The detection of drug content and excipient content of transdermal formulation is one of the quality control steps in the production process of transdermal formulation. CD Formulation has rich project experience in the testing of drug content and excipients in transdermal drug delivery formulation.
The drug content of transdermal formulation refers to the amount of principal components contained in the drug, which is an important index to evaluate the quality of the drug.
Medicinal excipients refer to all medicinal materials except the main drug that are added to the prescription to solve the formability, effectiveness, stability, and safety of the formulation when designing the prescription. The selection and concentration of excipients may affect the properties of the drug.
Our transdermal formulation drug content and excipient content assays mainly have the following applications:
By testing the content of drug and excipient in different batches of transdermal formulation, changes in the production process can be understood and the production process can be optimized.
Through testing, it can be ensured that the content of active ingredients and excipient in transdermal formulation meets standards and specifications.
Content testing of drug and excipient can help R&D personnel understand the composition and properties of the product, thereby optimizing the formula and improving the preparation process.
Fig.1 Flow chart of drug content and excipient content assays (CD Formulation)
1. Sample preparation
For transdermal formulation, the determination of the content needs to be processed in a specific way for subsequent analysis. The patch was cut up and the main drug was extracted with a suitable solvent. The selection of solvent, extraction time and interference of isolation layer/backing layer would affect the accuracy of content determination.
2. Setting chromatographic conditions
The column selection, mobile phase combination, flow rate, column temperature and other conditions need to be determined according to the nature of the drug, the interference of the excipients and the sensitivity of the method.
3. Instrument analysis
The prepared sample is injected into the analytical instrument to detect the content of drugs and excipients.
4. Result processing and reporting
Multiple measurements and averaging, or methodological validation, are required. The final results are presented in the form of a report, including sample information, assay methods, assay results, etc.
Technology: Methods to the testing of drug content and excipient content
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 content testing of drugs and raw materials and excipients based on United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards. 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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