(106a) Assessment of the Influence of Surface Modified Pharmaceutical Powders On Dissolution and Mechanical Properties of the Tablets

Engineered particles, which are surface modified via dry coating have been shown to have improved flow and handling properties, and hence are very useful for a number of industrial applications. Recent work in our group has indicated that dry coating makes it possible to impart improved flowability for blends with very high API contents (higher than 75 %) even for very cohesive micronized API powders. This is very useful for pharmaceutical processing including flow, handling and downstream processing. However, the influence of such surface modification on downstream product properties has not been well investigated. In this work, preparation, characterization and applications of such engineered particles to pharmaceutical applications is considered, and in particular, the influence of such powders on tablet properties, including dissolution is examined.

Acetaminophen and ibuprofen are considered as model active pharmaceutical ingredients (APIs), and are surface modified via dry coating of nano-additives. The study considers use of hydrophobic as well as hydrophilic nano-additives. Tablets are prepared for two types of API loadings, low API concentration and high API concentration. Drug release profile and disintegration time from these tablets are examined and compared with that of tablets made from comparable formulations containing uncoated APIs. In addition, mechanical properties of these tablets are evaluated, including strength, weight and content uniformity, friability, density, hardness, etc.