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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

INTERNATIONAL JOURNAL OF PHARMACEUTICS

ISSN

0378-5173

e-ISSN

1873-3476

Svazek periodika

630

Číslo periodika v rámci svazku

January

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

12

Strana od-do

"Article Number: 122444"

Kód UT WoS článku

000897775400005

EID výsledku v databázi Scopus

2-s2.0-85144590047