Development and in vitro evaluation of fast dissolving films of levocetirizine dihydrochloride

Abstract

The study attempts to design oral dispersible film of Levocetirizine dihydrochloride by solvent casting method. The films were made in such a way that each 2X2 cm² of film contains 5mg of Levocetirizine. The preliminary 10 batches were formulated for designing the Oral dispersible film wherein the effects of plasticizer, effectiveness of CCS and CP; and concentration of HPMC were assessed on the characteristics of the films. Then design, characterization, optimization and evaluation of film using Box Behnken design was used to investigate the influence of independent factors, i.e. content of HPMC-15 cps, PEG and Crospovidone on response variable, i.e. disintegration time. When target of 22 seconds DT is made, the combination of the three variables should be such that HPMC should be used at around 35% w/w, CP at around 4% w/w and PEG should be used at around 10% v/w. Further, from the study it was found that HPMC had increasing effect in DT while, crospovidone and PEG had decreasing effect. Thus, it can be concluded that oral dispersible film of Levocetirizine dihydrochloride for quick relief from allergic rhinitis can be made by using HPMC as polymer using solvent casting method.