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CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION WITH RESISTANCE AGAINST THE INFLUENCE OF ETHANOL EMPLOYING A COATING COMPRISING NEUTRAL VINYL POLYMERS AND EXCIPIENTS

  • US 20120045506A1
  • Filed: 03/18/2009
  • Published: 02/23/2012
  • Est. Priority Date: 03/18/2009
  • Status: Active Grant
First Claim
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1. A controlled release pharmaceutical composition, comprising a core comprising a pharmaceutical active ingredient,wherein:

  • the core is coated with a coating layer, which confers ethanol resistance to a release profile of the pharmaceutical active ingredient under in-vitro conditions at pH 1.2 and at pH 6.8 in a buffered medium;

    wherein ethanol resistance means that the release profile is not accelerated by more than 20% and is not delayed by more than 20% under the influence of a 40% ethanol-containing medium in comparison to a release profile of a medium without ethanol;

    the coating layer comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipients portion b);

    the polymeric portion a) consists of a water insoluble, essentially neutral vinyl polymer or copolymer; and

    the excipients portion b) is at least one excipient selected from group consisting of;

    100 to 250% by weight of a non-porous inert lubricant;

    1 to 35% by weight of a cellulosic compound;

    0.1 to 25% by weight of an emulsifier; and

    0.1 to 30% by weight of a plasticizer.wherein the percent (%) by weight of the at least one excipient is based on the dry weight of the polymeric portion a).

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