A review discusses how dissolution in the context of drug absorption from the gastrointestinal (GI) tract can be modeled to gain insight into the important factors that control the rate of dissolution, and as a result, provide a mechanistic basis for predicting a correlation between in vitro dissolution and in vivo time profile of drug in the blood.The potential benefit from this insight will arise from the recognition of the critical factors that must be understood and controlled, and how to best design tests to ensure the quality of the finished drug products.A mechanistic model also provides a more proactive approach to the design of dosage forms, increasing the chances that the dosage form will have the desired release characteristics resulting in an efficacious drug plasma profile.It starts with an oversimplified view of dosage forms by assuming that all drugs are given as solutions with no need for disintegration and dissolution testing.It assumes that only drug in solution can cross the GI membrane.

Particle size of drug substance and product content uniformity-theoretical considerations

Author: Johnson, Kevin C.

A review on the effect of drug particle size on drug content uniformity using the concept of ideal mixing, with the goal of providing a model to predict when poor content uniformity will likely occur, and thereby, provide a strategy to set drug particle size specifications to avoid the problem.The concept of ideal mixing is compared to the approach of Yalkowsky and Bolton.The concept of ideal mixing is to make the drug particle size distribution in each dosage form the same as the lot of drug used to make the dosage forms.This is a reasonable goal, for if the particle size makeup of the drug in the dosage form did not match the drug itself, some segregation of drug particles would have to have occurred, leading to a lack of homogeneity.Any drug particle size reduction after the original milling due to processing, such as blending, roller compaction, and further milling of the drug and excipient blend, in general will be favorable to content uniformity.

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