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

1
ClinSearch, 110 Avenue Pierre Brossolette, 92240 Malakoff, France
2
Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK
3
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
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Hôpital Sainte-Périne, Hôpitaux Universitaires Paris Ile-de-France Ouest, Assistance Publique-Hôpitaux de Paris (AP-HP), 11 rue Chardon-Lagache, 75016 Paris, France
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Unité de R&D Galénique, Agence Générale des Equipements et Produits de Santé (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), 7 rue du Fer À Moulin, 75005 Paris, France
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(8), 368; https://doi.org/10.3390/pharmaceutics11080368
Received: 27 June 2019 / Revised: 19 July 2019 / Accepted: 23 July 2019 / Published: 1 August 2019
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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. View Full-Text
Keywords: medicine; acceptability; palatability; taste assessment; older population; formulation; Alzheimer; sex; CAST—clinsearch acceptability score test; brief-access taste aversion medicine; acceptability; palatability; taste assessment; older population; formulation; Alzheimer; sex; CAST—clinsearch acceptability score test; brief-access taste aversion
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Ruiz, F.; Keeley, A.; Léglise, P.; Tuleu, C.; Lachuer, C.; Rwabihama, J.-P.; Bachalat, N.; Boulaich, I.; Abdallah, F.; Rabus, M.; Ribemont, A.-C.; Michelon, H.; Wojcicki, A.D.; Orlu, M.; Vallet, T.; Boudy, V. Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation. Pharmaceutics 2019, 11, 368.

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