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Bioadhesive films containing fluconazole for mucocutaneous candidiasis.

Patel SK, Shah DR, Tiwari S - Indian J Pharm Sci (2015 Jan-Feb)

Bottom Line: Bioadhesive strength was found to be more than 18 g.Microenvironment pH was near to 7.0 for most of the formulations.As revealed in FT-IR and DSC studies, drug was found to be compatible with the excipients used in this study.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, Maliba Pharmacy College, Uka Tarasadia University, Bardoli-394 350, India.

ABSTRACT
Fluconazole is a broad spectrum antifungal agent that has been extensively applied for the management of oral, pharyngeal and cutaneous candidiasis. Fluconazole has a high volume of distribution (0.55-0.65 l/kg) and has systemic toxicity due to high drug-drug interaction. The present study focuses on the formulation of bioadhesive film as a controlled release carrier for fluconazole. The formulation was intended to provide localized delivery of fluconazole exclusively at the site of infection, thereby reducing its total dose and hence, dose-related toxicities. Bioadhesive films were prepared by solvent casting method using sodium alginate and polyvinyl alcohol alone as well as in various combinations. Prepared films were evaluated for physical characteristics like, weight and content uniformity, film thickness, swelling index, microenvironment pH and folding endurance. In vitro drug release, in vitro and ex vivo residence time, bioadhesive strength and skin irritation were also studied. Accelerated stability study was conducted on the optimized formulation as per ICH guidelines. Weight of all the films were not more than 20 mg. Thickness of the films ranged between 0.09 to 0.15 mm whereas swelling indices showed a high extent of variation. Films composed of polyvinyl alcohol alone provided a swelling index of 6%. Bioadhesive strength was found to be more than 18 g. Microenvironment pH was near to 7.0 for most of the formulations. Ex vivo residence time of optimized batch was more than 5 h and it provided controlled drug release up to 8 h. As revealed in FT-IR and DSC studies, drug was found to be compatible with the excipients used in this study.

No MeSH data available.


Related in: MedlinePlus

Scanning electron microscopic image of optimized formulation F5.
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Figure 4: Scanning electron microscopic image of optimized formulation F5.

Mentions: SEM analysis of the optimized batch was carried out using SEM (JSM-5610 LV). SEM micrograph indicated uniform dispersion of drug with polymer dispersion (fig. 4). Formulation appeared to be smooth with no roughness on its surface. This is conducive in terms of offering better appearance and therefore, patient acceptability.


Bioadhesive films containing fluconazole for mucocutaneous candidiasis.

Patel SK, Shah DR, Tiwari S - Indian J Pharm Sci (2015 Jan-Feb)

Scanning electron microscopic image of optimized formulation F5.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4355883&req=5

Figure 4: Scanning electron microscopic image of optimized formulation F5.
Mentions: SEM analysis of the optimized batch was carried out using SEM (JSM-5610 LV). SEM micrograph indicated uniform dispersion of drug with polymer dispersion (fig. 4). Formulation appeared to be smooth with no roughness on its surface. This is conducive in terms of offering better appearance and therefore, patient acceptability.

Bottom Line: Bioadhesive strength was found to be more than 18 g.Microenvironment pH was near to 7.0 for most of the formulations.As revealed in FT-IR and DSC studies, drug was found to be compatible with the excipients used in this study.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, Maliba Pharmacy College, Uka Tarasadia University, Bardoli-394 350, India.

ABSTRACT
Fluconazole is a broad spectrum antifungal agent that has been extensively applied for the management of oral, pharyngeal and cutaneous candidiasis. Fluconazole has a high volume of distribution (0.55-0.65 l/kg) and has systemic toxicity due to high drug-drug interaction. The present study focuses on the formulation of bioadhesive film as a controlled release carrier for fluconazole. The formulation was intended to provide localized delivery of fluconazole exclusively at the site of infection, thereby reducing its total dose and hence, dose-related toxicities. Bioadhesive films were prepared by solvent casting method using sodium alginate and polyvinyl alcohol alone as well as in various combinations. Prepared films were evaluated for physical characteristics like, weight and content uniformity, film thickness, swelling index, microenvironment pH and folding endurance. In vitro drug release, in vitro and ex vivo residence time, bioadhesive strength and skin irritation were also studied. Accelerated stability study was conducted on the optimized formulation as per ICH guidelines. Weight of all the films were not more than 20 mg. Thickness of the films ranged between 0.09 to 0.15 mm whereas swelling indices showed a high extent of variation. Films composed of polyvinyl alcohol alone provided a swelling index of 6%. Bioadhesive strength was found to be more than 18 g. Microenvironment pH was near to 7.0 for most of the formulations. Ex vivo residence time of optimized batch was more than 5 h and it provided controlled drug release up to 8 h. As revealed in FT-IR and DSC studies, drug was found to be compatible with the excipients used in this study.

No MeSH data available.


Related in: MedlinePlus