Abstract
The elderly are seen as a distinct population in which medications should be used with extreme caution. Age-related physiological characteristics of the body affect the safety profile of drugs and may increase the risk of adverse reactions. Pharmaceutical drug development in geriatrics is designed to consider said characteristics of patients in this category. Objectives of the study: to highlight the features of pharmacokinetics and pharmacodynamics of drugs in the geriatric population in the context of age-related, physiological, and pathophysiological changes in individuals of this group and related approaches to minimizing the risks of pharmacotherapy at the stage of pharmaceutical drug development. Materials and methods are analysis of publications from the PubMed database using such approaches as system analysis, generalization, and systemic approach, as well as a bibliographic method based on the processing of sources of information on the features of pharmacokinetics and pharmacodynamics of drugs in geriatrics, as well as the use of drugs in this group of patients and the development of geriatric dosage forms. The article discusses an impact of such factors as the features of pharmacokinetics and pharmacodynamics of drugs, concomitant diseases and polypharmacy, and decrease in compliance (adherence to treatment) on the safety of pharmacotherapy in patients of the geriatric population. Also, considering the above factors, approaches to the pharmaceutical drug development in geriatrics and the management of patients of this group are highlighted. Attention is paid to the provisions of the draft reflection paper of the European Medicines Agency on the pharmaceutical development of medicines for use in the older population, namely, recommendations on the tablet breaking, administration of drugs through enteral feeding tubes, and temporary storage of medicines outside the original packaging. The advantages of using multi-particulate dosage forms, fixed-dose combinations, and orodispersible dosage forms are summarized. Pharmacokinetics and pharmacodynamics of drugs in geriatric patients have their peculiarities due to age-related, physiological, and pathophysiological factors in this category of patients. This should be considered in pharmaceutical drug development. The use of fixed-dose combinations and multi-particulate dosage forms, as well as adherence to good pharmacotherapy practices in geriatrics, are designed to ensure the safety of pharmacotherapy and improve compliance in elderly patients. It is expedient to further establish regulatory guidelines and recommendations in pharmaceutical geriatric drug development and conduct clinical research on drugs for use in this population.
Published Version
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