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Controlled release hydrocodone formulations

  • US 9,056,107 B1
  • Filed: 03/02/2015
  • Issued: 06/16/2015
  • Est. Priority Date: 10/29/1999
  • Status: Expired due to Fees
First Claim
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1. A solid oral controlled-release dosage form comprising a pharmaceutically acceptable capsule or tablet comprising:

  • multiparticulates comprising (i) a material selected from the group consisting of gums, alkylcelluloses, acrylic polymers, waxes, shellac, oils and mixtures thereof, and (ii) a pharmaceutically acceptable salt of hydrocodone selected from the group consisting of bitartrate salts of hydrocodone, hydrocodone hydrochloride, hydrocodone p-toluenesulfonate, hydrocodone phosphate, hydrocodone thiosemicarbazone, hydrocodone sulfate, hydrocodone trifluoroacetate, hydrocodone hemipentahydrate, hydrocodone pentafluoropropionate, hydrocodone p-nitrophenylhydrazone, hydrocodone o-methyloxime, hydrocodone semicarbazone, hydrocodone hydrobromide, hydrocodone mucate, hydrocodone oleate, hydrocodone phosphate dibasic, hydrocodone phosphate monobasic, hydrocodone acetate trihydrate, hydrocodone bis(heptafuorobutyrate), hydrocodone bis(methylcarbamate), hydrocodone bis(pentafluoropropionate), hydrocodone bis(pyridine carboxylate), hydrocodone bis(trifluoroacetate), hydrocodone chlorhydrate, and hydrocodone sulfate pentahydrate,wherein at least some of the multiparticulates are coated with a coating comprising an alkylcellulose, an acrylic polymer, or a mixture thereof,the total amount of the pharmaceutically acceptable salt of hydrocodone in the dosage form is equivalent to from about 0.5 mg to about 1250 mg of hydrocodone, andthe dosage form after a first administration to a human providesa plasma concentration of hydrocodone of at least 8 ng/ml at from about 2 to about 8 hours after administration and a plasma concentration of hydrocodone of at least 6 ng/ml at about 12 hours after administration, based on oral administration of a dosage form containing 15 mg hydrocodone bitartrate,a C12/Cmax hydrocodone ratio of 0.55 to 0.85, anda therapeutic effect for at least about 12 hours.

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