Manufacturing and purification technology for high purity Propofol
OwnerNandkumar Kashinath Chodankarinventor
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Abstract
A process for manufacturing Pure Propofol with a purity of more than 99.90% is disclosed, said process comprising dissolving Crude Propofol in a solvent in which it is soluble to form a solution, treating the solution with aqueous alkali to form an aqueous alkali layer and a solvent layer, separating the aqueous alkali layer from the solvent layer using a phase separation technique, distilling off the solvent from the solvent layer, and distilling a residue of the solvent containing Propofol using steam or boiling water in a presence of dilute alkali and antioxidant like metabisulfite, under normal pressure or mild vacuum.
Claims19
A process for manufacturing a substantially pure Propofol from a Crude Propofol, said Crude Propofol comprising Propofol and phenolic impurities, said process comprising:
- i. adding an aqueous alkali to the Crude Propofol thereby forming a mixture comprising the Crude Propofol and the aqueous alkali;
- ii. doing a steam-distillation and/or co-distillation of the mixture with boiling water at normal atmospheric pressure to provide a bi-phasic distillate comprising an oily liquid layer of distilled Propofol and an aqueous layer;
- and
- iii. separating the oily liquid layer of the distilled Propofol;
- wherein the process comprises at least decarboxylation to provide the Crude Propofol;
- wherein the process excludes the presence of an inert atmosphere during the addition of the alkali to the crude Propofol;
- wherein the phenolic impurities in the Crude Propofol form alkali salts under alkaline condition and the alkali salts of the phenolic impurities do not distill with a-steam or with boiling water;
- wherein Propofol in the Crude Propofol does not form the alkali salt under alkaline condition and Propofol distills with the steam or with boiling water to provide the distilled Propofol;
- and
- wherein, during distillation, the protects the steam distilled Propofol from oxidation.
A process for manufacturing a substantially pure Propofol from a Crude Propofol, said Crude Propofol comprising Propofol and phenolic impurities, said process comprising:
- i. adding an alkali to the Crude Propofol thereby forming a mixture comprising the Crude Propofol and the alkali;
- ii. doing a steam-distillation and/or co-distillation of the mixture with boiling water at normal atmospheric pressure to provide a bi-phasic distillate comprising an oily liquid layer of a steam-distilled Propofol and an aqueous layer;
- iii. doing phase separation of the bi-phasic distillate wherein the oily liquid layer of the distilled Propofol is separated from the aqueous layer using a phase separation technique;
- iv. removing any remaining water in the oily liquid layer of the distilled Propofol using a dehydrating agent;
- and
- v. filtering the oily liquid layer of the distilled Propofol through an ultra-fine micron filter;
- wherein the process comprises at least decarboxylation to provide the Crude Propofol;
- wherein the process excludes the presence of an inert atmosphere during the addition of the alkali to the crude Propofol;
- wherein the phenolic impurities in the Crude Propofol form alkali salts under alkaline condition and the phenolic impurities do not distil with a steam;
- wherein Propofol in the Crude Propofol does not form the alkali salt under alkaline condition and Propofol distils with the steam to provide the distilled Propofol;
- and
- wherein, during distillation, the steam protects the distilled Propofol from oxidation.
Dependencies are inferred from the claim text.