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Development of Advanced 3D-Printed Solid Dosage Pediatric Formulations for HIV Treatment
Azizah M Malebari1, Aytug Kara2, Ahdab N Khayyat1
1Department of Pharmaceutical Chemistry, College of Pharmacy, King Abdulaziz University, Jeddah 21589, Saudi Arabia.
Insights
Direct powder extrusion 3D printing offers a novel method for creating personalized pediatric HIV medications. This approach overcomes challenges with existing formulations, providing improved drug delivery for children.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Pediatric Formulations
Background:
- Lopinavir/ritonavir is a first-line pediatric HIV treatment but faces formulation challenges.
- Current liquid formulations have issues with cold-chain, alcohol content, and palatability.
- Crushing tablets negatively impacts drug bioavailability, highlighting a need for better pediatric dosage forms.
Purpose of the Study:
- To explore the feasibility of 3D printing pediatric HIV dosage forms using direct powder extrusion.
- To develop personalized, child-friendly formulations of lopinavir/ritonavir.
- To improve the oral bioavailability and release profile of pediatric HIV medications.
Main Methods:
- Utilized direct powder extrusion 3D printing to create 6 mm spherical tablets.
- Incorporated hydroxypropyl methylcellulose and polyethylene glycol as excipients.
- Analyzed drug-excipient interactions and characterized the release profile of the 3D printed tablets.
Main Results:
- Successfully manufactured personalized pediatric HIV dosage forms via 3D printing.
- Achieved amorphous solid dispersions through hydrogen bonding between drugs and excipients.
- Demonstrated a zero-order sustained release profile, contrasting with precipitation issues of the commercial formulation.
Conclusions:
- Direct powder extrusion 3D printing is a feasible technology for pediatric HIV drug formulation.
- The developed 3D printed tablets offer improved drug release characteristics compared to existing options.
- This innovative approach addresses critical needs for safer and more effective pediatric HIV treatments.
Abstract:
The combination of lopinavir/ritonavir remains one of the first-line therapies for the initial antiretroviral regimen in pediatric HIV-infected children. However, the implementation of this recommendation has faced many challenges due to cold-chain requirements, high alcohol content, and unpalatability for ritonavir-boosted lopinavir syrup. In addition, the administration of crushed tablets has shown a detriment for the oral bioavailability of both drugs. Therefore, there is a clinical need to develop safer and better formulations adapted to children's needs. This work has demonstrated, for the first time, the feasibility of using direct powder extrusion 3D printing to manufacture personalized pediatric HIV dosage forms based on 6 mm spherical tablets. H-bonding between drugs and excipients (hydroxypropyl methylcellulose and polyethylene glycol) resulted in the formation of amorphous solid dispersions with a zero-order sustained release profile, opposite to the commercially available formulation Kaletra, which exhibited marked drug precipitation at the intestinal pH.
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