Abstract
Objective: The present research work of Amphotericin B Proniosomal gel focuses on improving patient compliance by reducing the side effects of conventional intravenous injections and minimizing the problem of physical stability and to localize drug at site of action. Methods: Proniosomal gels are prepared by coacervation phase separation technique using different concentration of non-ionic surfactants (Span and Tween) for uniform vesicle formation, lecithin as permeation enhancer/membrane stabilizer and cholesterol as a vesicle cement providing prolonged release. Prepared gels were evaluated for their viscosity, pH, spreadability, entrapment efficiency, drug content uniformity, extrudability, in vitro drug release, permeability and stability studies. Results: Among the nine formulations, F2 (containing 10 mg drug, 250 mg Span 60, 50 mg Soya lecithin) was found to be promising. Fourier Transform infra-red (FT-IR) spectra studies represented no interaction and physicochemical characteristics were found within the limits. The percentages of drug content and entrapment efficiency were determined to be 95.16%±0.40 and 94.20%±0.20, respectively. In vitro drug release was about 95.72%±0.30. Conclusion: Proniosomal gel could constitute a promising approach for topical delivery of Amphotericin B by encapsulating it in non-ionic surfactant to provide patient compliance with cutaneous fungal infection, which was found to be safe, tolerable and efficacious.
Highlights
Drugs for oral and intravenous administration can be commonly used to treat skin conditions, they can cause gastrointestinal irritation and minimise the effects of first pass metabolism
The Melting point of Amphotericin B was found to be in the range of 97.8 °C-199 °C shown in fig. 7 and it complies with the Indian Pharmacopoeia (IP) standard, indicating the purity of the sample
The results of the study indicated that Amphotericin B proniosomal gel containing lecithin, cholesterol, and surfactant Span and Tween formulations were prepared successfully using the coacervationphase separation method
Summary
Drugs for oral and intravenous administration can be commonly used to treat skin conditions, they can cause gastrointestinal irritation and minimise the effects of first pass metabolism. Proniosomes are much more advanced than liposomes and niosomes, which is a provesicular carrier that showcasts both an improvisation in their physicochemical properties like prolonged stability, easy transportation, distribution and storage and of pharmacological properties like prolonged existence in the systemic circulation, controlled release of the drug, augmented penetration to target organs via different routes of administration and reduced toxicity. These vesicles can encapsulate both hydrophobic and hydrophilic drugs, acting as a promising candidate for drug delivery [4]. The current work deals with the formulation and characterization of topical proniosomal gel using cholesterol, soya lecithin and non-ionic surfactants as prime excipients
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