Assessing Penetration into Keratinized Structures

MedPharm offers specialized hard tissue and nail permeation testing to evaluate drug absorption, retention, and diffusion in keratinized structures, such as the nail plate, calloused skin, and hyperkeratotic lesions. These studies provide critical insights for the development of topical and transungual therapies targeting conditions like onychomycosis, psoriasis, and nail dystrophies.

Our validated ex vivo nail and keratinized tissue models help optimize penetration enhancer strategies, formulation selection, and treatment efficacy, ensuring that your drug achieves maximum therapeutic impact.

Why Hard Tissue & Nail Permeation Testing Matters

Critical for Transungual & Hard Tissue Drug Development: Helps design effective treatments for onychomycosis, nail psoriasis, and hyperkeratotic disorders.

Optimizes Penetration Enhancement Strategies: Evaluates the impact of formulation excipients, chemical enhancers, and mechanical treatments.

Regulatory & Bioequivalence Support: Provides FDA, EMA, and ICH-compliant permeation data to support drug approvals and generic equivalence studies.

Reduces Clinical Risk: Predicts in vivo drug penetration to optimize dose and delivery strategies before clinical trials.

How Hard Tissue & Nail Permeation Testing Works

MedPharm employs validated in vitro and ex vivo nail penetration models using human and porcine nails, keratinized tissue, and specialized diffusion cells to assess drug transport dynamics.

1. Test Formulation Application: A known quantity of the drug is applied to nail plates or thickened keratinized tissue.
2. Permeation & Diffusion Analysis: The drug penetrates and diffuses through the keratinized structure over time.
3. Timed Sample Collection: Receptor solution samples are collected at regular intervals to measure drug permeation.
4. Quantification via HPLC/LC-MS: Drug concentrations in tissue and receptor solutions are analyzed to generate permeation profiles.

MedPharm’s Hard Tissue/Nail Permeation Capabilities

Validated In Vitro & Ex Vivo Nail Models: Testing with human, porcine, and artificial nails.

Franz Diffusion Cell & Static Nail Permeation Systems: Optimized for transungual drug delivery.

Quantification via Advanced Analytical Techniques: Including LC-MS/MS, HPLC, and UV-Vis detection.

Penetration Enhancement Testing: Assessing the impact of chemical, physical, and enzymatic enhancers.

Regulatory-Compliant Methodologies: Developed in accordance with FDA, EMA, and ICH bioequivalence guidelines.

Key Applications of Hard Tissue/Nail Permeation Testing

Onychomycosis Treatment Development: Evaluating antifungal drug penetration into nail tissue.

Transungual Drug Delivery: Assessing therapeutic penetration through nail keratin.

Psoriasis & Nail Dystrophy Therapies: Optimizing the penetration of anti-inflammatory and immune-modulating drugs.

Penetration Enhancer Studies: Determining the effectiveness of chemical and physical enhancers (e.g., keratolytics, microneedles, iontophoresis).

Generic Bioequivalence Studies: Demonstrating similar penetration profiles for ANDA submissions.

Why Choose MedPharm for Nail & Hard Tissue Permeation Testing?

• Industry-Leading Expertise: In topical and transungual drug testing.
• Proven Methodologies: For hard tissue and nail penetration studies.
• Regulatory Alignment: With global submission standards.
• Cutting-Edge Analytical Capabilities: For drug quantification.
• Customizable Study Designs: To meet formulation and bioequivalence needs.