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3D printed furosemide and sildenafil tablets: Innovative production and quality control
I Lafeber1, J M Tichem1, N Ouwerkerk2
1Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Albinusdreef 2, 2333ZA Leiden, the Netherlands.
This study demonstrates the feasibility of using a novel 3D printer to create personalized paediatric medicines. The printed furosemide and sildenafil tablets met European Pharmacopoeia quality standards for drug content and release.
Area of Science:
- Pharmaceutical Technology
- Additive Manufacturing
- Personalized Medicine
Background:
- Three-dimensional (3D) printing offers potential for personalized medicine but remains largely unexplored in pharmaceutical applications.
- Current pharmaceutical manufacturing methods may not be optimal for small, customized batches.
Purpose of the Study:
- To evaluate a novel heated, piston-driven semi-solid extrusion 3D printer for pharmaceutical applications.
- To produce and characterize 3D printed furosemide and sildenafil tablets for paediatric use.
Main Methods:
- A proof-of-concept study utilizing a novel semi-solid extrusion 3D printer.
- Production of furosemide (2 mg, 10 mg) and sildenafil (4 mg) tablets.
- Assessment of tablet weight, content uniformity, and dissolution rate according to European Pharmacopoeia (EP) standards.
Main Results:
- 3D printed tablets exhibited consistent weight (RSD 1.26%) and drug content uniformity (RSD 0.41-1.44%).
- Tablets demonstrated immediate release profiles, with dissolution limited by matrix dissolving and eroding.
- All produced tablets complied with EP requirements for uniformity of mass, content uniformity, and conventional release.
Conclusions:
- The novel 3D printer is capable of producing paediatric tablets meeting pharmacopoeial standards.
- Existing quality control tests may require adaptation for 3D printed pharmaceuticals due to their layered nature and small batch sizes.
- Adjusted friability and resistance to crushing tests are proposed to assess layer adhesion in 3D printed tablets.
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