A new mucoadhesive dosage form for the management of oral lichen planus: Formulation study and clinical study

作者：Cilurzo Francesco; Gennari Chiara G M; Selmin Francesca; Epstein Joel B; Gaeta Giovanni M; Colella Giuseppe; Minghetti Paola^*

来源：European Journal of Pharmaceutics and Biopharmaceutics, 2010, 76(3): 437-442.

DOI：10.1016/j.ejpb.2010.07.014

• Oral lichen planus
• Mucoadhesive tablet
• Topical corticosteroids

The work aimed at studying a new mucoadhesive prolonged release tablet containing 24 mu g clobetasol-17 propionate (CP) suitable for the management of oral lichen planus. Low swellable dosage forms were designed by combining a mucoadhesive polymer, i.e. poly(sodium methacrylate, methylmethacrylate), with hydroxypropylmethylcellulose and MgCl(2). This formulation was selected to modify the tablet erosion rate in order to obtain a release of CP over a 6-h period. A double-blind, controlled study was performed using three groups of patient (n = 16) who received three applications-a-day over 4 weeks of the developed CP tablets (group CP-T), placebo tablets (group CP-P) or commercial CP ointment for cutaneous application (123 mu g/application) extemporary mixed with Orabase (TM) (group CP-O). At the end of the study, pain and ulceration resolved in 13/16 and 11/16 patients of group CP-T and group CP-O, respectively. In the group CP-O, a transient acute hyperaemic candidosis (n = 2) and taste alteration (n = 4) were also observed. No changes in clinical signs of patients in the group CP-P were evident. The application of mucoadhesive tablet containing 24 mu g CP 3 times a day appeared to be effective, avoiding the side effects of the generally used treatment.

• 出版日期2010-11