Development and characterization of taste masked orodispersible film of chlorpromazine hydrochloride

Abstract

Thin-film drug delivery, also referred to as orodispersible film has emerged as an advanced alternative to the traditional tablets, capsules, and liquids. The present work investigates the improvement in solubility to have a rapid onset of action, and palatability of chlorpromazine hydrochloride (CPZ) by developing an orodispersible film (ODF) using the solvent casting method. CPZ indicated for the control of nausea and vomiting, and in the treatment of schizophrenia in adults and children, has low bioavailability (30-50%) when taken orally as a tablet due to extensive first-pass metabolism. Moreover, it is very bitter and has an unpleasant after-taste. In this study, seven placebo formulations were prepared containing different concentrations of film-forming polymers (hydroxypropyl methylcellulose E5 and polyvinyl pyrrolidone K30) and plasticizers (propylene glycol and glycerin), and the most suitable polymer-plasticizer combination was screened to obtain required physical properties. CPZ loaded film was made using an optimized polymer-plasticizer combination employing sucralose and menthol as taste-masking agents. Drug-loaded films were transparent, smooth, and disintegrated in 14.67 ± 1.53 sec. Films showed a folding endurance of > 400, tensile strength of 1.54 ± 0.11 N/mm2 and percentage elongation of 18.7% ± 0.50 suggesting good mechanical strength. More than 90% drug release was obtained within 3 min in dissolution media. FTIR analysis displayed no significant interactions between drug and polymer. The film was also found palatable with a sweet taste by human volunteers. Hence the taste-masked films of CPZ can be a potential alternative to conventional oral dosage forms and may also enhance patient compliance.