Selective Laser Sintering 3D Printing of Orally Disintegrating Printlets Containing Ondansetron

Nour Allahham,Wolfgang Mohr,Simon Gaisford,Lilia Kraschew,Alvaro Goyanes,Carmen Marcuta,Fabrizio Fina,Abdul W Basit

doi:10.3390/pharmaceutics12020110

Nour Allahham, Wolfgang Mohr + Show 6 more

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https://doi.org/10.3390/pharmaceutics12020110

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Abstract

The aim of this work was to explore the feasibility of using selective laser sintering (SLS) 3D printing (3DP) to fabricate orodispersable printlets (ODPs) containing ondansetron. Ondansetron was first incorporated into drug-cyclodextrin complexes and then combined with the filler mannitol. Two 3D printed formulations with different levels of mannitol were prepared and tested, and a commercial ondansetron orally disintegrating tablet (ODT) product (Vonau® Flash) was also investigated for comparison. Both 3D printed formulations disintegrated at ~15 s and released more than 90% of the drug within 5 min independent of the mannitol content; these results were comparable to those obtained with the commercial product. This work demonstrates the potential of SLS 3DP to fabricate orodispersible printlets with characteristics similar to a commercial ODT, but with the added benefit of using a manufacturing technology able to prepare medicines individualized to the patient.

Highlights

Ondansetron is an anti-emetic drug, listed on the World Health Organisation (WHO) List of Essential Medicines, which is used as the first-line therapy for chemotherapy- and radiation-induced nausea and vomiting with a dose of 16 mg daily [1]
This work demonstrates the potential of selective laser sintering (SLS) 3D printing (3DP) to fabricate orodispersible printlets with characteristics similar to a commercial orally disintegrating tablet (ODT), but with the added benefit of using a manufacturing technology able to prepare medicines individualized to the patient
The excipients were selected with the aim of producing accelerated drug release formulations, with the objective of fabricating printlets with orally disintegrating characteristics

Summary

Introduction

Ondansetron is an anti-emetic drug, listed on the World Health Organisation (WHO) List of Essential Medicines, which is used as the first-line therapy for chemotherapy- and radiation-induced nausea and vomiting with a dose of 16 mg daily [1]. A family of taste masking excipients often used are cyclodextrins They are cyclic oligosaccharides that can encapsulate hydrophobic drugs into their cavity while having a hydrophilic outer surface [6,7]. The formation of these inclusion complexes helps to improve the physiochemical properties of hydrophobic drugs, increasing their water solubility, bioavailability and stability [6]. Cyclodextrin-drug inclusion complexes can be prepared in different ways, with co-precipitation being the most common [8]. In this method, the cyclodextrin is dissolved in an appropriate solvent such as ethanol, and the drug is added gradually under continuous stirring until evaporation of the solvent. The drug-cyclodextrin complexes may be formed “in situ” in the mouth facilitated by the saliva as a solvent [6]

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