Pharmaceutical Dosage Forms: Tablets Rational Design and Formulation

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Volume 2 addresses this goal with a series of chapters that are replete with practical illustrations and formulation examples. A tablet may be viewed as a delivery system that must be designed to meet four specific criteria: first the drug must be “delivered” to the site of action in an active form in sufficient quantity and at the correct rate to meet the therapeutic objectives, second, the product must be physically and chemically stable to assure potency, safety, and consistent drug delivery performance over the use-life of the product, third, the tablet must be capable of being economically mass-produced in a manner that assures reliable dosing, and fourth, to the extent possible, the product must be patient acceptable. Accomplishing these tasks can be a substantial challenge. Formulation scientists are often confronted with a broad array of formulation and process variables that can interact in complex ways. The chapters on preformulation testing, drug product stability, and unit processes presented in Volume 1 provide an essential background for the rational development of dosage forms.