Optimisation of Patient Centric Medicines for the Older Population

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: closed (30 November 2020) | Viewed by 23285

Special Issue Editors


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Guest Editor
Aston Pharmacy School, College of Health and Life Sciences, Aston University, Birmingham B4 7ET, UK
Interests: drug delivery; formulation; pharmaceutics; age-appropriate formulation; particulate drug delivery systems; paediatrics; 3D printing
Research Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK
Interests: patient centric medicine; oral drug delivery; biopharmaceutics; 3D printing; geriatrics; paediatrics; medicine acceptability; formulation; reformulation; repurposing; orodispersible

Special Issue Information

Dear Colleagues,

Improvements in healthcare and lifestyles have increased the proportion of people aged 65 and above, whilst this population also represents a major user group of prescribed medicines. Optimising the use of these medicines is important to ensure that these patients are willing and able to take their medication as intended in order to manage conditions effectively; however, age-related changes, the presence of co-morbidities and issues of acceptance and adherence can lead to complexities in medicines optimisation in this heterogeneous population.

This Special Issue serves to highlight and capture the contemporary progress and current landscape of patient-centric pharmaceutical drug product design, formulation and optimisation for the older population. We invite articles on all aspects of research focused on identifying, understanding and utilising the comprehensive needs and diverse complexities of this patient group in order to achieve optimum health outcomes, particularly those studies highlighting the requirements for a multidisciplinary approach, including the use of healthcare technologies.

Dr. Daniel J. Kirby
Dr. Mine Orlu
Guest Editors

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Keywords

  • patient centric medicines
  • ageing
  • older people
  • acceptance
  • adherence
  • formulation
  • medicines optimisation

Published Papers (6 papers)

