ABSTRACT

Lorazepam which belongs to Benzodiazepines and is a novel drug used for the treatment of anxiety. The oral films which dissolves easily can mostly absorb in systemic circulation. The present study aimed to formulate and evaluate oral fast dissolving films of lorazepam using HPMC E 50 used as a film-forming polymer, sodium starch glycolate, citric acid used as a saliva stimulating agent, and crospovidone which acts as a super disintegrant in different concentrations. The films were prepared by solvent casting method characterized by Fourier Transform infrared spectroscopy and ultra-violet spectroscopy. The prepared films were evaluated for folding endurance, surface pH, content uniformity, disintegration time, mouth dissolving time, thickness, weight variation, in vitro, and in vivo studies. In vitro release rate of Lorazepam was studied in pH 6.8 phosphate buffer. From in vitro drug release, the optimized formulation F3(HPMC E 50, sodium starch glycolate, citric acid) has given 99.4% drug release than other formulations and a satisfactory disintegration time of 32sec respectively. In vivo pharmacokinetic results showed that the Lorazepam film had higher maximum plasma concentrations(Cmax). In conclusion, the optimized fast dissolving film formulation showed a high absorption rate, rapid onset of action, and improved bioavailability as well as patient compliance. Perhaps the optimized F3 formulation is safe for film application. Keywords: Fast dissolving films, Lorazepam, sodium starch glycolate, solvent casting method
Publication date: 01/06/2023

https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_7180.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2023/12.6.7180