In Situ Fiber Optics UV Monitoring System
Automatic addition of test solution, stirring, and temperature control functions enable real-time measurement of the dissolution rate and membrane permeability of small volumes of APIs. ◆ Measurement of API dissolution rate Evaluation of dissolution rates based on differences in crystal forms and salt forms of APIs. ◆ Measurement of dissolution rates using pH shift models Simulation of gastric-duodenal transition in the gastrointestinal tract and evaluation of drug effects. ◆ Measurement of drug permeability Analysis of drug permeability combined with PAMPA membranes that mimic intestinal epithelial cells. ◆ Measurement of dissolution rates of formulations Evaluation of dissolution rates based on differences in additives and particle shapes.
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basic information
It consists of four main components: - Dry heat stirring device - Precision test liquid injection device - Temperature monitoring device - UV generation and reception device The UV generation and reception device is composed of six UV optical fibers, which are automatically inserted into the sample by an elevating mechanism at the start of the test, collecting and displaying the UV signals from the sample in real-time (within 5 seconds) during the test.
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Applications/Examples of results
Intrinsic Solubility Rate Measurement It is used to distinguish between the dissolution rates of API crystals and salts, and to measure the dissolution rate of NCE molecules. It aids in the evaluation of the BCS classification of APIs, the selection of appropriate test solutions, and the optimization of APIs (crystal/salt forms). The impact on the rate of increase in drug concentration in the blood is lower the faster the dissolution rate; if the dissolution rate is slow, it becomes the rate-limiting step. pH Shift Model The environment within the human body is not static. The pH values can vary significantly between different organs or even at different stages within the same organ. These changes affect the dissolution of formulations and even their absorption. Therefore, understanding the dissolution of drugs under different pH environments helps predict the dissolution behavior of formulations in vivo. Permeation Model After dissolution, formulations permeate through membranes in the body. The permeability of a drug directly affects its efficacy. The common route for drug uptake into the human body is through intestinal epithelial cells. Raytor NCE DP constructs an in vitro permeation model using Bio-Flux membranes to simulate passive transport in the body and evaluate permeability.
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Company information
Aivic Research was established with the aim of contributing to the improvement of healthcare by helping to enhance the data accuracy of dissolution testing through the provision of excellent dissolution testers and dissolution tester inspection services, as well as introducing the latest dissolution testing information by utilizing various pipes from overseas, thereby supporting the development of the pharmaceutical industry in Japan.
