Presentation
MDD18 - Incorporating Human Factors into Pediatric Oral Formulation Development: A User-Centered Framework
DescriptionTo deliver the oral pediatric drug product to the patient safely and effectively, human factors must be considered early in the formulation development for preparation, administration, and patient acceptability.
In the early stages of formulation development, when companies are beginning to frame the drug product form that is most appropriate, the HF assessment should include a relatively comprehensive review of four areas: patient, drug product, device, and use. The patient review should configure development of the product based on the patient population that is targeted; the physiological development of neonates differs greatly to a developed adolescent and may therefore drive different target product needs. Drug product review should consider characteristics of the drug product including palatability, stability, dose constraints, frequency, and duration. The device consideration should consider the interactions expected through device use (e.g., oral syringe or feeding tube), including measurement accuracy, support for dosage range, ability to deliver full dose, potential impact on device function, and durability given the use frequency and length. Lastly, understanding the use of the product including preparation and administration steps will inform the likelihood to experience use errors due to limitations of drug characteristics, selected device, and expected user population whether caregiver, health care professional or other.
When all factors are considered, the various risks and user constraints identified will drive the development of drug product form, device selection and continued risk reduction. The early integration of these factors during formulation development is expected to provide a robust drug product or combination product in a streamlined approach.
In the early stages of formulation development, when companies are beginning to frame the drug product form that is most appropriate, the HF assessment should include a relatively comprehensive review of four areas: patient, drug product, device, and use. The patient review should configure development of the product based on the patient population that is targeted; the physiological development of neonates differs greatly to a developed adolescent and may therefore drive different target product needs. Drug product review should consider characteristics of the drug product including palatability, stability, dose constraints, frequency, and duration. The device consideration should consider the interactions expected through device use (e.g., oral syringe or feeding tube), including measurement accuracy, support for dosage range, ability to deliver full dose, potential impact on device function, and durability given the use frequency and length. Lastly, understanding the use of the product including preparation and administration steps will inform the likelihood to experience use errors due to limitations of drug characteristics, selected device, and expected user population whether caregiver, health care professional or other.
When all factors are considered, the various risks and user constraints identified will drive the development of drug product form, device selection and continued risk reduction. The early integration of these factors during formulation development is expected to provide a robust drug product or combination product in a streamlined approach.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives