END-POINT DETERMINATION AND ITS RELEVANCE TO PHYSICOCHEMICAL CHARACTERISTICS OF SOLID DOSAGE FORMS

The focus of this research paper is on various aspects of endpoint det ermination of a typical wet granulation process. The determination of endpoint is highly variable for a conventional wet granulation process . However, high-shear granulators provide for precision in granulation , via the control of a majority of variables that are critical in wet granulation. Therefore, the use of precision in determination of endpo int to beneficially affect the performance of compressed tablets is ve ry desirable. The main objective of this study is to examine the relev ance of endpoint determination in controlling performance characterist ics of compressed tablets such as hardness, friability, disintegration time, and dissolution time. The effect of three variables-namely endp oint of wet granulation process, press speed (or dwell time), and comp ression force-on the performance of compressed tablets has been evalua ted using a full-factorial experimental design and response surface me thodology. Also, the hypothesis of counteracting inherent variability of a wet granulation process by rational selection of press speed and compression force has been investigated.