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

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 (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.

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

“…There is a consensus that the size, shape, color, taste, and mouthfeel have a significant impact on drug product swallowability and acceptance. In order to achieve good compliance, as well as effective, safe, and independent pharmacotherapy, it is important for physicians and pharmaceutical professionals to be informed regarding potential problems that are related to a patient’s inability to swallow SODF, in order to prescribe/dispense suitable drug formulations and/or designs that can better meet the specific needs of each patient [ 26 , 32 , 121 , 207 ].…”

“…A usual approach for increasing patient compliance and reducing pill burden is done by increasing the SODF size in order to accommodate a higher dose strength [ 104 ]. This rule does not apply to older patients, as these perceive SODF as being more difficult to swallow with increasing size and consider the size of the SODF to be the most important physical attribute for swallowing safety [ 26 , 100 , 102 ]. This is supported by a study that identified a correlation between higher esophageal muscle effort with an increasing size of the SODF to be administered.…”

“…As it is well understood that older patients struggle to swallow large SODF, a simple patient-centric approach could focus on the manufacturing of reduced dosage form sizes in order to enhance swallowing experience and patient compliance [ 26 , 128 , 129 , 130 , 131 , 132 , 133 ]. Following this concept, and for a given pharmaceutical drug product, a wide range of SODF presentations should be available on the market to meet the heterogeneous needs of the older patient population [ 134 , 135 , 136 , 137 ].…”

“…Furthermore, the available literature published in recent years has tended to focus more on observational studies to measure overall patient acceptability in older patient populations, rather than investigating SODF characteristics and their critical endpoints for swallowability enhancement. Therefore, the current lack of research on developing relevant evidence on the relationship between the physical characteristics of SODF and their direct correlation to swallowability appears to be the main reason for the limited number of scientific articles that were identified within this literature review [ 26 , 147 , 208 , 209 , 210 ].…”

“…Swallowability and palatability are attributes that impact the acceptability of SODF by patients [ 9 , 10 , 11 ], which can be affected by the SODF physical properties upon deglutition and esophageal transit time [ 1 , 9 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. As such, more effort needs to be put into the design of patient centric drug products that can benefit older patients and their experience with prescribed medicines [ 8 , 25 , 26 ].…”