Abstract

Aims: The aims of this research were to develop and characterize liquid and solid micro emulsifying drug delivery system (L-SMEDDS and S-SMEDDS) containing black seed oil. 
 Study Design: Experimental Research Design (laboratory).
 Place and Duration of Study: The study was conducted at research laboratory of pharmacy department UNISBA, between August 2018- August 2019.
 Methodology: The optimization of L-SMEDDS was carried out using various comparison of oil, surfactant, and cosurfactant. All formulations were evaluated for percent transmittance, emulsification time, dispersibility, robustness, and thermodynamic stability. The best formula of L-SMEDSS was evaluated for globule size distribution and converted to S-SMEDDS by spray drying method using aerosil 200 as adsorbent. S-SMEDDS were evaluated for organoleptic, flowability, compressibility, emulsification time, dispersibility, robustness and surface morphology.
 Results: The best formula of L-SMEDDS contains tween 80 as a surfactant and PEG 400 as cosurfactant (2:1) with a ratio of oil and Smix (2:8). The L-SMEDDS preparation meets the requirement of percent transmittance (95.77%), emulsification time (37.67 seconds), grade A of dispersibility, stable of robustness and thermodynamics study with the average of globule size was 231 nm. S-SMEDDS preparation meets the requirement of the moisture content, flowability, emulsification time, and stable on robustness testing with a spherical shape.
 Conclusion: L-SMEDDS and S-SMEDDS of black seed oil have been developed and have good physical characteristics and stability.

Highlights

  • Nigella sativa L known as black cumin and black seed that used medicinally for hundred years and considered as the greatest forms of healing medicine in Islamic literature [1]

  • The L-self-microemulsifying drug delivery system (SMEDDS) preparation meets the requirement of percent transmittance (95.77%), emulsification time (37.67 seconds), grade A of dispersibility, stable of robustness and thermodynamics study with the average of globule size was

  • It will improve the efficiency of SMEDDS formation

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Summary

Introduction

Nigella sativa L known as black cumin and black seed that used medicinally for hundred years and considered as the greatest forms of healing medicine in Islamic literature [1]. The black seed oil has a hydrophobic property which causes low oral bioavailability and limited therapeutic effects [4]. One formulation strategy that can enhance the solubility and bioavailability of a hydrophobic drug is a self-microemulsifying drug delivery system (SMEDDS). SMEDDS is an isotropic mixture of oil, surfactant, and cosurfactant which can form fine oil in water emulsion upon mild agitation followed with dilution in aqueous media such as GI (Gastrointestinal) fluids with globule size less than 250 nm [5]. The previous study showed that a self-emulsifying system could increase oral bioavailability (Cmax value/maximum concentration) of zedoary essential oil 2.5 times compared with pure oil. In SMEDDS formulation, the oil will form a very small droplet at gastrointestinal and facilitate the dissolution and absorption process [6]

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