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Transdermal Formulation Cold Flow Evaluation

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The cold flow of the transdermal patch might alter the contact area between the drug carrier substrate and the skin, affecting the patch's therapeutic effect. It could also cause the adhesive dispersed patch to stick to the inside of the bag, making it difficult to remove and apply, or even decreasing the available dose. CD Formulation can offer a professional evaluation of cold flow in transdermal formulations.

About Transdermal Formulation Cold Flow Evaluation

Cold Flow refers to the phenomenon of creep or seepage of the pressure-sensitive adhesive matrix at the edge of the backing layer or the gap of the anti-adhesive layer. The lack of cohesion of the pressure-sensitive adhesive itself or the weakening of cohesion caused by the addition of drugs and other additives can cause cold flow of the pressure-sensitive adhesive, which is manifested as the pressure sensitive adhesive spilling over the cut edge of the patch during long-term storage, or the patch wrinkling and displacement during administration, or the pressure sensitive adhesive residue at the administration site after removal of the patch (black circle phenomenon).

Our Workflow of Transdermal Formulation Cold Flow Evaluation

Cold flow may change the contact area between the drug carrier substrate and the skin, affecting the efficacy of the patch, and may also cause the adhesive dispersed patch to adhere to the inside of the bag, difficult to remove and apply, and even reduce the available dose. Excessive cold flow under storage and clinical use conditions may affect product performance and safety of transdermal patches. In CD Formulation, our usual testing methods are wiping and stripping the migrated parts of the substrate, and then determination by gravimetric analysis or by API assay.

Our steps for cold flow evaluation are as follows:

Workflow of transdermal formulation cold flow evaluation. Fig.1 Flow chart of transdermal formulation cold flow evaluation (CD Formulation)

Our Technology Platform

Because the cold flow performance of different products may vary, we have developed several different cold flow tests. These include:

Technologies
  • Linear measurement of radial cold flow using a microscope.
  • The distance of the migrating adhesive matrix is measured at predefined and evenly spaced locations of the TDS.
  • Measure cold flow by applying TDS dimensions plus a reference plate with an acceptable cold flow rate.
  • Wipe and strip the migrating portion of the substrate and determine by gravimetric analysis or by BMA assay.
  • Die cut and flush out the original dimensions of the TDS and determine the number of external migration matrices.

Why Choose Us for Evaluating Transdermal Formulation Cold Flow?

  • We have rich experience and expertise in transdermal patch testing, with advanced testing equipment and instruments, and can accurately understand and apply relevant testing standards and methods to ensure the accuracy and reliability of test results.
  • We have a comprehensive range of transdermal patch cold flow testing capabilities and have developed a variety of testing methods, including wiping method, microscope evaluation method and so on.
  • We can provide customized inspection services according to the specific needs of customers. Design testing schemes, select testing methods and equipment based on product formulation, packaging design, storage conditions and storage time, and provide personalized technical support and consulting services.

Published Data

Technology: Methods to transdermal formulation cold flow evaluation

Journal: Chinese Pharmaceutical Affairs

IF: 1.16

Published: 2023

Results: In the study, the characteristics and technological progress of transdermal patches' dosage forms were reviewed. The quality control indicators of transdermal patches were systematically summarized. The key quality indexes of transdermal patches, including drug release, transdermal property, adhesion, cold flow, and drug residue, were evaluated.

We have rich experience and expertise in transdermal patch testing, with advanced testing equipment and instruments, and have developed a variety of cold flow assessment methods, can provide you with professional transdermal patch testing services. If you have any needs, please feel free to contact us and our colleagues will reply to you within three working days.

References

  1. Huang Ting, Zhang Jing, et al. Research Progress in Technology and Quality Control of Transdermal Patches. Chinese Pharmaceutical Affairs. 2023, Volume 37, issue 9.
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