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14 pages, 7775 KB

Open AccessArticle

Acceptability of Mebendazole Chewable Tablet in Children Aged 2 to 4 Years in Peru

by Fernando Perez, Thibault Vallet, Zarela Bravo, Kristin Callahan and Fabrice Ruiz

Pharmaceutics 2022, 14(1), 27; https://doi.org/10.3390/pharmaceutics14010027 - 23 Dec 2021

Cited by 8 | Viewed by 6152

Soil-transmitted helminthiasis (STH) is among the most common of parasitic infections, affecting vulnerable populations in tropical/subtropical areas globally. In endemic countries, children, a high-risk population, require treatment and preventive interventions. Mebendazole, a WHO-recommended medicine, originally formulated as a tablet that was often crushed for administration to young children unable to swallow it, was reformulated as a chewable tablet. Acceptability is a key aspect for treatment effectiveness in pediatrics. Herein, we used a validated data-driven approach to investigate the acceptability of the 500-mg mebendazole chewable tablet in children aged 2 to 4 years in Peru. Observer-reported outcomes were collected for 182 medicine intakes. Acceptability was scored using the acceptability reference framework: a three-dimensional map juxtaposing “positively accepted” and “negatively accepted” profiles. Results found that the 500-mg mebendazole chewable tablet was classified as “positively accepted” in children aged 2 to 4 years. Acceptability increased with age and some acceptability issue remain for the younger children. Nevertheless, this formulation was considerably better accepted than the conventional tablets regardless of treatment in young children. This chewable formulation appears to be an appropriate alternative to the hard tablet of mebendazole for treatment of STH and preventive interventions in children aged 2 to 4 years. Full article

(This article belongs to the Special Issue New Developments in Pediatric Drug Formulations)

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17 pages, 3785 KB

Open AccessArticle

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

by Thibault Vallet, Yahya Bensouda, Jumpei Saito, Liv Mathiesen, Varsha Pokharkar, Viviane Klingmann, Matthew Peak, Omar Elhamdaoui, Akimasa Yamatani, Ivana Ivanovic, Manjusha Sajith, Juliane Münch, Louise Bracken, Jennifer Claire Duncan, Smita Salunke, Siri Wang and Fabrice Ruiz

Pharmaceutics 2021, 13(10), 1721; https://doi.org/10.3390/pharmaceutics13101721 - 18 Oct 2021

Cited by 15 | Viewed by 5652

Abstract

Antibiotics are among the most commonly prescribed drugs in children. Adherence to the treatment with these drugs is of the utmost importance to prevent the emergence of resistant bacteria, a global health threat. In children, medicine acceptability is likely to have a significant impact on compliance. Herein we used a multivariate approach, considering simultaneously the many aspects of acceptability to explore the drivers of oral antibiotic acceptability in children under twelve, especially in toddlers and in preschoolers. Based on 628 real-life observer reports of the intake of 133 distinct medicines, the acceptability reference framework highlighted the influence of many factors such as age and sex of patients, previous exposure to treatment, place of administration, administration device, flavor agent in excipients and active pharmaceutical ingredient. These findings from an international observational study emphasize the multidimensional nature of acceptability. Therefore, it is crucial to consider all these different aspects for assessing this multi-faceted concept and designing or prescribing a medicine in order to reach adequate acceptability in the target population. Full article

(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form)

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12 pages, 1655 KB

Open AccessArticle

Adherence and Acceptability of an Oral Antibiotic Used for the Prevention of Pediatric Urinary Tract Infection in Japan

by Jumpei Saito, Sayaka Miyamoto, Mayumi Yamada, Akimasa Yamatani, Fabrice Ruiz and Thibault Vallet

Pharmaceutics 2021, 13(3), 345; https://doi.org/10.3390/pharmaceutics13030345 - 6 Mar 2021

Cited by 9 | Viewed by 4024

Abstract

Urinary tract infection (UTI) is a common health care-associated adverse event and the leading nosocomial complication following pediatric urological surgery. While continuous antimicrobial prophylaxis effectively reduces the risk of UTI following such a surgery, non-adherence is common and represents a distinct clinical entity that is associated with renal scarring. Acceptability is likely to have a significant impact on patient adherence. Herein we used a validated data-driven approach—the ClinSearch acceptability score test (CAST)—to investigate the acceptability of cefaclor, an oral antibiotic widely used for the prevention of pediatric UTI in Japan. Standardized observer reports were collected for 58 intakes of cefaclor 10% fine granules in patients aged from 0 to 17 years. The medicine was classified as positively accepted on the acceptability reference framework. According to the percentage of the prescribed dose taken reported at the end of the treatment, patients exhibited good adherence to this well-accepted medicine. Nonetheless, requirements for greater dosing frequency or poor acceptability in certain patients could affect adherence. Acceptability should be established to ensure patient adherence to medicines used for long-term prophylaxis and consequently guarantee the safety and efficacy of the treatment. Full article

