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The main objective of developing and evaluating an IVIVC is to establish the dissolution test as a surrogate for human studies, as stated by the Food and Drug Administration (FDA). [5] Analytical data from drug dissolution testing are sufficient in many cases to establish safety and efficacy of a drug product without in vivo tests, following ...
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.
Interface/slow mixing (often performed in an NMR tube). Similar to the above, but instead of one solvent gas-diffusing into another, the two solvents mix (diffuse) by liquid-liquid diffusion. Typically a second solvent is "layered" carefully on top of the solution containing the compound. Over time the two solution mix.
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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The rate of dissolution will decrease substantially once it needs to penetrate through the pores of substance A in order to continue targeting substance B. [1] This penetration can often lead to dissolution of substance A, [1] or the product of more than one solute, [10] both unsatisfactory if specific leaching is desired.
Japan’s government on Friday asked a court to order the dissolution of the Unification Church branch in Japan following the assassination of former Japanese prime minister Shinzo Abe in July 2022.