IngentaConnect Efficacy of a Mucoadhesive Patch Compared with an Oral Solution f...

Authors: Shemer, Avner¹; Amichai, Boaz²; Trau, Henri¹; Nathansohn, Nir¹; Mizrahi, Boaz³; Domb, Abraham J.³

Source: Drugs in R&D, Volume 9, Number 1, 2008 , pp. 29-35(7)

Abstract:

Objective: The purpose of this study was to evaluate the efficacy and tolerability of a mucoadhesive patch compared with a pain-relieving oral solution for the treatment of aphthous stomatitis.

Methods: Patients with active aphthous stomatitis were randomly treated either once a day with a mucoadhesive patch containing citrus oil and magnesium salts (n = 26) or three times a day with an oral solution containing benzocaine and compound benzoin tincture (n = 22). All patients were instructed to apply the medication until pain had resolved, and completed a questionnaire detailing multiple clinical parameters followed by an evaluation of the treatment.

Results: The mucoadhesive patch was found to be more effective than the oral solution in terms of healing time (mean ± SD: 36.0 ± 22.8 hours vs 134.7 ± 57.7, p < 0.001) and pain intensity after 12 and 24 hours (3.7 ± 2.8 vs 6.3 ± 2.6, p = 0.003, and 2.3 ± 2.7 vs 5.7 ± 2.5, p < 0.001, respectively). Local adverse effects 1 hour after treatment were significantly (p < 0.01) less frequent among the mucoadhesive patch patients compared with the oral solution patients.

Conclusions: The mucoadhesive patch was found to be significantly more effective and better tolerated than the oral solution in the treatment of aphthous stomatitis.

Keywords: Aphthous ulcer; Drug delivery systems

Document Type: Research article

Affiliations: 1: 1 Department of Dermatology, C. Sheba Medical Center, Ramat-Gan, Israel 2: 2 Huzot Clinic, Clalit Health Services, Ashkelon, Israel 3: 3 Department of Medicinal Chemistry and Natural Products, School of Pharmacy, Faculty of Medicine, The Hebrew University, Jerusalem, Israel

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Efficacy of a Mucoadhesive Patch Compared with an Oral Solution for Treatment of Aphthous Stomatitis