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

The work aimed at studying a new mucoadhesive prolonged release tablet containing 24 μg 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 MgCl2. 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 μg/application) extemporary mixed with Orabase™ (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 μg CP 3 times a day appeared to be effective, avoiding the side effects of the generally used treatment.

Upon contact with water the tablets made of the pure PMM (insert A) rapidly hydrated and a slight increase in their size was observed. Tablets containing 10% w/w MgCl2 (insert B) did not swell significantly, while the addition of HPMC (insert C) caused a significant increase in tablet weight and diameter. When the mixture of HPMC and MgCl2 was added to PMM (insert D) the increase in tablet dimension due to hydratation was closer to that of the pure PMM and the weight remained almost constant over 90 min. In conclusion HPMC and MgCl2 are effective in controlling PMM hydration/erosion and drug release without significantly modifying mucoadhesion.Figure optionsDownload as PowerPoint slide