A new self-emulsifying drug delivery system (SEDDS) for poorly soluble drugs: Characterization, dissolution, in vitro digestion and incorporation into solid pellets

Abdalla, Ahmed M. E.; Klein, Sandra; Mäder, Karsten

doi:10.1016/j.ejps.2008.09.006

Cited by 98 publications

(42 citation statements)

References 18 publications

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“…Equally an adequate dosage form must be 115 chosen for the administration of these lipid systems, because liquids produce some disadvantages; the large quantity of surfactants in the formulations can induce gastrointestinal irritation (Tang et al, 2008). An optimal alternative to tackle these disadvantages are hard gelatine capsules (Wang et al, 2009;Halbaut et al, 1996), pellets (Abdalla et al, 2008), tablets (Attama et al, 2003), gelatine hollow type suppositories (Kim and Ku, 2000), and so on. There 120 have been relatively few studies that introduce SNEEDS in a systemic way, especially with respect to dosage form development, preparation techniques (Tang et al, 2008) and quantification of the release patterns of these emulsions from their dosage forms (Nazzal et al, 2002).…”

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confidence: 99%

Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Villar

Naveros

Campmany

et al. 2012

International Journal of Pharmaceutics

143

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Self nanoemulsifying drug delivery systems of gemfibrozil were developed under Quality by Design approach for improvement of dissolution and oral absorption. Preliminary screening was performed to select proper components combination. Box-Behnken experimental design was employed as statistical tool to optimize the formulation variables, X1 (Cremophor® EL), X2 (Capmul® MCM -C8), and X3 (lemon essential oil). Systems were assessed for visual characteristics (emulsification efficacy), turbidity, droplet size, polydispersity index and drug release. Different pH media were also assayed for optimization. Following optimization, the values of formulation components (X1, X2, and X3) were 32. 43%, 29.73% and 21.62 %, respectively (16.22% of gemfibrozil). Transmission electron microscopy demonstrated spherical droplet morphology. SNEEDS release study was compared to commercial tablets. Optimized SNEDDS formulation of gemfibrozil showed a significant increase in dissolution rate compared to conventional tablets. Both formulations followed Weibull mathematical model release with a significant difference in td parameter in favour of the SNEDDS. Equally amodelistic parameters were calculated being the dissolution efficiency significantly higher for SNEDDS, confirming that the developed SNEDDS formulation was superior to commercial formulation with respect to in vitro dissolution profile. This paper provides an overview of the SNEDDS of the gemfibrozil as a promising alternative to improve oral absorption. She is an expert in nanotechnology (colloids and nanoparticles) with a wide experience. She has extensive curriculum of published paper about this subject Jose Luis Arias Mediano Ph. D. Professor reseracher, Pharmacy and Pharmaceutical Technology , University of Granada jlarias@ugr.es He is an expert in nanotechnology (colloids and nanoparticles) with a wide experience in this type of investigation. Also is reviewer in specialized pharmaceutical journal. He is an expert in nanotechnology (colloids and nanoparticles) with a wide experience in this type of investigation. Also is reviewer of Pharmaceutical science journals. IJP AUTHOR CHECKLISTDear Author, It frequently happens that on receipt of an article for publication, we find that certain elements of the manuscript, or related information, is missing. This is regrettable of course since it means there will be a delay in processing the article while we obtain the missing details.In order to avoid such delays in the publication of your article, if accepted, could you please run through the list of items below and make sure you have completed the items. Overall Manuscript Electronic artwork format? ---------------------------------------------------TIFF

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mentioning

confidence: 99%

Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Villar

Naveros

Campmany

et al. 2012

International Journal of Pharmaceutics

143

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“…Solid dispersions and in particular self-emulsifying drug delivery systems (SEDDS) have proved to be the most practical route to commercialization. Success of Fortovase ® (Saquinavir), Norvir ® (Ritonavir) and Neoral ® cyclosporine as lipid suspensions have prompted formulators to develop more stable forms by converting these suspensions into powder (12). Neusilin ® 's high specifi c area, increased surface adsorption, porosity, anticaking, fl ow enhancing properties and its ability to keep the drug stable under amorphous state make it one of the best choices among the adsorbents available today (13).…”

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Dissolution improvement of solid self-emulsifying drug delivery systems of fenofi brate using an inorganic high surface adsorption material

