Patent ID: 8802087

Claim:
A pharmaceutical composition for oral administration as a solid dosage form, comprising an active pharmaceutical agent and a surfactant system, which is self-emulsifiable on contact with a hydrophilic phase and a lipophilic phase, said composition comprising: (i) an active pharmaceutical agent which (a) is an enzyme or an enzyme mixture with at least lipolytic activity which exerts its action in the gastrointestinal tract, and (b) is admixed with a surfactant system to form the pharmaceutical composition wherein the pharmaceutical composition does not contain an enteric coating and does not contain any lipophilic active substances to be absorbed into the bloodstream; and (ii) wherein the surfactant system comprises a. a surfactant in an amount of 2% to 90% by weight of the surfactant system selected from either a first group or an ionic surfactant, wherein the first group consists of: polyethylene glycol fatty acid mono-esters and/or di-esters with aliphatic C 6 -C 22 carboxylic acids; polyethylene glycol glycerol fatty acid esters with aliphatic C 6 -C 22 carboxylic acids; polyethylene glycol alkyl mono-ethers and/or di-ethers with aliphatic C 12 -C 18 alcohols, and mixtures of the foregoing; and wherein the ionic surfactant is selected from the group consisting of: lecithin, lysolecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidylserine, lysophosphatidylcholine, lysophosphatidylethanolamine, lysophosphatidylglycerol, lysophosphatidylinositol, lysophosphatidic acid, lysophosphatidylserine, and mixtures of the foregoing; b. a co-surfactant in an amount of 5% to 60% by weight of the surfactant system, selected from a group consisting of monoacylglycerides with aliphatic C 6 -C 22 carboxylic acids, monoethers of glycerol ethers with aliphatic C 12 -C 18 alcohols, partial esters of propylenglycol with aliphatic C 6 -C 22 carboxylic acids, partial esters of polyglycerol with aliphatic C 6 -C 22 carboxylic acids, and mixtures of the foregoing; and c. a lipophilic phase in an amount of 0% to 70% by weight of the surfactant system, represented by diacylglyerides and/or triacylglycerides with aliphatic C 6 -C 22 carboxylic acids; wherein the surfactant system comprises 10% to 95% by weight of the pharmaceutical composition.