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Research

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20 pages, 2548 KiB  
Article
Multi-Analytical Framework to Assess the In Vitro Swallowability of Solid Oral Dosage Forms Targeting Patient Acceptability and Adherence
by Abdul Latif Ershad, Ali Rajabi-Siahboomi, Shahrzad Missaghi, Daniel Kirby and Afzal Rahman Mohammed
Pharmaceutics 2021, 13(3), 411; https://doi.org/10.3390/pharmaceutics13030411 - 19 Mar 2021
Cited by 7 | Viewed by 3687
Abstract
A lack of effective intervention in addressing patient non-adherence and the acceptability of solid oral dosage forms combined with the clinical consequences of swallowing problems in an ageing world population highlight the need for developing methods to study the swallowability of tablets. Due [...] Read more.
A lack of effective intervention in addressing patient non-adherence and the acceptability of solid oral dosage forms combined with the clinical consequences of swallowing problems in an ageing world population highlight the need for developing methods to study the swallowability of tablets. Due to the absence of suitable techniques, this study developed various in vitro analytical tools to assess physical properties governing the swallowing process of tablets by mimicking static and dynamic stages of time-independent oral transitioning events. Non-anatomical models with oral mucosa-mimicking surfaces were developed to assess the swallowability of tablets; an SLA 3D printed in vitro oral apparatus derived the coefficient of sliding friction and a friction sledge for a modified tensometer measured the shear adhesion profile. Film coat hydration and in vitro wettability was evaluated using a high-speed recording camera that provided quantitative measurements of micro-thickness changes, simulating static in vivo tablet–mucosa oral processing stages with artificial saliva. In order to ascertain the discriminatory power and validate the multianalytical framework, a range of commonly available tablet coating solutions and new compositions developed in our lab were comparatively evaluated according to a quantitative swallowability index that describes the mathematical relationship between the critical physical forces governing swallowability. This study showed that the absence of a film coat significantly impeded the ease of tablet gliding properties and formed chalky residues caused by immediate tablet surface erosion. Novel gelatin- and λ-carrageenan-based film coats exhibited an enhanced lubricity, lesser resistance to tangential motion, and reduced stickiness than polyvinyl alcohol (PVA)–PEG graft copolymer, hydroxypropyl methylcellulose (HPMC), and PVA-coated tablets; however, Opadry® EZ possessed the lowest friction–adhesion profile at 1.53 a.u., with the lowest work of adhesion profile at 1.28 J/mm2. For the first time, the in vitro analytical framework in this study provides a fast, cost-effective, and repeatable swallowability ranking method to screen the in vitro swallowability of solid oral medicines in an effort to aid formulators and the pharmaceutical industry to develop easy-to-swallow formulations. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
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11 pages, 255 KiB  
Article
Review of Clinical Questions Submitted to Norwegian Drug Information Centres Concerning Administration and Dosage to Older Patients of Relevance to Patient-Centric Care
by Jan Schjøtt, Lillan Mo Andreassen, Gro Helen Dale and Charlotte Lorentze Stokes
Pharmaceutics 2021, 13(1), 105; https://doi.org/10.3390/pharmaceutics13010105 - 14 Jan 2021
Cited by 1 | Viewed by 2198
Abstract
Patient-centric care entails optimising healthcare provision to patients based on their perspective and opinion. It involves appropriate treatment at a reasonable cost and a focus on patient characteristics in the decision-making process to make it more personally useful. The optimisation of medicines in [...] Read more.
Patient-centric care entails optimising healthcare provision to patients based on their perspective and opinion. It involves appropriate treatment at a reasonable cost and a focus on patient characteristics in the decision-making process to make it more personally useful. The optimisation of medicines in the older population is a challenge due to physiological changes, comorbidity, and polypharmacy. Furthermore, patient-centric care is difficult to achieve due to the high proportion of patients with dementia and frailty. Decision support concerning the appropriateness of indication, formulation, dose, administration, co-prescribing, and length of treatment to older patients is frequently in demand. In the current study, we aimed to review clinical questions concerning administration and dosage to older patients of relevance to patient-centric care. We analysed questions concerning medicines to patients 65 years or older in the database of the network of Norwegian drug information centres from 2010 to 2020. The analysis included the distribution of drugs, diseases, and recurring topics among the questions. Through a Boolean search that combined the indexed categories of “older” and “administration and dosage”, we retrieved 84 question-answer pairs. Questions about psychotropic and cardiovascular drugs in relation to therapy, adverse drug reactions, and pharmacokinetics dominated, and more than 60% of the questions came from physicians. Topics relevant to patient-centric pharmacotherapy were drug withdrawal (10 questions), drug formulation (8 questions), drug initiation (8 questions), and switching drugs (5 questions). One question concerned drug withdrawal and switching, and one question drug formulation and switching. Answers provided decision support regarding appropriate formulations of drugs to patients with dementia who chew capsules or tablets, the use of parenteral administration in patients who refuse to take oral formulations, and the pharmacokinetics of transdermal or rectal drug administration. The results highlight the importance of including pharmacological factors in the assessment of the acceptability and appropriateness of oral and parenteral medicine to older patients. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
10 pages, 1131 KiB  
Article
An Investigation into the Relationship between Xanthan Gum Film Coating Materials and Predicted Oro-Esophageal Gliding Performance for Solid Oral Dosage Forms
by Nélio Drumond and Sven Stegemann
Pharmaceutics 2020, 12(12), 1241; https://doi.org/10.3390/pharmaceutics12121241 - 20 Dec 2020
Cited by 4 | Viewed by 2712
Abstract
Oral drug therapy is generally provided in the form of solid oral dosage forms (SODF) that have to be swallowed and move throughout the oro-esophageal system. Previous studies have provided evidence that the oro-esophageal transit of SODF depends on their shape, size, density, [...] Read more.
Oral drug therapy is generally provided in the form of solid oral dosage forms (SODF) that have to be swallowed and move throughout the oro-esophageal system. Previous studies have provided evidence that the oro-esophageal transit of SODF depends on their shape, size, density, and surface characteristics. To estimate the impact of SODF surface coatings during esophageal transit, an in vitro system was implemented to investigate the gliding performance across an artificial mucous layer. In this work, formulations comprised of different slippery-inducing agents combined with a common film forming agent were evaluated using the artificial mucous layer system. Xanthan gum (XG) and polyethylene glycol 1500 (PEG) were applied as film-forming agents, while carnauba wax (CW), lecithin (LE), carrageenan (CA), gellan gum (GG) and sodium alginate (SA), and their combination with sodium lauryl sulfate (SLS), were applied as slippery-inducing components. All tested formulations presented lower static friction (SF) as compared to the negative control (uncoated disc, C, F0), whereas only CW/SLS-based formulations showed similar performance to F0 regarding dynamic friction (DF). The applied multivariate analysis approach allowed a higher level of detail to the evaluation and supported a better identification of excipients and respective concentrations that are predicted to improve in vivo swallowing safety. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
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15 pages, 1326 KiB  
Article
Patient-Centric Medicine Design: Key Characteristics of Oral Solid Dosage Forms that Improve Adherence and Acceptance in Older People
by Zakia Shariff, Daniel Kirby, Shahrzad Missaghi, Ali Rajabi-Siahboomi and Ian Maidment
Pharmaceutics 2020, 12(10), 905; https://doi.org/10.3390/pharmaceutics12100905 - 23 Sep 2020
Cited by 25 | Viewed by 4753
Abstract
Older people represent a very heterogeneous patient population and are the major user group of medication. Age-related changes mean that this population can encounter barriers towards taking medicines orally. The aim of this study was to investigate the characteristics of oral solid dosage [...] Read more.
Older people represent a very heterogeneous patient population and are the major user group of medication. Age-related changes mean that this population can encounter barriers towards taking medicines orally. The aim of this study was to investigate the characteristics of oral solid dosage forms that contribute to an age appropriate dosage design, with an aim to improve overall medication adherence and acceptance in older people. Fifty-two semistructured interviews were conducted with older people, informal (family) carers, and health and social care professionals. Formulation characteristics impacted three stages of the medication taking process: (1) medication identification and memorability, (2) medication handling and (3) swallowability. Small round tablets (≤7 mm) are least accepted amongst older people and their carers and had a negative impact on all stages. The use of bright, two-coloured preparations and interesting shapes improves identification and further aids memorability of indications and the timing of tablets. Palatability, while useful to enhance swallowability, also has an impact on the visual appeal and memorability of medication. Environmental, patient, medication and disease characteristics also determine preferences for formulation. Developing an age appropriate dosage design for older people, therefore, requires a holistic, patient-centric approach to improve adherence and acceptance. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
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11 pages, 1537 KiB  
Article
Acceptability in the Older Population: The Importance of an Appropriate Tablet Size
by Thibault Vallet, Hugues Michelon, Mine Orlu, Yogini Jani, Patrick Leglise, Sandra Laribe-Caget, Matthieu Piccoli, Aurélie Le Fur, Fang Liu, Fabrice Ruiz and Vincent Boudy
Pharmaceutics 2020, 12(8), 746; https://doi.org/10.3390/pharmaceutics12080746 - 8 Aug 2020
Cited by 28 | Viewed by 4181
Abstract
Presenting many advantages, solid oral dosage forms (SODFs) are widely manufactured and frequently prescribed in older populations regardless of the specific characteristics of patients. Commonly, patients with dysphagia (swallowing disorders) experience difficulties taking SODFs, which may lead to non-adherence or misuse. SODF characteristics [...] Read more.
Presenting many advantages, solid oral dosage forms (SODFs) are widely manufactured and frequently prescribed in older populations regardless of the specific characteristics of patients. Commonly, patients with dysphagia (swallowing disorders) experience difficulties taking SODFs, which may lead to non-adherence or misuse. SODF characteristics (e.g., size, shape, thickness) are likely to influence swallowability. Herein, we used the acceptability reference framework (the ClinSearch acceptability score test (CAST))—a 3D-map juxtaposing two acceptability profiles—to investigate the impact of tablet size on acceptability. We collected 938 observer reports on the tablet intake by patients ≥65 years in hospitals or care homes. As we might expect, tablets could be classified as accepted in older patients without dysphagia (n = 790), while not in those with swallowing disorders (n = 146). However, reducing the tablet size had a significant impact on acceptability in this subpopulation: tablets <6.5 mm appeared to be accepted by patients with swallowing disorders. Among the 309 distinct tablets assessed in this study, ranging in size from 4.7 to 21.5 mm, 83% are ≥6.5 mm and consequently may be poorly accepted by institutionalized older people and older inpatients suffering from dysphagia. This underlines the need to develop and prescribe medicines with the best adapted characteristics to reach an optimal acceptability in targeted users. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
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Review

