International researchers are delving further into the manufacturing of patient-specific medications, outlining their findings in ‘Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron.’ Experimenting with a new type of tablet, the authors found that they were able to make a product similar to commercially manufactured pills used for treating cancer.
A pill meant to prevent vomiting in cancer patients, ondansetron is prescribed for patients suffering from nausea due to chemotherapy and radiation. 3D printed pharmaceuticals, while exhibiting enormous potential for positive benefits, may not be making the rapid speed progress expected due to numerous challenges—despite ongoing studies regarding methods for creating more effective medication.
3D printed pills, however, can offer incredible advantages for patients, and especially in the case of ondansetron which can have side effects like life-threatening arrhythmia; however, with patient-specific medications, ‘vulnerable’ patients who may be suffering from diseases like cancer, are more protected. With the addition of SLS 3D printing, a variety of items related to pharmaceuticals are already being fabricated, to include:
- Printlets
- Miniprintlets
- Drug delivery lattice structures
- Drug delivery devices
- Formulations for quick dose verification
Orally disintegrating tablets (ODTs) are also a possibility for SLS 3D printing—in the hopes that the process could be substantially improved over current, conventional methods that are expensive and often overly complex.
In this study, the researchers developed a new type of ondansetron-cyclodextrin complexes meant to disintegrate rapidly. Upon analysis of two different types of 3D printed samples, they were compared to Vonau® Flash 8 mg, a commercial example of ondansetron.
Composition of the formulations (w/w).
The samples (cylindrical, and yellow) were printed in batches of six, leaving the researchers to measure diameter and thickness, determination of mechanical properties via breaking force of each printlet, and examine internal structures, density, and porosity shown in X-ray form.
Images of the Formulation I (left) and Formulation II (right) (units are in cm).
Both samples printed for the study displayed fast disintegration of ~15 s, releasing over 90 percent of the drugs, in five minutes ‘independent of mannitol content.’
“Although a small part of the drug may be not incorporated into the cyclodextrin, drug-cyclodextrin complexes may be formed “in situ” in the mouth facilitated by the saliva as a solvent,” stated the researchers.
“The DSC data of the formulations before and after printing showed a sharp endothermic peak at around 168 °C which corresponds to the melting point of the mannitol. The absence of the endothermic peak corresponding to the melting point of the ondansetron indicates that the drug is in the amorphous form within the formulations or that the drug percentage is so low that the crystals (if any) are not detected using DSC.”
X-ray micro-CT Images of the (Formulation I) and (Formulation II).
Data was evaluated with a CT analyzer, density was displayed with different colors, and porosity was measured through the morphometry preview consisting of 100 layers to be assessed at the top, middle, and bottom of the printlets. Success in the project left the research team to note:
“The opportunity to manufacture this drug product in an automatic manner close to the point of dispensing opens new opportunities in the implementation of personalized medicine as there is the need for automatic, cost-effective and reliable systems to prepare oral medicines personalized to the individual.”
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Dissolution profiles of the commercial and the 3D printed formulations.