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In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
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.
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.
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]
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For instance, calcium dissolution tests have shown that other ions present in the medium can be well resolved among themselves and also from the calcium ion. Therefore, IC has been employed in drugs in the form of tablets and capsules in order to determine the amount of drug dissolve with time. [ 59 ]
According to the U.S. Department of Health and Human Services, anywhere from 1 percent to 5 percent of the more than 100,000 annual adoptions in the US are legally terminated in a “dissolution.”
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