Formulation development and characterization of chlorpheniramine maleate mouth dissolving films

Chlorpheniramine Maleate (CPM) is a first generation alkylamine antihistamine used in the prevention of the symptoms of allergic conditions such as rhinitis and urticaria. The purpose of the present study was to formulate and evaluate mouth dissolving films of Chlorpheniramine Maleate (4mg). The films were prepared with various water soluble polymers such as HPMC (3cps and 5cps), Methyl Cellulose (MC E 15), and Kollicoat IR with suitable plasticizers like PEG 400 and glycerin. Citric acid was used in this study as saliva stimulating agent. Superdisintegrant was also included in the formulation to improve the release characteristics. Chlorpheniramine Maleate films were prepared with different ratios of water soluble polymers and plasticizers by solvent evaporation technique. The prepared films were evaluated for vitro dissolution studies. The release of CPM from Kollicoat IR films was 100% in 5mins in the dissolution medium of (pH 6.8 phosphate buffer). The release profiles of films were analyzed by using the UV- Visible spectrophotometer at 223nm. In vitro parameters like thickness, disintegration, folding endurance, assay and weight of the films were evaluated. Preformulation studies of CPM like compatibility studies with polymers, using Fourier transform infrared spectroscopy (FTIR), X ray diffraction (XRD) and Scanning electron microscopy (SEM) were carried out. The drug and polymers were found to be compatible with each other. These results strongly suggested that the water soluble polymers were suitable for the formulation of mouth dissolving films of CPM.
Author(s): Pamula Reddy B., M. Mohan Varma, Sudheer Betha, D. Basava Raju, Ramu Mecha and J. Vijaya Ratna

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