(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.
(ZH) 本发明涉及即席而发明的药物组合物，该药物组合物允许经由蛋白质/肽或它们的缀合物和/或阳离子?胰岛素缀合复合物的经口递送的摄取，在狗和人的糖尿病效能模型中显示所希望的药代动力学曲线和效力。优选的制剂包含0.01％?20％w/w的胰岛素、胰岛素化合物缀合物和/或阳离子胰岛素缀合物，10％?60％w/w的一种或多种选自饱和或不饱和的C4?C12脂肪酸和/或这种脂肪酸的盐的脂肪酸组分，以及另外包含最佳量的其它药学适当的聚合物赋形剂，所述赋形剂允许实现水溶性差的组合物的改善的溶解度、溶出速率和有效生物利用度以及在生产期间放大时的一致性的体内释放曲线。本发明的另一方面的特征在于制备上述制剂的方法。
