Abstract
This chapter explores in detail the many considerations to be factored into the design of oral drug product s 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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Quillivant XR, Quillavant XR is a Registered Trademark of Pfizer Inc.
- 2.
Prevalence of Age-Related Macular Degeneration in the United States, The Eye Diseases Prevalence Research Group, Arch Ophtalmol. 2004;122:564–572.
- 3.
Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products; U.S. Dept. of Health and Human Services, Food and Drug Administration (CDER); May 2011.
- 4.
Aricept® Oral Jelly is a registered trademark of Eisai Co. Ltd.
- 5.
Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human factors and Usability Engineering to Medical Devices; U.S. Dept. of Health and Human Services, Food and Drug Administration (CDRH); February 3, 2016.
- 6.
Guidance for Industry (Draft): Safety Considerations for Product Design to Minimize Medication Errors; U.S. Dept. of Health and Human Services, Food and Drug Administration (CDER); December 2012.
References
Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy, 3rd ed., 1986.
Patient Adherence: The Next Frontier in Patient Care; Vision and Reality, 9th Edition; Global Research Report by Capgemini Consulting, 2011.
Cooper, Vanessa; From Hospital to Home: The Changing Therapeutic Area of Oncology, Adherence Researchâ„¢ Summarized; Atlantis Healthcare, 2013.
Charlesworth et al. Polypharmacy among adults age 65 years and older in the United States: 1988–2010, J Gerontolog A Biol Sci Med Sci. 2015;989–95.
Ben Shlomo Y, Kuh D. A life course approach to chronic disease epidemiology: empirical challenges and interdisciplinary perspectives. Int J Epidemiol 2002;31:285–93.
Stegemann S, et al. Geriatric drug therapy: neglecting the inevitable majority. Aging Res Rev. 2010;9:384–98.
Sampson EL et al. Enteral tube feeding for older people with advanced dementia (review). The Cochrane Collaboration; 2009.
Garin N, et al. Global multimorbidity patterns: a cross-sectional, population-based, multi-country study. J Gerontol A Biol Sci Med Sci. 2016;71(2):205–14.
Chen PH, et al. Prevalence of perceived dysphagia and quality-of-life impairment in a geriatric population. Dysphagia. 2009;24(1):1–6.
Stegemann S, Gosch M, Breitkreutz J. Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy. Int J Pharm. 2012;430(1):197–206.
Liu F et al. Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs 74.16 2014:1871–89.
Hey H, et al. Esophageal transit of six commonly used tablet and capsules. Br Med J. 1982;285:717.
Slavkova, et al. Orodispersible drug formulations for children and elderly. Eur J Pharm Sci. 2015;75:2–9.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Ternik, R.L. (2016). Oral Drug Product Use in the Elderly Patient Population. In: Stegemann, S. (eds) Developing Drug Products in an Aging Society. AAPS Advances in the Pharmaceutical Sciences Series, vol 26. Springer, Cham. https://doi.org/10.1007/978-3-319-43099-7_15
Download citation
DOI: https://doi.org/10.1007/978-3-319-43099-7_15
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-43097-3
Online ISBN: 978-3-319-43099-7
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)