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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.
The integral heat of dissolution is defined as a process of obtaining a certain amount of solution with a final concentration. The enthalpy change in this process, normalized by the mole number of solute, is evaluated as the molar integral heat of dissolution. Mathematically, the molar integral heat of dissolution is denoted as
Gravimetric analysis describes a set of methods used in analytical chemistry for the quantitative determination of an analyte (the ion being analyzed) based on its mass. The principle of this type of analysis is that once an ion's mass has been determined as a unique compound, that known measurement can then be used to determine the same analyte's mass in a mixture, as long as the relative ...
Adding of an isotopically altered standard to the sample changes the natural isotopic composition of the analyte. By measuring the resulting isotopic composition, it is possible to calculate the amount of the analyte present in the sample. Isotope dilution analysis is a method of determining the quantity of chemical substances. In its most ...
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]
In a dissolution process, a solute is changed from a pure phase—solid, liquid, or gas—to a solution phase. If the pure phase of the solute is a solid or gas (presuming the solvent itself is liquid), the process can be seen in two stages: the phase change into a liquid, and the mixing of liquids. The dissolution process is generally ...
Lipinski's rule of five, also known as Pfizer's rule of five or simply the rule of five (RO5), is a rule of thumb to evaluate druglikeness or determine if a chemical compound with a certain pharmacological or biological activity has chemical properties and physical properties that would likely make it an orally active drug in humans.
A solubility equilibrium exists when a chemical compound in the solid state is in chemical equilibrium with a solution containing the compound. This type of equilibrium is an example of dynamic equilibrium in that some individual molecules migrate between the solid and solution phases such that the rates of dissolution and precipitation are equal to one another.