Solving the challenge in pediatric drug development
The development of age appropriate formulations can pose a major challenge in pediatric drug development. In contrast to adults, where oral solid dosage forms are generally acceptable, pediatric patients including neonates, newborns, toddlers and young children cannot typically swallow tablets or capsules.
Many commonly used excipients cannot be used in pediatric formulations due to toxicity issues
Oral liquids or suspensions may also have issues from a palatability and/or stability perspective that necessitate the development of alternative dosage forms. In addition, certain commonly used excipients such as ethanol, benzyl alcohol, PEGs and polysorbate cannot be used in pediatric formulations due to toxicity issues.
Addressing the need for flexible dosing forms development to safeguard accuracy with low dosages and small volumes
A pediatric dose may vary by up to fifty-fold across the wide range of age, bodyweight and surface area (BSA) typical in a pediatric patient population. This necessitates the development of a flexible dosing form that can be accurately delivered in a uniform manner at low dosages and with small volumes.
Understand the challenges of pediatric formulation development
KinderPharm’s formulation scientists understand the challenges of pediatric formulation development and have experience in the development, testing, manufacture and commercialization of a wide variety of age appropriate formulations including:
- Taste masking
- Powders for reconstitution
- Dispersible/effervescent tablets
- Chewable tablets
- Orally disintegrating tablets
- Sprinkles and granules
Contact us with any questions you may have on pediatric PK/PD modeling and simulation.