FORMULATION AND EVALUATION OF MECLIZINE HYDROCHLORIDE MOUTH DISSOLVING FILMS

Abstract

The objective of this research was to formulate and evaluate Meclizine Hydrochloride (MCZ) mouth dissolving films (MDFs) to
overcome the impediments associated with the administration of oral route dosage forms such as tablets and capsules especially for
age-specific patients like pediatrics and geriatrics. In the formulation of MDFs, various viscosity grades of Hydroxy propyl methyl
cellulose (HPMC) E3, E5, E15 were used as a film-forming agent. PEG 400 and glycerol were used to enhance the plasticity of MDFs
and Poly vinyl pyrrolidine (PVP), Sodium lauryl sulphate (SLS) as solubilizing agents. MDFs were prepared in Petri plates using the
solvent casting method. FTIR studies confirmed that no interactions between MCZ and excipients were used in MDFs. DSC studies
showed the absence of MCZ recrystallization within the MDFs. SEM analysis confirmed that MCZ was in a dispersed state within the
MDFs. The formulated MDFs were examined for physical characteristics such as weight variation, thickness, loss of drying,
mechanical properties (folding endurance), and chemical properties like MCZ content, in vitro disintegration time, and in vitro drug
release studies. Overall, the MDF fabricated with polymer HPMC E3 in a combination of PVP and PEG showed a better result of
MCZ release about 98.05% within 5 minutes compared to other formulations.