Propiedades tecnologicas del sistema de excipientes Pharmatose 100®- Helmcel 100®

Today, optimization of excipients is made in three different ways: Synthesis of new chemical products, new grades of existing materials, and new combinations of existing materials or coprocessed excipients. A fourth way is the study of excipient systems to find their uses and limitations and know their possibilities when mixed with a given drug. An example is the study of the technological properties of the excipient system made of Pharmatose 100M® and Helmcel 100®. The technological properties used as a reference are: Compactibility, disintegration time and ejection force of the tablets, and the powder flow, using reported methos or methods designed for this purpose. The results showed an increasing tablet hardness with increasing compaction forces according to a mathematical model previously established. Moreover, increasing proportions of Helmcel 100® in the excipient system produced tablets with a linearly increasing hardness. The disintegration time decreased linearly with increasing concentrations of Pharmatose 100M® in the mixtures, up to a concentration of 70%. After this, the disintegration time decreased linearly at a lower rate. The distintegrability, defined as the time necessary to disintegrate bonds of mechanical strength equivalent to 1 newton, was better for lactose matrices (lower disintegration times) than for matrices of cellulose. The ejection force of the tablets increased linearly with increasing compaction forces. A trend to decreasing of ejection forces with increasing Helmcel 100® concentrations was also observed. The rate of powder flow is low at low concentrations of Pharmatose 100M® up to a concentration of 70-80%, were the powder flow increases drastically until a tenfold value. This occurs measuring the powder flow through a funnel with an output diameter of 10 mm as well as with the determination of the Hausner Factor. These results allow the conclusion that some properties of the excipient system apparently depend on which substance constitutes the matrix or continuous phase of the powder mixture, Helmcel 100® or Pharmatose 100M® (disintegration time and powder flow). For the compactibility and ejection force, the continuous phases present a behavior similar enough to make the response independent of a change of phases. The purpose of an excipient system is the expansion of the technological properties of the individual excipients to provide a broader range of uses of the excipient during formulation. The studied system showed limited possibilities to expand the technological properties of individual excipients.