| abstract |
The present invention can ingest proteins / peptides or their conjugates and / or cation-insulin conjugate complexes by oral delivery that exhibit desirable pharmacokinetic profiles and efficacy in diabetes efficacy models in dogs and humans, It relates to an instant pharmaceutical composition. Preferred formulations are 0.01% (w / w) to 20% (w / w) insulin, insulin compound conjugate and / or cationic insulin conjugate, 10% (w / w) to 60% (w / w) ) Saturated or unsaturated C4 to C12 fatty acids and / or one or more fatty acid components selected from salts of such fatty acids, and the solubility, elution rate and effective bioavailability of the poorly water soluble composition It further contains an optimal amount of other pharmaceutically suitable polymer excipients that can be improved and can stabilize the release profile in vivo as production scales. A further aspect of the invention features a process for producing the above-described formulation. |