As a leader in pharmaceutical technology, CD Formulation is dedicated to the advanced research and development of transdermal formulation technology. Our expertise lies in providing custom R&D services for researchers, focusing on developing safe and efficient transdermal drug delivery systems. We employ cutting-edge techniques to ensure precise, reliable evaluation and formulation processes.

Biological evaluation is crucial for verifying the safety and efficacy of transdermal formulations. At CD Formulation, our interdisciplinary team of experienced scientists and pharmacologists utilizes state-of-the-art biotechnology, cell culture methods, and molecular biology to conduct comprehensive, multi-level assessments. Our services include skin permeability testing, irritation evaluation, and pharmacokinetic and pharmacodynamic studies, ensuring accurate data to support your R&D efforts.

What We Can Offer

In Vivo Skin Permeation and Accumulation Study

In vivo animal experiments, we have observed that the accumulation of drugs in the skin is closely related to the formulation and mode of administration of the preparation. By optimizing the formulation, we can control skin drug levels, enhancing efficacy and minimizing adverse effects.

Skin Irritation Testing

To evaluate the irritation and sensitization of transdermal preparations to the skin to ensure safety. Animal experiments (such as a guinea pig sensitization test) or human experiments (such as a skin patch test) are usually used to detect whether the preparation will cause skin irritation or allergic reaction.

Adhesion Testing

Adhesion testing of transdermal products is an important step in evaluating the adhesion performance of transdermal products (such as transdermal patches) on the skin. This test ensures that the patch can effectively adhere to the skin during the intended use and avoid falling off during daily activities.

Pharmacokinetic Study

To understand the absorption, distribution, metabolism, and excretion of transdermal preparations in vivo through experimental animals or human trials. The plasma drug concentration-time curve is usually used to calculate the drug's bioavailability, maximum concentration (Cmax), time to reach maximum concentration (Tmax), and drug half-life.

Pharmacodynamic Evaluation

Evaluate the therapeutic effect and mechanism of action of transdermal preparations. Usually verify the efficacy and duration of action of the preparation through animal models.

Our Technology Platform

In Vitro Models

• Skin Models: Use human skin explants or reconstructed human epidermis models (e.g., EpiDerm, MatTek) to evaluate penetration and absorption. These models can mimic the barrier properties of human skin.
• Diffusion Cells: Franz diffusion cells are commonly used to the rate of drug penetration through the skin. They help the amount of drug that penetrates through the skin over time.
• Cell-Based Assays: Utilize keratinocyte or fibroblast cultures to study cytotoxicity, irritation, and cellular uptake of the transdermal formulations.

Fig.1 Schematic diagram of in vitro permeation. (Francesco Cilurzo, et al. 2018)

Analytical Techniques

• Mass Spectrometry (MS): Quantifies drug concentration in skin layers, plasma, or other tissues.
• High-Performance Liquid Chromatography (HPLC): Identifies and quantifies components within formulations.
• Imaging Techniques: Confocal microscopy, Raman spectroscopy, and fluorescence microscopy visualize drug penetration into skin layers.

In Vivo Models

• Animal Models: Rodents (e.g., mice, rats) are used for studying pharmacokinetics, efficacy, and potential skin reactions, aiding in the prediction of human responses.

Our Instrumentation Platform

• High-performance liquid chromatography (HPLC)
• Ultra-high performance liquid chromatography (UPLC)
• LCMS and LCMS/MS
• Franz diffusion cells

Why Choose Us for Biological Evaluation of Transdermal Formulation?

• Advanced Testing Equipment: Our state-of-the-art skin penetration testing tools ensure precise measurement of drug penetration rates, using reliable Franz diffusion cells and LC-MS/MS techniques.
• Expertise in Pharmacokinetics: With extensive experience, we deliver accurate insights into the absorption, distribution, metabolism, and excretion profiles of transdermal formulations.
• Robust Pharmacodynamic Evaluation: We provide reliable pharmacodynamic assessments using validated animal models.
• Rigorous Safety Testing: We adhere to strict standards for skin irritation and allergenicity testing, ensuring safety and efficacy in all formulations.

Published Data

CD Formulation has a professional technical team and perfect testing equipment, to provide quality biological evaluation services for transdermal formulations. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.