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Assessment of antifungal efficacy of itraconazole loaded aspasomal cream: comparative clinical study
Caroline Lamie1, Enas Elmowafy2, Maha H Ragaie3
1Pharmaceutics and Pharmaceutical Technology, The British University in Egypt, Cairo, Egypt.
Abstract:
Topical conveyance of antifungal agents like itraconazole ITZ has been giving good grounds for expecting felicitous antifungal medicines. The defiance of topical delivery of this poorly water soluble and high-molecular-weight drug, however, mightily entail an adequate vehiculation. ITZ aspasomes, newer antioxidant generation of liposomes, have been designed and enclosed in a cream to ameliorate skin deposition. The proposed creams containing non-formulated ITZ or encapsulated in aspasomes (0.1% or 0.5%) were topically applied in patients with diagnosed diaper dermatitis complicated by candidiasis, tinea corporis (TC), and tinea versicolor (TVC). Placebos (void aspasomal cream and cream base) were also utilized. The obtained results for diaper rash revealed that aspasomal cream (0.5% ITZ) was eminent with respect to complete cure and negative candida culture after 10-day therapy relative to counterparts containing 0.1% ITZ aspasomes or non-formulated ITZ (0.1% and 0.5%). For tinea, the same trend was manifested in terms of 'cleared' clinical response in 90% of patients and absence of fungal elements after 4-week treatment. Relative to non-formulated ITZ, ITZ aspasomal cream was endorsed to be auspicious especially when ITZ concentration was lowered to half commercially available cream concentration (1%), pushing further exploitation in other dermal fungal infections.
Insights
New antioxidant liposomes called aspasomes improve topical delivery of itraconazole (ITZ) for fungal skin infections. Aspasomal ITZ cream demonstrated superior efficacy in treating diaper dermatitis and tinea infections compared to non-formulated ITZ.
Area of Science:
- Dermatology
- Pharmaceutics
- Mycology
Background:
- Topical antifungal therapy is crucial for skin infections.
- Poor water solubility and high molecular weight of itraconazole (ITZ) pose challenges for topical delivery.
- Aspasomes, a novel generation of antioxidant liposomes, offer potential for enhanced drug vehiculation.
Purpose of the Study:
- To evaluate the efficacy of itraconazole (ITZ) encapsulated in aspasomes for treating common fungal skin infections.
- To compare the therapeutic effect of ITZ aspasomes with non-formulated ITZ in cream formulations.
- To assess the potential of aspasomal ITZ for improved skin deposition and treatment outcomes.
Main Methods:
- Development of ITZ-loaded aspasomal cream formulations at 0.1% and 0.5% concentrations.
- Topical application of ITZ aspasomal creams, non-formulated ITZ creams, and placebos in patients with diaper dermatitis, tinea corporis (TC), and tinea versicolor (TVC).
- Clinical assessment of treatment response, including complete cure rates and mycological evaluation (fungal culture/element absence).
Main Results:
- The 0.5% ITZ aspasomal cream achieved complete cure and negative Candida cultures in 10 days for diaper dermatitis, outperforming lower concentrations and non-formulated ITZ.
- For tinea infections (TC and TVC), 90% of patients treated with ITZ aspasomal cream showed a 'cleared' clinical response and absence of fungal elements after 4 weeks.
- Aspasomal encapsulation enhanced ITZ efficacy, allowing for a potential reduction in drug concentration compared to standard formulations.
Conclusions:
- ITZ aspasomal cream represents a promising advancement in topical antifungal therapy for various dermal infections.
- Aspasomal technology significantly improves the delivery and efficacy of poorly soluble drugs like itraconazole.
- This formulation warrants further investigation for treating a broader range of superficial fungal infections.
