Stabilized pharmaceutical composition
AssigneeDabur Research Foundation
InventorsRama Mukherjee, Arnand C. Burman, Dhiraj Khattar, Mukesh Kumar
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Abstract
A stabilized pharmaceutical composition of anticancer drug and a solvent like dehydrated alcohol is disclosed. A method is disclosed that includes the addition of a stabilizing agent Malic acid having a unique triple action property of being an antioxidant, a chelating agent and an acidifying agent. Compositions prepared using this pre-treated dehydrated alcohol enhance the stability of paclitaxel in alcohol. A method of removing ionic, metallic and oxidizing impurities from alcohol using ion exchange and clay treatment is also disclosed.
Claims34
A stabilized pharmaceutical composition comprising an antineoplastic compound and a solvent capable of solubilizing said antineoplastic compound comprising alcohol that has been stabilized by the addition/treatment of/with a stabilizing agent.
A stabilized pharmaceutical composition comprising an antineoplastic compound selected from the group consisting of teniposide, paclitaxel, camptothecin, and derivatives thereof and a solvent comprising an alcohol that has been stabilized by the addition of malic acid or citric acid.
A method for the preparation of a stabilized pharmaceutical composition which comprises adding to an antineoplastic compound, a solvent comprising of an alcohol that has been stabilized by the addition/treatment of/with a stabilizing agent.
A kit suitable for bedside reconstitution comprising two distinct containers, ampoules, a dual chamber syringe, or vials one of which contains paclitaxel solution in a solvent consisting of a dehydrated alcohol that has been, optionally pre-treated to reduce metallic, ionic and oxidative impurities by complexation, absorption, removal or neutralization of impurities or stabilized by the addition of a stabilizing agent and the other container, ampoule, chamber, vial containing a solubilizer such as a concentrate/combination of excipients for keeping the drug in solution when mixed together with a clinically acceptable aqueous dilution fluid for infusion.
Dependencies are inferred from the claim text.