Dosage form suitability in vulnerable populations: A focus on paracetamol acceptability from infants to centenarians

Abstract

Introduction Medicine acceptability is a multi-faceted concept driven by both product and user characteristics. Although a key factor for treatment effectiveness, especially in vulnerable populations, knowledge of those medicine features that best promote individual user acceptability remains fragmented. Focusing on paracetamol, this study has explored the appropriateness of pharmaceutical products in different dosage forms to achieve adequate patient acceptability from infants to centenarians. Methods This observational, multicentre, prospective study was carried out in 10 hospitals, 8 nursing homes and over 150 community dispensaries. Observers reported several behaviours/events evaluating acceptability for 1016 different pharmaceutical product uses in paediatrics (<18y.) and 1288 in the elderly (≥65y.). Using mapping and clustering, a multivariate approach offered an intelligible reference framework for each population, providing comprehensive scores: positively or negatively accepted. Results Among all the evaluations supporting the acceptability reference frameworks, there were 502 reports on paracetamol products intake. Herein we focused on the 5 products with ≥30 evaluations. Although oral suspension and powder for oral solution were positively-accepted in the paediatric group, the powder had a higher rate of negative patient reaction (p<0.001). Of those that received this formulation, 72% were ≤8y., and therefore suitable to receive the better accepted oral suspension. In the elderly, patients with swallowing disorders were preferentially treated with such powders (p<0.001), which were less often fully taken than orally disintegrating tablets (p<0.001). Even in those patients ≥90y., capsule formulations appeared to be the best accepted product in patients without swallowing alterations, and thus could be a suitable alternative to the powder in this population. Conclusions By better integrating patient characteristics when choosing dosage forms, clinicians and caregivers may improve treatment acceptability and adherence. Moreover, hospitals and healthcare institutions could optimise purchasing to best suit their local population, disseminating information to help staff align specific dosage forms to targeted patients.

Microneedle-Based Delivery: An Overview of Current Applications and Trends

“…In addition to these drawbacks, non-adherence to the therapeutic guidelines by the patients is relatively common and makes it harder to achieve drug plasma levels within the therapeutic range [7]. Another factor to consider for oral administration of solid dosage forms is patient acceptance, which can be lower in children and elderly people [8], leading to formulation of oral liquid forms as an alternative. The optimization of these oral pharmaceutical dosage forms has been mostly directed to the prolongation of drug release to reduce the frequency of administration [4].…”

Acceptability in the Older Population: The Importance of an Appropriate Tablet Size

“…In such cases, prescribers may be forced to resort to an inappropriate dosage form. Indeed, some patients still able to swallow SODFs, even two capsules in a single sitting, could receive a less accepted powder for oral solution [ 20 ]. The recourse of oral liquid preparations is a widely used alternative to SODFs for inpatients with dysphagia, even though their acceptability appeared to be suboptimal [ 21 ].…”

“…The recourse of oral liquid preparations is a widely used alternative to SODFs for inpatients with dysphagia, even though their acceptability appeared to be suboptimal [ 21 ]. Orodispersible tablets (ODTs) seem to be a suitable option for those patients [ 20 ]. However, further investigations are needed to better understand the ODT acceptability drivers, as palatability may be an issue and some dysphagic patients could experience difficulty coordinating swallowing during the tablet’s disintegration.…”

“…To perform our explorations, we used the CAST (ClinSearch Acceptability Score Test ® ), which is briefly described in this section. This data driven approach, initially developed and validated in pediatrics [ 17 , 18 ] and then transposed to the elderly [ 19 ], provides relevant knowledge on medicine features that best fit different subpopulations of patients [ 20 , 21 , 22 ].…”

Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

“…Herein we used a multivariate approach [ 25 , 26 , 27 , 28 , 29 , 30 ] mining a large set of international real-life data to explore acceptability drivers of oral antibiotics in children.…”