METHODS AND COMPOSITIONS FOR ORAL ADMINISTRATION OF PROTEIN AND PEPTIDE THERAPEUTIC AGENTS

摘要

The present invention provides a pharmaceutical composition formulated for oral delivery, comprising a particulate non-covalently associated mixture of pharmacologically inert silica nanoparticles having a hydrophobic surface, a polysaccharide, and a biologically active protein or peptide suspended in an oil. The present invention further provides methods of manufacturing same and therapeutic methods utilizing same for oral delivery of a therapeutic protein or peptide.

主权项

1. An oral pharmaceutical composition, comprising an oil having particulate matter suspended therein, wherein the composition is not an emulsion and the particulate matter comprises:
a. a polysaccharide in non-covalent association with silica nanoparticles having a hydrophobic surface, wherein the size of the silica nanoparticles is between 1-100 nanometers and wherein the weight of the polysaccharide is at least twice that of the silica nanoparticles; and b. a protein or peptide having therapeutic activity, non-covalently associated with said silica nanoparticles and the polysaccharide.