Abstract:
Background. Pediatric drug formulations are difficult
due to a variety of factors relating to pediatric population
differences from adult populations due to different physiology and pathological processes. The pediatric drugs are
expected be safe and effective to treat the child in an easy
way, without causing any harm and less drugs adverse reactions. Objective of the study. To study and understand the
problems of the pediatric drugs formulations. Identify new
directions in development of pediatric formulations, especially mini-tablets, orodispersible, chewable dosage forms
for providing better medicines for children. Material and
methods. In this review was conducted literature research
from the PubMed and European guideline database, regarding to highlight the problems and expectations of formulating the pediatric drugs. Results. The use of unlicensed and
off-label medicines for treating children is widespread with
associated risks as these products have not been properly studied in pediatric populations. Healthcare professionals
and parents are often required to manipulate an adult medicine to obtain an appropriate dose for a child, for example,
by splitting a tablet to provide a smaller dose or preparing
a suspension from a crushed tablet. Such manipulations
increase the variability in the product by inaccurate measurement, issues with stability or errors in instruction for
manipulation. There are currently regulatory to develop
age-appropriate medicines for new drugs. Both, oral and
buccal dosage formulations uphold great application qualities for pediatric patients. Conclusion. Unlike adult pharmaceutical formulations, pediatric dosage developments
tend to be a challenge. The rising availability of labelling
information and the tendency toward more cautious usage
of these substances will aid health care practitioners in selecting appropriate pediatric-friendly products.