(This article belongs to the Special Issue Development and Adaptation of New and Better Pediatric Drugs)

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12 pages, 7007 KB

Open AccessArticle

Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

by Andrzej Emeryk, Thibault Vallet, Ewelina Wawryk-Gawda, Arkadiusz Jędrzejewski, Frederic Durmont and Fabrice Ruiz

Pharmaceutics 2021, 13(2), 294; https://doi.org/10.3390/pharmaceutics13020294 - 23 Feb 2021

Cited by 15 | Viewed by 4459

Abstract

In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers. Full article

(This article belongs to the Special Issue Development and Adaptation of New and Better Pediatric Drugs)

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12 pages, 5047 KB

Open AccessArticle

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

by Thibault Vallet, Omar Elhamdaoui, Amina Berraho, Lalla Ouafae Cherkaoui, Yamna Kriouile, Chafiq Mahraoui, Nezha Mouane, Anne-Marie Pense-Lheritier, Fabrice Ruiz and Yahya Bensouda

Pharmaceutics 2020, 12(8), 766; https://doi.org/10.3390/pharmaceutics12080766 - 13 Aug 2020

Cited by 31 | Viewed by 4936

Abstract

Although knowledge on medicine acceptability remains fragmented, this multi-faceted concept has emerged as a key factor for compliance in pediatrics. In order to investigate the acceptability of medicines used in the University Medical Centre Ibn Sina (CHIS) of Rabat, Morocco, an observational study was conducted. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for 570 medicine intakes in patients up to the age of 16, then analyzed on a reference framework. Tablets appeared to be well accepted in children greater than 6 years old, but were crushed/dissolved for 90% of the 40 children aged from 3 to 5, and 100% of the 38 patients younger than 3. Moreover, the prescribed dose was fully taken for only 52% and 16% of these younger children, respectively. Despite this, tablets represented 24% of evaluations in children from 3 to 5 and 20% in infants and toddlers. Oral liquid preparations appeared to be better accepted than tablets in preschoolers, but not for those under 3. Overall, these findings highlight the lack of suitable alternatives for the younger children, especially for formulations of antiepileptics, antithrombotic, and psycholeptic agents in the local context. Full article

(This article belongs to the Special Issue Paediatric Drug Delivery)

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11 pages, 1537 KB

Open AccessArticle

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

by Thibault Vallet, Hugues Michelon, Mine Orlu, Yogini Jani, Patrick Leglise, Sandra Laribe-Caget, Matthieu Piccoli, Aurélie Le Fur, Fang Liu, Fabrice Ruiz and Vincent Boudy

Pharmaceutics 2020, 12(8), 746; https://doi.org/10.3390/pharmaceutics12080746 - 8 Aug 2020

Cited by 44 | Viewed by 7334

Abstract

Presenting many advantages, solid oral dosage forms (SODFs) are widely manufactured and frequently prescribed in older populations regardless of the specific characteristics of patients. Commonly, patients with dysphagia (swallowing disorders) experience difficulties taking SODFs, which may lead to non-adherence or misuse. SODF characteristics (e.g., size, shape, thickness) are likely to influence swallowability. Herein, we used the acceptability reference framework (the ClinSearch acceptability score test (CAST))—a 3D-map juxtaposing two acceptability profiles—to investigate the impact of tablet size on acceptability. We collected 938 observer reports on the tablet intake by patients ≥65 years in hospitals or care homes. As we might expect, tablets could be classified as accepted in older patients without dysphagia (n = 790), while not in those with swallowing disorders (n = 146). However, reducing the tablet size had a significant impact on acceptability in this subpopulation: tablets <6.5 mm appeared to be accepted by patients with swallowing disorders. Among the 309 distinct tablets assessed in this study, ranging in size from 4.7 to 21.5 mm, 83% are ≥6.5 mm and consequently may be poorly accepted by institutionalized older people and older inpatients suffering from dysphagia. This underlines the need to develop and prescribe medicines with the best adapted characteristics to reach an optimal acceptability in targeted users. Full article

(This article belongs to the Special Issue Optimisation of Patient Centric Medicines for the Older Population)

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12 pages, 1712 KB

Open AccessArticle

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

by 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 and Vincent Boudy

Pharmaceutics 2019, 11(8), 368; https://doi.org/10.3390/pharmaceutics11080368 - 1 Aug 2019

Cited by 14 | Viewed by 5196

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. Full article

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