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24 pages, 3477 KiB  
Review
Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience
by Nélio Drumond and Sven Stegemann
Pharmaceutics 2021, 13(1), 32; https://doi.org/10.3390/pharmaceutics13010032 - 28 Dec 2020
Cited by 21 | Viewed by 5033
Abstract
Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially [...] Read more.
Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially when considering the multimorbid, frail, and polymedicated patients. Swallowing impairments have a negative impact on SODF administration, which leads to poor adherence and inappropriate alterations (e.g., crushing, splitting). Different strategies have been proposed over the years in order to enhance the swallowing experience with SODF, by using conventional administration techniques or applying swallowing aids and devices. Nevertheless, new formulation designs must be considered by implementing a patient centric approach in order to efficiently improve SODF administration by older patient populations. Together with appropriate SODF size reductions, innovative film coating materials that can be applied to SODF and provide swallowing safety and efficacy with little effort being required by the patients are still needed. With that in mind, a literature review was conducted in order to identify the availability of patient centric coating materials claiming to shorten esophageal transit times and improve the overall SODF swallowing experience for older patients. The majority of coating technologies were identified in patent applications, and they mainly included well-known water soluble polymers that are commonly applied into pharmaceutical coatings. Nevertheless, scientific evidence demonstrating the benefits of given SODF coating materials in the concerned patient populations are still very limited. Consequently, the availability for safe, effective, and clinically proven solutions to address the increasing prevalence of swallowing issues in the older patient population is still limited. Full article
(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)
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