Transdermal Formulation Temperature Cycling Testing

Drug temperature cycling testing is a widely used method for evaluating the quality and stability of pharmaceuticals. It simulates the temperature fluctuations that drugs may experience during storage and transportation. CD Formulation offers professional temperature cycling testing services specifically tailored for transdermal formulations.

About Temperature Cycling Testing of Transdermal Formulation

Temperature cycle testing is to place the drug in different temperature environments, including high temperature, low temperature, and room temperature, to simulate the various environmental conditions that the drug may encounter during actual transportation and storage. It is used to evaluate whether the stability and quality of the drug are affected under these conditions and to determine whether additional protective measures are needed to ensure the stability of the drug.

What Can We Offer

When examining how temperature changes impact drugs, the temperature range selected is based on the possible temperature fluctuations the drug could face. Our testing includes assessing patch effectiveness by examining factors like dissolution, drug release, skin penetration, and adhesion, by EMA regulations. The following are the temperature ranges employed for two specific situations:

The temperature range of drug freeze-thaw cycle testing may also include more extreme temperatures, such as -20°C or -40°C, which are often used to test the stability and quality changes of drugs under extreme temperature conditions.

Our Workflow for Temperature Cycling Testing of Transdermal Formulation

Fig.1 Flow chart of temperature cycling testing. (CD Formulation)

1. Conduct Hot and Cold Cycle Test: Based on the characteristics of the drug and the test requirements, place the sample and initiate the hot and cold cycle test according to the predetermined temperature range and duration.
2. Record Test Data: Throughout the test, temperature data and other pertinent data must be recorded in real time.
3. Evaluate Test Samples: Remove the test sample from the test chamber for evaluation and analysis, including observing the sample's appearance and measuring its physical and chemical properties.
4. Analyze Stability and Quality Changes: Utilize the test data and evaluation results to analyze the drug's stability and quality changes under hot and cold cycle conditions.

Our Technology Platform

Our temperature cyclers have the following advantages:

• We have a variety of models and specifications to suit different drugs and testing needs.
• With the ability to quickly raise and lower temperatures and accurately control them, they can simulate environmental conditions from extremely cold to extremely hot.
• With humidity control function, they can more comprehensively simulate actual storage and transportation environments.
• Temperature stability: The fluctuation range of the equipment at the set temperature is usually small to ensure the accuracy of the test.
• Capacity: The size of the internal space of the equipment varies depending on the model and can accommodate from a few samples to a large number of samples for testing.

Why Choose Us for Temperature Cycling Testing of Transdermal Formulation?

• We are equipped with professional temperature control equipment, data loggers, sensors, and other high-precision equipment and technologies, which can provide a controlled experimental environment to ensure the accuracy and repeatability of the test.
• We have extensive knowledge and skills in patch testing and can create suitable testing strategies tailored to the specific features and needs of the patch. Additionally, we offer expert technical assistance and guidance.
• We offer a variety of temperature testing conditions to replicate different scenarios that drugs may experience while being transported and stored.

CD Formulation provides you with professional temperature cycle testing for transdermal formulations. 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.