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LAPSE:2023.5853

Development and Evaluation of Fluoxetine Fast Dissolving Films: An Alternative for Noncompliance in Pediatric Patients

Emőke-Margit Rédai, Paula Antonoaea, Nicoleta Todoran, Robert Alexandru Vlad, Magdalena Bîrsan, Anamaria Tătaru, Adriana Ciurba

February 23, 2023

Abstract
The most used pharmaceutical formulations for children are syrups, suppositories, soft chewable capsules, and mini-tablets. Administrating them might create an administration discomfort. This study aimed to develop and evaluate orodispersible films (ODFs) for pediatric patients in which the fluoxetine (FX) is formulated in the polymeric matrix. Six FX fast dissolving films (10 mg FX/ODF), FX1, FX2, FX3, FX4, FX5, and FX6, were prepared by solvent casting technique. In the composition of the ODFs, the concentration of the hydroxypropyl methylcellulose and the concentration of the propylene glycol were varied. Each formulation of fluoxetine ODF was evaluated by determining the tensile strength, folding endurance, disintegration, behavior in the controlled humidity and temperature conditions, and adhesiveness. All the obtained results were compared with the results obtained for six ODFs prepared without FX. The disintegration time of the FX ODFs was of maximum 88 s for FX2. Via the in vitro releasing study of the FX from the ODFs it was noticed that FX1 and FX2 allow a better release of the drug 99.98 ± 3.81% and 97.67 ± 3.85% being released within 15 min. From the obtained results it was also confirmed that FX ODFs were found to follow first-order release kinetic.

Record ID

LAPSE:2023.5853

Keywords

fluoxetine, HPMC, kinetic, orodispersible film, pediatric

Subject

Process Control

Suggested Citation

Rédai EM, Antonoaea P, Todoran N, Vlad RA, Bîrsan M, Tătaru A, Ciurba A. Development and Evaluation of Fluoxetine Fast Dissolving Films: An Alternative for Noncompliance in Pediatric Patients. (2023). LAPSE:2023.5853

Author Affiliations

Rédai EM: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania
Antonoaea P: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania
Todoran N: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania [ORCID]
Vlad RA: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania [ORCID]
Bîrsan M: Department of Pharmaceutical Technology, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy of Iasi, 16 Universitatii Street, 700115 Iasi, Romania
Tătaru A: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania
Ciurba A: Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology “George Emil Palade” of Targu Mures, 38 Gheorghe Marinescu Street, 540142 Targu Mures, Romania

Journal Name

Processes

Volume

Issue

First Page

778

Year

2021

Publication Date

2021-04-28

DOI:

https://doi.org/10.3390/pr9050778