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.
Cilurzo
Francesco
F
Department of Pharmaceutical Science "Pietro Pratesi", Università degli Studi di Milano, Italy.
Gennari
Chiara G M
CG
Selmin
Francesca
F
Epstein
Joel B
JB
Gaeta
Giovanni M
GM
Colella
Giuseppe
G
Minghetti
Paola
P
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002990:Clobetasol / Q000008:administration & dosage* / Q000032:analysis / Q000378:metabolism / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000032:analysis / Q000378:metabolism / Q000627:therapeutic use; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D003692:Delayed-Action Preparations; D004304:Dosage Forms; D005938:Glucocorticoids; D002990:Clobetasol