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WE CLAIM:
A controlled-release pharmaceutical dosage form of a^poorly water-soluble or insoluble
drug comprising the solid dispersion of said drug, one or more of controlled-release
material and one or more of pharmaceutically acceptable excipients; wherein the said
solid dispersion comprises the said drug dispersed in polyvinyl caprolactam-polyvinyl
acetate-polyethylene glycol graft copolymer.
2. The controlled-release pharmaceutical dosage form of claim 1, wherein the dosage form
is a matrix-type dosage form or a reservoir-type dosage form.
3. The controlled-release pharmaceutical dosage form of claim 1, wherein the dosage form
is in the form of hard or soft gelatin capsules, tablets, capsules, caplets, pills, granules or
mini-tablets.
4. The controlled-release pharmaceutical dosage form of claim 1, wherein the controlledrelease
material comprises hydrophilic polymers, hydrophobic polymers, water-swellable
polymers, hydrophobic materials, or mixtures thereof
5. The controlled-release pharmaceutical dosage form of claim 4, wherein the amount of
the controlled-release material comprises from about 2% to about 95% by weight of the
dosage form.
6. The controlled-release pharmaceutical dosage form of claim 1, wherein the drug to
polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer ratio
weight by weight may vary from 1:1 to 1:5.
7. The controlled-release pharmaceutical dosage form of claim 1, wherein the
pharmaceutically acceptable excipients comprise one or more of binders, fillers/diluents,
disintegrants, anti-adherents, lubricants/glidants, plasticizers, coloring agents and
flavoring agents.
A process for the preparation of a controlled-release pHpiniaceutical dosage Yorm of a
poorly water-soluble or insoluble drug comprising the solid dispersion of said drug, one
or more of controlled-release material and one or more of pharmaceutically acceptable
excipients; wherein the said solid dispersion comprises said drug dispersed in polyvinyl
caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; and wherein the
process includes combining the solid dispersion, the controlled-release material and
pharmaceutically acceptable excipient and processing into the dosage form using
appropriate toolings.