Solid pharmaceutical preparations containing copolymers based on polyethers combined with poorly water-soluble polymers
AssigneeBASF SE
InventorsKarl Kolter, Dejan Djuric, Stefan Fischer
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Abstract
Dosage forms comprising preparations of slightly water-soluble active substances in a polymer matrix of polyether copolymers, the polyether copolymers being obtained by free radical polymerization of a mixture of from 30 to 80% by weight of N-vinyllactam, from 10 to 50% by weight of vinyl acetate and from 10 to 50% by weight of a polyether, and of at least one slightly water-soluble polymer in which the slightly water-soluble active substance is present in amorphous form in the polymer matrix.
Claims11
A dosage form comprising preparations of slightly water-soluble active substances in a polymer matrix comprising:
- a polyether copolymer and at least one slightly water-soluble polymer,
- the polyether copolymer being obtained by free radical polymerization of a mixture of from 30 to 80% by weight of N-vinyllactam, from 10 to 50% by weight of vinyl acetate and from 10 to 50% by weight of a polyether,
- the slightly water-soluble active substance being present in amorphous form in the polymer matrix, and
- wherein the preparations remain amorphous after storage for 6 months at 30° C./70% relative humidity;
- and
- wherein the slightly water-soluble polymer are selected from the group consisting of:
- polymers based on acrylic acid, methacrylic acid, or mixtures thereof, or esters thereof;
- homo- and copolymers of vinyl acetate;
- and ethylcelluloses.
A process for the production of preparations for dosage forms of slightly water-soluble active substances in a polymer matrix comprising:
- embedding the slightly water-soluble active substances in amorphous form in the polymer matrix based on a polyether copolymer of from 30 to 80% by weight of N-vinyllactam, from 10 to 50% by weight of vinyl, acetate and from 10 to 50% by weight of a polyether;
- incorporating at least one slightly water-soluble polymer into the polymer matrix;
- and
- mixing the polyether copolymer and the polymer matrix thoroughly with the slightly water-soluble active substances;
- wherein the preparations remain amorphous after storage for 6 months at 30° C./70% relative humidity, and
- wherein the slightly water-soluble polymer are selected from the group consisting of:
- polymers based on acrylic acid, methacrylic acid, or mixtures thereof, or esters thereof;
- homo- and copolymers of vinyl acetate;
- and ethylcelluloses.
Dependencies are inferred from the claim text.