Transdermal Formulation Bioequivalence Evaluation

In the ongoing evolution of medicine, transdermal patches represent a convenient and innovative method of drug delivery, offering patients a more accessible and effective treatment option. Ensuring the bioequivalence of transdermal patches across different preparations or batches is crucial for guaranteeing their efficacy and safety. CD Formulation specializes in providing professional bioequivalence evaluations for transdermal formulations.

About Transdermal Formulation Bioequivalence Evaluation

The U.S. Food and Drug Administration (FDA) has issued several guidelines for topical semisolid generic drugs. For some generic drugs, if the quality (Q1), quantity (Q2), and physical properties of the APIs and excipients in the prescription are the same or like the reference drug in terms of microstructure (Q3), they do not need to undergo bioequivalence studies after completing IVRT. For example, acyclovir ointment, clindamycin phosphate gel, metronidazole vaginal gel, tretinoin gel, bexarotene gel, and docosanol cream, as well as many more topical semisolid generic drugs, require IVRT and IVPT before applying for exemption from clinical studies.

What Can We Offer

In vitro release test (IVRT)

In vitro release rate can reflect the combined effect of multiple physical and chemical parameters such as drug solubility, particle size, dosage form rheology, etc., and can identify the impact of prescription and process changes on preparations. It is an important quality control item for product development, quality control, stability testing, and post-approval changes of products.

In vitro permeation test (IVPT)

In vitro transdermal test (IVPT) uses ex vivo human or animal skin as a physiological barrier and a solution with similar physiological conditions as a receiving medium to simulate the transdermal behavior of drugs under physiological conditions. The IVPT test can explore the differences in skin permeability in the early absorption stage by accurately measuring the distribution, permeation amount, and permeation rate of compounds in each skin layer.

IVPT research is also crucial for evaluating the bioequivalence (BE) of topical products. Combining the results of IVRT can provide important evidence for the equivalence evaluation of microstructural properties (Q3) in the equivalence evaluation of topical drugs for the skin.

Our Workflow for Transdermal Formulation Bioequivalence Evaluation

For the selection of BE test parameters, the test method needs to be developed and validated before the key test:

Fig.1 Flow chart of transdermal formulation bioequivalence evaluation. (CD Formulation)

1. Study Planning and Design: Decide on the study design—such as randomized, crossover, or parallel group—based on regulatory guidelines and the specific characteristics of the formulation. Develop a detailed study protocol that outlines the methodology and procedures.
2. Formulation Characterization: Analyze both the test and reference transdermal formulations to ensure they meet the specified criteria for active ingredient content, excipient composition, and physicochemical properties. Conduct In Vitro Release Test (IVRT) studies to evaluate the drug release profile from the transdermal formulation under simulated physiological conditions.
3. Study Conduct - Bioequivalence Phase: Administer the test and reference formulations to participants following the study protocol, which may include details on application technique and frequency. Collect blood samples at predetermined time points to measure drug concentrations in plasma or serum.
4. Analytical Methods: Develop and validate analytical methods, such as Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), for quantifying drug levels in biological samples with the necessary sensitivity and specificity. Analyze the pharmacokinetic parameters to determine the drug's behavior in the body.
5. Bioequivalence Assessment: Evaluate whether the test formulation meets the bioequivalence criteria established by regulatory agencies, such as the FDA or EMA.

Our Technology Platform

Why Choose Us for Transdermal Formulation Bioequivalence Evaluation?

• Our in vitro permeation tests provide accurate and quantifiable data to evaluate the permeability of drugs or active ingredients through the skin barrier. These data are essential for evaluating the bioavailability of drugs.
• We are familiar with the principles, methods, and operating procedures of various in vitro release tests, and can select the most appropriate test methods and parameter settings according to different drug types and needs.
• We have advanced equipment and professional technicians to ensure the accuracy and reliability of in vitro permeation tests and in vitro release tests.

Published Data

CD Formulation provides you with professional bioequivalence evaluation 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.