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

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.

Enhancing Pharmacokinetics and Pharmacodynamics of Rosuvastatin Calcium through the Development and Optimization of Fast-Dissolving Films

“…Regarding Y1, all formulas yielded a response of < 60 s except for F6, which disintegrated after 62 s; this may have been because of its higher content of HPMC, as reported by Rédai et al [16]. The generated polynomial equation for Y1 is presented in Equation (3).…”

“…Fast-dissolving films, among other dosage forms, are highly accepted by pediatric and elderly patients due to their ease of use. Recently, many researchers published new polymer-based fast-dissolving films, e.g., fluoxetine [16], metoclopramide [17], lamotrigine [18], ondansetron hydrochloride [19], olanzapine [20], and tenoxicam [21]. Fast-dissolving films can be prepared using various techniques, such as solvent casting, characterized by combining the polymer solution with the plasticizer and drug solution, mixing, degassing, pouring into a suitable dish, and heating to evaporate the solvent [21].…”

In Vitro and In Vivo Evaluation of Composite Oral Fast Disintegrating Film: An Innovative Strategy for the Codelivery of Ranitidine HCl and Flurbiprofen

“…An ideal film should have moderate tensile strength to endure the force or stress experienced during manufacturing, handling, packaging, and transportation. Furthermore, too rigid films also give a bad mouthfeel [ 54 ]. The tensile strength of the composite films ( Table 7 ) lie in a moderate range to endure all possible stresses.…”

Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability

“…The film was placed between these two clamps with recording the point at which the film was broken ( Takeuchi et al, 2020 ). Tensile strength was stated as force/unit area and computed from the following equation ( Ali et al, 2016 , Rédai et al, 2021 ): Tensile strength (N/cm 2 ) = the force at which the film broke (Newton)/(Film thickness (cm) × film width (cm)). …”