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Controlled release formulations coated with aqueous dispersions of acrylic polymers
| Details |
Inventors: Oshlack, Benjamin; Chasin, Mark; Pedi, Jr., Frank;
Assignee: Purdue Pharma LP (Stamford, CT)
Primary Examiner: Wang; Shengjun
Assistant Examiner:
Attorney, Agent or Firm: Davidson Davidson and Kappel, LLC
A stable solid controlled release formulation having a coating derived from an aqueous dispersion of a hydrophobic acrylic polymer includes a substrate including an active agent selected from the group consisting of a systemically active therapeutic agent, a locally active therapeutic agent, a disinfecting and sanitizing agent, a cleansing agent, a fragrance agent and a fertilizing agent, overcoated with an aqueous dispersion of the plasticized water-insoluble acrylic polymer. The formulation provides a stable dissolution of the active agent which is unchanged after exposure to accelerated storage conditions. |
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DETAILED DESCRIPTION It is therefore an object of the present invention to provide a controlled release formulation of a substrate comprising an active agent, e.
g.
a therapeutically active agent, a disinfecting agent, a cleansing agent, a sanitizing agent and a fertilizing agent, coated with an aqueous dispersion of a hydrophobic acrylic polymer such that there is a stable dissolution or other release profile of the active agent when placed in an environment of use, despite exposure to a variety of storage conditions, including accelerated storage conditions.
It is another object of the present invention to provide a controlled release formulation comprising a plurality of inert beads comprising an active agent, and a controlled release tablet comprising a core containing an active agent, the beads or tablet core being coated with an aqueous dispersion of a hydrophobic polymer and providing a reproducible, stable dissolution despite exposure to accelerated storage conditions, as well as a method of preparing the same.
Still another object of the present invention is to provide a controlled release formulation comprising a substrate containing an active agent coated with an aqueous dispersion of a hydrophobic polymer which upon dissolution in-vitro provides a band range, when comparing the dissolution profile of the formulation after exposure to a variety of storage conditions including "stressed" or accelerated storage conditions, which is not wider than about 15% of total active agent released at any point of time during the dissolution.
A further object of the present invention is to provide a controlled release formulation wherein the controlled release is caused by a coating on the formulation of an aqueous dispersion of a hydrophobic polymer such as an acrylic polymer which coating provides a stable dissolution of an active agent contained in the formulation, despite exposure to accelerated storage conditions such that the dissolution would be deemed acceptable by a governmental regulatory agency such as the U
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Gene Therapy 
