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By: J. Carolina Visser

J. Carolina Visser For many drugs commonly used in pediatrics, a suitable drug formulation or dosage strength is not commercially available. For that reason, children frequently receive medicines that are designed for adults, a practice called “unlicensed” or “off-label use.” The dose of commercially available products is adapted, mostly based on the child’s bodyweight, thereby neglecting differences in pharmacokinetic and pharmacodynamic parameters. Nowadays, serious attempts are being made to develop medicines, formulations, and dosage forms that are adapted to the specific needs of children. Several scientific guidelines have been released by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) concerning the development of medicines for children.

Main problems related to the modification of commercially available oral dosage forms and good alternatives

Main problems related to the modification of commercially available oral dosage forms and good alternatives

Personalized medicine is becoming increasingly important in contemporary pharmacotherapeutics. If commercially available products are unsuitable or unavailable, pharmacy preparations such as orodispersible films (ODFs) can fulfill the patient’s individual need. For children, ODFs can be a highly attractive dosage form for the oral administration of drugs. ODFs are easy to administer and require almost no intake of water. ODFs may especially suit the individual approach needed for patients having difficulties swallowing tablets. In clinical conditions where volume restriction is important, ODFs may gain in place in the therapeutic arsenal. Many cardiovascular drugs are administered to patients in which the fluid balance is rigidly monitored and carefully balanced because of a comprised cardiac output.

According to the European Pharmacopoeia, pharmacy preparations include extemporaneous preparations made for an individual patient or for a small patient population, which are supplied immediately after preparation, as well as stock preparations, which are made in advance and stored until requested. In view of this definition, pharmacy preparations are very suitable to overcome the problem related to a lack of commercially available medicines for pediatric patients and the need for tailor-made, personalized medicines for children. An important precondition, however, is that extemporaneous manufacturing is performed under circumstances that guarantee good product quality. In hospital pharmacies or large manufacturing pharmacies, such preconditions can be achieved and thus pediatrics preparations can be manufactured there for the individual patient. Currently, research in the field of ODFs as pharmacy preparations is promising. Different ODF formulations have already been developed that are suitable as a starting point for further research. ODFs are relatively easy to prepare in a hospital setting and they create dose flexibility as they can be cut precisely in any desired dosage strength with a pair of scissors. Good quality ODFs containing low-dose enalapril maleate, prednisolone, or diazepam have been successfully prepared on a lab scale, which could be suitable as standardized formulations.

Read more about the need for personalized pediatric therapies and the promising potential of ODFs in my team’s recently published AAPS PharmSciTech open access mini-review Personalized Medicine in Pediatrics: The Clinical Potential of Orodispersible Films.

J. Carolina Visser, Ph.D., is a lecturer at the Department of Pharmaceutical Technology and Biopharmacy at the University of Groningen, The Netherlands. Her research focuses on orodispersible films as pharmacy preparations.