Controlled Release Dosage Forms
AssigneeValeant International Bermuda
InventorsFang ZHOU, Paul MAES
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Abstract
The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
Claims26
A stable controlled release monolithic coating composition for use in coating a pharmaceutical oral dosage form, said coating comprising:
- a) an aqueous dispersion of a neutral ester copolymer without any functional groups;
- b) a poly glycol having a melting point greater than 55° C., and
- c) one or more pharmaceutically acceptable excipients;
- wherein said coating composition is coated onto said pharmaceutical oral dosage form and cured at a temperature at least equal to or greater than the melting point of said poly glycol.
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A stable controlled release monolithic coating composition for use in coating a pharmaceutical oral dosage form, said coating comprising an aqueous dispersion of Eudragit NE300, polyethylene glycol 8000, hydroxypropyl methylcellulose, talc, simethicone, titanium dioxide, and polyoxyethylene sorbitan mono-oleate, said Eudragit NE300 is present in an amount of from about 1% to about 35% by weight of the coat composition, said polyethylene glycol is present in an amount of from about 0.1% to about 3% by weight of the coat composition, said hydroxypropyl methylcellulose is present in an amount of from about 0.1% to about 6% by weight of the coat composition, said talc is present in an amount of from about 0.1% to about 7% by weight of the coat composition, said simethicone is present in an amount up to about 0.5% by weight of the coat composition, said polyoxyethylene sorbitan mono-oleate is present in an amount of up to about 0.5% by weight of the coat composition, said titanium dioxide is present in an amount of from about 0% to about 2% by weight of the coat composition;
- and composition is coated onto said pharmaceutical oral dosage form and cured at a temperature at least equal to or greater than the melting point of said polyglycol.
A controlled release oral dosage form comprising:
- a) a core, wherein said core comprises:
- i) an effective amount of at least one therapeutically active agent, and
- ii) one or more first pharmaceutically acceptable excipients, and
- b) a stable controlled release monolithic coating composition for coating said core, said coating composition comprising:
- i) an aqueous dispersion of a neutral ester copolymer without any functional groups;
- ii) a poly glycol having a melting point greater than 55° C., and
- iii) one or more second pharmaceutically acceptable excipients;
- wherein said coating composition is coated onto said core and cured at a temperature at least equal to or greater than the melting point of the poly glycol.
Dependencies are inferred from the claim text.