Approaches to the modeling of tablet processing and stability of solid dosage forms

Jothi Ganesh Kesavan, Purdue University

Abstract

Tablet formulation presents a challenge. This is because of the competing and counteracting requirements of a tablet system. Three objectives relevant to the development of a tablet dosage form were investigated. A model granulation and tablet system was designed. In this model system, four variables were chosen and they were the granulation equipment, the diluent, the binder concentration, and the binder addition method. Granulations and tablets were prepared according to a fixed experimental design and were evaluated. The results of the model system were used for developing neural network models and for studying the tablet compaction event. Neural networks were utilized for modeling and predicting the characteristics of the granulation and tablet system. The neural networks satisfactorily predicted all the granulation and tablet properties in the training step. The neural networks also satisfactorily predicted all the granulation and tablet properties in the testing step except for hardness and friability. The second objective was to study the effect of the tablet compaction on the tablet properties. Both the time and force compression parameters were significant in predicting the tablet properties. The third objective addressed the stability of theophylline anhydrous present in a theophylline anhydrous-polyvinylpyrrolidone physical mixture. The effect of relative humidity on the stability was investigated. The glassy and rubbery states of polyvinylpyrrolidone affected the hydration of theophylline anhydrous in the physical mixture by different mechanisms.

Degree

Ph.D.

Advisors

Peck, Purdue University.

Subject Area

Pharmaceuticals|Industrial engineering|Artificial intelligence

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