Abstract
Film dosage forms (FDs) containing miconazole (MCZ) for the treatment of oral candidiasis were prepared using water-soluble polysaccharides, and the dissolution profiles of MCZ from the FDs were investigated. In addition, the forms were modified by the addition of a surface active agent to accelerate the drug dissolution rate. Circular films incorporating MCZ were obtained using each polysaccharide. Most FDs were easy to handle and resistant to tearing. No diffraction peaks were observed in the X-ray diffractograms of FDs. FDs prepared with sodium alginate or pullulan immediately swelled and disintegrated in aqueous medium, whereas MCZ incorporated in the FD gradually dissolved. A marked acceleration in the MCZ dissolution rate was observed when FD was prepared with polysaccharide containing a surfactant. These results confirmed that modified FDs are useful for treating localized conditions in the oral cavity, such as oral candidiasis, and that FDs can simplify the administration of drugs to patients.
Highlights
Films are used as a functional dosage form in oral care
FDs prepared with sodium alginate or pullulan immediately swelled and disintegrated in aqueous medium, whereas MCZ incorporated in the FD gradually dissolved
These results confirmed that modified FDs are useful for treating localized conditions in the oral cavity, such as oral candidiasis, and that FDs can simplify the administration of drugs to patients
Summary
Films are used as a functional dosage form in oral care. Film dosage forms (FDs) adhere to a surface in the presence of a small amount of liquid and the active compound incorporated in the film is released. FDs prepared with water-soluble polymer disintegrate upon contact with saliva, allowing the FD to deliver the incorporated drug quickly to the affected part of the oral cavity [1,2]. We have reported that algal polysaccharide sodium alginate (ALG) consisting of α-L-guluronate and β-D-mannuronate, and pullulan (PUL) composed of α-D-maltotriose, are useful polymers for preparing FDs [4,5]. These natural polysaccharides are safe, and thin films can be formed using simple methods that do not require dissolution in organic solvents. It was expected that MCZ would be active following dissolution of the FD in saliva and would be useful for the treatment of oral candidiasis. The form was modified by the addition of a surface active agent, a surfactant, to accelerate the drug dissolution rate into limited dissolution medium
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