Patient needs and regulatory requirements are driving the development of age-appropriate formulations.
The demand for pediatric dosage forms continues to increase; however, the number of approved pediatric drug treatments on the market remains substantially less than those for adults. Legislation in the US and EU also requires the submission of pediatric plans at given points in the adult development of a new medicine.
These factors have made the development of acceptable pediatric formulations a highlight in the development of modern medicines for over two decades.
Overcoming development challenges to create effective & age-appropriate pediatric formulations.
Our pediatric formulation development expertise—combined with global drug product manufacturing and clinical pharmacology services—allows us to deliver tailored solutions for your development program.
With decades of experience in creating palatable pediatric formulations for the over-the-counter (OTC) and consumer healthcare markets, we understand what it takes to succeed. We guide you through the critical considerations for developing a pediatric product that meets clinical, regulatory, and commercial goals, including:
- The route of administration
- The safety profile
- Taste and palatability
- The child’s age, weight, and physiologic condition
- The treatment plan’s requirements
Pediatric drug development capabilities
Taste masking
We have an extensive track record developing age-appropriate dosage forms of aversive, bitter drug substances using a range of taste-modifying and taste-masking techniques without compromising on product stability and PK performance.
Taste assessment and PK studies
Using our integrated GMP manufacturing and clinical testing platform, we perform rapid, adaptive trials in humans to optimize taste attributes and PK performance. This provides you with the clinical validation that you need prior to proceeding to your pediatric trials.
Clinical trial drug product manufacture
We manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with your study and recruitment needs. Our flexible options range from a personalized, per-patient basis to more traditional batch manufacturing.
Commercial drug product manufacture
Our production facilities in Philadelphia, PA are fully inspected and approved by FDA, EMA, PMDA and DEA and specialize in low-volume products. We support regulatory processes for your pediatric investigation plans and pediatric study plans.
