Effect of Film Coating on Xanthan Gum Solution-induced Delays in the Disintegration and Dissolution of Tablets

抄録

A solution containing xanthan gum (XTG), a thickening polysaccharide, as a main ingredient is used in taking medicines to prevent aspiration in patients with difficulty swallowing. Recently, there have been reports of XTG thickening solution (XTG-SOL) causing delays in the disintegration and dissolution of uncoated tablets and hindering the medicinal effects. However, studies on film-coated tablets have not yet been conducted. Since the film coating of tablets prevents direct contact with the thickening solution, we investigated whether film coating reduces delays in disintegration and dissolution of tablets.

Tablets were first immersed in XTG-SOL for 1 minute and then subjected to disintegration and dissolution tests. Disintegration tests on water-soluble coated placebo tablets were conducted in the first Japanese Pharmacopoeia solution (JP1, pH 1.2), and the results were compared with those of uncoated tablets and orally disintegrating (OD) tablets. Likewise, commercially available OD tablets containing film-coated multi-particulates, uncoated tablets, and OD tablets were also subjected to identical tests in JP1. For enteric-coated tablets, a disintegration test was conducted in JP1 and JP2 (pH 6.8).

Compared with the uncoated and OD placebo tablets, the film-coated tablets immersed in XTG-SOL showed the shortest delay in disintegration. Although a delay in the disintegration time was observed for the OD tablets containing film-coated multi-particulates, no delay in the dissolution rate or profile of the active ingredient was evident. XTG-SOL showed no effect on disintegration of the enteric-coated tablets, indicating no influence on the enteric property. These results demonstrate that film-coated tablets appear unaffected by immersion in XTG-SOL.