Oral Dissolving Films of Chlorpheniramine Maleate: Formulation and Evaluation

Background

The primary purpose of this research was to carry out the study of the Orally Dissolving Films (ODFs) of chlorpheniramine Maleate (CM). The films were formulated by solvent casting method. This research was also performed to evaluate the characteristics of the film and to examine the release kinetics of CM from the polymeric film.

Materials and Methods

The oral films were formulated utilizing polymers that include Hydroxypropyl methylcellulose E 15, and polyvinyl acetate. The combination of two polymers with Polyvinyl Pyrrolidine K-30 (PVP K-30) was used to optimize the drug release. The study utilized Citric acid as a saliva-stimulating factor, Mannitol as a sweetening factor and Polyethylene Glycol 400 (PEG 400) as a plasticizer. Water and methanol were used as solvents. The effect of film-forming polymers, film thickness on the physicochemical characteristics, and drug release from ODFs was determined. The CM ODFs were evaluated for specific quality control factors.

Results and Discussion

The ODFs passed all the tests. Among different batches, the F8 batch was found suitable which contains Hydroxypropyl methylcellulose E15 with a combination of polyvinyl pyrrolidine K-30 to achieve low disintegration time along with good physicochemical properties. Formulation F8 releases 99% of the drug in 8 min. Stability studies revealed that formulations were stable.

Conclusion

These results suggested that the disintegration and drug release of Chlorpheniramine maleate could be controlled to a greater degree by optimizing the formulation variables in the formulation of CM ODFs.