NEW CONCEPTS AND STANDARDS OF QUALITY CONTROL AS APPLIED TO CONTROLLED DRUG DELIVERY SYSTEMS

Publisher Summary This chapter focuses on new concepts and standards of quality control as applied to controlled drug delivery systems. It discusses about ALZA that has pioneered in the development, production, and commercial introduction of a new family of pharmaceutical products described as therapeutic systems—drug-containing devices or dosage forms that provide precise control over the rate and duration of administration of a specific drug to a particular body site, for the primary purposes of maximizing safety and therapeutic efficacy of the selected drug for the indicated therapeutic purpose. The principal objectives underlying the design and use of such therapeutic systems are: (1) to optimize in time and space the concentration of the pharmaceutically active substance—a result often unachievable with conventional modes of drug administration, and (2) to remove the vagaries and uncertainties of self-medication from the hands of the patient, and place them under the control of a “preprogrammed” delivery system that administers drug according to a prescribed period, irrespective of interpatient physiological differences, patient habits, or environment. The chapter highlights that for all such products, the principal claim that is sought for their registration and sale is their superiority over conventional dosage forms of the same drug-entity, from the standpoint of safety, and/or therapeutic efficacy.