Pharmaceutical Sciences II.
Dr. Balint, Basa
USVCLO
Semmelweis University - Department of Pharmaceutics
06309511779
basa.balint@semmelweis.hu
The Comparison of Conventionally and Additively Manufactured Tablets
Bálint Basa1, Nikolett Kállai-Szabó1, Miléna Lengyel1, István Antal1
1 Semmelweis University, Department of Pharmaceutics
Szóbeli
Pharmaceutical Sciences II.
English
Pharmaceutical Sciences
Oral administration of the active pharmaceutical ingredients is still the most commonly used route of administration. Beside the conventional tablet production, the 3D printed formulations are getting more emphasis to provide small batch, personalized therapies. The purpose of this study is to reveal the differences and similarities in the micro- and macrostructure that can be observed between the tablet cores produced by the two methods.
In our study microcrystalline cellulose (Vivapur)-based tablets were compressed with Fette Exacta 1 single punch tablet press ( with different applied forces. The comparator 3D printlets were produced by Prusa Sl1S resin printer. As post-productional quality check, In Process Control Tests were performed according to the European Pharmacopoeia including the uniformity of height and diameter and mass. In order to gain adequate information about the mechanical characteristics friability and hardness tests were also executed. For additional and innovative quality control, image analysis was also utilized.
In case of the uniformity of mass, the standard deviation was minimal by both methods, well below the allowed 5% in the Pharmacopeia. The values of the friability test were below 1% in all cases, so they also met the Pharmacopoeial prescriptions. However, differences may arise during further procedures with tablet form. Furthermore, based on the acquired data, both the conventional tablets and innovative printed formulations can be placed into a common matrix, but the critical production parameters are different. Furthermore, the In Process Control tests of the compressed tablets are proved to be applicable for stereolitography made printlets as well.
It can be concluded, that tablet forms can be prepared as successfully with Stereolitography 3D printer as with the traditional direct compression method. Due to the unclear regulatory atmosphere, the additive manufacturing has not been a casual alternative production line yet, however these results can lead to significant advances in order to become a comparable parallel. The deeper understanding of the connections behind the additive processes has future perspectives along with pharmaceutical coatings and environment-friendly development processes.
Semmelweis University, Doctoral School of Pharmaceutical Sciences
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Prof. Antal István
I do not give consent to the publication of my abstract on the website of the congress.
Szabad
elfogadva
szóbeli
nem rendelkezett róla
7377
15:15
15:30
Bálint Basa1, Nikolett Kállai-Szabó1, Miléna Lengyel1, István Antal1
1 Semmelweis University, Department of Pharmaceutics