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Published on: December 9, 2010
Developing a Flexible Pediatric Dosage Form for Antiretroviral Therapy: A Fast-Dissolving Tablet
Manjari Lal1, Manshun Lai1, Marcus Estrada1
1PATH, PO Box 900922, Seattle, Washington 98121.
Developing new fast-dissolving tablets (FDTs) improves dosing of anti-HIV drugs lopinavir and ritonavir for children. This flexible pediatric formulation ensures accurate medication delivery, especially in resource-limited settings.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Pharmacology
Background:
- Current anti-HIV drug formulations pose challenges for pediatric dosing.
- Accurate and flexible dosing is critical for effective pediatric antiretroviral therapy.
Purpose of the Study:
- To develop a child-safe, flexible dosage form for lopinavir and ritonavir.
- To create fast-dissolving tablets (FDTs) suitable for infants and children of all ages.
Main Methods:
- Utilized a freeze-drying in blister approach to create FDTs.
- Incorporated hydrophobic drugs using optimized ratios of polymers, surfactants, and bulking agents.
- Evaluated drug stability, disintegration time, dissolution recovery, and handling properties.
Main Results:
- Achieved rapid disintegration (10 seconds) in small fluid volumes.
- Demonstrated high drug recovery (90%-105%) after dissolution.
- Confirmed FDT stability under accelerated conditions (40°C, 75% RH for 3 months).
Conclusions:
- Fast-dissolving tablets offer a promising, flexible dosage form for pediatric antiretroviral treatment.
- This formulation enhances medication adherence and accuracy for children.
- The FDT approach is particularly beneficial for low-resource settings.
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