Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone

• US 20070117829A1
• Filed: 01/16/2007
• Published: 05/24/2007
• Est. Priority Date: 03/30/2004
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Euroceltique SA
• Inventors: Hong, Qi, Kyle, Donald, Chapman, Robert, Kupper, Robert, Rider, Lonn
• Granted Patent: US 7,683,072 B2
• Time in Patent Office: Days
• US Class Current: 514/282
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: C07D 489/02 with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
• CPC Class Codes: C07D 489/04 Salts; Organic complexes
• CPC Class Codes: C07D 489/08 Oxygen atom

Abstract

In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.

Claims

1-70. -70. (canceled)

71. An oxycodone hydrochloride composition having a 14-hydroxycodeinone level in an amount of less than 25 ppm.

72. The oxycodone hydrochloride composition of claim 71, having a 14-hydroxycodeinone level in an amount of less than 15 ppm.

73. The oxycodone hydrochloride composition of claim 71, having a 14-hydroxycodeinone level in an amount of less than 10 ppm.

74. The oxycodone hydrochloride composition of claim 71, having a 14-hydroxycodeinone level in an amount of less than 5 ppm.

75. The oxycodone hydrochloride composition of claim 71, having a lower limit of 0.25 ppm 14-hydroxycodeinone.

76. The oxycodone hydrochloride composition of claim 71, having a lower limit of 0.5 ppm 14-hydroxycodeinone.

77. The oxycodone hydrochloride composition of claim 71, having a lower limit of 1 ppm 14-hydroxycodeinone.

78. The oxycodone hydrochloride composition of claim 71, having a lower limit of 2 ppm 14-hydroxycodeinone.

79. The oxycodone hydrochloride composition of claim 71, having a lower limit of 5 ppm 14-hydroxycodeinone.