Building Better Oral Suspensions for Pediatric & Real-World Use
Greg Thomas, Kiel Laboratories’ Vice President of R&D, discusses oral suspensions, excipients, and patient-centered formulation
Clinical Scorecard: Building Better Oral Suspensions for Pediatric & Real-World Use
At a Glance
| Category | Detail |
|---|
| Condition | Juvenile rheumatoid arthritis |
| Key Mechanisms | Development of oral solutions and suspensions for pediatric use |
| Target Population | Patients down to the age of 2 years |
| Care Setting | Pharmaceutical research and development |
Key Highlights
- Challenges in developing oral suspensions include palatability and stability.
- The Vyscoxa project aimed to create a liquid dosage form for celecoxib.
- Novel excipients can enhance homogeneity and dissolution profiles.
- Increasing prevalence of chronic diseases drives demand for complex formulations.
- Future formulation scientists will need skills in digital fluency and collaboration.
Guideline-Based Recommendations
Diagnosis
- Identify the need for liquid dosage forms in pediatric patients.
Management
- Utilize novel excipients to improve formulation characteristics.
Monitoring & Follow-up
- Assess stability and palatability of oral suspensions.
Risks
- Regulatory hurdles associated with novel excipients.
Patient & Prescribing Data
Pediatric patients with juvenile rheumatoid arthritis
Oral suspensions are preferred for patients unable to swallow capsules.
Clinical Best Practices
- Define a Target Product Profile for suspension development.
- Optimize excipient selection for desired product characteristics.
- Ensure adequate shelf-life for successful commercialization.
References
