Controlled release and taste masking oral pharmaceutical composition

  • US 9,592,203 B2
  • Filed: 07/06/2016
  • Issued: 03/14/2017
  • Est. Priority Date: 06/14/1999
  • Status: Active Grant
First Claim
Patent Images

1. A tablet oral formulation for enhancing release of budesonide in the colon, consisting essentially of:

  • a tableted extended release core comprising 9 mg of budesonide, hydroxypropyl cellulose and optionally other excipients, wherein the tableted extended release core is macroscopically homogeneous; and

    a gastro-resistant coating on the tableted extended release core, the gastro-resistant coating comprising a copolymer of methacrylic acid and methyl methacrylate in a 1;

    1 ratio, a copolymer of methacrylic acid and methyl methacrylate in a 1;

    2 ratio, and optionally other excipients to control the release of said budesonide from the solid oral formulation, wherein following oral administration of a single dose to a human, the formulation provides a mean AUC0-t of said budesonide in said human of about 13555.9±

    7816.9 (pg)(hr)/mL in 36 hours.

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