Abstract
The oesophago-irritant potential of terodiline hydrochloride 25 mg tablets was evaluated by use of one acute and two recovery animals models, each documented to be sensitive for predicting local irritant and/or ulcerogenic effects of drugs on the human oesophageal mucosa. Both uncoated and coated terodiline hydrochloride tablets produced slight to moderate oesophageal lesions in cats sacrificed after 4 to 8 hours of tablet exposure, whereas emepronium bromide, a drug associated with oesophageal injury in man, showed moderate to severe oesophago-irritant properties when tested in the same model. No significant oesophageal changes were, however, observed with coated terodiline hydrochloride tablets in cats or pigs subjected to five days of recovery after an initial tablet exposure period of eight and five hours, respectively. The results indicate that the oesophago-irritant effect of terodiline hydrochloride 25 mg tablets is very mild and also transient. Thus no or only a minimal risk of oesophageal irritation after accidental lodging of the tablet in the oesophagus is to be anticipated in patients.
Published Version
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