R.p. Scherer Corporation

Bernd Stockebrand

Peter C Schmidt

Gerhard Fischer

A pharmaceutical preparation having an active substance of low solubility in water and gastric juices that has an initially liquid carrier system consisting of a hydrophilic component, a hydrophobic component and a solubilizer. The solvent mixture contains 9 to 90 parts by weight of solubilizer and 90 to 5 parts by weight of a hydropholic component, such as polyethylene glykol, 1,2-propylene glykol, 1,3-butanediol, 1,4-butanediol, 1,2-propanediol, glycerol, mannitol, sorbitol or polyoxyethylene polyoxypropylene copolymerisate or mixtures of such substances, and 40 to 1 parts by weight of an oleophilic component, such as natural and/or semisynthetic vegetable or animal oils or synthetic oils, such as neutral oil or waxes. The active substance is dissolved in the carrier system or dispersed in a stable way and for an oral application, is filled into drug capsules made of gelatine. In order to achieve a delayed release of the active substance (delayed-action effect), an adjuvant that is soluble in the carrier system is also added to the carrier system in the amount of up to 10 parts by weight, preferably 2 to 5 parts by weight that, after the dissolving of the capsule wall, develops in contact with the gastric juices a renewing permeable membrane. Suitable adjuvants are ethylcellulose, cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate and vinylacetate crotonic acid copolymers or mixtures thereof.

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Monchen-Gladbach, Germany

Bernd Stockebrand