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There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
Typically, the parameter derived from the biological property is AUC or Cmax, while the physicochemical property is the in vitro dissolution profile. The main roles of IVIVC are: To use dissolution test as a surrogate for human studies. To supports and/or validate the use of dissolution methods and specifications.
During the dissolution testing, "sink condition" is a mandatory requirement, otherwise when the concentration begins to get too close to the saturation point, even though the total soluble amount still remains constant, the dissolution rate will gradually begin to reduce in significant amounts, enough to corrupt the test results. . [2] [3] [4]
Both tests should accurately measure the purity of the sample. Quantitative tests of either the active moiety or other components of a sample can be conducted through assay procedures. Other analytical procedures such as dissolution testing or particle size determination may also need to be validated and are equally important.
When the dissolution rate of a pure substance is normalized to the surface area of the solid (which usually changes with time during the dissolution process), then it is expressed in kg/m 2 s and referred to as "intrinsic dissolution rate". The intrinsic dissolution rate is defined by the United States Pharmacopeia.
Of course, if you're feeling sick, it’s a good idea to test yourself so you can know the full picture of what you’re dealing with, says Thomas Russo, MD, a professor and chief of infectious ...
Leaching is the process of a solute becoming detached or extracted from its carrier substance by way of a solvent. [1]Leaching is a naturally occurring process which scientists have adapted for a variety of applications with a variety of methods.
Andalusia describes Caper’s time spent in the hospital after his second surgery as “awful,” saying that they felt like they could see him regressing.