公开(公告)号：EP2203181A4

公开(公告)日：2013-01-16

申请号：EP08840520

申请日：2008-10-16

申请人： BIOCON LTD

发明人： KHEDKAR ANAND ,  RANGAPPA SHARATH KUMAR MALLAPURA ,  SUBRAMANI RAMESH ,  DAVE NITESH ,  RADHAKRISHNAN DEVESH ,  SHANKAR SUNDARESH ,  CHIVUKULA SUDHEER ,  RAMAKRISHNA RANJITH ,  MURTHY SHANMUGAM THANDAVA ,  PAI HARISH VENKATRAMAN ,  SENGUPTA NILANJAN ,  MELARKODE RAMAKRISHNAN ,  IYER HARISH

IPC分类号： A61K9/20 ,  A61K9/16 ,  A61K38/28 ,  A61K47/48

CPC分类号： A61K9/2077 ,  A61K9/1617 ,  A61K9/2013 ,  A61K9/2018 ,  A61K9/2054 ,  A61K38/28 ,  A61K47/542 ,  A61K47/543

摘要： 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.