Protect Your Business: The Importance of Topical Drug Sensitization Tests
Applying a topical medication directly to the skin’s surface or mucous membranes produces a local therapeutic effect. It is often used to deal with a variety of skin conditions, such as itching, rash, infection, and inflammation. Topical medicines are available in various forms and have different functions, including:
- Cream is water-based, easy to absorb, and often used for oily or scratched skin.
- Ointment: fat-based, thicker, and suitable for dry skin or to protect skin from dryness.
- Gel is water-based and has a lighter texture; it is often used for oily or scratched skin.
- Lotion: more liquid than creams and ointments, suitable for large areas of skin
Topical formulations contain active ingredients, often drugs, medicines, or plants, and carrier ingredients. They usually contain water, oils, alcohol, or propylene glycol mixed with preservatives, emulsifiers, absorption drivers, and scents.
Since topical medicines contain active ingredients, of course, topical drug products need to be tested before being distributed to the general public. Topical products such as creams, lotions, and ointments are applied directly to the skin, thus increasing the risk of allergic reactions. Sensitization or sensitivity tests help identify substances that may cause irritation or allergies to the skin.
What is a sensitization test?
A sensitization test is a series of tests performed to evaluate the potential of a substance or product to cause an allergic reaction on the skin.
A sensitization test, also known as the Repeated Insult Patch Test (RIPT) or repeated skin irritation test, is a toxicological method to assess the potential of a chemical or product to cause a recurring allergic reaction or skin sensitivity in humans.
The test aims to identify whether a substance can trigger an unwanted skin reaction, such as contact allergic dermatitis, after repeated use. These tests are usually performed using animal models to ensure accuracy in evaluating allergy potential and sensitivity. The model animals used are rats, marmots, or rabbits. However, with the advancement of technology, there are now alternative methods that do not involve animals.
Why do business owners need to know about sensitization tests?
From the perspective of business owners, there are several reasons your optical medicine product needs to undergo sensitization testing, as follows:
- Prevent Product Claims: If your product causes an allergic reaction in consumers, you risk facing legal claims and brand reputation damage.
- Ensuring Product Safety: By conducting sensitivity tests, manufacturers can ensure that their products are safe for use by consumers. This is crucial to preserving brand reputation and avoiding legal claims.
- Compliance with Regulations: States have regulations that require cosmetic products and topical medicines to undergo sensitization testing before being marketed.
- Strengthening Consumer Confidence: By showing that your product has passed sensitization tests, you will build consumer confidence in the safety and quality of your product.
- Optimize Product Formula: The sensitivity test results can be used to improve the product formula, making it safer and more effective.
Sensitivity tests must be carried out in accordance with SOPs or rules established by the relevant agency. Sensitization tests are generally carried out in accredited testing laboratories that have special facilities and equipment required to perform various types of sensitivity tests, such as patch tests, intradermal tests, provocation tests, etc.
The laboratory factors you should consider when choosing your topical drug testing site are as follows:
- Accredited laboratories: Make sure that the laboratory has accreditation from a recognized agency such as ISO. This guarantees that the resulting test results are accurate and reliable.
- Expertise of the Research Team: Trained and experienced laboratory personnel will run the test procedures correctly.
- Adequate equipment: The laboratory is equipped with modern and calibrated equipment to produce valid data.
- Provides a complete test report containing test results, methods used, and conclusions.
IML Testing and Research is a laboratory that has ISO 9001:2015 accreditation, which means it has recognized its international standards of excellence. The research team is led by principal investigators who have more than two decades of experience. IML testing and research also guarantee accurate and reliable test reports that are supported by adequate equipment.
IML Testing and Research also provides a free consultation service for those of you who want to discuss the testing of your product. Contact us immediately and get sensitization results on your topical drug product!
