Development, stability and in vitro permeation studies of gels containing mometasone furoate for the treatment of dermatitis of the scalp

Ana Cristina Gomes Barros Salgado,Alexandra Maria Nunes Nogueira Da Silva,Marta Cristina Jorge Cabral Machado,Maria Aida Da Silva Costa Duarte,Helena Margarida De Oliveira Marques Ribeiro

doi:10.1590/s1984-82502010000100012

Ana Cristina Gomes Barros Salgado, Alexandra Maria Nunes Nogueira Da Silva + Show 3 more

Open Access

https://doi.org/10.1590/s1984-82502010000100012

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Abstract

Dermatological inflammatory diseases such as atopic dermatitis, psoriasis and seborrhoeic dermatitis often affect the scalp and the eyebrows. Although there are many dosage forms available, these are particularly critical anatomic regions for application of topical formulations because of the presence of hair. Lotions are therefore the recommended type of drug delivery system for these areas. The presence of hair may limit the application and thus the acceptability of the formulation and its compliance. Because of its low apparent viscosity, lotion application is unpleasant. Gels, given their consistency and adhesiveness, are a suitable alternative to lotions in this situation. The aim of this study was to formulate a stable gel containing mometasone furoate, which is an anti-inflammatory and anti-pruritic corticosteroid, in order to improve topical treatment of scalp dermatitis. In this study, pharmaceutical development, physical-chemical characterization, stability and in vitro permeation studies were performed. In terms of the pH, viscosity, assay and macroscopic and microbiological properties, the gel was stable over the period of study. The in vitro permeation studies allowed the characterization of the mometasone furoate permeation profile for the gel through different membranes. Mometasone furoate presented a slow permeation through the skin. This gel appears safe for topical application.

Highlights

The most common types of dermatitis include atopic dermatitis, seborrhoeic dermatitis and psoriasis
The final formulation was prepared with 1.5% hydroxypropyl methylcellulose (HPMC), obtained from Fluka ChemieGmbH, previously swollen in purified water, isopropyl alcohol FP VIII and propyleneglycol USP (40:40:20)
Mometasone furoate is only stable at pH 4 – 4.5 and so significant changes in pH of the gel would lead to instability of the formulations and entail their abandonment for not meeting the range of pH

Summary

Introduction

The most common types of dermatitis (inflammatory condition of the skin) include atopic dermatitis ( known as eczema), seborrhoeic dermatitis and psoriasis. Each of these conditions has an impact on quality of life and requires good compliance to therapy. (Agner, 2005; Thestrup-Pedersen, 2005) Typical symptoms of these diseases are inflammatory type rash, redness and itching (Koda et al, 2004). Drug therapy of the inflammatory states of the skin is mainly topical. This addresses the treatment of symptoms, since in most cases causal treatment is impossible due to unknown etiology. Topical corticosteroids are the most commonly used drugs in these skin conditions (Marks et al, 1973)

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