Alex Yu, Jason R Baker, Ann F Fioritto, Ying Wang, Ruijuan Luo, Siwei Li, Bo Wen, Michael Bly, Yasuhiro Tsume, Mark J Koenigsknecht, Xinyuan Zhang, Robert Lionberger, Gordon L Amidon, William L Hasler, Duxin Sun
As an orally administered, locally acting gastrointestinal drug, mesalamine products are designed to achieve high local drug concentration in the gastrointestinal (GI) tract for the treatment of ulcerative colitis. The aim of this study was to directly measure and compare drug dissolution of three mesalamine formulations in human GI tract and to correlate their GI concentration with drug concentration in plasma. Healthy human subjects were orally administered Pentasa, Apriso, or Lialda. GI fluids were aspirated from stomach, duodenum, proximal jejunum, mid jejunum, and distal jejunum regions...
February 6, 2017: Molecular Pharmaceutics