Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms

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. Incomplete or undesirable prolonged release drugs may merely cause therapeutic confusion and, in addition may interfere with development and spread of good quality drugs. As part of the effort to ensure and promote drug reliability, it appears necessary to establish appropriate guidelines for the design and evaluation of prolonged release dosage forms. The present guidelines are prepared for oral prolonged release dosage forms, mainly for drugs with new pharmaceutical forms. However, many of the general principles of the guideline are also applicable to other controlled release dosage forms.