Content uniformity refers to the extent to which the content of small-dose solid preparations, semi-solid preparations and heterogeneous liquid tablets conforms to the labeled amount. During the pharmaceutical production process, certain small-dose dosage forms are prepared by advanced processes, which may cause differences in content uniformity. CD Formulation is equipped with a variety of testing instruments to provide professional testing services for the content uniformity of your transdermal formulation.
The content uniformity of the transdermal formulation is not good, that is, there are significant differences in the drug content in different parts. Then when used, the release and absorption of the drug on the skin will also be uneven, which may lead to inconsistent or reduced therapeutic effects. Therefore, the drug content uniformity test of transdermal formulation is to ensure that the distribution of the drug in the preparation is uniform, thereby ensuring the accuracy of the drug dosage and the consistency of the therapeutic effect.
At CD Formulation, the commonly used method flow is as follows:
Fig.1 Flow chart of drug content uniformity testing (CD Formulation)
Our transdermal formulation drug content uniformity testing methods include but are not limited to the following:
Technologies | Description |
Chemical analysis | We take samples from different locations and analyze the samples using high-performance liquid chromatography (HPLC) or mass spectrometry (MS) to determine the drug content at different locations. The uniformity of the drug is assessed by comparing the drug content at different locations. |
Microscopic Imaging | Using a microscope to observe cross-sections of transdermal formulation can assess drug distribution within the formulation. The uniformity of a drug can be judged by observing the distribution of drug particles or crystals in the formulation. |
Image analysis | Images of transdermal formulations are digitized and image analysis software is used to quantitatively analyze drug distribution. This method can provide more objective and quantitative drug distribution information. |
We have a variety of equipment to meet your testing needs:
Technology: Methods to the testing of drug content uniformity
Journal: Journal of analytical science and technology
IF: 2.4
Published: 2016
Results: In the study, Evaluation of the prepared films in terms of physical appearance, weight uniformity, thickness uniformity, surface pH, flatness test, water vapor absorption, water vapor transmission, and drug content uniformity suggest that the method employed for formulation of the transdermal patches was reproducible and ensured excellent quality and uniformity in patch characteristics with minimum variability.
CD Formulation provides drug content uniformity testing based on the United States Pharmacopeia (USP) and European Pharmacopeia (EP) standards, in compliance with relevant regulations and requirements to ensure the accuracy and reliability of test results. Contact us to learn more about how we can work for you, and our colleagues will reply to you within three working days.
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