Review article: oral, modified‐release mesalazine formulations — proprietary versus generic

Products containing mesalazine have been used in the treatment of inflammatory bowel disease for many years. Many of the oral, modified‐release products are reaching the point of patent expiration, and it is expected that several new ‘generic’ versions will be developed. As mesalazine acts topically, the drug needs to be available at the site of inflammation to be effective. For this reason, the currently available products have been developed with individual formulations so that physicians have a choice when matching the different release profiles to the site and extent of disease. As such, the current guidelines state that oral, delayed‐release mesalazine formulations are not interchangeable and should be prescribed by their proprietary (brand) name.

[1]  Frcp Dr. Francois Martin MD Oral 5-aminosalicylic acid preparations in treatment of inflammatory bowel disease an update , 2005, Digestive Diseases and Sciences.

[2]  M. A. Kamm,et al.  Maintenance of remission in ulcerative colitis , 2002, Alimentary pharmacology & therapeutics.

[3]  M. Kamm Review article: maintenance of remission in ulcerative colitis. , 2002, Alimentary pharmacology & therapeutics.

[4]  P. Gionchetti,et al.  Treatment of mild to moderate ulcerative colitis and pouchitis , 2002, Alimentary pharmacology & therapeutics.

[5]  M. Peppercorn,et al.  Equimolar doses of balsalazide and mesalamine: are we comparing apples and oranges? , 2002, American Journal of Gastroenterology.

[6]  H. Ogata,et al.  Measurement of Colonic Mucosal Concentrations of 5-Aminosalicylic Acid Is Useful for Estimating Its Therapeutic Efficacy in Distal Ulcerative Colitis: Comparison of Orally Administered Mesalamine and Sulfasalazine , 2001, Inflammatory bowel diseases.

[7]  D. Rampton,et al.  Intestinal luminal pH in inflammatory bowel disease: possible determinants and implications for therapy with aminosalicylates and other drugs , 2001, Gut.

[8]  R. Giacomelli,et al.  Mucosal 5-aminosalicylic acid concentration inversely correlates with severity of colonic inflammation in patients with ulcerative colitis , 2000, Gut.

[9]  G. May,et al.  Oral 5-aminosalicylic acid for maintaining remission in ulcerative colitis. , 2000, The Cochrane database of systematic reviews.

[10]  A. Markham,et al.  Prolonged-release mesalazine: a review of its therapeutic potential in ulcerative colitis and Crohn's disease. , 2000, Drugs.

[11]  F. Podczeck,et al.  Determination of the gastric emptying of solid dosage forms using gamma-scintigraphy: a problem of image timing and mathematical analysis , 1999, European Journal of Nuclear Medicine.

[12]  A. Markham,et al.  Oral delayed-release mesalazine: a review of its use in ulcerative colitis and Crohn's disease. , 1999, Drugs.

[13]  M. Kumar,et al.  Tuberculosis control in India: role of private doctors , 1997, The Lancet.

[14]  A. Forbes,et al.  Mesalazine preparations , 1997, The Lancet.

[15]  J A Lewis,et al.  Trials to assess equivalence: the importance of rigorous methods , 1996, BMJ.

[16]  A. Forbes 5-Aminosalicylates in inflammatory bowel disease – the more the merrier? , 1995, European Journal of Gastroenterology and Hepathology.

[17]  J. Rask-Madsen,et al.  Disposition of 5-aminosalicylic acid by olsalazine and three mesalazine preparations in patients with ulcerative colitis: comparison of intraluminal colonic concentrations, serum values, and urinary excretion. , 1990, Gut.

[18]  S. Hansen,et al.  Topical and systemic availability of 5‐amino‐salicylate: comparisons of three controlled release preparations in man , 1990, Alimentary pharmacology & therapeutics.

[19]  J. Hardcastle,et al.  Measurement of gastrointestinal pH profiles in normal ambulant human subjects. , 1988, Gut.

[20]  S. Bondesen,et al.  Kinetics of 5-aminosalicylic acid after jejunal instillation in man. , 1983, British journal of clinical pharmacology.

[21]  S. Truelove,et al.  AN EXPERIMENT TO DETERMINE THE ACTIVE THERAPEUTIC MOIETY OF SULPHASALAZINE , 1977, The Lancet.