07. October 2017
SYN-004 (ribaxamase) delayed release drug product is a multi-particulate, hard capsule for oral delivery of a recombinant β-lactamase enzyme designed to degrade β-lactam antibiotics administered intravenously, and thus prevent colon dysbiosis. Here we describe the development of the SYN-004 enteric coated pellet formulation, which has been tested in multiple clinical trials. Since the SYN-004 drug substance is a buffered liquid, several binder excipients in different ratios were tested to...
10. July 2016
Abstract: The aim of the present study was to design a new pH–enzyme double-dependent mesalamine colon-specific delivery system. The drug release behaviors in vitro and pharmacokinetics and biodistribution in vivo were further evaluated. The mean particle diameters of mesalamine-coated microparticles were 312.2 μm. In vitro, a small amount of mesalamine was released in HCl at a pH of 1.2 and PBS medium at a pH of 7.4 for 5 hours, and 71% of the entrapped mesalamine was further released...
15. March 2016
The objective of this study was to develop a dry powder coating technique applied to colon targeting tablets containing metronidazole (MET) by using a pan coater. The coating formulation consisted of a polymer mixture (pectin/HPMC) and plasticizer (dibutyl phthalate). Dissolution rate of MET was conducted at pH 1.2, 7.4 and 6.8 in the presence of pectinolytic enzyme. The lag time release of MET was simultaneously controlled by enzyme signal in colonic medium and coating level. There was a...