초록 ▼

Disclosed are gastric acid-resistant polymer-coated, buffered digestive enzymes/ursodeoxycholate compositions, process for their preparations and methods for treating digestive disorders, pancreatic enzyme insufficiency, impaired liver function, and cystic fibrosis for regulating the absorption of d

Disclosed are gastric acid-resistant polymer-coated, buffered digestive enzymes/ursodeoxycholate compositions, process for their preparations and methods for treating digestive disorders, pancreatic enzyme insufficiency, impaired liver function, and cystic fibrosis for regulating the absorption of dietary iron and cholesterol, and for dissolving gallstones by administering the compositions to a mammal in need of such treatment.

대표청구항 ▼

A buffered digestive enzyme/bile salt composition for the treatment of digestive enzyme/bile salt deficiency of mammals comprising, by weight per weight percentages based on the total weight of the composition: a) from about 10 to about 90.0% of a concentrate of an enzyme selected from the group con

A buffered digestive enzyme/bile salt composition for the treatment of digestive enzyme/bile salt deficiency of mammals comprising, by weight per weight percentages based on the total weight of the composition: a) from about 10 to about 90.0% of a concentrate of an enzyme selected from the group consisting of pancreatic proteases, pancreatic lipases, pancreatic nucleases and pancreatic amylases; b) from about 0.3 to about 75% of a bile salt in powder form; c) from about 7.35 to about 40.50% of a buffering agent selected from the group consisting of anhydrous sodium carbonate, sodium bicarbonate, potassium carbonate, ammonium carbonate, tromethamine, di(tris(hydoxymethyl)aminomethane) carbonate, tris-glycine, di-arginine in the molecular weight range of 350 to 50,000 daltons, tri-arginine in the molecular weight range of 350 to 50,000 daltons, poly-arginine in the molecular weight range of 350 to 50,000 daltons, di-lysine in the molecular weight range of 290 to 15,000 daltons, tri-lysine in the molecular weight range of 290 to 15,000 daltons, poly-lysine in the molecular weight range of 290 to 15,000 daltons, diethylamine and triethanolamine; d) from about 0.9 to about 16% of a disintegrant selected from the group consisting of starch, modified starches, microcrystalline cellulose and propylene glycol alginate; e) from about 0.3 to about 15.0% of an adhesive polymer selected from the group consisting of hydroxypropyl cellulose, polyvinylpyrrolidone, cellulose acetate phthalate, methyl cellulose and propylene glycol alginate; and f) from about 7.0 to about 15% of an non-porous, gastric acid-resistant and pharmaceutically acceptable polymer-coating which contains from about 0.2 to about 2% talc and which is insoluble in the pH range of from about 1.5 to about 5 but is soluble in the pH range of from about 5.5 to about 9.