Multivariate methods in the development of a new tablet formulation: optimization and validation.

In a previous study of the development of a tablet formulation approximately 100 excipients were characterized in screening experiments using multivariate design. Acceptable values for important responses were obtained with some of the formulations. The relationships between the properties of the excipients and the responses were evaluated using PLS.

Flowability measurements of pharmaceutical powder mixtures with poor flow using five different techniques.

Four different tablet formulations for direct compression with poor flow properties were tested regarding flowability using five different techniques: Hausner ratio, avalanching behavior, powder rheometer, uniaxial tester, and Jenike tester. In addition, the behavior of three of the formulations during emptying of the mixer and tableting was observed and compared to the results of the flowability measurements. The rank order correlation of the formulations was generally the same with all techniques.

Multivariate methods in the development of a new tablet formulation.

The overall objective of this article is to use an efficient approach to find a suitable tablet formulation for direct compression. By using traditional approaches to statistical experimental design in tablet formulation, the number of experiments quickly grows when many descriptive variables or many excipients are included. To facilitate the screening process, a multivariate design, which allows a systematical evaluation of a large number of excipients with a limited number of experiments, was implemented.