Formulation And Evaluation Of Fast Dissolving Film For The Treatment Of Hypertension

Abstract

The present study looked at ways to improve the drug's solubility and dissolution in order to treat hypertension. In this work, a fast-dissolving film comprising a solid dispersion of reserpine and polythene glycol was developed and optimised using a QBD strategy for the treatment of hypertension. The PEG 20000 carrier fusion technique was used to create the reserpine solid dispersion. Preliminary screening led to the selection of PEG 20000 concentration and reserpine concentration as the two parameters to be optimised. Thirteen different formulations of a reserpine-poly ethylene glycol solid dispersion were proposed using a central composite response surface design with three different levels of PEG 20000 (80mg and 160mg) and reserpine (2mg and 6mg). The % solubility of each batch was calculated after 20 minutes of reserpine dissolution from the solid dispersion. Using a numerical optimisation method based on desirability approaches, we were able to get the newly optimised solid dispersion (DKFDF14), which served as a benchmark. The best solid dispersion was formulated using 3.66 mg of reserpine (X1) and 124.88 mg of PEG 20000 (X2), producing theoretical values of 14.94% solubility and 96.88% dissolution after 20 minutes. A fast-dissolving film containing DKFDF14 was made via solvent casting. Variables such as HPMC concentration, plasticiser concentration, and plasticiser type were studied in relation to the fast-dissolving film's defining characteristics. There were 12 distinct formulations made and analysed. Customised formulations were found to have a surface pH range of 6.83 to 7.19, which is near to neutral and indicative of a lack of irritation to the sublingual mucosa and, therefore, greater patient acceptance. The medication was evenly distributed throughout the polymer film, with a percentage content ranging from 91.082±1.540% to 98.977±0.253% for all created formulations. The total amount of reserpine (98.977±0.253%) in formulation DKFDF14FDF11 is the highest of any of the formulations. In vitro dissolution investigations of the DKFDF14FDF11 formulation of reserpine-polyethylene glycol fast dissolving film revealed rapid disintegration of up to or more than 90% within 6 minutes.