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

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

doi:10.3390/pharmaceutics13101721

Cited by 10 publications

(14 citation statements)

References 39 publications

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“…Acceptability of drugs is crucial for children due to inherent characteristics of this population including swallowing difficulties and strong taste sensitivity [ 18 , 19 , 20 ]. Acceptability as defined by drug agencies includes the pharmaceutical characteristics of the medicine such as palatability, size and shape [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

Pharmaceutical Oral Formulation of Methionine as a Pediatric Treatment in Inherited Metabolic Disease

et al. 2023

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L-Methionine (Met) is an essential alpha-amino acid playing a key role in several metabolic pathways. Rare inherited metabolic diseases such as mutations affecting the MARS1 gene encoding methionine tRNA synthetase (MetRS) can cause severe lung and liver disease before the age of two years. Oral Met therapy has been shown to restore MetRS activity and improve clinical health in children. As a sulfur-containing compound, Met has a strongly unpleasant odor and taste. The objective of this study was to develop an optimized pediatric pharmaceutical formulation of Met powder, to be reconstituted with water, to obtain a stable oral suspension. Organoleptic characteristics and physicochemical stability of the powdered Met formulation and suspension were evaluated at three storage temperatures. Met quantification was assessed by a stability-indicating chromatographic method as well as microbial stability. The use of a specific fruit flavor (e.g., strawberry) with sweeteners (e.g., sucralose) was considered acceptable. No drug loss, pH changes, microbiological growth, or visual changes were observed at 23 ± 2 °C and 4 ± 2 °C with the powder formulation for 92 days, and the reconstituted suspension for at least 45 days. The developed formulation facilitates the preparation, administration, the dose adjustment and palatability of Met treatment in children.

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Section: Discussionmentioning

confidence: 99%

Pharmaceutical Oral Formulation of Methionine as a Pediatric Treatment in Inherited Metabolic Disease

et al. 2023

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“…Oral liquid formulations have major disadvantages such as chemical, physical or microbial instability, taste issues, need for refrigerated storage conditions and lack of controlled release properties. WHO now recommends that, where available, dispersible tablets should be chosen above suspensions due to advantages in dosing, stability, storage, cost and transportation, especially in LMICs ( Angwa et al, 2020 ; Vallet et al, 2021 ; Parrish et al, 2022 ; WHO, 2023a ).…”

Section: Discussionmentioning

confidence: 99%

Paediatric medicine issues and gaps from healthcare workers point of view: survey results and a narrative review from the global accelerator for paediatric formulations project

et al. 2023

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The WHO Model List of Essential Medicines for Children (EMLc) has not been systematically revised in the last few years. We conducted a survey addressed to healthcare professionals prescribing, preparing, or administering medicines to children and a narrative review to identify problematic paediatric formulations or missing medicines in all therapeutic fields to inform the review of the EMLc in 2023. A total of 285 physicians (63%), 28 nurses (6%) and 142 pharmacists (31%), mostly working in the hospital setting, reported at least one problematic medicine. 290 medicines were reported as missing (completely or the child-appropriate formulation). The top three most mentioned were ciprofloxacin together with phenobarbital and omeprazole. 387 medicines were reported as problematic (34% were oral liquid formulations, 34% tablets, 18% parenteral preparations. Mostly of the products were antibacterials (27%), cardiovascular medicines (11%) and antivirals (11%). The obtained responses show the perspective of healthcare workers working around the world, particularly in the European region (25%), in the African region (24%), and in the Region of the Americas (19%), with limited representation from Northern Africa and the Middle East. Our results need to be analysed with the outputs of other ongoing works before specific products can enter the WHO-hosted Global Accelerator for Paediatric formulations network prioritisation process. Efforts to develop appropriate formulations for children should be accelerated so that the uncertainties associated with off-label drug preparation and use are minimised, and therapeutic benefits are optimised.

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“…The particle size of manufactured and developed powders, flavoring (taste), tablet size and color are mostly based on empirical evidence such as sensory testing by adults 24,25 rather than subjective data from pediatric patients. [26][27][28]…”

Section: Evidence On the Dosage Of Pediatric Oral Antimicrobials Issu...mentioning

confidence: 99%

Drug Formulation for Pediatric Oral Antimicrobial Agents in Japan: Current Status, Prospects, and Challenges

Saito

Shoji

Miyairi

et al. 2023

Pediatric Infectious Disease Journal

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The development of antibiotics that are acceptable and easy for children to take and use is highly desirable. As advocated by the World Health Organization, solid oral formulations with excellent shelf-life, taste masking and dose adjustment are attracting attention as appropriate pediatric oral antimicrobial formulations, but liquid formulations remain the most common worldwide. Apparently unique to Japan, the most common formulations of oral antimicrobials for pediatric use are dispensed as a powder with most being flavored powders. Powdered formulations are packaged in single doses, which eliminates the need for parents to weigh them before administration and may reduce the possibility of dosage errors. On the other hand, there are some formulations that require large doses of powder due to inappropriate concentrations, granular formulations that have a rough texture that affects palatability, and some formulations that require flavoring agents to mask the bitter taste of the main drug. Such inappropriate formulations have a significant impact on adherence to antimicrobial therapy. It remains unclear whether solid oral dosage forms might be as acceptable worldwide as in Japan. To ensure that appropriate antimicrobials are delivered to children worldwide, a direction for the development of appropriate dosage forms in children needs to be established.

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

Cited by 10 publications

References 39 publications

Pharmaceutical Oral Formulation of Methionine as a Pediatric Treatment in Inherited Metabolic Disease

Pharmaceutical Oral Formulation of Methionine as a Pediatric Treatment in Inherited Metabolic Disease

Paediatric medicine issues and gaps from healthcare workers point of view: survey results and a narrative review from the global accelerator for paediatric formulations project

Drug Formulation for Pediatric Oral Antimicrobial Agents in Japan: Current Status, Prospects, and Challenges

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