Drug Product Development for Older Adults – Multiparticulate Formulations

The multiparticulate drug product concept covering micropellets, pellets,and mini-tablets is presented as a highly feasible approach to present convenient and patient friendly medication for the geriatric population. Improved swallowability and optimized administration regimen going along with defined drug dosage are achievable. Extemporaneous preparation of medicines from standard medication can be avoided going along with improved patient safety. With one multiparticulate pellet, micropellet, or mini-tablet bulk formulation a broad range of final drug products is presentable applying well-established manufacturing technologies at viable cost.

Introduction

The demographic trend in both developed and developing countries is moving towards a society with an increasing percentage of people above 65 years of age. More significant will be the shift of composition of the elderly population over the next four decades toward more people above 80 years of age, because of increasing life expectancy and the generation of baby boomers passing the age of 65 years. The use of medicinal drug products is the main intervention when treating and managing medical conditions of people in our society. Safe and effective medicinal drug products have contributed significantly to the increasing health and longevity of mankind.

With our increasing medical knowledge and the heterogeneity of patients, the therapeutic approaches will become more specific for patient populations and thus more individualized in terms of drug selection, dose strength, dosage form convenience, drug combinations as well dosing regimen. Consequently, drug product development will have to change its paradigm by including the geriatric patients and heading toward an approach of integrating new medicinal products into a disease management concept.

ICH Guideline “Pharmaceutical Development Q8 (R2) (2009)” requires under “approaches to Pharmaceutical Development”: “In all cases, the product should be designed to meet patients’ needs and the intended product performance”. The multiparticulate formulation approach is meant to positively support the aspects of patient safety, usability, and compliance by offering drug products considering the overall health status of geriatric patients.

The Elderly Patient

Aging is a gradual change of various physiological, biological, physical, and social functions of the human being. Along with age-related gradual changes, the incidence for chronic diseases and comorbidity, chronic drug therapy becomes very challenging and complex with the increasing number of drugs for the treatment.

The major age-related changes and differences compared to a young adult concern the physiological functions, the cognitive, visual, motoric, and swallowing capabilities. Geriatric patients often require different doses that are often not available and dosage form splitting by the patient or the caregivers is required. Geriatric patients, due to their limited and varying motoric capabilities might have considerable problems for accurate splitting of tablets. Click here to get the full chapter from “Developing Drug Products in an Aging Society” – Link to book