vv 009 Citation: Ammar HO, Ghorab MM, Mostafa DM, Ghoneim AM (2018) Spray dried self-nanoemulsifying drug delivery systems for sertraline HCl: Pharmacokinetic study in healthy volunteers. Int J Pharm Sci Dev Res 4(1): 009-019. DOI: http://doi.org/10.17352/ijpsdr.000017 https://dx.doi.org/10.17352/ijpsdr DOI: 2640-7760 ISSN: PHARMACY GROUP Abstract Purpose: The aim of this study is to improvelow oral bioavailability of sertraline HCl by formulation and characterization ofsolid self-nanoemulsifying drug delivery system [SNEDDS] using spray drying technique. Methods: Solubility of sertraline HCl in different vehicles was determined, and ternary phase diagrams were constructed.Various formulations were prepared and characterized by morphological characterization, differential scanning calorimetry and droplet size analysis. The formulations were evaluated for in vitro release profile in comparison to the marketed product [Lustral® tablets]. The in vivo study was performed on healthy human volunteers for pharmacokinetic analysis of the optimized formulations. Results: In vitro release data showed significant improvement of dissolution rate of sertraline HCl in form of liquid SNEDDS compared to the plain drug. Optimized liquid SNEDDS were chosen for the preparation of solid SNEDDS by spray drying technique. High dissolution efficiency values of solid SNEDDS indicated the increase in dissolution characteristics of sertraline HCL in solid SNEDDS. F6 SNEDDS, comprising Capmul® 20%, Cremophor® 53.4%, Transcutol® 26.6% showed highervalues for AUC[0-72 h], AUC [0-∞] and AUMC[0-72h] compared to Lustral® tablets. Conclusion: The prepared formulation reveals the potentiality of incorporating sertraline HCl in a SNEDDS formulation to improve the biological performance of the drug. Research Article Spray dried self-nanoemulsifying drug delivery systems for sertraline HCl: Pharmacokinetic study in healthy volunteers Hussein O. Ammar 1 , Mahmoud M. Ghorab 2 , Dina M. Mostafa 3 , and Amira M. Ghoneim 1 * 1 Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University in Egypt 2 Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Egypt 3 Department of Pharmaceutical Technology, National Research Centre, Cairo, Egypt Received: 09 June, 2018 Accepted: 25 June, 2018 Published: 27 June, 2018 *Corresponding author: Hussein O. Ammar, Future university in Egypt, 90th St., Fifth Settlement, New Cairo, Cairo Egypt, Tel: 01224472851; E-mail: Keywords: Sertraline HCl; Spray drying; Self-Nano- emulsifying; Release, Bioavailability; Pharmacokinet- ics; Anti-depressives https://www.peertechz.com Introduction Depression is the most familiar mental disorder that affects a large number of individuals in all countries. However, depression is under diagnosed and often under cured [1]. Recent research believes that depressive episodes may intensify severity of following episodes and may escalate theurgency for more health care resources, if left untreated. Sertraline HCl – a selective serotonin re-uptake inhibitor – is indicated for the treatment of depression and anxiety disorders, panic disorder and post-traumatic stress disorder [2]. It is considered appropriate for the treatment of depressive symptoms in elderly patients, including those suffering from Alzheimer’s disease, as it has minimal anticholinergic activity and is essentially devoid of cardiovascular effects [2]. However, sertralineHCl is practically insoluble in water and undergoes extensive first pass metabolism, resulting in poor bioavailability [40–45%]. Therefore, this required the drug to be taken in high doses in order to maintain adequate plasma levels [3]. Various problems are associated with its oral delivery such as gastrointestinal disturbances such as dry mouth, diarrhea, decreased appetite, nausea, impotence and insomnia [4]. In order to overcome the solubility problems, several formulation techniques can be approached. Among these techniques are self-nanoemulsifying drug delivery systems. Nanoemulsions are isotropic systems, thermodynamically stable and the diameter of the droplets are within the range of 10-100 nm [5]. Self-nanoemulsifying drug delivery system is a pre-mixture of drug, oil, surfactant and cosurfactant that can be used to deliver drugs that are oil soluble. After gentle shaking and gastric juice dilution in stomach, it can form nanoemulsion spontaneously [6]. It is a suitable drug delivery system for oil-soluble drugs because it can be self-emulsified