Shazly

Kazi

2015

Acta Pharmaceutica

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Dissolution improvement of solid self-emulsifying drug delivery systems of fenofi brate using an inorganic high surface adsorption materialSolidifi cation of lipid formulations using adsorbents is a recent technique a racting great interest due to its favourable properties including fl exibility in dose division, reduction of intra-subject and inter-subject variability, improvement in effi cacy/safety profi le and enhancement of physical/ chemical stability. The current study aims to convert liquid self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) into solid SEDDS/SNEDDS and to assess how adsorption of the drug onto an inorganic high surface area material, Neusilin ® grade US2 (NUS2), aff ects its in vitro dissolution performance. Lipid formulation classifi cation systems (LFCS) Type III formulations were designed for the model anti-cholesterol drug fenofi brate. NUS2 was used to solidify the SEDDS/SNEDDS. Particle size and SEM analyses of solid SEDDS/SNEDDS powder were carried out to investigate the adsorption effi ciency. In vitro dissolution studies were conducted to compare the developed formulations with the marketed product. The results of characterization studies showed that the use of 50 % (m/m) adsorbent resulted in superior fl owability and kept the drug stable is amorphous state. Dissolution studies allow the conclusion that the formulation containing a surfactant of higher water solubility (particularly, Type IIIB SNEDDS) has comparably faster and higher release profi les than Type IIIA (SEDDS) and marketed product.Keywords: self-emulsifying/nanoemulsifying drug delivery systems, fenofi brate, in vitro dissolution test, solidifi cation technique, adsorptionLipid-based dosage forms have gained high priority and become more prominent in the pharmaceutical industry in recent years (1-4). Lipids have been used as carriers in various delivery systems for drug administration, including solutions, suspensions, emulsions, self-emulsifying systems, microemulsions and, recently, solid dosage forms (via

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“…Nowadays, several approaches are available to improve the bioavailability of dutasteride, such as solid dispersion , polymeric nanoparticle , Hydroxypropyl-β-cyclodextrin (HP-β-CD) nanostructures , and self-emulsifying drug delivery system (SEDDS). SEDDS is a promising method as it is anhydrous isotropic mixture of oil, surfactant, co-surfactant, and drug, which spontaneously form oil-in-water emulsion following the dilution in aqueous medium upon agitation (Abdalla et al, 2008;Balakrishnan et al, 2009;Gursoy and Benita., 2004). Lee et al, (2015), designed supersaturable Self -microemulsifying drug delivery system (S-SMEDDS) of dutasteride for oral administration.…”

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confidence: 99%

Self-Nanoemulsifying Drug Delivery Systems of Poorly Soluble Drug Dutasteride: Formulation and In-Vitro characterization

2017

J App Pharma Sci

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The present study aims to prepare and evaluate the self-nanoemulsifying drug delivery system (SNEDDS) to enhance the dissolution rate of a poorly soluble drug dutasteride. The formulation was prepared using capryol PGMC, Cremophor EL, and polyethylene glycol (PEG) 400 as oil, surfactant and co-surfactant, respectively. The pseudo-ternary phase diagrams with presence and absence of drug were plotted to find out the nanoemulsification range and also to evaluate the effect of dutasteride on the emulsification behavior of the phases. Prepared SNEDDS formulations were evaluated for its particle size distribution, nanoemulsifying properties, robustness to dilution, self-emulsification time, turbidity measurement, drug content and in-vitro dissolution. Furthermore, the optimized formulations were evaluated for heating cooling cycle, centrifugation studies, freeze thaw cycling, particle size distribution and zeta potential to confirm the stability of the formed SNEDDS formulations. The particle size, zeta potential and polydispersity index of the optimized formulation was found to be 35.45 nm, -15.45 and 0.19, respectively. The in vitro results revealed that the prepared formulation enhanced the dissolution rate of dutasteride significantly compared to pure drug. In 60 minutes, the formulation showed 83.15% and 82.04 % drug release for pH 6.8 and pH 1.2 respectively. Based on the results, it was concluded that the dutasteride-loaded SNEDDS revealed better dissolution compared to the raw drug suspension and commercial drug.

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A new self-emulsifying drug delivery system (SEDDS) for poorly soluble drugs: Characterization, dissolution, in vitro digestion and incorporation into solid pellets

Cited by 98 publications

References 18 publications

Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil

Dissolution improvement of solid self-emulsifying drug delivery systems of fenofi brate using an inorganic high surface adsorption material

Self-Nanoemulsifying Drug Delivery Systems of Poorly Soluble Drug Dutasteride: Formulation and In-Vitro characterization

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