초록 ▼

The novel diclofenac preparation with controlled release is in the form of pellets. The active ingredient, applied to inert pellets, is coated with a membrane layer which contains, in addition to 35-65% by weight of a water-insoluble polymer, 5-20% by weight of at least one water-soluble and/or wate

The novel diclofenac preparation with controlled release is in the form of pellets. The active ingredient, applied to inert pellets, is coated with a membrane layer which contains, in addition to 35-65% by weight of a water-insoluble polymer, 5-20% by weight of at least one water-soluble and/or water-insoluble pore-forming agent and 20-50% by weight of adjuncts. The pore-forming agents permit a very uniform release of diclofenac such that administration twice a day is sufficient. A film coating resistant to gastric juice is applied over the membrane layer.

대표청구항 ▼

[ What is claimed is:] [1.] A pelleted oral drug preparation comprising:an active ingredient layer including an active ingredient consisting of diclofenac or one of its salts, with controlled release of the active ingredient, the active ingredient layer surrounding an inert pellet;an inner diffusion

[ What is claimed is:] [1.] A pelleted oral drug preparation comprising:an active ingredient layer including an active ingredient consisting of diclofenac or one of its salts, with controlled release of the active ingredient, the active ingredient layer surrounding an inert pellet;an inner diffusion membrane layer absent water-soluble cellulose derivatives containing(i) 35-65% by weight of a pH independent water-insoluble polymer,(ii) 5-20% by weight of at least one pore-forming agent, and(iii) 20-50% by weight of adjuncts, rein said inner diffusion membrane layer surrounds said active ingredient layer and further wherein said inner diffusion membrane layer is built to determine the release of said active ingredient; andan outer film coating resistant to gastric juice, the film coating surrounding said inner diffusion membrane layer and comprising 5-20% by weight based on the final pellet, wherein said film coating is soluble above a pH of 5.5, said film coating further comprising at least one acid insoluble polymer and adjuncts, the at least one acid insoluble polymer selected from the group consisting of methacrylic acid/methacrylic acid ester copolymers, methacrylic acid/acrylic acid ester copolymers, carboxy methyl ethyl cellulose, cellulose acetate phthalate, and mixtures thereof.