Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation

Abstract

Palatability is a recognized driver of medicine acceptability in pediatrics but deemed less relevant in older populations due to sensory decline. Preliminary findings from an observational study implicated palatability problems with one Alzheimer’s medicine. Among 1517 observer reports combining multiple measures on medicines uses in patients aged over 64, we focused on two original formulations of memantine (Ebixa®, tablets (n = 25) and oral solution (n = 60)). Evaluations were scored with an acceptability reference framework (CAST), the rodent Brief Access Taste Aversion (BATA) model tested aversiveness. Focusing on women treated with Ebixa® (n = 54), the oral formulation sub-group was classified as “negatively accepted”, while the coated tablet was associated with the “positively accepted” cluster. In men, both formulations belonged to the “positively accepted” profile. Using BATA, the original oral solution was categorized as highly aversive/untolerated while solutions of excipients only were well tolerated. Furthermore, the number of licks was significantly lower in female than in male rats. These results revealed that medicine palatability remains important for acceptability in older populations. Moreover, converging results from humans and animal models highlighted that palatability profiles can significantly vary between the sexes. These drivers should be closely considered during drug development to enhance acceptability in this population.

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

“…In our investigations in young children, there was always a greater issue with girls when an acceptability difference occurred between both sexes. This echoes with a higher sensitivity among older women to the unpalatable oral liquid products which has been similarly observed in elderly patients [ 35 , 36 ].…”

Human mouthfeel panel investigating the acceptability of electrospun and solvent cast orodispersible films

“…A difference of 28 % was observed for the male participants in their ranking of electrospun films as more preferable, while female participants had no overall preference with an equal split for both formulations. The reasons for these differences are not clear, and need further investigation (Ruiz et al, 2019). It should also be noted that the male sample size was approximately 50 % of the number of female participants and therefore the data here have low power.…”

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

“…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 ].…”