Safety as a determining factor in the pharmaceutical drug development for patients of the pediatric population
DOI:
https://doi.org/10.24959/sphhcj.24.328%20Keywords:
pediatric population; drug safety; adverse drug reactions; pharmaceutical drug development; dosage forms; excipientsAbstract
Patients in the pediatric population are characterized by differences in the pharmacokinetics and pharmacodynamics of drugs and the range of acceptable dosage forms compared to adult patients. The development of safe drugs is designed to reduce the incidence of adverse reactions in this group.
Aim. To highlight physiological features of the body of patients in the pediatric population, the corresponding differences in the pharmacological characteristics of drugs, and approaches to minimizing the risks of pharmacotherapy at the stage of pharmaceutical drug development.
Materials and methods. Such general scientific theoretical methods as system analysis, generalization, and system approach, as well as the bibliographic method consisted in processing scientific sources of information on drug use in pediatrics and developing pediatric dosage forms were used.
Results. When prescribing drugs to pediatric patients, the physiological features of the child’s body development should be considered, using a flexible approach to pharmacotherapy. Many drugs used in pediatrics have not been officially studied in pediatric clinical trials, and therefore, children often receive them off-label. The use of drugs in pediatrics requires special knowledge about the influence of age-related aspects of the child’s physiology on the absorption, distribution, metabolism and excretion of a drug, as well as on its interaction with receptors and organs. This article discusses approaches to the pharmaceutical development of drugs for use in the pediatric population.
Conclusions. In pharmaceutical development of drugs for use in pediatric practice, it is necessary to keep in mind the features of drugs due to age and physiological factors in this category of patients, as well as to take into account the route of administration, the choice of the optimal dosage form, the safety profile of excipients, taste and ease of use of drugs. The development of new medicinal products, including multiparticulate solid dosage forms, is designed to improve the safety profile of drugs in children.
References
Clavenna, A., Bonati, M. (2009). Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Archives of Disease in Childhood, 94(9), 724-728. doi: 10.1136/adc.2008.154377.
Impicciatore, P., Choonara, I., Clarkson, A., Provasi, D., Pandolfini, C., Bonati, M. (2001). Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. British Journal of Clinical Pharmacology, 52(1), 77-83. doi: 10.1046/j.0306-5251.2001.01407.x.
Bouquet, E., Star, K., Jonville-Bera, A. P., Durrieu, G. (2018). Pharmacovigilance in pediatrics. Therapie, 73(2), 171-180. doi: 10.1016/j.therap.2017.11.012.
Joseph, P. D., Craig, J. C., Caldwell, P. H. (2015). Clinical trials in children. British Journal of Clinical Pharmacology, 79(3), 357-369. doi: 10.1111/bcp.12305.
Korth-Bradley, J. M. (2018). The path to perfect pediatric posology – drug development in pediatrics. Journal of Clinical Pharmacology, 58(Suppl 10), S48-S57. doi: 10.1002/jcph.1081.
Benard, B., Bastien, V., Vinet, B., Yang, R., Krajinovic, M., Ducharme, F. M. (2017). Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice. European Respiratory Journal, 50(2), 1700148. doi: 10.1183/13993003.00148-2017.
Van Riet-Nales, D. A., Kozarewicz, P., Aylward, B., de Vries, R., Egberts, T. C., Rademaker, C. M. (2017). Paediatric drug development and formulation design – a European perspective. AAPS PharmSciTech, 18(2), 241-249. doi: 10.1208/s12249-016-0558-3.
Corny, J., Lebel, D., Bailey, B., Bussieres, J. F. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316-328. doi: 10.5863/1551-6776-20.4.316.
Batchelor, H. K., Fotaki, N., Klein, S. (2014). Paediatric oral biopharmaceutics: key considerations and current challenges. Advanced Drug Delivery Reviews, 73, 102-126. doi: 10.1016/j.addr.2013.10.006.
Daousani, C., Karalis, V. D. (2017). Paediatric medicines: regulatory and scientific issues. Drug Research (Stuttgart), 67(7), 377-384. doi: 10.1055/s-0043-109788.
Mulla, H. (2010). Understanding developmental pharmacodynamics: importance for drug development and clinical practice. Pediatric Drugs, 12(4), 223-233. doi: 10.2165/11319220-000000000-00000.
Hanning, S. M., Lopez, F. L., Wong, I. C., Ernest, T. B., Tuleu, C., Orlu Gul, M. (2016). Patient centric formulations for paediatrics and geriatrics: similarities and differences. International Journal of Pharmaceutics, 512(2), 355-359. doi: 10.1016/j.ijpharm.2016.03.017.
Thabet, Y., Klingmann, V., Breitkreutz, J. (2018). Drug formulations: standards and novel strategies for drug administration in pediatrics. Journal of Clinical Pharmacology, 58(Suppl 10), S26-S35. doi: 10.1002/jcph.1138.
Ivanovska, V., Rademaker, C. M., van Dijk, L., Mantel-Teeuwisse, A. K. (2014). Pediatric drug formulations: a review of challenges and progress. Pediatrics, 134(2), 361-372. doi:10.1542/peds.2013-3225.
Salunke, S., Brandys, B., Giacoia, G., Tuleu, C. (2013). The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 – the pilot version. International Journal of Pharmaceutics, 457(1), 310-322. doi: 10.1016/j.ijpharm.2013.09.013.
Polova, Z. M., Gala, L. O., Kosiachenko, K. L. (2024). Suviaz farmatsevtychnoi rozrobky ta farmakonagliadu u pediatrychnykh likarskykh zasobah. Ukrainski zhurnal viiskovoi medycyny, 5(2), 129-136. doi: 10.46847/ujmm.2024.2(5)-129.
Fabiano, V., Mameli, C., Zuccotti, G. V. (2011). Paediatric pharmacology: remember the excipients. Pharmacological Research, 63(5), 362-365. doi: 10.1016/j.phrs.2011.01.006.
Jijo, A., Flowerlet, M. (2014). Taste masking of paediatric formulation: a review on technologies, recent trends and regulatory aspects. International Journal of Pharmacy and Pharmaceutical Sciences, 6, 12-19. Available at: https://www.innovareacademics.in/journal/ijpps/Vol6Issue1/7873.pdf.
Woertz, K., Tissen, C., Kleinebudde, P., Breitkreutz, J. (2011). Taste sensing systems (electronic tongues) for pharmaceutical applications. International Journal of Pharmaceutics, 417(1-2), 256-271. doi: 10.1016/j.ijpharm.2010.11.028.
Arima, H., Higashi, T., Motoyama, K. (2012). Improvement of the bitter taste of drugs by complexation with cyclodextrins: applications, evaluations and mechanisms. Therapeutic Delivery, 3(5), 633-644. doi: 10.4155/tde.12.28.
Walsh, J., Bickmann, D., Breitkreutz, J., Chariot-Goulet, M., European Paediatric Formulation Initiative (EuPFI). (2011). Delivery devices for the administration of paediatric formulations: overview of current practice, challenges and recent developments. International Journal of Pharmaceutics, 415(1-2), 221-231. doi: 10.1016/j.ijpharm.2011.05.048.
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