Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation
Fabrice Ruiz,
Alexander Keeley,
Patrick Léglise,
Catherine Tuleu,
Célia Lachuer,
Jean-Paul Rwabihama,
Nathalie Bachalat,
Imad Boulaich,
Fattima Abdallah,
Maité Rabus,
Annie-Claude Ribemont,
Hugues Michelon,
Amélie Dufaÿ Wojcicki,
Mine Orlu,
Thibault Vallet,
Vincent Boudy
Affiliations
Fabrice Ruiz
ClinSearch, 110 Avenue Pierre Brossolette, 92240 Malakoff, France
Alexander Keeley
Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK
Patrick Léglise
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Catherine Tuleu
Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK
Célia Lachuer
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Jean-Paul Rwabihama
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Nathalie Bachalat
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Imad Boulaich
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Fattima Abdallah
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Maité Rabus
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Annie-Claude Ribemont
Hôpital Joffre Dupuytren, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 rue Eugène Delacroix, 91210 Draveil, France
Hugues Michelon
Hôpital Sainte-Périne, Hôpitaux Universitaires Paris Ile-de-France Ouest, Assistance Publique-Hôpitaux de Paris (AP-HP), 11 rue Chardon-Lagache, 75016 Paris, France
Amélie Dufaÿ Wojcicki
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
Mine Orlu
Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK
Thibault Vallet
ClinSearch, 110 Avenue Pierre Brossolette, 92240 Malakoff, France
Vincent Boudy
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
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.