Abstract

Objective: To overcome the limitations of fast dissolving tablets, a novel fast dissolving film of ebastine was formulated for attaining quick onset of action, aiding in the enhancement of bioavailability favorable in severe conditions of allergies.
 Methods: Films of ebastine were prepared by the solvent casting method using hydroxypropyl methylcellulose E-15, hydroxypropyl methylcellulose K-4 as a film base with different concentrations of crospovidone as superdisintegrant and polyethylene glycol-400 as a plasticizer. Further physical characteristics such as uniformity of weight, thickness, and drug content uniformity, tensile strength, folding endurance, percentage elongation, surface pH, disintegration and in vitro drug release were evaluated.
 Results: The optimized formulations with film base hydroxypropyl methylcellulose E-15 and hydroxypropyl methylcellulose K-4 containing 8% crospovidone showed 99.34 % and 97.42 % of maximum cumulative percentage release respectively exhibiting first order kinetics. However, no significant change was observed in stability studies.
 Conclusion: The concept of formulating fast dissolving films of ebastine offers a suitable approach in exhibiting rapid onset of action with improved delivery.

Highlights

  • Fast dissolving films (FDF), a more advanced drug delivery system have started gaining popularity and acceptance as new drug delivery systems, which aim to enhance the rapid onset of action to provide the drug molecule in a more convenient dosage form of administration and patient compliance formulation [1].Allergic manifestation is quite uneasy and requires immediate medical treatment, the delivery system has to show the rapid onset of action which except for fast dissolving tablets (FDT), no other drug delivery system shows

  • fast dissolving films (FDF) of ebastine were prepared by the solvent casting method using Hydroxypropyl methylcellulose (HPMC) E-15 and HPMC K-4 as a film base with different concentrations of crospovidone as superdisintegrant and polyethylene glycol-400 (PEG-400) as a plasticizer

  • HPMC E-15 alone was used in four formulations while in the other four formulations a combination of HPMC E-15 and HPMC K-4 was used in the ratio of 9:1 respectively

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Summary

Introduction

Fast dissolving films (FDF), a more advanced drug delivery system have started gaining popularity and acceptance as new drug delivery systems, which aim to enhance the rapid onset of action to provide the drug molecule in a more convenient dosage form of administration and patient compliance formulation [1].Allergic manifestation is quite uneasy and requires immediate medical treatment, the delivery system has to show the rapid onset of action which except for fast dissolving tablets (FDT), no other drug delivery system shows. Fast dissolving films (FDF), a more advanced drug delivery system have started gaining popularity and acceptance as new drug delivery systems, which aim to enhance the rapid onset of action to provide the drug molecule in a more convenient dosage form of administration and patient compliance formulation [1]. Ebastine provides efficacy throughout the 24 h dosing interval with once-daily administration and clinical benefit are seen from the first day of treatment. It is rapidly absorbed after oral administration and undergoes extensive hepatic and intestinal first-pass metabolism [5, 6]

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