Lecture 19

Question 1

Pediatric drug dosing: General considerations

Answer 1

• Usually weight-based OR stratified according to weight bands or age groups
• Parenteral dosage forms may require dilution prior to administration to avoid toxicity
• Children are often unable to swallow pills or capsules
• Palatability of oral liquids
• Dosage forms with modified release are not engineered to take into account unique pediatric GI physiology

Question 2

Formulations for Pediatric Patients

Answer 2

*Age, ability to swallow capsules/tablets, and the disease being treated influence formulation selection

• Liquid preparations 
• Solid dosage forms 
• Parenteral
• Rectal 
• Transcutaneous delivery systems 
• Opened capsules or crushed tablets
– May be mixed with water, juice, or food 
– Problematic if “homemade”

Question 3

Ethical Framework for Studying Drugs in Children

Answer 3

• Children should only be enrolled in a clinical trial if the scientific objectives cannot be met by enrolling subjects who can provide informed consent
• Clinical trial must either (i) have prospect of direct therapeutic benefit to the child or (ii) involve “not greater than minimal risk”
• Children should not be placed at a disadvantage after being enrolled in a clinical trial, either through exposure to excessive risks or by failing to get necessary health care.

Question 4

Key issues in developing pediatric formulations

Answer 4

• Bioavailability/bioequivalence of the new formulation
• Stability of formulation
• Impact of crushed tablets/open capsules
• Palatability
• Ability to achieve target PK parameter associated with efficacy in adults
• Convenience

Question 5

PK of altered adult formulations can vary significantly from intact form

Answer 5

• Danger of causing toxicity
• Possibility of under-dosing
• Product quality issues
– Stability

Question 6

Ideal oral pediatric dosage form

Answer 6

• Tasteless/taste-masked
• Minimal excipients
• Flexible dosage
• Orally dissolvable or easy to swallow
• Stable