- Overview
- Factors We Consider
- What Can We Do
Overview
Pediatric formulations are pharmaceutical dosage forms designed and developed specifically for pediatric patients, including infants, children and adolescents. When selecting medications for the pediatric population, it is important to consider factors such as the age of this population, ability to swallow, ease of administration, and accessibility of appropriate product formulations.
Factors We Consider
Some of the factors our platform will consider are:
Dosage Form Selection
Pediatric formulations encompass various dosage forms tailored to different age groups and patient populations. These may include oral solutions suspension, pellets, mini tablets, and extended release coatings. Appropriate dosage form selection is critical for the pediatric population.
Palatability Enhancement
Children often exhibit aversion to bitter or unpleasant tastes, which can affect medication adherence and compliance. Palatability enhancement techniques, such as the use of flavoring agents, sweeteners, and masking agents, are employed to improve the taste and acceptability of pediatric formulations.
Dose Flexibility
Pediatric formulations should offer flexibility in dosing to accommodate variations in weight, age, and dosage regimen. Liquid formulations, for example, may be available in multiple strengths to allow for accurate dosing based on the child's weight or age.
Safety and Efficacy
Safety is the most important consideration in pediatric formulations to minimize the risk of adverse effects and ensure therapeutic efficacy. Formulation components should be carefully selected to avoid allergens, excipients with known safety concerns, and unnecessary additives. Additionally, dosage forms should be designed to minimize the risk of choking or aspiration, particularly in infants and young children.
Regulatory Considerations
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), provide guidelines and recommendations for the development and evaluation of pediatric formulations. These guidelines address aspects such as pediatric study design, age-appropriate formulations, pharmacokinetic considerations, and pediatric labeling requirements.
What Can We Do
Our research team employs a variety of formulation development strategies, such as taste masking technology, particle size reduction technology and novel drug delivery systems, to address the unique challenges associated with pediatric drug delivery. If you need, please contact us.