Content Uniformity Testing Through Utilization of Automated Dissolution Technologies

摘要

Content uniformity testing of solid dosage forms is a critical test in almost all aspects of the drug development process. In both early-and late-phase development, uniformity testing meets a regulatory requirement for clinical release as directed by agencies globally. In scale-up efforts and design of experiment (DOE) tests in formulation development, it aids in the understanding of the effects of variation of parameters involved in solid dose formulation, including excipient compositions, blend rates, drying times, and tablet compression forces. As an increasing number of variables are examined in such testing, the number of individual dosage form units which need to be examined in chemical assays can become considerably large. Additionally, the manpower and reagents needed to carry out this testing become resource intensive as the amount of testing expands.