Influence of Solid Oral Dosage Form Characteristics on Swallowability, Visual Perception, and Handling in Older Adults

The oral route of administration is the most common. Solid oral dosage forms, SODFs, are the predominant type of dosage form for this route of administration. This also applies to older adults, being 65 years or older [1]. If tablets or capsules are too large, patients often modify their dosage forms with unknown consequences on the efficacy and/or safety. Swallowing difficulties are present in a large proportion of older adults and have been reported to be the main reasons for dosage form modifications [2,3,4]. Therefore, alternative dosage forms (e.g., mini tablets) have been developed in the past. These dosage forms have already been evaluated extensively in the context of pediatric medicines [5], however, assessments of alternative dosage forms in older adults are scarce [6].
Patients need to be willing to take their medication in order to adhere to their pharmacotherapy. Therefore, adequate acceptability is essential for the development of drug products [7]. The needs of the intended subset of patients have to be identified at the beginning of drug product development [7,8]. Drug product characteristics influencing the acceptability of medicines in older adults are stated in a reflection paper by the European Medicines Agency. Among others, appearance, swallowability, patient perception, and any handling to be conducted prior to use are listed [7].
Patient perception is described as the anticipated swallowability and palatability before the patient takes the medication. Furthermore, it is an appreciation of the color, size, shape, and viscosity of the individual product [7].

In the past, it has been reported that between 14% and 40% of the general population experience swallowing difficulties when taking medication [9,10,11,12]. These swallowing difficulties are often not due to any abnormalities found in a physical examination or laboratory findings such as videofluoroscopy and barium swallow studies, but are rather described as a psychogenic dysphagia, called phagophobia [13]. Younger age, female sex, as well as poor mental health were found to be associated with phagophobia [10,12,14]. Thus, phagophobia needs to be kept in mind when studying the patients’ visual perception of different dosage forms. Besides the size and shape of the different dosage forms, the color is expected to impact the visual perception. However, color was found to be of greater relevance for the identification and memorability of the products than for patients’ medication adherence [15].
The handling of dosage forms prior to use is part of medication management and is dependent on the type of dosage form. For tablets and capsules, handling includes the removal from the secondary and primary packaging as well as any necessary dose adjustment [7]. As multi-compartment compliant aids are commonly used by older adults, they need to pick the SODFs out of those boxes or from a table. Thus, in these cases, the need to remove packaging is eliminated. Impaired dexterity as well as a decrease in hand and grip strength are common within this patient population [16,17,18,19,20]. The aforementioned handling processes can become difficult for older adults, and thus might lead to non-adherence. It has been reported that tablets that are too small and too flat generally affect handling [21,22].

Swallowability, visual perception, as well as the handling of SODFs are all influenced by the size and shape of the individual dosage form. It is a balancing act to find the right size and shape of SODFs, allowing for acceptable handling and swallowability. This is especially true for the vulnerable patient population of older adults. Older adults, representing the greatest group of medication end users, are a heterogeneous group with diverse needs. Multimorbidity and consequently polypharmacy, being defined as an intake of five or more medications, are common within this patient population [23,24,25,26].

Thus, we aimed to gain information on acceptable sizes and shapes of SODFs for older adults with respect to swallowability, visual perception, and handling. Hereby, we focused on tablets, as they are the major type of SODFs being prescribed to older adults [1]. Since the results of the deglutition part of the study have already been reported [1], this article addresses the handling assessment of the different tablets as well as the visual perception assessment of different SODFs. Besides tablets, the visual perception part included capsules and mini tablets. Capsules are the second most common SODF and mini tablets have been proposed as an alternative dosage form to overcome swallowing difficulties. The acceptability of mini tablets has previously been tested in comparison with other alternative dosage forms, but a comparison to monolithic SODFs such as tablets is still missing [6]. Furthermore, the participants’ evaluation of swallowability after actual deglutition was compared to the one after the visual observation of SODFs. We also seeked to provide a limit to the upper and lower end of appropriate tablet size as well as appropriate tablet shapes for older adults. Additionally, we investigated the differences between older adults and a control group of younger adults.

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Hummler, H.; Page, S.; Stillhart, C.; Meilicke, L.; Grimm, M.; Mannaa, M.; Gollasch, M.; Weitschies, W. Influence of Solid Oral Dosage Form Characteristics on Swallowability, Visual Perception, and Handling in Older Adults. Pharmaceutics 2023, 15, 1315. https://doi.org/10.3390/pharmaceutics15041315