# A Randomized, Open, Single-Administration, Cross-Over Study to Investigate the Acceptability, Swallowability, Palatability, and Preference of Different Oral Placebo Formulations in Patients with Multiple Sclerosis

## TL;DR

This study compared how well multiple sclerosis patients can swallow and prefer different pill forms, finding film-coated tablets and gels as top choices.

## Contribution

The study provides new insights into patient preferences for oral drug formulations in MS patients with varying disability levels.

## Key findings

- Film-coated tablets had the highest acceptability rates for both EDSS < 4 and EDSS ≥ 4 patients.
- Gels were frequently preferred but also often rated as 'Unpleasant' in palatability.
- All formulations were considered safe for use in the study population.

## Abstract

Background: There is a paucity of systematic investigations of the acceptability and preference of alternative oral drug formulations in multiple sclerosis (MS) patients. The use of appropriate oral dosage forms has the potential to circumvent challenges associated with the ingestion of tablets. Objective: This randomized, open, cross-over study aimed to investigate acceptability, swallowability, palatability, and preference of four oral placebo drug formulations of similar sizes/given volumes but different modes of ingestion (film-coated tablet, orodispersible tablet, orodispersible film, and gel) in MS patients. Methods: Acceptability was tested in two patient subgroups (32 participants each) of different MS disability levels (expanded disability status scale [EDSS] < 4 and ≥4). The primary endpoint was acceptability derived as a composite of swallowability (rated by investigator) and palatability (rated by participant). Results: The film-coated tablet showed the highest acceptability rates for EDSS < 4 and EDSS ≥ 4 (100.0%, 93.8%), followed by gel (81.3%, 68.8%). Acceptability rates for all formulations were consistently higher for EDSS < 4 compared to EDSS ≥ 4. Concerning the subjective assessment of palatability, the gel received the highest rate of positive ratings, but also was frequently judged as ‘Unpleasant’. Furthermore, the gel was ranked as the first or second choice as the most-preferred formulation, followed by the film-coated tablet. All formulations were considered safe in the study population. Conclusions: Film-coated tablets are well-suited for use in MS patients and gels may represent an interesting alternative for a certain subgroup of MS patients.