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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.
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]
Sample preparation may involve dissolution, extraction, reaction with some chemical species, pulverizing, treatment with a chelating agent (e.g. EDTA), masking, filtering, dilution, sub-sampling or many other techniques. Treatment is done to prepare the sample into a form ready for analysis by specified analytical equipment.
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.
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.
Solvation or dissolution is a kinetic process and is quantified by its rate. Solubility quantifies the dynamic equilibrium state achieved when the rate of dissolution equals the rate of precipitation. The consideration of the units makes the distinction clearer. The typical unit for dissolution rate is mol/s.
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Extraction is a diffusion-based process, in which the solvent is required to diffuse into the matrix and the extracted material to diffuse out of the matrix into the solvent. Diffusivities are much faster in supercritical fluids than in liquids, and therefore extraction can occur faster.