Newton, M.; Mwalupindi, A.
April 2003
Gut;Apr2003 Supplement 1, Vol. 52, pA68
Academic Journal
Background: The release profile of mesalazine from different aminosalicylates preparations are matched to the site and extent of an individual patient's inflammatory bowel disease. A new enteric coated mesalazine 400mg tablet (Ipocol) has been launched in the UK. Analytical assessment of Asacol and Ipocol was undertaken for comparative purposes. Methodology: Three methods were used: scanning electron microscopy for coating thickness; near infrared absorption tor coating thickness and tablet composition (evaluated by principal component analysis, (PCA)); and in vitro disintegration with dissolution testing to evaluate 5-ASA release, using the standard methodology for Asacol as found in the UK marketing authorisation application. Both Asacol 400mg tablets and Ipocol 400mg tablets were purchased commercially and assessed under conditions of good laboratory practice. Results: Scanning electron microscopy showed the mean thickness of the enteric coating of Ipocol ranged from 51 to 57µm. Ipocol had a significantly thinner coating over the dome (50-66µm) (p=0.0002) and edges (38-47µm) (p<0.0001) than Asacol. Near infrared absorption, analysed by PCA, showed Asacol and Ipocol to have unique spectral signatures. PCA plots are influenced by coating thickness, formulation and tablet shape. In vitro dissolution at pH 6.4 showed a mean release of 5-ASA of < 1% from Asacol tablets v 27% from Ipocol tablets. At pH 7.2, the 5-ASA release profiles of the two products were significantly different at all time points (p<0.0001). Conclusions: The two formulations exhibit significantly different coating characteristics and in vitro dissolution profiles. Since they are not pharmaceutically equivalent this raises concerns about their substitutability.


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