| 摘要 |
This invention provides oral dosage forms of therapeutic agents such as digestive enzymes which are subject to degradation and loss of activity at gastric pH. and compositions and methods for preparing same. Capsules of their components are formulated from a composition comprising a plastic homogeneous mass of gastric fluid impervious material such as cellulosic derivatives or collagenous material; from 10-65% by weight of a diluent selected from the group consisting of water, a lipid having a melting point above mammalian body temperature and a water miscible solvent; 4-60% by weight of procollagen; and 30-86% by weight of collagen or elastin. The composition is formed into finished capsules of relatively homogeneous composition comprising 10-50% by weight of procollagen and 40-96% by weight of a material selected from the group consisting of collagen and elastin, and having less than 4% by weight of fat and water-soluble protein. Prior art pH dependent enteric coat materials such as cellulose acetate phthalate may be incorporated at a level of 1.0-40%. At time of oral administration, an activator capable of dissolving the capsule wall is allowed to contact the interior surface of the capsule. In the case of cellulosic composition outer walls, cellulose or a non-enzymatic alkaline buffer is applied, and a proteolytic enzyme is employed to dissolve collagenous materials.
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