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.
Pamula Reddy B., M. Mohan Varma, Sudheer Betha, D. Basava Raju, Ramu Mecha
and J. Vijaya Ratna