Title
Development and potential application of an oral ColoPulse infliximab tablet with colon specific release: A feasibility study
Author
Jacoba M. Maurer, Susan Hofman, Reinout C.A. Schellekens, Wouter F. Tonnis, Annelien O.T. Dubois, Herman J. Woerdenbag, Wouter L.J. Hinrichs, Jos G.W. Kosterink, Henderik W. Frijlink
Year
2016
Journal
Internation Journal of Pharmaceutics
Abstract
The monoclonal antibody infliximab is one of the cornerstones in the treatment of Crohn’s disease. Local delivery of infliximab would be an alternative to overcome the inherent disadvantages of intravenous therapy. For this purpose 5 mg infliximab tablets were developed. To stabilize the antibody during production and storage it was incorporated in a sugar glass containing the oligosaccharide inulin. To obtain colon-specific release a ColoPulse coating was applied. The tablets were stored for 16 months under different conditions based on ICH climatic zone I:
Instrument
J-850
Keywords
Circular dichroism, Secondary structure, Tertiary structure, Pharmaceutical, Biochemistry