Necessity for Compendial Dissolution Testing Requirements

Dissolution testing has become an important component of the assessment of the quality of solid oral dosage forms and oral suspensions. The basic procedures for these oral dosage forms have been extended to transdermal delivery systems as well. The release rate for modified-release oral dosage forms adds a level of sophistication to the concept of dissolution testing, setting acceptance criteria at multiple time points. 

The relationship between manufacturing variables and therapeutic action of compressed oral dosage forms was noted early in the history of mass-produced medicines. Caspari (6), in the late 19th century, recommended that a tablet have a composition that promotes disintegration and subsequent solution in the stomach to avoid impairment of its therapeutic value. The implementation of a disintegration procedure to 

INTRODUCTION AND IMPLEMENTATION OF COMPENDIAL DISSOLUTION TEST REQUIREMENTS 

USP recognition of the need to control the in vitro dissolution performance of oral products by some level of compendial requirement was evidenced by the formation of a joint USP-NF panel on physiological availability in 1967. The USP 

Early optimism about the possibility of in vitro-in vivo correlation was tempered by the need for a performance test that would yield reproducible results (10). Even though not necessarily correlated to bioavailability, dissolution requirements were seen as useful in controlling variables in formulation or processing. Thus, from the start, sources of variability in the results were seen as factors to be minimized in any proposed compendial method. 

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