Journal of Bioequivalence & Bioavailability

Roda Giulia

Publications

• Research Article
  Pharmacokinetics and Safety of a New 1200 mg Single-Dose Delayed Release Mesalazine Microgranule Formulation
  Author(s): Roda Aldo, Simoni Patrizia, Roda Giulia, Caponi Alessandra, Pastorini Elisabetta, Locatelli Marcello and Roda EnricoRoda Aldo, Simoni Patrizia, Roda Giulia, Caponi Alessandra, Pastorini Elisabetta, Locatelli Marcello and Roda Enrico
  
  The treatment of Inflammatory Bowel Diseases (IBDs) requires a relative high therapeutic daily dose of mesalazine and thus, the drug formulation need to b e well tolerate and safe. A new pH-dependent controlled release 5-ASA microgr anule formulation in 1.2 g sachets has been develop ed. The plasma levels of both the active principle 5-AS A and the main metabolite N-Acetyl-5-ASA, after ora l administration of the new formulation or after an e quimolar dose of three separated enteric coated 400 mg tablets administered in the same time (Pentacol® 40 0, SOFAR, Milan, ITALY), were measured with a valid ated high performance liquid chromatography-tandem mass spectrometry method. C max , t max and AUC values were considered as primary variables and the drug safety was the secondary one. The plasma 5-ASA concentration appearance was faste r after microgranule administration ( tmax of 8.1.. View More»
  DOI: 10.4172/jbb.1000008

  Abstract PDF