Formulation and Comparative In-vitro Evaluation of Fast Disintegrating Mouth Films of Betaxolol Hydrochloride for Hypertension

The present study is aimed at preparing a fast disintegrating oral film of Betaxolol Hydrochloride for the treatment of hypertension using solvent casting method. In the formulation of fast disintegrating mouth films, various trials have been carried out using two grades of HPMC (E15 and E50) as film forming polymer, PEG-4000 as plasticizer, citric acid as saliva stimulating agent, peppermint oil as flavoring agent and sucrose as sweetener. The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, %drug content, tensile strength, In vitro disintegration time and In vitro dissolution studies. The formulation F8 prepared by using HPMC E50 as polymer and PEG-4000 as plasticizer shows the best result with minimum disintegration time of 45.78±0.521, % drug content of 99.03±0.276%, and 96.19±0.51% CDR within 10 minutes, with satisfactory physiological properties. The result of FT-IR showed that there is no incompatibility found between the drug and the excipients used in the formulations. This suggests that fast disintegrating mouth films of Betaxolol Hydrochloride could be potentially a useful formulation for the treatment of hypertension where quick onset of action is desired.