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Silvio Danese, Ailsa Hart, Axel Dignass, Edouard Louis, Geert D'Haens, Iris Dotan, Gerhard Rogler, Laurence D'Agay, Claudio Iannacone, Laurent Peyrin-Biroulet
INTRODUCTION: A study has been developed to assess the use and effectiveness of budesonide MMX for mild-to-moderate active ulcerative colitis (UC) in routine clinical practice. METHODS AND ANALYSIS: A prospective, multicentre, observational, cohort study of 300 patients prescribed budesonide MMX for the treatment of mild-to-moderate active UC will be conducted in Europe, Israel and Canada. Patients will be treated with budesonide MMX9 mg daily for induction of remission for ≤8 weeks...
2016: BMJ Open Gastroenterology
Alvaro Goyanes, Hanah Chang, Daniel Sedough, Grace B Hatton, Jie Wang, Asma Buanz, Simon Gaisford, Abdul W Basit
The aim of this work was to explore the feasibility of using fused deposition modelling (FDM) 3D printing (3DP) technology with hot melt extrusion (HME) and fluid bed coating to fabricate modified-release budesonide dosage forms. Budesonide was sucessfully loaded into polyvinyl alcohol filaments using HME. The filaments were engineered into capsule-shaped tablets (caplets) containing 9mg budesonide using a FDM 3D printer; the caplets were then overcoated with a layer of enteric polymer. The final printed formulation was tested in a dynamic dissolution bicarbonate buffer system, and two commercial budesonide products, Cortiment® (Uceris®) and Entocort®, were also investigated for comparison...
December 30, 2015: International Journal of Pharmaceutics
Sheridan M Hoy
Budesonide MMX(®) (Cortiment(®); Uceris(®)) is a novel once-daily oral formulation of budesonide using Multi Matrix (MMX(®)) colonic delivery technology to permit the release of budesonide at a controlled rate throughout the colon. It is available in the USA for the induction of remission in patients with active, mild to moderate ulcerative colitis, and in various European countries for the induction of remission in patients with active, mild to moderate ulcerative colitis where 5-aminosalicylic acid (5-ASA) therapy is not sufficient...
May 2015: Drugs
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