Giselle Carnaby-Mann1, Michael Crary. 1. Department of Psychiatry, McKnight Brain Institute, University of Florida, Gainesville 32610, USA. gmann@psychiatry.ufl.edu
Abstract
OBJECTIVE: To evaluate differences in swallowing physiology and safety in patients with dysphagia between conventional tablets and a new method of tablet transportation, orally disintegrating technology (ODT) (RapiTab; Schwarz Pharma Inc, Milwaukee, Wis). DESIGN: The study observed a single group, crossover design. SETTING:Outpatient clinic within an academic teaching hospital. PARTICIPANTS: A total of 36 adult dysphagic patients referred to the clinic. INTERVENTIONS: All subjects underwent simultaneous nasopharyngeal endoscopic evaluation, surface electromyographic (sEMG) measurement, and respiratory monitoring during swallowing. Subjects were evaluated swallowing the ODT and a conventional tablet formulation. Tablets were randomly and blindly presented to each subject. Subjects completed a preference survey subsequent to swallowing both tablets. RESULTS: Significant differences included greater sEMG amplitude and longer apneic duration when swallowing a conventional tablet compared with the ODT (P<.001). Patients with dysphagia demonstrated significantly longer total swallow durations (P<.001), a higher number of swallows per tablet (P<.002), and the need for fluid to assist in the clearance of the conventional tablet (P<.001). No significant difference was noted between the 2 tablet preparations in amount of residue or airway compromise during or following the swallow. On a postevaluation survey, patients reported that they preferred the ODT preparation for most of the parameters assessed. CONCLUSIONS:Patients with dysphagia frequently complain of trouble swallowing medication. In this study, an ODT formulation provided a method of delivery that required less effort to swallow, did not result in increased levels of airway compromise, and was preferred by dysphagic patients. The ODT medication delivery technology may provide benefit to adults with dysphagia in convenience, compliance, and accuracy of dosing.
RCT Entities:
OBJECTIVE: To evaluate differences in swallowing physiology and safety in patients with dysphagia between conventional tablets and a new method of tablet transportation, orally disintegrating technology (ODT) (RapiTab; Schwarz Pharma Inc, Milwaukee, Wis). DESIGN: The study observed a single group, crossover design. SETTING:Outpatient clinic within an academic teaching hospital. PARTICIPANTS: A total of 36 adult dysphagic patients referred to the clinic. INTERVENTIONS: All subjects underwent simultaneous nasopharyngeal endoscopic evaluation, surface electromyographic (sEMG) measurement, and respiratory monitoring during swallowing. Subjects were evaluated swallowing the ODT and a conventional tablet formulation. Tablets were randomly and blindly presented to each subject. Subjects completed a preference survey subsequent to swallowing both tablets. RESULTS: Significant differences included greater sEMG amplitude and longer apneic duration when swallowing a conventional tablet compared with the ODT (P<.001). Patients with dysphagia demonstrated significantly longer total swallow durations (P<.001), a higher number of swallows per tablet (P<.002), and the need for fluid to assist in the clearance of the conventional tablet (P<.001). No significant difference was noted between the 2 tablet preparations in amount of residue or airway compromise during or following the swallow. On a postevaluation survey, patients reported that they preferred the ODT preparation for most of the parameters assessed. CONCLUSIONS:Patients with dysphagia frequently complain of trouble swallowing medication. In this study, an ODT formulation provided a method of delivery that required less effort to swallow, did not result in increased levels of airway compromise, and was preferred by dysphagic patients. The ODT medication delivery technology may provide benefit to adults with dysphagia in convenience, compliance, and accuracy of dosing.
Authors: Julia T Schiele; Renate Quinzler; Hans-Dieter Klimm; Markus G Pruszydlo; Walter E Haefeli Journal: Eur J Clin Pharmacol Date: 2012-09-29 Impact factor: 2.953
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Authors: Christoph Rosenbaum; Michael Grimm; Julius Krause; Adrian Rump; Rebecca Kessler; Norbert Hosten; Werner Weitschies Journal: Pharmaceutics Date: 2021-06-02 Impact factor: 6.321