Levocetirizine dihydrochloride and ambroxol hydrochloride oral soluble films: Design, optimization, and patient compliance study on healthy volunteers
Abstract
Objective: The aim of this study was to develop taste masked oral soluble films (OSFs) for levocetirizine dihydrochloride (LCT) and ambroxol hydrochloride (AMB) using different combination of polymers such as polyvinyl pyrrolidone (PVP) K30, propylene glycol (PG), gelatin, sodium alginate (SA), pectin, gaur gum (GG), and hydroxypropyl methylcellulose (HPMC) K15M and super disintegrants like carboxymethyl cellulose (CMC) and sodium starch glycolate (SSG). Materials and Methods: The different basic formulations were developed using solvent casting method for with and without drugs loading and prepared films were evaluated different morphological and mechanical parameters facilitated the screening of a formulation with best characteristics. Results: The films made from HPMC K15M (42.2% w/w) and pectin (35.2% w/w) and considered as an optimized batch among the other formulations. The addition of (titanium dioxide) (TiO 2 ) films was shown opaque nature. The optimized films were subjected to further of drugs content, drugs release profile, stability, and organoleptic properties by human volunteers. The percentage release at end of 90 th s found 73.11 ± 5.2% in pH 6.0 and 81.07 ± 5.6% in water for LCT and 89.2 ± 4.5% in pH 6.0 and 86.22 ± 4.2% in water for AMB, respectively and there were insignificant changes showed at stability study. The organoleptic properties revealed that by complexing drugs with hydroxypropyl β-cyclodextrin (HPβ-CD) in 1:1.5 ratios masked the bitter taste…
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