Abstract

Oral candidiasis is a common disease in patients with dry mouth. In this study, film dosage forms (FD) incorporating miconazole nitrate, an antifungal agent, were prepared with water-soluble polysaccharide and cyclodextrin (CD). The dissolution profiles of the drug from the FDs were investigated in limited dissolution medium. Soft films were obtained from sodium alginate containing 0.5% α-CD, β-CD, or γ-CD. Most FDs were easy to handle, though the film tearing resistance was lower than that of CD-free FDs. Addition of CD to the FD accelerated the drug dissolution rate. Interestingly, this phenomenon was also observed in FDs prepared with pullulan. In contrast, acceleration of the drug dissolution rate was not observed when CD polymer was added to the base solution. The initial drug dissolution rate was controllable by the amount of CD added to the FD. Therefore, FDs prepared with these materials are useful to treat oral candidiasis in patients with dry mouth syndrome.

Highlights

  • Dry mouth syndrome is a risk factor for oral diseases, including microbial infections, such as dental caries, periodontitis, and candidiasis [1]

  • Oral candidiasis is a fungal infection caused by Candida strains, including Candida albicans

  • FDs prepared with natural polysaccharides, including sodium alginate (ALG) and pullulan (PUL), which are safe for ingestion were previously characterized [7]

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Summary

Introduction

Dry mouth syndrome is a risk factor for oral diseases, including microbial infections, such as dental caries, periodontitis, and candidiasis [1]. (2015) Cyclodextrin-Modified Film Dosage Forms for Oral Candidiasis Treatment. MCZ gel preparations are commonly used to topically treat oral candidiasis. The patient has to apply the gel evenly in the oral cavity with their tongue. FDs prepared with natural polysaccharides, including sodium alginate (ALG) and pullulan (PUL), which are safe for ingestion were previously characterized [7]. These polysaccharides can form films using simple methods that do not require dissolution in organic solvents. For FDs incorporating MCZ, the drug dissolution rate is enhanced by the addition of a surfactant to the base solution [8]. FDs modified using the adsorbent, cyclodextrin polymer (CDP), were investigated [13] [14]

Materials
FD Preparation
Film Thickness and Rheological Properties
Solubility of MCZ
Determination of MCZ Content
MCZ Dissolution Test
Results and Discussion
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