(EN)
The invention relates to improvised pharmaceutical compositions permitting
ingestion via oral
delivery of proteins/peptides or their conjugates, and/or cation-insulin
conjugate complexes
demonstrating desirable pharmacokinetic profiles and potency in efficacy
models of diabetes in dogs and
humans. A preferred formulation comprises 0.01% - 20% w/w of insulin, insulin
compound conjugates
and/or cation insulin conjugates, 10% - 60% w/w of one or more fatty acid
components selected from
saturated or unsaturated C4-C12 fatty acids and/or salts of such fatty acids
and additionally contains
optimal amounts of other pharmaceutically suitable polymer excipients which
permit improved solubility,
dissolution rate and effective bioavailability of poorly water soluble
compositions and consistent in-vivo
release profiles upon scalability during manufacture . A further aspect of the
invention features the
process of preparing the aforesaid formulations.