Formulation development of fast releasing oral thin films of levocetrizine dihydrochloride with Eudragit^®Epo and optimization through Taguchi orthogonal experimental design

Abstract

T he aim of this study was to develop a fast releasing oral polymeric film, prepared using the solvent casting method, with good mechanical properties, instant disintegration and dissolution, an acceptable taste in the oral cavity. Levocetirizine dihydrochloride, an antihistamine, was incorporated to relieve the symptoms of allergic rhinitis. Four batches of films with drug were prepared using different combinations of polymers and plasticizers Eudragit ® EPO, HPMC E 5 LV, and PVA were the selected polymers. Glycerin, dibutyl phthalate, propylene glycol, and PEG 400 were the selected plasticizers. The resultant films were evaluated for weight variation, assay, content uniformity, folding endurance, thickness, tensile strength, percent elongation, surface pH, in vitro disintegration and in vitro dissolution. The formulations from the preliminary trial were analyzed using Taguchi OA experimental design, which was applied to optimize the type of polymers, concentration of polymers, plasticizer, and sweetener based on their disintegration data at three different levels. The optimized films disintegrated in less than 30s, releasing 70-90% of drug within 2 mins. The percentage release varied with the type of polymer and concentration of polymer. The films made with EPO released 96% of drug in 2 mins, which was the best release among all.

Formulation and Evaluation of Oral Films of Atomoxetine Hydrochloride

“…ANOVA is used to determine whether the factors are significantly related to the response). It was found that type of polymer has significant effect on the disintegration time as the 'P' value is 0.000 at 95% confidence interval (p<0.05) 2,20 .…”

Physical, Mechanical, Functional, and Thermal Characterization of Chitosan: Maltodextrin Blends Edible Oral Film Incorporated with Aqueous Clove Extract

“…The film solutions were formulated in different combinations of chitosan (CH) and maltodextrin (MD) with 10% (v/v) constant amount of pullulan (PL). [ 14,15 ] In the present study, five different formulations of chitosan, maltodextrin were prepared ( Table 2 ) [ 16,17 ] with the incorporation of pullulan (10%), glycerol (1%), [ 18,19 ] and clove extract (15%) total amount. [ 20 ] Briefly, chitosan solution (2%, w/v) was prepared by dissolving 2 g of chitosan in 100 mL in citric acid solution (2% v/v).…”

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“…The mean thickness is calculated, the patches having thickness variation greater than 5% were excluded from analysis. 8 : Folding endurance of film was determined by repeatedly folding the films of uniform cross sectional area (4*4 cm 2 ) until it breaks 3. Swelling index: Swelling index is performed to analyse the swelling of the film due to polymer (Gelatin and HPMC E-15).…”