Development of a new diluent for tableting: Agglomerated talc

Kangwen L Lin, Purdue University

Abstract

In this study, the physical properties of talc samples from different sources were analyzed and examined. Agglomerated talc was produced by the wet granulation process using the fluidized bed granulator, planetary mixer, and high speed high shear mixer. Experiments were designed to characterize the agglomerated talc produced using different granulating agents and different granulation apparatus, to formulate agglomerated talc with active drug, and to explore the feasible formulation for the agglomerated talc-drug system. The granulation process is complicated because everything that is associated with this process becomes a variable that must be carefully controlled. Therefore, different statistical designs were applied to study the effect of processing variables on the characteristics of the resultant agglomerated talc. By evaluating the physical properties of the agglomerated talc prepared by different granulation equipment, the mechanism of granulation for each process can be elucidated. The results of the experiments suggested that U.S.P. grade talcs varied in physical properties and that the talc with lower bulk density and higher surface area requires less peak force to break the tablet/die-wall adhesion. It was also found that agglomerated talc produced by a fluidized bed granulator is more porous, has a more irregular shape, a lower bulk density and has numerous binder talc contacts. This higher surface area of binder-talc interface and the highly porous and irregular shape of the agglomerated talc produced by the fluidized bed granulator result in stronger intergranular bonding and harder compact. Phenylpropanolamine HCl tablets which contained 77.5% agglomerated talc as the diluent were prepared. The friability and disintegration behavior of the tablet were found to be satisfactory. The importance of these studies is that, through the granulation process, some undesirable properties of talc as a tablet diluent were successfully altered and that agglomerated talc is a promising self-lubricating direct compression diluent. It has been demonstrated that the quality of the product and granulation process can be successfully controlled by using an appropriate statistical design.

Degree

Ph.D.

Advisors

Peck, Purdue University.

Subject Area

Pharmacology|Pharmaceuticals

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