Considering the factors of SEDDS technology:
(1) The classification of drug vehicles or nutrient molecules; (2) The SEDDS system classification, Surfactant, Cosurfactant, Solvent, Oil selection; (3) The preparation process of SEDDS.
The preparation process of SEDDS :
(1) The method of self assembly of the solvent evaporation. (2) Dialysis. (3) The evaporation method of emulsion and solvent (4) The chemical combination method.
Detection technology of SEDDS:
(1) Its distribution of the morphology, particle size. (2) The measure of entrapment efficiency and drug loading. (3) The extent of oxidized phospholipids (4) The provisions complying with the general principles of phamaceutics. (5) The stability of solution (pH, Temperature, Centrifugation, Test). (6) Zeta potential, Viscosity, Cloud Point, Dye Solubilization Test.
The new technology of s-SEDDS and its problems:
SEDDS has low stability, the irreversible separation of drug loading and lipid carrier system, big dose, difficultly portable dosage form. Therefore the solid -SEDDS is the developing hotspot at present, Examples of such problems include the following:
(1) Amount of solidifying excipients may affect the release of the drug.
(2) Nature of the excipients used may affect the drug absorption.
(3) Probability of irreversible phase separation on reconstitution.
(4) Clogging of spray nozzles due to oil content in spraydrying method.
(5) Degradation of drug during solidification process.
(6) Reduction in drug loading capacity.
(7) Difficulty in ensuring content uniformity.
(8) Probability of residual solvents used during granulation.
Clinical trial of the MTC research group:
In a recent double-blind clinical study, SEDDS
Coenzyme Q10 softgel has shown almost three
times (287%) higher bio-availability than
traditional Coenzyme product.