Triamcinolone Acetonide Oromucoadhesive Paste for Treatment of Aphthous Stomatitis.

Hamed Hamishehkar,Saeed Ghanbarzadeh,Ali Nokhodchi,Maryam Kouhsoltani

doi:10.15171/apb.2015.038

Hamed Hamishehkar, Saeed Ghanbarzadeh + Show 2 more

Open Access

https://doi.org/10.15171/apb.2015.038

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Abstract

The aim of this study was to prepare the optimized oral paste formulation of Triamcinolone acetonide intended to be used in aphtous stomatitis. Plastibases were prepared using mineral oil and polyethylene (95:5). Oral paste formulations were prepared with different mixtures of three hydrocolloids solids, including gelatin, pectin and sodium carboxymethylcellulose, with different ratios, as well as Plastibase. Long-term and short-term stability of prepared formulations were studied in the case of color and consistency of pastes. Franz diffusion cell and dialysis membrane were employed for release study. Release data were fitted in the kinetic models to find out the mechanism of drug release. Formulation containing 60% plastibase, 3.3% pectin, 6.6% gelatin and 30% carboxymethylcellulose showed desired durability of adhesion, spreadability and rheology property in healthy volunteers and was compared with reference formulation (Adcortyl(®)) in the case of release profile. Although, optimized formulation and Adcortyl followed the Higuchi and first order release kinetics respectively, optimized formulation showed similar release profile to reference formulation. Optimized oral paste formulation of Triamcinolone Acetonide showed similar characteristics with reference formulation and could be used as an effective drug delivery system for the treatment of recurrent aphthous stomatitis.

Highlights

The mucosa lining of the oral cavity is susceptible to many inflammatory, atrophic and ulcerative conditions, including aphthous stomatitis, lichen planus, erythema multiforme and Behcet’s syndrome
The preparation of Plstibase with both low density polyethylene (LDPE) and high density polyethylene (HDPE) showed that LDPE provides better Plastibase based on the least paraffin oil leak during the storage for one month in different storage conditions
Preliminary studies revealed that formulations containing about 60% of Plastibase® and 40 % of solid colloids with equivalent amount of gelatin, pectin and NaCMC (A4), suitable characteristics (Table 1)

Summary

Introduction

The mucosa lining of the oral cavity is susceptible to many inflammatory, atrophic and ulcerative conditions, including aphthous stomatitis, lichen planus, erythema multiforme and Behcet’s syndrome. Despite multiple investigations about this disease, its etiology remains unknown.[1,2,3] The main treatment strategy of RAS and other inflammatory conditions of the mouth is the use of corticosteroids. These corticosteroids are normally formulated in ointments, pastes, lozenges and mouthwashes, and applied topically in order to avoid systemic side effects.[46]. Triamcinolone Acetonide, a medium to high potency corticosteroid, is a fluorinated prednisolone derivative and considered an intermediate-acting glucocorticoid It is effective in the treatment of dermatoses, asthma and allergic rhinitis and is used in the decreasing of the signs and symptoms of many oral inflammatory conditions, including RAS.

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