Daulat Kumar
Research Scholar, Department of Pharmaceutics, Jaipur College of Pharmacy, Jaipur, Rajasthan
Arindam Chattrejee
Professor, Department of Pharmaceutics, Jaipur College of Pharmacy, Jaipur, Rajasthan
Sunil Sain
Associate professor, Department of pharmaceutics, Jaipur College of Pharmacy, Jaipur, Rajasthan
Priya Sharma
Research Director, Axico Healthcare Pvt. Ltd., New Delhi
Mayank Bansal
Professor& Principal, Department of Pharmaceutics, Jaipur College of Pharmacy, Jaipur, Rajasthan
Ashutosh Sharma
Associate Professor, Department of Pharmaceutics, Jaipur College of Pharmacy, Jaipur, Rajasthan
Abstract
Background: Disturbed sleep can cause to many health problems such as cognitive impairment, depressed mood, and negative effects on cardiovascular, endocrine, and immune function. This study formulates and optimizes Fast Dissolving film of zopiclone.
Methods: Fast Dissolving film of zopiclone prepared by solvent casting method. Prepared zopiclone fast dissolving film was characterized by disintegration time, drug release, surface pH, tensile strength (TS), folding endurance and in vitro dissolution test. ZF15 film [(7.5) mg HPMCE 15, 40 (mg) Eudragit RL 100 , 30 (mg) PEG 40] were selected among formulation. A, B, and C are the amounts of HPMC E15, Eudragit RL 100, and polyethylene glycol, respectively were used as independent variables, their interactions, which quantify the effects on tensile strength (Y1), disintegration time (Y2), and cumulative percent of drug release after 10 minutes (Y3). Optimised zopiclone thin film undergoes 90 days of stability testing.
Results: The results indicated with a minimum thickness of 0.10 nm, maximum tensile strength of 56.73 gm, maximum folding endurance of 290, maximum drug uniformity of 99.13%, surface pH of 6.78, and minimum disintegration time of 27 seconds, formulation ZF15 demonstrated exceptional properties. Within a 10-minute period, ZF15 demonstrated the most amount of drug release. The optimal formulation was determined to be ZF15 based on its physico-chemical characteristics and the amount of medication released in vitro. disintegration time was in the range of 940 m. . All formulas exhibited acceptable uniformity content, surface pH, film thickness, and a good taste feeling.
Conclusion: Thus, employing a solvent casting method, a fast-dissolving thin film of zopiclone was created with effective taste masking and prompt in vitro drug release.
Keywords: Zopiclone , Fast dissolving oral film, HPMC E15, Eudragit RL100 , Solvent casting