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      Oil–water partition coefficient preparation and detection in the dihydroartemisinin self-emulsifying drug delivery system

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          Abstract

          Background

          The aim of the present study is to increase the solubility of dihydroartemisinin (DHA) using the self-emulsifying drug delivery system (SEDDS).

          Methods

          We first conducted solubility test and ternary phase diagram, then, in order to optimize the formulation of the DHA self-emulsifying agent, the design mixture method was selected in the design expert software. Next, optimal prescription validation and preliminary formulation evaluation were conducted. By comparing the oil–water partition coefficient in vitro, the improvement of the in vivo osmotic absorption of DHA via self-emulsification was evaluated.

          Results

          The optimal prescription ratio of oleic acid polyethylene glycol glyceride, polyoxyethylene hydrogenated castor oil, and diethylene glycol monoethyl ether in the DHA self-emulsifying preparation = 0.511:0.2:0.289 (w/w/w), with a drug-loading capacity of 26.3634 mg/g, solubility of 2.5448 mg/ml, and self-emulsification time of 230 s. The solubility self-emulsification was approximately 20.52 × higher in DHA than in the crude drug. The self-emulsification could improve DHA permeability and promoting in vivo DHA absorption.

          Conclusion

          The DHA SEDDS could significantly improve DHA solubility and in vivo absorption.

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          Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs.

          R Gürsoy, Simon Benita (2004)
          The oral delivery of hydrophobic drugs presents a major challenge because of the low aqueous solubility of such compounds. Self-emulsifying drug delivery systems (SEDDS), which are isotropic mixtures of oils, surfactants, solvents and co-solvents/surfactants, can be used for the design of formulations in order to improve the oral absorption of highly lipophilic drug compounds. SEDDS can be orally administered in soft or hard gelatin capsules and form fine relatively stable oil-in-water (o/w) emulsions upon aqueous dilution owing to the gentle agitation of the gastrointestinal fluids. The efficiency of oral absorption of the drug compound from the SEDDS depends on many formulation-related parameters, such as surfactant concentration, oil/surfactant ratio, polarity of the emulsion, droplet size and charge, all of which in essence determine the self-emulsification ability. Thus, only very specific pharmaceutical excipient combinations will lead to efficient self-emulsifying systems. Although many studies have been carried out, there are few drug products on the pharmaceutical market formulated as SEDDS confirming the difficulty of formulating hydrophobic drug compounds into such formulations. At present, there are four drug products, Sandimmune and Sandimmun Neoral (cyclosporin A), Norvir (ritonavir), and Fortovase (saquinavir) on the pharmaceutical market, the active compounds of which have been formulated into specific SEDDS. Significant improvement in the oral bioavailability of these drug compounds has been demonstrated for each case. The fact that almost 40% of the new drug compounds are hydrophobic in nature implies that studies with SEDDS will continue, and more drug compounds formulated as SEDDS will reach the pharmaceutical market in the future.
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            Formulation Strategies to Improve the Bioavailability of Poorly Absorbed Drugs with Special Emphasis on Self-Emulsifying Systems

            Shweta Gupta, Rajesh Kesarla, Abdelwahab Omri (2013)
            Poorly water-soluble drug candidates are becoming more prevalent. It has been estimated that approximately 60–70% of the drug molecules are insufficiently soluble in aqueous media and/or have very low permeability to allow for their adequate and reproducible absorption from the gastrointestinal tract (GIT) following oral administration. Formulation scientists have to adopt various strategies to enhance their absorption. Lipidic formulations are found to be a promising approach to combat the challenges. In this review article, potential advantages and drawbacks of various conventional techniques and the newer approaches specifically the self-emulsifying systems are discussed. Various components of the self-emulsifying systems and their selection criteria are critically reviewed. The attempts of various scientists to transform the liquid self-emulsifying drug delivery systems (SEDDS) to solid-SEDDS by adsorption, spray drying, lyophilization, melt granulation, extrusion, and so forth to formulate various dosage forms like self emulsifying capsules, tablets, controlled release pellets, beads, microspheres, nanoparticles, suppositories, implants, and so forth have also been included. Formulation of SEDDS is a potential strategy to deliver new drug molecules with enhanced bioavailability mostly exhibiting poor aqueous solubility. The self-emulsifying system offers various advantages over other drug delivery systems having potential to solve various problems associated with drugs of all the classes of biopharmaceutical classification system (BCS).
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              Self-emulsifying drug delivery systems: an approach to enhance oral bioavailability.

              Sascha Chopra, R. K. Khar, Kanchan Kohli … (2010)
              Self-emulsifying drug delivery systems are a vital tool in solving low bioavailability issues of poorly soluble drugs. Hydrophobic drugs can be dissolved in these systems, enabling them to be administered as a unit dosage form for per-oral administration. When such a system is released in the lumen of the gastrointestinal tract, it disperses to form a fine emulsion (micro/nano) with the aid of GI fluid. This leads to in situ solubilization of drug that can subsequently be absorbed by lymphatic pathways, bypassing the hepatic first-pass effect. This article presents an exhaustive account of various literature reports on diverse types of self-emulsifying formulations with emphasis on their formulation, characterization and in vitro analysis, with examples of currently marketed preparations. Copyright © 2010 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Yanlei Guo: guoyanlei5g7@163.com
                Yong Yang: yangyong_259@163.com
                Journal
                Journal ID (nlm-ta): BMC Biotechnol
                Journal ID (iso-abbrev): BMC Biotechnol
                Title: BMC Biotechnology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1472-6750
                Publication date (Electronic): 27 May 2022
                Publication date PMC-release: 27 May 2022
                Publication date Collection: 2022
                Volume: 22
                Electronic Location Identifier: 16
                Affiliations
                [1 ]GRID grid.469520.c, ISNI 0000 0004 1757 8917, Chongqing Academy of Chinese Materia Medica, ; No.34 of Nanshan Road, Nanan District, Chongqing, 400065 China
                [2 ]GRID grid.411304.3, ISNI 0000 0001 0376 205X, Chengdu University of TCM, ; Chegndu, 611137 China
                [3 ]GRID grid.495238.1, ISNI 0000 0000 8543 8239, Chongqing University of Education, ; Chongqing, 400065 China
                Article
                Publisher ID: 746
                DOI: 10.1186/s12896-022-00746-6
                PMC ID: 9137071
                SO-VID: 760b495b-9fcb-4a8a-b041-abfa189fe626
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 21 March 2022
                Date accepted : 11 May 2022
                Funding
                Funded by: National Major New Drug Creation Major Science and Technology Projects
                Award ID: 2017ZX09101002-002-004
                Funded by: Talent Project of Chongqing Academy of Chinese Materia medica
                Award ID: cqac20190004
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                ScienceOpen disciplines: Biotechnology
                Keywords: dihydroartemisinin,sedds,ternary phase diagram,central composite design-response surface methodology,oil–water partition coefficient
                Data availability:
                ScienceOpen disciplines: Biotechnology
                Keywords: dihydroartemisinin, sedds, ternary phase diagram, central composite design-response surface methodology, oil–water partition coefficient

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