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Studies in drug transport vs. current in iontophoretic onychomycosis treatment
Michael Barsness1, Shawn P Davis, Robert Etheredge
1Transport Pharmaceuticals, Framingham, MA 01540, USA. mbarsness@transportpharma.com
Abstract:
An iontophoretic treatment system for onychomycosis, using drug applicators targeting either toe nail only or nail and surrounding tissue, is analyzed. Phase 1 clinical data shows levels of drug delivery that differ unexpectedly from relative dosing level to multiple tissue types. Current monitoring and analysis techniques, coupled with assays of drug delivery into excised nail and cadaver toe, were used to evaluate drug delivery vs. current flow. The results indicate good correlation with piecewise linear models of current flow and extracted drug in the nail-only application. For the nail and surrounding tissue application, assayed drug levels indicate that on average, drug load per unit dose (mA-min) is more efficient into nail than into surrounding tissue (2.38:1 ug/mA-min nail vs. surrounding tissue, n=6, p=0.009).
Insights
This study analyzed an iontophoretic system for onychomycosis treatment. Drug delivery into nail tissue was more efficient than into surrounding tissue with the nail and surrounding tissue applicator.
Area of Science:
- Dermatology
- Pharmaceutics
- Biomedical Engineering
Background:
- Onychomycosis (fungal nail infection) presents treatment challenges.
- Iontophoresis offers a potential method for targeted drug delivery to nails.
- Optimizing drug delivery systems is crucial for effective onychomycosis treatment.
Purpose of the Study:
- To analyze the drug delivery efficiency of an iontophoretic system for onychomycosis.
- To compare drug delivery into nail versus surrounding tissue using different applicator types.
Main Methods:
- Phase 1 clinical data analysis of an iontophoretic system.
- Assays of drug delivery into excised nail and cadaver toe models.
- Evaluation of drug delivery in relation to current flow and applicator type.
Main Results:
- Drug delivery levels varied unexpectedly across tissue types relative to dosage.
- A good correlation was observed between current flow and extracted drug in nail-only application.
- Drug load per unit dose was significantly more efficient into nail tissue (2.38:1 ratio) compared to surrounding tissue for the combined applicator.
Conclusions:
- The iontophoretic system demonstrates variable drug delivery depending on applicator and tissue type.
- The nail-only applicator showed predictable drug delivery correlated with current flow.
- Targeted delivery to nail tissue is more efficient than to surrounding tissue when using the combined applicator.
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