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Review
. 2025 Jul 25;17(8):963.
doi: 10.3390/pharmaceutics17080963.

Personalized Neonatal Therapy: Application of Magistral Formulas in Therapeutic Orphan Populations

Wenwen Shao  1 , Angela Gomez  2 , Alejandra Alejano  1 , Teresa Gil  2 , María Cristina Benéitez  2
Affiliations
Review

Personalized Neonatal Therapy: Application of Magistral Formulas in Therapeutic Orphan Populations

Wenwen Shao et al. Pharmaceutics. .

Abstract

This review explores the potential of magistral formulas (MFs) as a viable option to meet the needs of neonates, given the lack of adequate therapies for this vulnerable group. The scientific literature on medicines available for neonates is limited. The physiological differences between neonates and adults make it difficult to formulate these medicines. In addition, there are a variety of difficulties in conducting research on neonates: few clinical trials are performed, and there is frequent use of unauthorized medicines. Pharmacokinetics in neonates was investigated in comparison to adults, and different aspects of the absorption, distribution, metabolism, and excretion were observed. One of the main problems is the different pharmacokinetics between the two populations. It is necessary to promote and allow research related to pediatric drug design, approve a specific authorization for use in age-appropriate dosage forms, and improve the quality and availability of information on drugs. This study focused on the MFs typically used for pediatrics, specifically for neonates, analyzing the pharmaceutical forms currently available and the presence of indications and dosage recommendations of the European Medicines Agency. Medications were classified according to therapeutic group, as antihypertensives, corticosteroids, and antiepileptics. The use of off-label medicines remains high in neonatal intensive care units and in primary healthcare, besides in the preparation of MFs by pharmacists. The shortage of medicines specifically designed and approved for neonates is a serious problem for society. Neonates continue to be treated, on numerous occasions, with off-label medicines. Studies and research should be expanded in this vulnerable population group.

Keywords: drug preparation; extemporaneous preparation; newborn; personalized medicine; unlicensed drug.

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Conflict of interest statement

The authors declare no conflicts of interest. The company had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Comparison of neonatal pharmacokinetics versus adult pharmacokinetics.
See this image and copyright information in PMC

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