FORMULATION, DEVELOPMENT AND EVALUATION OF FAST DISSOLVING SUBLINGUAL WAFERS OF PROMETHAZINE HYDROCHLORIDE
Karishma Jaiswal, Ramujagar Singh, Kavita R. Loksh
ABSTRACT
The purpose of present work was a development of fast dissolving sublingual wafers of promethazine hydrochloride to overcome the limitation of current routes of administration, to provide faster dissolution rate and increase patient compliance, especially for outpatient setting. The wafers were prepared by solvent casting method, using polymers such as gelatin and xanthan gum in different ratios. All films were evaluated for tensile strength, weight variation, thickness, disintegration time, drug content, pH, folding endurance and in vitro drug release. Thus stable, porous, uniformly loaded fast disintegrating, taste masked promethazine hydrochloride sublingual wafers with good compatibility and stability was achieved.Satisfactory results were obtained when the wafers were subjected to tests such as uniformity of weight, thickness, surface pH, drug content, disintegration time, moisture content and in vitro drug release studies. Films were smooth, acceptable and translucent in colour. For optimized batch, drug content (99.12±0.61%), disintegration time (6±1 sec), dissolution (98.15% in 360 sec) were acceptable. Optimized batch F7, due to its potential to deliver through fast dissolving film, can be developed for clinical use.
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