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The invention provides new compositions containing taxane derivatives, consisting of solutions of such derivatives in a solvent mixture composed of ethanol and polysorbate. These compositions are used to prepare perfusions.

Inventors: Jean-Pierre Bastart, Thierry Dupechez, Jean-Louis Fabre
Original Assignee: Rhone-Poulenc Rorer, S.A.
Current U.S. Classification: 514/449; 424/502; 514/408; 514/471
International Classification: A61K 31335; A61K 3134; A61K 950

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Citations

Cited PatentFiling dateIssue dateOriginal AssigneeTitle
US4206221Jan 3, 1979Jun 3, 1980The United States of America as represented by the Secretary of AgricultureCephalomannine and its use in treating leukemic tumors
US4814470Jul 14, 1987Mar 21, 1989Rhone-Poulenc SanteTaxol derivatives, their preparation and pharmaceutical compositions containing them
US4960790Mar 9, 1989Oct 2, 1990University of KansasDerivatives of taxol, pharmaceutical compositions thereof and methods for the preparation thereof
US5403858Aug 23, 1993Apr 4, 1995Rhone-Poulenc Rorer, S.A.New compositions containing taxane derivatives

Referenced by

Citing PatentFiling dateIssue dateOriginal AssigneeTitle
US6395770Aug 28, 1999May 28, 2002Baker Norton Pharmaceuticals, Inc.Method and compositions for administering taxanes orally to human patients
US6610735Apr 10, 2001Aug 26, 2003Baker Norton Pharmaceuticals, Inc.Method, compositions and kits for increasing the oral bioavailability of pharmaceutical agents
US6730698Feb 6, 2002May 4, 2004Baker Norton Pharmaceuticals, Inc.Method and compositions for administering taxanes orally to human patients
US6818615Sep 12, 2002Nov 16, 2004Baker Norton Pharmaceuticals, Inc.Method, compositions and kits for increasing the oral bioavailability of pharmaceutical agents
US6936583Mar 5, 2004Aug 30, 2005Baker Norton Pharmaceuticals, Inc.Method and compositions for administering taxanes orally to human patients
US7041640Mar 15, 2004May 9, 2006Baker Norton Pharmaceuticals, Inc.Method, compositions and kits for increasing the oral bioavailability of pharmaceutical agents
US7772274Mar 11, 2010Aug 10, 2010Scidose, LLCDocetaxel formulations with lipoic acid

Claims

1. A composition consisting essentially of a compound of formula: ##STR2## in which R represents a hydrogen atom or an acetyl radical and R.sub.1 represents a tert-butoxycarbonylamino or benzoylamino radical, dissolved in a mixture of ethanol and a polysorbate whereby said composition is used to form an injectable solution which contains up to about 1 mg/ml of the compound of formula I, said injectable solution being capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith.

2. A composition according to claim 1, wherein, in the compound of formula (I), R represents a hydrogen atom and R.sub.1 represents a tert-butoxycarbonylamino radical.

3. A composition according to claim 1, wherein, in the compound of formula (I), R represents an acetyl group and R.sub.1 represents a benzoylamino radical.

4. A composition according to claim 1, which contains between 6 and 15 mg/ml of compound of formula (I).

5. A perfusion, which contains approximately 1 mg/ml or less of compound of formula as defined in claim 1, and which contains less than 35 ml/l of ethanol and less than 35 ml/l of polysorbate, wherein said perfusion is capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith.

6. A stock solution consisting essentially of a mixture of taxotere and ethanol in a ratio of about 3:100 by weight, and an amount of polysorbate to provide a solution containing about 10 to 15 mg/ml of taxotere, whereby said stock solution is used to form an injectable solution which contains up to about 1 mg/ml of the compound of formula as defined in claim 1, said injectable solution being capable of being injected without anaphylactic or alcohol intoxication manifestations being associated herewith.

7. A perfusion consisting essentially of the stock solution of claim 6 and an amount of glucose solution or dextrose solution to obtain a solution containing about 1 mg/ml of taxotere.

8. A therapeutic composition consisting essentially of a taxane derivative dissolved in a mixture of ethanol and a polysorbate, whereby said therapeutic composition forms or is used to form an injectable solution which contains up to about 1 mg/ml of the compound of formula as defined in claim 1, said injectable solution being capable of being injected without anaphylactic or alcohol intoxication manifestations being associated herewith.

9. The composition of claim 8 wherein said taxane derivative is taxol or an analogue or derivative thereof.

10. The composition of claim 8 wherein said taxane derivative is taxotere or an analogue or derivative thereof.

11. A composition consisting essentially of a compound of formula ##STR3## in which R represents a hydrogen atom or an acetyl radical and R.sub.1 represents a tert-butoxycarbonylamino or benzoylamino radical,

dissolved in a mixture of ethanol and polysorbate, wherein said ethanol is present in an amount of less than 5% and said polysorbate is present in an amount of less than 5%, said composition being used to form an injectable solution capable of being injected without anaphylactic or alcohol intoxication manifestations being associated herewith.