The work aimed at studying a new mucoadhesive prolonged release tablet containing 24μg 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 4weeks of the developed CP tablets (group CP-T), placebo tablets (group CP-P) or commercial CP ointment for cutaneous application (123μg/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 24μg CP 3 times a day appeared to be effective, avoiding the side effects of the generally used treatment.

A new mucoadhesive dosage form for the management of oral lichen planus : formulation study and clinical study / F. Cilurzo, C.G.M. Gennari, F. Selmin, J.B. Epstein, G.M. Gaeta, G. Colella, P. Minghetti. - In: EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS. - ISSN 0939-6411. - 76:3(2010 Nov), pp. 437-442.

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

F. Cilurzo
Primo
;
C.G.M. Gennari
Secondo
;
F. Selmin;P. Minghetti
2010

Abstract

The work aimed at studying a new mucoadhesive prolonged release tablet containing 24μg 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 4weeks of the developed CP tablets (group CP-T), placebo tablets (group CP-P) or commercial CP ointment for cutaneous application (123μg/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 24μg CP 3 times a day appeared to be effective, avoiding the side effects of the generally used treatment.
Oral lichen planus; Mucoadhesive tablet; Topical corticosteroids
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
nov-2010
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/443310
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