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US 9,309,257 B2Granted
Preparation of oxycodone base form 14-hydroxycodeinone sulfate
AssigneeCody Laboratories, Inc.
InventorsZinovy Itov, Vladimir F. Kuznetsov, Iouri Voitsekhovski
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Abstract
Synthetic methods are provided for preparation of oxycodone and salts thereof with an improved impurity profile. Thebaine is converted to 14-hydroxycodeinone sulfate intermediate to minimize a 7,8-dihydro-8,14-dihydroxycodeinone impurity. Efficient methods for conversion of oxycodone base to oxycodone hydrochloride are provided to minimize 14-hydroxycodeinone impurity in the final product.
Claims20
A method for preparation of oxycodone base from isolated 14-hydroxycodeinone hemisulfate dihydrate comprising
- providing isolated 14-hydroxycodeinone hemisulfate dihydrate;
- mixing the isolated 14-hydroxycodeinone hemisulfate dihydrate in water or aqueous acetic acid with calcium acetate or barium acetate to prepare a 14-hydroxycodeinone acetate solution;
- reducing the 14-hydroxycodeinone acetate solution in the presence of a catalyst and hydrogen and/or a hydrogen transfer agent to form oxycodone acetate solution;
- basifying the oxycodone acetate solution;
- and
- isolating oxycodone base.
3 more elements
Dependencies are inferred from the claim text.