Newton, M.; Mwalupindi, A.; Forbes, A.
April 2003
Gut;Apr2003 Supplement 1, Vol. 52, pA70
Academic Journal
Background: The original developers of "Asacol' in Europe were Tillots Laboratories. The subsequent out-licensing of the product across Europe has given rise to potential of variations in tablets. If the companies change excipients &/or manufacturing processes, this can affect the release profile. This in turn influences availability of the product locally in the intestinal mucosa & the amount of product absorbed systemically & hence the products' overall profile. Analytical assessment of different European "Asacols" (400mg tabs) was undertaken to evaluate tablet characteristics. Tablets were sourced from France (Fivasa), Germany (Asacolitin), Italy (Asacol It), the Netherlands (Asacol NL) & the UK (Asacol UK). Methodology: Three assessment tools were used in the analysis; scanning electron microscopy (SEM) for coating thickness; near infra red (NIR) absorption for coating thickness & tablet composition, (which was evaluated by principal component analysis (PCA)); & in vitro disintegration and dissolution testing to characterise 5-ASA release. Batches of each product were purchased commercially & assessed under good laboratory practice. Results: PCA of NIR absorption demonstrated clear differences in individual spectra. These spectra are influenced by coating thickness, formulation & tablet shape. SEM results further showed a range of coating thicknesses. Asacol (It) had the thinnest (39-62µm) & Asacol (NL) the thickest (64-129µm) coating. Since the coating is critical to the release mechanism of 'Asacol' the variations shown both by NIR & SEM analysis would be expected to impact the in vitro dissolution profile of 5-ASA release. Differences between the products were identified in terms of the initial release pH & overall profile. Conclusion: The currently available "Asacol" 400mg tablets across Europe differ from each other in vitro with respect to the pH at which 5-ASA release started and their overall...


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