Pediatric drug development offers advantages to younger patients through the availability of newly developed medicine forms as well as advantages to the sponsor pharmaceutical companies through extended exclusivity for their marketed product. As a result of this, the number of pediatric drug approvals has increased 5 fold over the last 20 years, rising from 10-20 approvals per year to 50-60 approvals annually today. Pediatric (infants, children and adolescents) patients require different oral dosage forms from adults due to differences in swallowing abilities, taste preferences, and dosage requirements. In general, the pediatric population is not homogeneous, and requires different formulations depending on the age, developmental and clinical state of the patients. Therefore, oral pediatric formulation designs are primarily focused on the patient age, body size, and the swallowing capability of the target population.
- Provide an overview of the pediatric market and discuss potential growth areas
- Consider the challenges and opportunities of pediatric formulations
- Review several pediatric formulation dosage forms including liquid dosage forms and solid dosage forms (mini-tablets, orodispersible tablets (ODT) and chewable formulation)
- Conclude with an overview of the regulatory considerations for new pediatric formulations