Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone

  • US 7,674,799 B2
  • Filed: 01/16/2007
  • Issued: 03/09/2010
  • Est. Priority Date: 03/30/2004
  • Status: Active Grant
First Claim
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1. An oral dosage form comprising particles, the particles comprising from about 5 mg to about 320 mg oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from 8α

  • ,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride, said particles being coated with an amount of hydrophobic material effective to provide a sustained release of the oxycodone hydrochloride when the coated particles are exposed to an aqueous solution.

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