In the most recent Formulation Forum column, Ascendia Pharmaceutical Solutions founder and CEO Jim Huang, PhD explains the biopharmaceutical considerations and clinical development strategy around pediatric formulations. This is particularly important, considering developing pharmaceuticals for children is extremely challenging due to specific requirements of the patient population.
As the article in Drug Development & Delivery explains, a pediatric formulation should consider multiple factors. Among the considerations are:
- Difference in physiological and pharmacokinetic of patient populations
- Dosage form selection
- Route of administration
- Dose accuracy and flexibility
- Drug and excipient tolerability (safety and toxicity)
- Patient compliance (palatability/ swallowability)
- Stability
- Drug accessibility
You can read Jim’s entire contributed piece, by visiting the Drug Development & Delivery website.