Transdermal Formulation API and Excipient Characterization

Active pharmaceutical ingredients (API) and excipient characterization in transdermal formulations are critical to ensure their efficacy, safety, and overall performance. CD Formulation has decades of experience in developing transdermal formulations and provides you with API and excipient characterization.

About Transdermal Formulation API and Excipient Characterization

Excipients are non-active components found in drug formulations. They work alongside the active ingredient (API) to enhance various aspects of the drug, such as its physical properties, stability, solubility, and release characteristics. The API is the key ingredient in drug formulations. How the API interacts with excipients is crucial for the effectiveness of transdermal formulations.  For example, the ability of the active pharmaceutical ingredient (API) to dissolve, spread, and pass through the excipients has a direct effect on how quickly the drug is released and how effectively it is absorbed through the skin. Hence, it is crucial to thoroughly evaluate how the active pharmaceutical ingredient (API) interacts with other components in transdermal formulations to attain the best therapeutic results and medication effects.

What Can We Offer

Physicochemical properties

Determine the molecular configuration by using techniques such as spectroscopy (including NMR and IR), mass spectrometry, or X-ray crystallography to identify the chemical structure.

Assess the cleanliness of the API to confirm it complies with pharmacopoeial or regulatory requirements. Methods such as HPLC or GC are commonly employed for this purpose.

Find out how well the active pharmaceutical ingredient dissolves in different solvents to improve the development of formulations.

Assess the durability of the active pharmaceutical ingredient (API) in a product over a period, taking into account variables like pH, temperature, and exposure to light.

Excipient properties

Improve the solubility of the active pharmaceutical ingredient (API) in a formulation by adding excipients like surfactants or solubilizers.

Assess additives that can improve the ability of the active pharmaceutical ingredient to penetrate the skin barrier.

Examine how the active pharmaceutical ingredient (API) and other ingredients interact to ensure the stability and effectiveness of the formulation.

Assess the physical compatibility of excipients with patch components such as the backing layer and adhesive to avoid any potential issues related to physical instability or drug delivery.

Our Workflow for API and Excipient Characterization of Transdermal Formulation

Fig.1 Flow chart of transdermal formulation API and excipient characterization. (CD Formulation)

• Chemical Identity: Use spectroscopic methods such as Nuclear Magnetic Resonance (NMR), Fourier Transform Infrared Spectroscopy (FT-IR), and mass spectrometry to confirm the chemical structure and assess purity.
• Physical Form: Employ X-ray diffraction (XRD), differential scanning calorimetry (DSC), and microscopic techniques like Scanning Electron Microscopy (SEM) and Transmission Electron Microscopy (TEM) to ascertain crystallinity, polymorphism, and particle size.
• Solubility and Partition Coefficient: Perform solubility studies across various solvents and calculate partition coefficients (log P) to elucidate the behavior of the API in transdermal delivery systems.
• Stability Studies: Conduct accelerated stability tests under varying temperature and humidity conditions and determine the shelf-life to evaluate the long-term stability during storage.

Our Technology Platform

Why Choose Us for API and Excipient Characterization of Transdermal Formulation?

• We have an experienced team of chemical analysts and scientists who have deep expertise and skills in API and excipient characterization and can correctly select and apply appropriate analytical methods to ensure the accuracy and reliability of the results.
• We are equipped with advanced analytical instruments and equipment, such as mass spectrometers, nuclear magnetic resonance instruments, high-performance liquid chromatography, etc.
• We have efficient testing processes and technologies that can complete the testing of active ingredients in a relatively short time.

Published Data

Effective characterization of transdermal API and excipients helps optimize formulation, improve manufacturing efficiency, and ultimately ensure the clinical success of transdermal products. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.