In recent years, in association with progress and innovation in the
field of pharmaceutical technology, there has been an increasing
effort to develop prolonged release dosage forms for many drugs.
Correspondingly, a growing number of new prolonged release dosage
forms have been submitted for regulatory approval. Prolonged
release dosage forms have many advantages in safety and efficacy
over immediate release drug products in that the frequency of
dosing can be reduced, drug efficacy can be prolonged and the
incidence and/or intensity of adverse effects can be decreased.
However, some prolonged release dosage forms have less clear
rationale or are developed for active ingredients which are not
appropriate for prolonged release dosage forms. In other cases,
prolonged release dosage forms are designed without full
consideration of the basic properties of the drugs. Moreover,
standards for dissolution tests, which are important for evaluating
prolonged release dosage forms, have not appropriately been
established. As a result, it is often difficult to evaluate whether
a prolonged release dosage form is acceptable or not.
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