Development and Evaluation of Pullulan Based Mouth Dissolving Film of Furosemide

Abstract

Mouth dissolving oral film is an innovative approach as Oromucosal route for systemic delivery of therapeutically/medicinally active drug substance. As we know Furosemide belongs class IV in BCS classification of drug, having low solubility and permeability due to the presence of strong inter and intramolecular bond. Due to low aqeous solubility, it exhibits low oral bioavailability. Here we are preparing mouth dissolving film of furosemide to increase its solubility, which ultimately will enhance its bioavailability. By this way, we will achieve more rapid drug absorption, desired pharmacological effect with quick onset of action by avoiding degradation in GIT and first pass metabolism. This system will provide maximum therapeutic efficacy and maximum stability by reducing the frequency of dosage and as well as improve patient compliance. The present research aimed to prepare pullulan based mouth dissolving oral films of furosemide used in treatment and control of hypertension. Pullulan was selected as film former exhibit better moisture retention, oxygen barrier and uniform film forming properties. Due to the hydrophilic nature of pullulan, it provides quick dissolution. By considering above points, the film was prepared through solvent casting method by pullulan as film-forming polymer, glycerol as plasticizer and lepidium sativum mucilage as a natural disintegrant known as Asaliyo. Disintegration time, drug release, moisture loss and folding endurance of film were evaluated. Promising batch F6 exhibited better drug dissolution 98.75±0.09% within 8±0.4 minutes than the other films. The disintegration time for batch F6 was 23±5 sec. It is evident from the above results that it is an innovative dosage form to improve the drug delivery, onset of action as well as improve patient compliance.