Evaluating Drug Penetration Through Biological Membranes

MedPharm's in vitro Permeation Testing (IVPT) is a gold-standard method for assessing how drugs penetrate the skin, mucosal tissues, and other biological membranes. This process ensures that formulations achieve their intended therapeutic effects. IVPT is essential for various localized delivery systems, including topical, transdermal, ophthalmic, nasal, and mucosal applications, as it provides critical insights into permeation kinetics and bioavailability.

Why IVPT is Essential for Drug Development

Predicts In Vivo Performance: Measures drug absorption and penetration before clinical trials.

Supports Regulatory Submissions: Required by FDA, EMA, and ICH guidelines to demonstrate bioequivalence and formulation performance.

Reduces Clinical Study Costs: Helps demonstrate therapeutic equivalence for generic drug approvals (ANDA).

Guides Formulation Optimization: Evaluates penetration enhancers, excipients, and delivery technologies.

How IVPT Works

MedPharm's IVPT studies utilize ex vivo human or animal skin and mucosa models within a Franz Diffusion Cell apparatus, simulating real-world absorption conditions.

1. Test Formulation Application: A known quantity of the drug is applied to an ex vivo biological membrane (e.g., human skin, nasal, mucosal, or ophthalmic tissue).
2. Diffusion & Permeation: The drug diffuses through the membrane, reaching the receptor fluid.
3. Timed Sample Collection: Samples from the receptor chamber are collected over time to evaluate drug penetration rates.
4. Quantification via HPLC/LC-MS: The drug concentration in the receptor fluid is measured to generate permeation profiles.

MedPharm's IVPT Capabilities

Regulatory-Compliant IVPT Studies: Adheres to FDA, EMA, and ICH guidelines.

Human & Animal Skin Models: Utilizes fresh, frozen, or dermatomed human cadaver skin and animal-derived membranes.

Mucosal & Specialized Tissue Testing: Includes testing on nasal, vaginal, ocular, and other mucosal membranes.

Automated & High-Throughput IVPT: Enhances study efficiency and reduces variability.

Comprehensive Drug Permeation Analysis: Evaluates first-order kinetics, steady-state flux, lag time, and partition coefficients.

Key Applications of IVPT

Topical & Transdermal Drug Development: Assesses dermal penetration and systemic absorption.

Bioequivalence Testing (ANDA Submissions): Compares generic formulations against reference formulations.

Ophthalmic & Nasal Drug Delivery: Measures penetration through corneal and nasal tissues.

Mucosal Permeation Studies: Supports the development of buccal, vaginal, and rectal formulations.

Enhancer & Excipient Testing: Optimizes formulations for improved drug permeability.

Why Choose MedPharm for IVPT?

• Global Expertise in Permeation Testing: Over 25 years of experience in IVPT method development and validation.
• Regulatory Alignment: Methods developed in accordance with FDA, EMA, and ICH guidelines.
• State-of-the-Art Franz Cell Systems: Conduct high-precision diffusion cell studies for topical and transdermal drugs.
• Comprehensive Permeation Testing Capabilities: Testing includes skin, mucosal, ocular, and respiratory membranes.
• Advanced Analytical Capabilities: Equipped with HPLC, LC-MS/MS, and UV-Vis quantification for highly sensitive detection.