Preparation and advanced characterization of highly drug-loaded, 3D printed orodispersible tablets containing fluconazole

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18470%2F23%3A50019815" target="_blank" >RIV/62690094:18470/23:50019815 - isvavai.cz</a>

Result on the web

<a href="https://www.sciencedirect.com/science/article/pii/S0378517322009991?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0378517322009991?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijpharm.2022.122444" target="_blank" >10.1016/j.ijpharm.2022.122444</a>

Result language

angličtina

Original language name

Preparation and advanced characterization of highly drug-loaded, 3D printed orodispersible tablets containing fluconazole

Original language description

Due to the possibility of designing various spatial structures, three-dimensional printing can be implemented in the production of customized medicines. Nevertheless, the use of these methods for the production of dosage forms requires further optimization, understanding, and development of printouts&apos; quality verification mecha-nisms. Therefore, the goal of our work was the preparation and advanced characterization of 3D printed oro-dispersible tablets (ODTs) containing fluconazole, printed by the fused deposition modeling (FDM) method.We prepared and analyzed 7 printable filaments containing from 10% to 70% fluconazole, used as model API. Obtaining a FDM-printable filament with such a high API content makes our work unique. In addition, we confirmed the 12-month stability of the formulation, which, to our knowledge, is the first study of this type.Next, we printed 10 series of porous tablets containing 50 mg of API from both fresh and stored filaments containing 20 %, 40 %, or 70 % fluconazole. We confirmed the high quality and precision of the printouts using scanning electron microscopy. The detailed analysis of the tablets&apos; disintegration process included the Phar-macopeial test, but also the surface dissolution imaging analysis (SDI) and the test simulating oral conditions performed in own-constructed apparatus.For each composition, we obtained tablets disintegrating in less than 3 min, i.e., meeting the criteria for ODTs required by the European Pharmacopeia. The filaments&apos; storage at ambient conditions did not affect the quality of the tablets. All printed tablets released over 95% of the fluconazole within 30 min. Moreover, the printouts were stable for two weeks.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30104 - Pharmacology and pharmacy

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

INTERNATIONAL JOURNAL OF PHARMACEUTICS

ISSN

0378-5173

e-ISSN

1873-3476

Volume of the periodical

630

Issue of the periodical within the volume

January

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

12

Pages from-to

"Article Number: 122444"

UT code for WoS article

000897775400005

EID of the result in the Scopus database

2-s2.0-85144590047