Oral drug product use in the elderly patient population

Abstract

This chapter explores in detail the many considerations to be factored into the design of oral drug products for use in the elderly patient. These considerations include characteristics of the dose form and holistic drug product, as well as characteristics of the intended patient population. These characteristics are detailed and discussed. For synthetically manufactured drug substances, oral administration is the most frequent and popular drug administration route used in medical practice today. Subsequently, drug products designed to be administered by the oral route are the most common dosage forms available worldwide. The popularity of the oral route is a result of a number of inherent advantages, and these advantages impact all key stakeholders in the pharmaceutical paradigm, including patients, healthcare providers, manufacturers, and regulators. A few of the advantages of oral drug products over alternative routes of delivery include self-administration, dose accuracy and uniformity, stability, portability, lack of invasiveness, familiarity to patients, and relatively low cost to manufacture. Additionally, to have the best chance at designing an outstanding product, gaining a comprehensive understanding of the target customer behaviors and needs, and incorporating that knowledge into the product design, is a must. The evolution toward drug products that are intentionally designed to meet not only their safety, efficacy and quality requirements, but also provide opportunity for improved outcomes through better patient experience and improved adherence should enhance overall therapeutic outcomes. When designing for an elderly target patient population, the drug product designer and developer should pay particular attention to the specific characteristics of the disease state, target patient population, comorbidities and other emotional, environmental, and sociological factors that have the potential to impact or interfere with the elderly patient’s ability to use the product as intended. Failure to take a diligent approach in this regard can result in a greater likelihood of poor adherence and improper usage of the drug product, resulting in lower effectiveness, poor therapeutic outcomes, and potential safety risks.