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Development of Novel Oral Delivery Systems Using Additive Manufacturing Technologies to Overcome Biopharmaceutical
Micol Cirilli1, Julius Krause2, Andrea Gazzaniga1
1Department of Pharmaceutical Sciences, University of Milan, GazzaLaB, via Giuseppe Colombo 71, 20133 Milan, Italy.
Pharmaceutics
|January 25, 2025
Summary
A novel 3D-printed expandable drug delivery system successfully targets the upper small intestine for improved drug bioavailability. This innovative device demonstrates controlled expansion in simulated gastrointestinal conditions, offering a promising solution for drugs with narrow absorption windows.
Area of Science:
- Pharmaceutical Sciences
- Biomedical Engineering
- Materials Science
Background:
- Targeted drug delivery is essential for active pharmaceutical ingredients with narrow absorption windows to enhance bioavailability.
- The upper small intestine offers an optimal site for drug absorption due to its unique physiological environment.
- Developing advanced delivery systems is crucial for overcoming limitations of conventional drug administration.
Purpose of the Study:
- To design and prototype a novel 3D-printed expandable drug delivery system for targeted administration to the upper small intestine.
- To evaluate the system's functionality, including organ retention and controlled drug release capabilities.
- To optimize spring geometries for mechanical strength and flexibility within the delivery system.
Main Methods:
- Utilized 3D printing technologies (FDM and SLA) with PLA and HPMC materials to fabricate the expandable device.
- Incorporated matrices and springs with varied geometries, tested for mechanical performance using a texture analyzer.
- Employed a gastro-resistant string for compact configuration, designed to dissolve at neutral pH in the small intestine.
Main Results:
- The system maintained its compact state for two hours in acidic conditions, demonstrating stability.
- Upon pH change to 6.8, the device successfully expanded within 2.5-5.5 minutes, depending on spring size.
- The expandable system demonstrated the ability to regain its expanded state, indicating potential for sustained drug release.
Conclusions:
- The 3D-printed expandable drug delivery system shows significant promise for targeted delivery to the upper small intestine.
- This technology offers a potential alternative for administering drugs with narrow absorption windows, improving therapeutic efficacy.
- Further in vivo studies are required to validate clinical potential and mechanical stability in actual gastrointestinal environments.
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