Design and development of fluoxetine hydrochloride oro flash films to alleviate major depressive disorder

Abstract

The current research concerns the development of the formulation of fluoxetine HCl (anti-depressant) oro flashes the new prospective by using solvent casting method. Oro flashes are quick dissolving oral films and the materials used were hydrophilic. Fluoxetine HCl formulations were developed since oro flashes improves bioavailability to attain onset of action, along with the patient compliance. Fluoxetine HCl is used to treat major depressive disorder, bulimia nervosa (an eating disorder), obsessive–compulsive disorder, panic disorder, and premenstrual dysphoric disorder. Polyvinyl alcohol (PVA) undergoes polymerization and forms oro flash film. Five different formulations were developed by using different polymeric concentrations of PVA. Polyvinyl pyrollidone K30 (PVP K30) used as super disintegrating agent and plasticizer, whereas menthol and mannitol were used as sweetener, flavoring agent respectively and water as a solvent system. In the study five formulations (F1, F2, F3, F4, and F5) were evaluated for the properties such as thickness, folding endurance, drug content uniformity, surface pH, in vitro disintegration time, dissolution studies, % moisture loss, % moisture uptake, weight variation test, conductivity test. Results revealed that, F3 formulation can be considered as best, which has morphological features are homogenous and transparent with optimum thickness 0.23 ± 0.02 µm, folding endurance (>250 times number of folds on the same crease), drug content uniformity (λ max at 225 nm) 97.60 ± 1.28, surface pH 6.654 ± 0.020, in vitro disintegration time 11 ± 1.20 s, in vitro dissolution studies 97.30 ± 0.75 %, % moisture loss 5.021 ± 0.052 %, % moisture uptake 3.634 ± 0.102 %, weight variation test 48.74 ± 1.0, conductivity test 61 µS which has maximum drug release (97.3 %) which facilitates maximum bioavailability.