Evaluation of formulation properties and skin penetration in the same additive-containing formulation

Area of Science:

• Pharmaceutical Sciences
• Dermatology
• Materials Science

Background:

• Topical antifungal treatments require optimized physicochemical properties for effective skin permeation.
• Variations in generic formulations can lead to differences in drug delivery and patient experience.
• Understanding cream properties is crucial for predicting in vivo performance.

Purpose of the Study:

• To evaluate physicochemical properties of miconazole nitrate cream formulations (one bland, three generics).
• To assess the impact of these properties on skin permeability and human sensory perception.
• To correlate formulation characteristics with drug diffusion and spreadability.

Main Methods:

• Physicochemical analysis including flattening, viscoelasticity, water content, and yield value.
• Near-infrared (NIR) absorption spectroscopy for non-destructive property assessment.
• Human sensory testing for spreadability and feel, alongside in vitro skin permeation tests.

Main Results:

• Significant variations observed in yield value, viscoelasticity (tanδ), and water content across formulations.
• NIR spectroscopy indicated differences in hydroxyl group absorption, correlating with water content.
• Sensory tests revealed distinct differences in spreadability and feel; skin permeation varied, with MCZ-C showing the highest drug amount (12.08 µg/cm²).

Conclusions:

• Formulation differences (water/oil content, emulsification) directly influence cream physical properties and skin permeation.
• Spreadability significantly affects potential dermal transfer and drug efficacy.
• NIR spectroscopy and viscoelasticity measurements are valuable tools for characterizing topical cream formulations.