Chapter 5 - Particulate Level Properties and its Implications on Product Performance and Processing

Abstract

The pharmaceutical industry relies on different aspects of the manufacturing and formulation of drugs and related products. In particular, particulate levels of properties as well as the processing have the greatest impact on pharmaceutical products performance. A change in the properties of the particulate matter including the physical, chemical, and the mechanical properties may affect the various pharmaceutical products behaviors such as the solubility, stability, bioavailability, content uniformity, and many other aspects. In this regard, both researchers as well as manufacturers pay their utmost attention to particles characterization as a way to control and evaluate final products performance. In the last few decades many new technologies have been introduced to the pharmaceutical industries for particle design, characterization, and evaluation. Besides, several approaches were also developed to enhance the manufacture processing and the performance of pharmaceutical products in order to produce new dosage forms with enhanced qualities. This chapter provides an insight into various levels of solid states, their properties, and the mechanisms of particle–particle interactions. Pharmaceutical particle technologies introduced to improve drug solubility and bioavailability are also discussed. Characterization of various physical, chemical, and mechanical properties of particles and their impact on product manufacturing and performance are discussed in brief. A particular focus is given to different processing parameters, evaluation of drug performance, and various implications of particles. Effect of particulate properties on powders, semisolid dosage forms like pastes, thermal conductivity, and others along with various regulatory guidelines are also emphasized in this chapter.