ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Evaluation of oral bioavailability and other pharmacy effects on sleep quality by using zaleplon nano emulsifying drug delivery systems carrying

Anupam Yadav, Ashwani Kumar, Junainah Abd Hamid, I. A. Ariffin, Nada Khairi Younis, Mohammed Ahmed Mustafa, Ghadir Kamil Ghadir, Avvaru Praveen Kumar, and Abdullah K. Alanazi

School of Basic & Applied Sciences, Shobhit University, Gangoh, India

E-mail: drkumar.kr@gmail.com

Received: 15 March 2024  Accepted: 25 September 2024

Abstract:

Non-benzodiazepine sedative-hypnotic zaleplon has showed potential in reducing symptoms of HIV infection in people who suffer from sleeplessness. It interacts with Gamma-aminobutyric acid (GABA) receptors and enhances sleep quality. Insomnia is associated with metabolic difficulties; zaleplon’s effects on metabolic alterations and branched-chain amino acid (BCAA) metabolism indicate it may be useful in treating these concerns. It also helps with secondary depression, demonstrating its therapeutic value. To evaluate the oral bioavailability and subjective sleep quality and duration of the newly designed Zaleplon nanoemulsifying drug delivery system (SNEDDS). This study developed a solution of optimised Zaleplon self-nanoemulsifying medication delivery devices and then pharmacokinetics and pharmacodynamics characteristics were compared with that of the market-available similar drug on psychiatric patients. Multiple components were obtained, and response surface design reduced tests. The UV–Vis spectrophotometry assessed optical clarity after dilution. Comparing Zal-SNEDDS to control capsules in simulated stomach fluid for dissolution examined medication concentration. High-performance liquid chromatography was used to measure serum Zaleplon concentration before and after administration. The study demonstrated significant improvements in subjective sleep quality for the Zaleplon-SNEDDS group, which scored lower (0.69 ± 0.066) compared to the usual Zaleplon group (1.25 ± 0.085) with a p-value of 0.0026. Sleep latency showed no significant difference between the groups. Both groups had low sleep disturbance scores, with no significant difference observed. Daytime dysfunction significantly improved in the Zaleplon-SNEDDS group (p = 0.0012). Sleep duration was significantly better in the Zaleplon-SNEDDS group (p = 0.045). Total PSQI scores showed a trend towards improvement in the Zaleplon-SNEDDS group, though not statistically significant (p = 0.065). The study concluded that Zaleplon-SNEDDS is highly effective in increasing subjective sleep quality, daytime dysfunction and sleep duration as compared to the Zaleplon available in the market.

Keywords: Zaleplon-SNEDDS; Sleep quality; Nano-emulsifying drug delivery system; Insomnia treatment; Metabolic effects of Zaleplon

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-024-03791-x

Chemical Papers 78 (18) 9627–9642 (2024)