Injectable composition

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

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A01D 4302, C07D30514

Patent

active

057338884

ABSTRACT:
A pharmaceutical formulation of taxol and polyethoxylated castor oil is disclosed to be relatively acidified to a pH of less than 8.1 and preferably within a pH range of 5 to 7, inclusively, by an acidifying agent. 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 mixing an acid with 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. A variety of acidifying agents, a preferred one being anhydrous citric acid, are described.

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Richheimer, Steven L., David M. Tinnermeier and Daniel W. Timmons (1992) "High-Performance Liquid Chromatographic Assay Of Taxol" Anal. Chem. 64:2323-2326.
Ringel, Israel, Susan Band Horwitz (1987) "Taxol is Converted to 7-Epitaxol, a Biologically Active Isomer, in Cell Culture Medium" Journal of Pharmacology and Experimental Therapeutics 242(1)692-698.
Kingston, David G. I. (1991) "The Chemistry of Taxol" Pharmac. Ther. 52:1-34.
Kingston, David, G. I., Neal F. Magri, Chote Jitrangsri (1986) "Synthesis And Structure-Activity Relationships of Taxol Derivatives As Anticancer Agents" Studies In Organic Chemistry 26:219-235.
Magri, Neal F. and David G.I. Kingston (1986) "Modified Taxols. 2. Oxidation Products of Taxol" Journal of Org. Chem. 51:797-802.
Stability, compatability, and plasticizer extraction of taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers, Reports Taxol, vol. 48, Jul. 1991 by Wanda N. Waugh, Lawrence A. Trissel and Valentino J. Stella.
High-Performance Liquid Chromatographic Assay for Taxol in Human Plasma and Pharmacokinetics in Phase I Trial, Cancer Treatment Reports, vol. 71, No. 1, Jan. 1987 by Stephen M. Longnecker, et al.

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