Tablets

Tablets

Introduction

The development of a new chemical entity (NCE) requires the testing of its biological activity at various stages of development. For systemically acting drugs, animal studies are carried out at early stages of development using parenteral administration of a solubilized form of the drug. As drug development proceeds to later stages, human clinical studies are preferred with an orally administered dosage form that is both simple to formulate and provides adequate bioavailability. Preferred drug product (DP) dosage form choices are determined based on the drug substance’s (DS’s) physico-chemical properties, patient and disease state constraints and preferences, dose, manufacturability, and commercial factors such as other therapeutic options available to the patient.

An oral tablet dosage form is usually the most preferred dosage form because of patient convenience and acceptance. Most drugs are formulated in tablet dosage forms. Tablets are available in a wide variety of shapes, sizes, colors, and surface markings. This chapter would describe the types of tablets and discuss its formulation components, manufacturing pro-cesses, quality attributes, and some key considerations in the design and development of an oral tablet dosage form.