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Published on: December 13, 2024
Preclinical development of sodium fusidate antibiotic cutaneous spray based on water-free lipid formulation system
Jan Holmbäck1, Vibhu Rinwa1, Jenny Johansson2
1Department of Materials and Environmental Chemistry, Stockholm University, Svante Arrhenius väg 16C, Stockholm SE-106 91, Sweden; Lipidor AB, Svärdvägen 13, Danderyd SE-182 33, Sweden.
Abstract:
Topical antibiotics are a key component in the management of mild to moderate skin and soft tissue infections. There are, however, concerns about the emerging bacterial resistance against topical antibacterial agents such as fusidic acid, due to the prolonged treatment period of its marketed dosage forms. Improving the efficacy of topical formulations could potentially shorten the treatment period and avoid the resistance growth. To provide a more effective drug delivery, a water-free lipid-based formulation system (AKVANO®) which can be applied by spraying, has been developed. In the current paper, different formulations containing sodium fusidate were evaluated for their in vitro skin permeability using artificial skin mimicking membranes and antibacterial properties using ex vivo and in vivo skin wound infection models. The novel formulations containing sodium fusidate showed a much higher skin permeation (up to 60% of nominal amount) than the commercially available Fucidin® cream (3%). These formulations also gave a significantly stronger antibacterial effect than Fucidin cream showing a clear dose-response relationship for the sodium fusidate content. A spray product based on the described formulation technology would therefore require a shorter treatment time and thereby lower the risk for the development of bacterial resistance. Spray administration of these formulations provides an even layer on the skin surface from which the solvent quickly evaporates and thereby facilitates a non-touch application where no rubbing is required.
Insights
New sprayable formulations of sodium fusidate demonstrate enhanced skin penetration and potent antibacterial activity, potentially reducing treatment times and combating antibiotic resistance in skin infections.
Area of Science:
- Dermatology
- Microbiology
- Pharmaceutical Sciences
Background:
- Topical antibiotics are crucial for treating skin infections, but resistance to agents like fusidic acid is a growing concern due to lengthy treatment durations.
- Developing more effective topical formulations could shorten treatment periods, mitigate bacterial resistance, and improve patient outcomes.
Purpose of the Study:
- To evaluate novel water-free, lipid-based sprayable formulations (AKVANO®) containing sodium fusidate for enhanced drug delivery.
- To assess the in vitro skin permeability and ex vivo/in vivo antibacterial efficacy of these new formulations compared to a commercial cream.
Main Methods:
- Formulations with varying sodium fusidate concentrations were tested for in vitro skin permeation using artificial skin membranes.
- Antibacterial properties were assessed using ex vivo and in vivo skin wound infection models.
- Comparison was made against a commercially available fusidic acid cream (Fucidin®).
Main Results:
- The novel sodium fusidate formulations exhibited significantly higher skin permeation (up to 60%) compared to Fucidin® cream (3%).
- These formulations demonstrated superior antibacterial effects, with a clear dose-response relationship observed for sodium fusidate.
- Spray application facilitated even skin coverage and non-touch application.
Conclusions:
- The developed sprayable formulations offer superior skin permeation and antibacterial efficacy for sodium fusidate.
- This technology has the potential to shorten treatment durations for skin infections, thereby reducing the risk of bacterial resistance.
- Spray administration ensures efficient, non-contact drug delivery.
