In vitro, or "within the glass," dissolution testing is a method used in pharmaceutical development and quality control to evaluate the release rate of an active ingredient or drug from its dosage form (such as tablets or capsules) under simulated physiological conditions.
During the test, the dosage form is placed in a dissolution apparatus, typically consisting of glass reservoirs containing a dissolution medium (such as water or simulated gastric/intestinal fluid,) with temperature and agitation controls. The dosage form slowly dissolves in the medium, releasing the active ingredient. The concentration of the released active ingredient in the medium is measured at regular intervals using various analytical methods (such as in situ UV spectroscopy or automated sampling for HPLC/UV-vis), which allows the determination of the release rate and dissolution profile of the drug.
In vitro dissolution testing helps to assess the performance and quality of different drug formulations, as well as to ensure consistency in drug release between different batches (QC dissolution testing.) It is a crucial step in drug development, as it provides valuable data for formulation optimization, comparison of generic drugs with innovator products (to demonstrate bioequivalence,) and assessing the impact of different variables (such as pH or enzymes) on drug release.
Regulatory authorities, such as the US Food and Drug Administration (FDA), often require in vitro dissolution testing as part of the approval process for new drug products, especially for oral solid dosage forms. The testing methodology may be specified in pharmacopeial monographs or in specific guidelines provided by regulatory agencies.
Pion Inc. has been helping drug formulators in their drug development efforts for more than 20 years. With tools to help assess in vitro dissolution and permeability including our in-situ fiber optic, UV spectrometer, Rainbow, Pion can help establish a correlation between in vitro results and in vivo, or "within the living," outcomes. We are experts in in vitro dissolution testing. Contact us to learn more.
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