Controlled release formulations coated with aqueous dispersions of acrylic polymers
AssigneePurdue Pharma L.P.
InventorsBenjamin Oshlack, Mark Chasin, Frank Pedi, Jr.
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Abstract
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.
Claims39
A method for preparing a controlled release formulation comprising:
- preparing a solid substrate comprising a therapeutically active agent,
- overcoating said substrate with an aqueous dispersion of a plasticized water-insoluble acrylic polymer, and
- curing said coated substrate at a temperature greater than the glass transition temperature of the coating for at least 24 hours, until a curing endpoint is reached, at which endpoint said cured coated substrate when subjected to accelerated storage conditions of at least one month at 37° C./80% RH releases an amount of said therapeutically active agent upon in-vitro dissolution which does not vary at any given time point by more than 20% of the total amount of active agent released, when compared to the in-vitro dissolution of said cured coated substrate prior to being subjected to said accelerated storage conditions.
A method for preparing a controlled release formulation, comprising:
- preparing a solid substrate comprising a therapeutically active agent,
- overcoating said substrate with an aqueous dispersion of a plasticized water-insoluble acrylic polymer, and
- curing said coated substrate at a temperature greater than the glass transition temperature of the coating for at least 24 hours, until a curing endpoint is reached, at which endpoint said cured coated substrate when subjected to accelerated storage conditions of at least one month at 37° C./80% RH and at least one month at 37° C./dry releases an amount of said therapeutically active agent upon in-vitro dissolution which does not vary at any given time point by more than 20% of the total amount of active agent released, when compared to the in-vitro dissolution of said cured coated substrate prior to being subjected to said accelerated storage conditions.
A method for preparing a controlled release formulation, comprising:
- preparing a solid substrate comprising a therapeutically active agent,
- overcoating said substrate with an aqueous dispersion of a plasticized water-insoluble acrylic polymer, and
- curing said coated substrate at a temperature greater than the glass transition temperature of the coating for at least 24 hours, until a curing endpoint is reached, at which endpoint said cured coated substrate when subjected to storage conditions of at least one month at 37° C./80% RH and at least one month at room temperature releases an amount of said therapeutically active agent upon in-vitro dissolution which does not vary at any given time point by more than 20% of the total amount of active agent released, when compared to the in-vitro dissolution of said cured coated substrate prior to being subjected to said accelerated storage conditions.
Dependencies are inferred from the claim text.