Badran Mohamed M, Alouny Nadia N, Aldosari Basmah N, Alhusaini Ahlam M, Abou El Ela Amal El Sayeh
Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11495, Saudi Arabia.
Department of Pharmaceutics, College of Pharmacy, Al-Azhar University, Cairo 11865, Egypt.
Pharmaceutics. 2022 Apr 10;14(4):826. doi: 10.3390/pharmaceutics14040826.
The current study aimed to develop and evaluate a sustained-release transdermal Glipizide (GLP) film to overcome its oral administration problems. Chitosan (CS)-coated deformable liposomes (DLs) were utilized to enhance the drug transdermal delivery. The formulations were characterized in terms of particle size, zeta potential, entrapment efficiency (EE%), vesicle deformability, morphology, stability, and in vitro release. Transdermal films of chosen formulations were prepared by the solvent casting technique, and an ex vivo study throughout rat skin was also performed. Moreover, a pharmacokinetics (PK) study was carried out and blood glucose levels were estimated. All the liposomes were in the nanometer range and a high EE% was obtained from DLs compared to conventional liposomes (CL). The prepared formulations showed a high stability and the DLs exhibited a high deformability compared to CL. The in vitro release study confirmed the sustained release of GLP from both CL and DL and a more pronounced sustained release of GLP was detected after coating with CS. Moreover, GLP was shown to efficiently permeate through the rat skin from transdermal films by an ex vivo permeation test. The transdermal films showed a promising PK profile in the rat as compared with oral GLP. Most importantly, GLP-CS-DL1 demonstrated a higher hypoglycemic effect, confirming the possibility of systemic action by the local topical delivery of GLP.
本研究旨在开发并评估一种缓释格列吡嗪(GLP)透皮膜剂,以克服其口服给药的问题。采用壳聚糖(CS)包衣的可变形脂质体(DLs)来增强药物的透皮递送。对制剂进行了粒径、zeta电位、包封率(EE%)、囊泡变形性、形态、稳定性和体外释放等方面的表征。通过溶剂浇铸技术制备了所选制剂的透皮膜,并进行了大鼠皮肤的离体研究。此外,还进行了药代动力学(PK)研究并估算了血糖水平。所有脂质体均在纳米范围内,与传统脂质体(CL)相比,DLs获得了较高的EE%。制备的制剂显示出高稳定性,与CL相比,DLs表现出高变形性。体外释放研究证实了GLP从CL和DL中均有缓释,并且用CS包衣后检测到GLP有更明显的缓释。此外,通过离体渗透试验表明,GLP能有效地从透皮膜透过大鼠皮肤。与口服GLP相比,透皮膜在大鼠中显示出有前景的PK曲线。最重要的是,GLP-CS-DL1表现出更高的降血糖作用,证实了通过局部局部递送GLP实现全身作用的可能性。