Pharmaceutical Formulations for Older Patients – Part 1
See the new book, edited by Mine Orlu, Fang Liu
- Provides a better understanding on the EMA reflection paper on pharmaceutical development for older patients
- Details reasons for applying advanced pharmaceutical technologies for the benefit of the ageing population
- Discusses Advanced pharmaceutical technologies for their potential use in older adults for medication optimization
Description
Pharmaceutical formulation design affects patient acceptability/adherence and pharmacokinetics of the drug. This is particularly important for older patients because of the physiological changes due to ageing and clinical/social circumstances related to medicine taking.
This book provides a comprehensive review in the design of formulations to meet the needs of older patients. An overview of the key clinical, social and pharmaceutical factors affecting medication optimization, safety and acceptability in older adults is included, followed by patient-centric considerations including regulatory requirements, dosage form design and human factor studies.
Advanced pharmaceutical technologies are discussed for their potential use in older adults such as 3D printing, long-acting oral formulations and novel vaccine technologies. The unique focus of the book will be of interest to pharmaceutical scientists in both industry and academia in searching for better formulations for older patients.
Chapter 1
Medication Optimisation in Older People
The population of the UK and many countries worldwide is ageing. Older people tend to suffer from more diseases and therefore take more medication. This is in addition to other factors, such as physical and mental frailty, which can make medication optimisation more challenging in older people.
This chapter introduces some of the key challenges associated with optimising medications for older people. It explores key social and clinical areas in older people and how this relates to medication optimisation including areas such as evidence-based prescribing, frailty, dementia, polypharmacy, deprescribing and swallowing difficulties. Ultimately, it aims to encourage person-centred care when optimising medications in the older person.
Smith, E.L., Maidment, I. (2023). Medication Optimisation in Older People. In: Orlu, M., Liu, F. (eds) Pharmaceutical Formulations for Older Patients. AAPS Advances in the Pharmaceutical Sciences Series, vol 51. Springer, Cham. https://doi.org/10.1007/978-3-031-35811-1_1
Chapter 2
Medication Safety in Older People
This chapter considers implications for medication safety due to pharmacokinetic and pharmacodynamic changes affecting the handling of medicines in older people and further considerations when switching medicine formulations with differing bioequivalences. This chapter outlines concerns around supply and administration of medicines, with attention paid to cognitive capacity, accessibility in relation to oral medications and skin, eye, and other routes of drug delivery. Monitoring of medication therapy and outcomes by patients, carers and healthcare professionals is discussed.
Support strategies to facilitate the safer use of medicines throughout the prescribing, supply, administration and monitoring process are provided. The wider, holistic aspects that need to be considered on initiation and cessation (deprescribing) of medicines, including the appropriateness of using single-condition guidelines in people suffering from multimorbidity, are provided. Important aspects of medicine use around shared decision-making and patient empowerment are briefly discussed. Finally, a case study reflecting on the medicine use process with a focus on formulation is provided.
Umaru, N., Ip, S.S.Y. (2023). Medication Safety in Older People. In: Orlu, M., Liu, F. (eds) Pharmaceutical Formulations for Older Patients. AAPS Advances in the Pharmaceutical Sciences Series, vol 51. Springer, Cham. https://doi.org/10.1007/978-3-031-35811-1_2
Chapter 3
Medicine Acceptability: A Key Aspect in the Older Population
Older people have particular needs that require special considerations concerning healthcare due to the effects of ageing, such as the deterioration of physical and cognitive abilities, multimorbidity, polypharmacy, or frailty. In recent years, acceptability has emerged as a key factor for patient adherence in vulnerable populations and, consequently, for treatment effectiveness. Acceptability has been defined as the ability and willingness of a patient to self-administer and also of any of his/her lay or professional caregivers, to administer a medicinal product as intended. Although this multi-faceted concept is likely to be driven by many factors such as product or user characteristics, knowledge on acceptability drivers remains fragmented. Herein we present a data-driven approach based on a large set of real-life observer-reported outcomes. Using examples, this chapter illustrates how this multivariate approach can contribute to provide the scientific community with relevant knowledge on medicine acceptability drivers in the older population. Evidence base on acceptability drivers should facilitate the identification of the medicine features that best fit user characteristics in order to ensure the choice of appropriate formulations for adequate acceptability.
Vallet, T., Ruiz, F. (2023). Medicine Acceptability: A Key Aspect in the Older Population. In: Orlu, M., Liu, F. (eds) Pharmaceutical Formulations for Older Patients. AAPS Advances in the Pharmaceutical Sciences Series, vol 51. Springer, Cham. https://doi.org/10.1007/978-3-031-35811-1_3
Chapter 4
The Design of Patient-centric Dosage Forms for Older Adults
The older population is very diverse with regard to the health condition, as well as the perception and physical and cognitive ability of each individual subject. Furthermore, the prevalence of multi- morbidity and polypharmacy is increasing in the aging population, and while some patients are able to manage their medication independently, others require a significant level of caregiver assistance. From a pharmaceutical industry perspective, the development of a patient-centric drug product is a key objective to ensure safe, effective, and efficacious treatments, thus reducing healthcare costs and increasing the patient’s quality of life. This mission requires a cross-functional effort within the companies, a constructive dialogue with health authorities, as well as the involvement of patient populations, caregivers, physicians, hospitals, nursing homes, and health insurance companies. It starts from a sound understanding of patient needs, requirements, and disease conditions, which then feed into the design of age-appropriate dosage forms, the use of patient-specific biopharmaceutics prediction tools, as well as the application of human factors engineering to carefully consider and test the safe and effective use of the drug product by its intended user populations under real life conditions.
Page, S., Da Costa, S.B., Stillhart, C., Timpe, C., Wagner, L. (2023). The Design of Patient-centric Dosage Forms for Older Adults. In: Orlu, M., Liu, F. (eds) Pharmaceutical Formulations for Older Patients. AAPS Advances in the Pharmaceutical Sciences Series, vol 51. Springer, Cham. https://doi.org/10.1007/978-3-031-35811-1_4
Chapter 5
Development of Appropriate Medicines for Older Patients: An Industrial Perspective
In this chapter, we review the regulatory context behind the development of medicines for the older adult population, how to define the needs of this population and then design a drug product that is appropriate. This patient-centric approach is explored in some detail and discusses various approaches to align patient needs and capabilities with the final drug product. Many factors need to be considered in dosage form design such as selecting appropriate excipients, taking into consideration cumulative effects, excipient sensitivity and potential pharmacokinetic impact; designing a product that can be easily identified, handled and swallowed by the patient is critical; and size, shape, colour and packaging need to be carefully selected. Another important area that is covered is the need to assess the effectiveness of these design features and ensure they meet patient needs in real-world simulations.
Hughes, K., Miller, C. (2023). Development of Appropriate Medicines for Older Patients: An Industrial Perspective. In: Orlu, M., Liu, F. (eds) Pharmaceutical Formulations for Older Patients. AAPS Advances in the Pharmaceutical Sciences Series, vol 51. Springer, Cham. https://doi.org/10.1007/978-3-031-35811-1_5
See the full book here:
Mine Orlu, Fang Liu, Pharmaceutical Formulations for Older Patients, DOI https://doi.org/10.1007/978-3-031-35811-1, ISBN 978-3-031-35810-4, Published: 11 November 2023
See also the other chapters of the book here:
- Part 2 – is coming soon