Formulation and Evaluation of Chlorpheniramine Maleate Mouth Dissolving Films
The present investigation was aimed at preparation and evaluation of mouth dissolving films (MDFs) of an anti-histamine drug, Chlorpheniramine Maleate (CPM) to enhance convenience and compliance to the elderly and paediatric patients. The MDFs were prepared using wet film applicator and evaluated for physicochemical and physicomechanical properties. MDFs were prepared with 0.6% and 0.8% w/w CPM. The MDFs with 0.8% w/w drug load showed re-crystallisation within 10 days, while the MDFs with 0.6% w/w CPM load were transparent with no re-crystallization. The effect of film formers, film thickness, film modifiers, saliva stimulating and soothing agents on the physicomechanical properties and CPM release from MDFs were evaluated. MDFs casted at 30mil thickness containing poly ethylene glycol (PEG-400) as plasticizer showed superior CPM release rates along with good physicomechanical properties. MDFs with hydroxy propyl methyl cellulose (HPMC) E3 as film former gave superior CPM release rate when compared to E5 and E15 formulations. MDFs with poly vinyl pyrrolidone K30 (PVPK30) gave superior drug release properties when compared to MDFs without PVP K30. The MDFs with citric acid (CA) and xylitol gave superior CPM release than the other MDFs. Release kinetics data reveals diffusion as drug release mechanism.
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