Robustness testing of a tablet formulation using multivariate design.

A total of 45 experiments were carried out to evaluate the robustness of two similar tablet formulations--a product of two strengths--with respect to normal batch-to-batch variation of the excipients and the active pharmaceutical ingredient. The formulations consist of 10 ingredients. Because of the differing amounts of active pharmaceutical ingredients, the two formulations also differ in the amounts of two of the diluents and one of the binders.

Multivariate methods in the development of a new tablet formulation: excipient mixtures and principal properties.

A tablet formulation for direct compression has previously been studied using multivariate design. An optimization study of one of the most important tablet properties, disintegration time, revealed that excipients with Principal Properties (PP's) that were predicted as suitable by the model were not represented within the studied material. The feasibility of using mixtures of excipients in the multivariate approach to tablet formulation to solve this problem has been investigated in the present study.

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.