Abstract: An oral delivery system based on in situ forming protein/polysaccharide coacervates is described herein. The system comprises an active ingredient dispersed in a dry, homogenous powder mixture of a protein powder and a polysaccharide powder, which is able to form a protein/polysaccharides complex coacervate in situ upon immersion in gastric fluid, thereby conferring gastric protection and/or modified-release to the active ingredient. Varying the ratio of protein powder to polysaccharide powder in the oral delivery system varies the level of gastric protection and/or rate of release to the active ingredient. The ability of the system described herein to be based on natural and/or naturally-derived biopolymers provides commercial advantages in terms of regulatory approval and/or growing consumer demand for such products.

Abstract: An oral delivery system based on in situ forming protein/polysaccharide coacervates is described herein. The system comprises an uncoacervated, dry homogenous mixture comprising a protein powder, a polysaccharide powder, and an active ingredient dispersed therein, wherein the polysaccharide powder has a Carr compressibility index greater than 25% to enable the protein and polysaccharide powders to form a protein/polysaccharide complex coacervate in situ upon immersion of the oral delivery system in a gastric fluid, thereby conferring gastric protection and/or modified release to the active ingredient.

Abstract: The use of chemically modified proteins as enteric or gastroresistant coatings for oral dosage forms containing an active ingredient is described. Typical enteric coatings are made from synthetic polymers and function by acting as a barrier to gastric medium penetration. In some cases, the manufacture of such coatings requires the use of hazardous chemicals and the safety of some of the synthetic polymers that have been used in enteric coatings have been questioned. Protein-based enteric coatings of the present description present a more natural alternative to enteric coatings produced from synthetic polymers to provide gastroresistance to oral dosage forms. Protein-based film-forming solutions and uses thereof in coating oral dosage forms are also provided.