutical formulation comprising a pharmaceutically-acceptable carrier and taxol, wherein said pharmaceutical formulation has a pH of about 7 or less.
Claim 13
Dependent Claim
34 words
An article of manufacture comprising a container and a pharmaceutical formulation contained therein, said pharmaceutical formulation comprising a pharmaceutically-acceptable carrier and taxol, wherein said pharmaceutical formulation has a pH of about 7 or less.
Claim 14
Dependent Claim
15 words
The article of manufacture of claim 10, wherein said pharmaceutically-acceptable carrier is polyethoxylated castor oil.
Claim 15
Dependent Claim
14 words
The article of manufacture of claim 10, wherein said pharmaceutical formulation further comprises ethanol.
Claim 16
Dependent Claim
19 words
The article of manufacture of claim 10, wherein said pharmaceutical formulation has a pH between 5 and 7, inclusive.
Claim 17
Dependent Claim
18 words
The article of manufacture of claim 10 further comprising instructions for administering said pharmaceutical formulation to a patient.
Claim 18
Dependent Claim
49 words
A pharmaceutical taxol composition comprising: taxol; polyethoxylated castor oil; and ethanol, wherein said taxol composition has a pH sufficient to improve the stability of said taxol such that at least 95% of the taxol potency is retained when the composition is stored at 40° C. for seven (7) days.
Claim 19
Dependent Claim
49 words
A pharmaceutical taxol composition comprising: taxol; polyethoxylated castor oil; and ethanol, wherein said taxol composition has a pH sufficient to improve the stability of said taxol such that at least 95% of the taxol potency is retained when the composition is stored at 40° C. for seven (7) days.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-10-25 | 2003-04-26 | 2003-10-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-10-25 | 2007-04-26 | 2007-10-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-10-25 | 2011-04-26 | 2011-10-26 | $7700.00 | Window Closed / Lapsed |