The development of pediatric formulations and presentations is necessary to ensure that children of all ages and their caregivers have access to safe and accurate medicinal dosage forms. However, pediatric formulation design and development is complex as there is a need to understand the physiological changes that occur during childhood and their impact on the absorption of drugs.
Some General Considerations for Pediatric Drug Development:
- When it comes to the design and development of pediatric formulations, the route of administration, dosage form, and dose of the active ingredient (API) are decided on the basis of the expected duration of the therapy, the disease affecting a patient and their age, size and stability during manufacture, storage, etc.
- Pediatric drug development or pediatric medicine development programs should include additional clinical studies to evaluate differences in pharmacokinetics and pharmacodynamics of drugs in adults and children because most pediatric patients are still physically developing.
- Pediatric drug development should consider ease of administration, palatability, stability and therapeutic equivalency of pediatric dosage forms.
- The selection of effective excipients for pediatric drug products is an important and often undervalued aspect of the pharmaceutical development process. Since pediatric patient safety is of paramount importance, toxicologically harmless excipients are required, especially in highly potent formulations.
- Age-appropriateness is an essential part of pediatric formulation and product development and adds additional biopharmaceutical considerations to an already complex problem. Biopharmaceutical considerations, which include physicochemical properties, can help one ultimately decide whether to start with a market image or an enabling formulation.
- Careful planning of biopharmaceutic considerations and data collection during the adult and pediatric development program can contribute significantly to the biopharmaceutic risk assessment and planning of appropriate clinical studies leading to the successful development of pediatric formulations.
- Additional considerations need to be applied for the development of pediatric drug products including those linked to cost, acceptability, usability, heat stability, healthcare provider training, health policy, and local regulatory requirements.
- Widely encompassing regulatory factors are to be considered when developing pediatric products following the correct good manufacturing practice approach to ensure high-quality pediatric formulations are produced that comply with standard customer specifications and pharmacopeial requirements.