Pediatric Formulation Development

The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. However, specialized drug development expertise and understanding of pediatric physiology, formulation science, and regulatory requirements are required.

Bringing decades of formulation development experience and industry insight to every pediatric drug program, we work closely with to overcome challenges such as palatability, dose flexibility, drug product manufacturing strategy and supply, ensuring safe and effective therapies for pediatric patients.

Our scientists have considerable experience in developing palatable pediatric formulations in the OTC and consumer healthcare industry, including customized pediatric formulations which have received regulatory approval. Some popular forms of drugs for pediatric administration include minitabs, sprinkles, and oral liquids.

We have an extensive track record developing age-appropriate dosage forms of aversive, bitter API using a range of taste modifying and taste masking techniques without compromising drug product stability and PK performance. 

Through our integrated cGMP drug product manufacturing and early clinical testing platform, Translational Pharmaceutics®, we can perform adaptive clinical trials to optimize taste attributes and PK performance. 

Using Translational Pharmaceutics®, we work with you to ensure clinical validation so you can feel confident in your pediatric formulation prior to proceeding to your pediatric trials.