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.

Evaluating Irritation, Metabolism, and Barrier Integrity

At MedPharm, we utilize Reconstructed Human Epithelium (RHE) models to assess the irritation potential, metabolic activity, and barrier integrity of topical and transdermal formulations. These advanced in vitro models provide highly predictive, reproducible, and regulatory-compliant data, assisting developers in optimizing formulations, minimizing risks in clinical studies, and meeting regulatory safety requirements—all while reducing the reliance on animal testing.

Our scientifically validated RHE models mimic the structural and functional properties of human skin and mucosal tissues, making them essential tools for the evaluation of pharmaceutical, cosmetic, and dermatological products.

Why RHE Testing Matters in Drug Development

Ethically Responsible and Regulatory Accepted: Provides animal-free, human-relevant data to support FDA, EMA, and ICH guidelines.

Highly Predictive for In Vivo Performance: Mimics the physiology, metabolism, and barrier function of actual human tissues.

Essential for Safety and Irritation Studies: Evaluates skin and mucosal irritation, corrosion, and toxicity.

Supports Drug Metabolism and Transport Studies: Assesses enzyme activity, drug metabolism, and permeability.

Ideal for Topical, Transdermal, and Mucosal Products: Supports dermatological, ophthalmic, respiratory, and vaginal drug delivery systems.

How RHE Testing Works

MedPharm employs live human epidermis and mucosal epithelium models to evaluate drug absorption, metabolism, irritation, and inflammatory responses:

1. Test Compound Application: The formulation is applied to RHE tissues, simulating clinical application.
2. Irritation and Toxicity Assessment: Tissue viability, cytokine release, and histological analysis determine irritation potential.
3. Metabolism and Enzyme Activity Analysis: Drug metabolism is assessed through enzyme expression and metabolite identification.
4. Barrier Function and Permeability Testing: Transepithelial electrical resistance (TEER) and dye penetration assays evaluate barrier integrity.

MedPharm’s RHE Testing Capabilities

Skin Irritation and Corrosion Testing: Predicts irritancy potential for drug, cosmetic, and chemical formulations.

Mucosal Irritation and Permeation Testing: Evaluates buccal, vaginal, nasal, and ocular formulations.

Drug Metabolism and Enzyme Activity Studies: Assesses metabolic stability and bioactivation in human-like tissue models.

Barrier Integrity and Permeability Analysis: Measures transepithelial resistance (TEER) and membrane disruption.

Inflammatory Response and Cytokine Profiling: Determines pro-inflammatory cytokine release (IL-1α, IL-8, TNF-α).

Key Applications of RHE Testing

Safety and Irritation Studies: Determines irritancy potential for regulatory approval and product optimization.

Transdermal and Topical Drug Metabolism: Evaluates enzyme activity and drug breakdown in the skin.

Bioavailability and Permeation Studies: Assesses drug penetration and systemic absorption.

Mucosal and Ophthalmic Drug Delivery: Supports nasal, vaginal, buccal, and ocular formulation development.

Cosmetic and Dermatological Testing: Verifies biocompatibility and efficacy of skincare products.

Why Choose MedPharm for RHE Testing?

• Industry-Leading Expertise in In Vitro Skin and Mucosal Models
• Validated, Regulatory-Compliant RHE Assays (OECD, FDA, EMA, ICH)
• State-of-the-Art 3D Tissue Engineering Capabilities
• Comprehensive Data Packages for IND, NDA, ANDA, and Global Filings
• Customizable Study Designs for Unique Formulations

Since 1999, MedPharm has established a strong reputation for delivering exceptional solutions to our clients. We help them navigate the complexities of topical and transdermal product development, ensuring they take the most effective formulation to the clinic.

Since 1999, MedPharm has established a strong reputation for delivering exceptional solutions to our clients. We help them navigate the complexities of topical and transdermal product development, ensuring they take the most effective formulation to the clinic.