Process for purification of solvents useful in the preparation of pharmaceutical compositions
AssigneeBen Venue Laboratories, Inc.
InventorPhillip J. Anevski
Life of this patent
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Abstract
A process for purifying a non-ionic surfactant or solvent capable of dispersing and solubilizing a pharmaceutical compound. In the process, a solution of solvent and alcohol is contacted with an activated carbon column and an ion exchange resin column. The process is particularly adapted to the purification of polyethoxylated castor oils. The purified solvent is useful in the preparation of pharmaceutic compositions having enhance shelf life, such as for use with paclitaxel.
Claims28
A process for purifying a non-ionic solvent comprising the steps of:
- (a) forming a solution of said solvent and alcohol;
- (b) contacting the solution with activated carbon;
- (c) contacting the solution with an ion exchange resin;
- and
- (d) evaporating residual water and alcohol;
- whereby said solvent is adapted to produce a stabilized pharmaceutical composition.
A process for purifying a polyoxyl 35 castor oil solvent comprising contacting the solvent with activated carbon and contacting the solvent with an ion exchange resin in an amount and for a duration sufficient to produce the polyoxyl 35 castor oil having a specific gravity of between about 1.05 and 1.06, a viscosity of between about 650 and 850 cps, an acid value of not more than about 2.0, a hydroxyl value of between about 65 and 80, an Iodine value of between about 25 and 35, a saponification value of between about 60 and 75, not more than about 15 ppm potassium, and not more than about 3.0% water, whereby said solvent is adapted to produce a stabilized pharmaceutical composition.
A process for purifying a polyoxyl 35 castor oil solution comprising contacting the solution with activated carbon and contacting the solution with an ion exchange resin in an amount and for a duration sufficient to produce a polyoxyl 35 castor oil adapted to produce, when combined with paclitaxel, a pharmaceutical composition comprising at least about 90% of the initial amount of paclitaxel after being stored at 40° C. for ninety days upon admixture therewith.
A process for purifying a non-ionic solvent comprising the steps of:
- (a) contacting the solvent with activated carbon;
- (b) contacting the solvent with an ion exchange resin;
- and
- whereby said solvent is adapted to produce a stabilized pharmaceutical composition.
A process for purifying a polyethoxylated castor oil comprising the steps of
- a.) forming a solution of the polyethoxylated castor oil and an alcohol;
- b.) adsorbing water and unsaturated aliphatic and aromatic compounds from said solution;
- c.) exchanging anions and cations other than H+ and OH− from said solution with H+ and OH−;
- and
- d.) evaporating said alcohol from said solution.
A process for purifying a polyethoxylated castor oil comprising exchanging carboxylate anions from the castor oil with OH− wherein said carboxylate anions are removed from the castor oil whereby the castor oil is adapted to produce a stabilized pharmaceutical composition.
A process for stabilizing a pharmaceutical composition comprising a solvent containing a polyethoxylated castor oil having carboxylate anions and a pharmaceutical agent, said method comprising the steps of exchanging carboxylate anions from the polyethoxylated castor oil with OH−;
- and dissolving the pharmaceutical agent in the castor oil to produce the stabile pharmaceutical composition.
Dependencies are inferred from the claim text.