Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019.

Jose-Manuel Delmoral-Sanchez,Marta Gonzalez-Alvarez,Marival Bermejo,Andres Navarro-Ruiz,Isabel Gonzalez-Alvarez

doi:10.3390/pharmaceutics12040316

Jose-Manuel Delmoral-Sanchez, Marta Gonzalez-Alvarez + Show 3 more

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https://doi.org/10.3390/pharmaceutics12040316

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Journal: Pharmaceutics	Publication Date: Apr 1, 2020
Citations: 19	License type: CC BY 4.0

Affiliation: Miguel Hernandez University

Abstract

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities demand pediatric forms different to adult formulations. The objective of this study was to evaluate the authorization availability from United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) of oral essential medicines for children and analyze its age-appropriateness for oral administration in children. All oral drugs from 7th List of Essential Medicines for Children by World Health Organization (WHO) were selected. Availability of commercial drug products was collected from OrangeBook, Spanish drug product catalogue, British electronic Medicines Compendium, and the International Vademecum. Tablets, effervescent tablets, and capsules were considered as not age-appropriate forms. Liquid forms, powder for oral suspension, mini tablets, granules, and soluble films were considered as age-appropriate forms due to their flexibility. More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA. Nevertheless, around 50% of these formulations are not age-appropriate for most pediatric groups. This study shows the lack of age-appropriate medicines for children. More efforts are needed to improve development and approval of pediatric medicines.

Highlights

Nowadays, formulation research and development in the pediatric area remains essential and is required [1,2]
Information from European Medicines Agency (EMA) was listed from Spanish drug product catalogue (CIMA) [17], British electronic Medicines Compendium [18], and the International Vademecum [19] due to these databases being public access formularies
The first step was taken in 1970s when Food and Drug Administration (FDA) stated that most prescription drugs were administered empirically and it called for innovative programs to provide pediatric information [23] and recognized that excluding children from clinical trials was an unethical fact and could create risk situations [4]

Summary

Introduction

Formulation research and development in the pediatric area remains essential and is required [1,2]. A lack of medicines developed for children may be managed by preparing medicines extemporaneously or by manipulating dosage forms designed for adults, e.g., splitting tablets, crushing, and administering with food or liquid. Physiological aspects like the pH of the gastrointestinal tract [5,6] or expression of drug-metabolizing enzymes and transporters [7] are major facts for oral drug absorption and can alter the bioavailability of the administered drug [8]. These facts change with age and appear to be necessary to develop age-appropriate formulations. In respect with drug administration, children have different capabilities from adults, such as palatability or swallowing facility

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