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Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILM OF LISINOPRIL USING NATURAL DISINTEGRANTS

Nikita Sanjay Chute*, Sachin B Dudhe

Maharashtra Institute of Pharmacy, Betala, Bramhapuri, Maharashtra

ABSTRACT

The formulation and evaluation of a fast-dissolving oral film of Lisinopril, a vital medication for hypertension treatment, were investigated in this study. A comprehensive preformulation study was conducted to characterize Lisinopril's physical and chemical properties, including organoleptic properties, solubility profile, infrared spectrum, loss on drying, melting point, and moisture content. Additionally, a calibration curve was established to quantify Lisinopril concentration accurately. Subsequently, various natural disintegrants were explored to optimize the formulation, considering parameters such as general appearance, thickness, weight, folding endurance, disintegrating time, tensile strength, moisture content, and assay. Among the formulations evaluated, F7 emerged as the optimized formulation, composed of Lisinopril, HPMC K4, HPMC K15, PEG-400, Xanthan gum, Mannitol, Citric acid, and DM water. The in-vitro release kinetics of formulation F7 revealed a diffusion-controlled release mechanism, with the Higuchi model providing the best fit. The study highlights the successful development of an optimized oral film formulation of Lisinopril, offering rapid drug dissolution and potential clinical benefits in hypertension management.

Keywords: Lisinopril, fast-dissolving oral film, natural disintegrants, optimization, in-vitro release kinetics.


[Full Text Article]