Development and potential application of an oral ColoPulse infliximab tablet with colon specific release: A feasibility study

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• 作者：Jacoba M. Maurer^a ; ^{m.maurer@umcg.nl" class="auth_mail" title="E-mail the corresponding author} ; Susan Hofman^a ; ^{s.hofman@umcg.nl" class="auth_mail" title="E-mail the corresponding author} ; Reinout C.A. Schellekens^a ; ^{reinout.schellekens@kpnplanet.nl" class="auth_mail" title="E-mail the corresponding author} ; Wouter F. Tonnis^b ; ^{w.tonnis@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Annelien O.T. Dubois^b ; ^{a.o.t.dubois@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Herman J. Woerdenbag^b ; ^{h.j.woerdenbag@rug.nl" class="auth_mail" title="E-mail the corresponding author} ; Wouter L.J. Hinrichs^b ; ^{w.l.j.hinrichs@rug.nl" class="auth_mail" title="E-mail the corresponding author} ; Jos G.W. Kosterink^a ; ^c ; ^{j.g.w.kosterink@umcg.nl" class="auth_mail" title="E-mail the corresponding author} ; Henderik W. Frijlink^b ; ^{h.w.frijlink@rug.nl" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Infliximab ; Colon specific delivery ; Oral delivery ; ColoPulse ; Crohn&rsquo ; s disease ; Protein stability ; Formulation
• 刊名：International Journal of Pharmaceutics
• 出版年：2016
• 出版时间：30 May 2016
• 年：2016
• 卷：505
• 期：1-2
• 页码：175-186
• 全文大小：1387 K

文摘

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: