TABLE OF CONTENTS Physical properties and mechanical integrity of drug tablets often affect their therapeutic functions. Therefore, the monitoring for defects and the characterization of tablet mechanical properties are of great practical interest in the pharmaceutical industry. In this chapter, a set of non-destructive and non-contact techniques for quality monitoring and the characterization of the mechanical properties of coated drug tablets are summarized. To the best of our knowledge, the non-contact/nondestructive approaches presented here are the first in the pharmaceutical industry.
The most commonly used dosage form for pharmaceutical preparations is currently the tablet, available in various shapes and often administered orally. The advantages of the tablet dosage form are manifold: tablets are cost effective to manufacture, convenient to dispense and store, easy for the patient to administer, and they provide a versatile means of delivering the drug's active ingredients. The release of drug from the tablet can be controlled by altering the design and content of the formulation. Since this is a dry dosage form, tablets also provide a supportive material matrix to active ingredients for drug stability and generally have a relatively long shelf life.
Tableting is a complex manufacturing process in which a large body of first-principle-based and empirical knowledge is utilized. Practices as well as results can vary largely from manufacturer to manufacturer and such variations are clearly not desirable from a safety and cost standpoint. The US Federal Drug and Food Administration (FDA) initiated a program named Process Analytical Technology (PAT) to address various aspects of...
