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Critical Reviews™ in Therapeutic Drug Carrier Systems
Главный редактор: Mandip Sachdeva Singh (open in a new tab)

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ISSN Печать: 0743-4863

ISSN Онлайн: 2162-660X

The Impact Factor measures the average number of citations received in a particular year by papers published in the journal during the two preceding years. 2017 Journal Citation Reports (Clarivate Analytics, 2018) IF: 2.7 To calculate the five year Impact Factor, citations are counted in 2017 to the previous five years and divided by the source items published in the previous five years. 2017 Journal Citation Reports (Clarivate Analytics, 2018) 5-Year IF: 3.6 The Immediacy Index is the average number of times an article is cited in the year it is published. The journal Immediacy Index indicates how quickly articles in a journal are cited. Immediacy Index: 0.8 The Eigenfactor score, developed by Jevin West and Carl Bergstrom at the University of Washington, is a rating of the total importance of a scientific journal. Journals are rated according to the number of incoming citations, with citations from highly ranked journals weighted to make a larger contribution to the eigenfactor than those from poorly ranked journals. Eigenfactor: 0.00023 The Journal Citation Indicator (JCI) is a single measurement of the field-normalized citation impact of journals in the Web of Science Core Collection across disciplines. The key words here are that the metric is normalized and cross-disciplinary. JCI: 0.39 SJR: 0.42 SNIP: 0.89 CiteScore™:: 5.5 H-Index: 79

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Recent Progress in Self-Emulsifying Drug Delivery Systems: A Systematic Patent Review (2011-2020)

Том 39, Выпуск 2, 2022, pp. 1-77
DOI: 10.1615/CritRevTherDrugCarrierSyst.2021038490
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Краткое описание

Self-emulsifying drug delivery systems (SEDDS) are lipid-based isotropic mixtures that enhance the bioavailability of poorly water-soluble drugs and reduce the possible side effects, offering a wide variety of treatments for several pathologies. The aim of this review is to discuss the state of the art of patents for this drug delivery system by studying recent patent applications (2011 to 2020). We performed a thorough screening using the European Patent Office's Espacenet database, from which 37 inventions were selected and fully studied. China had more patent applications, and the articles published about SEDDS exceeds both in number and technological advance the submitted inventions. Nevertheless, the patents presented herein are innovative to address known issues to traditional SEDDS, including storage and formulation stability, solid formulations, acute gastrointestinal toxicity from surfactants, and drug delivery through alternative routes of administration. This study also revealed that release behavior for SEDDS and associated pharmacokinetics were not completely disclosed by the inventors of the patents and that further studies are required.

Ключевые слова: surfactants, lipids, co-surfactant, oil carrier
ЛИТЕРАТУРА
  1. Yun YH, Lee BK, Park K. Controlled drug delivery: Historical perspective for the next generation. J Control Release. 2015;219(12):2-7.

  2. Pouton CW. Formulation of self-emulsifying drug delivery systems. Adv Drug Deliv Rev. 1997;25: 47-58.

  3. Chauhan G, Shaik AA, Kulkarni NS, Gupta V. The preparation of lipid-based drug delivery system using melt extrusion. Drug Discov Today. 2020;25(11):1930-43.

  4. Gershanik T, Benita S. Self-dispersing lipid formulations for improving oral absorption of lipophilic drugs. Eur J Pharm Biopharm. 2000;50(1):179-88.

  5. Singh S, Bajpai M, Mishra P. Self-emulsifying drug delivery system (SEDDS): An emerging dosage form to improve the bioavailability of poorly absorbed drugs. Crit Rev Ther Drug Carrier Syst. 2020;47(4):305-29.

  6. Chamieh J, Domenech Tarrat A, Doudou C, Jannin V, Demarne F, Cottet H. Peptide release from SEDDS containing hydrophobic ion pair therapeutic peptides measured by Taylor dispersion analysis. Int J Pharm. 2019;559:228-34.

  7. Griesser J, Hetenyi G, Federer C, Steinbring C, Ellemunter H, Niedermayr K, Bernkop-Schnurch A. Highly mucus permeating and zeta potential changing self-emulsifying drug delivery systems: A potent gene delivery model for causal treatment of cystic fibrosis. Int J Pharm. 2019;557: 124-34.

  8. KrauB J, Kuttenkeuler D. When to file for a patent? The scientist's perspective. N Biotechnol. 2021;60:124-9.

  9. Carter PH, Berndt ER, Joseph A, DiMasi A, Trusheim M. Investigating investment in biopharmaceutical R&D. Nat Rev Drug Discov. 2016;15(10):673-4.

  10. Qiu L, Chen ZY, Lu DY, Hu H, Wang YT. Public funding and private investment for R&D: A survey in China's pharmaceutical industry. Health Res Policy Syst. 2014;12(1):1-11.

  11. de Carvalho Pereira F, Costa HG, Pereira V. Patent filings versus articles published: A review of the literature in the context of multicriteria decision aid. World Pat Inf. 2017;50:17-26.

  12. Mukherjee A. Licensing a new product: Fee vs. royalty licensing with unionized labor market. Labour Econ. 2010;17(4):735-42.

  13. Mahmood A, Bernkop-Schnurch A. SEDDS: A game changing approach for the oral administration of hydrophilic macromolecular drugs. Adv Drug Deliv Rev. 2019;142:91-101.

  14. Griesser J, Hetenyi G, Moser M, Demarne F, Jannin V, Bernkop-Schnurch A. Hydrophobic ion pairing: Key to highly payloaded self-emulsifying peptide drug delivery systems. Int J Pharm. 2017;520(1-2):267-74.

  15. Leonaviciute G, Zupancic O, Prufert F, Rohrer J, Bernkop-Schnurch A. Impact of lipases on the protective effect of SEDDS for incorporated peptide drugs towards intestinal peptidases. Int J Pharm. 2016;508(1-2):102-8.

  16. Bernkop-Schnurch A. Thiomers: A new generation of mucoadhesive polymers. Adv Drug Deliv Rev. 2005;57(11):1569-82.

  17. Friedl H, Dunnhaupt S, Hintzen F, Waldner C, Parikh S, Pearson JP, Wilcox MD, Bernkop-Schnurch A. Development and evaluation of a novel mucus diffusion test system approved by self-nanoemulsifying drug delivery systems. J Pharm Sci. 2013;102(12):4406-13.

  18. Maisel K, Reddy M, Xu Q, Chattopadhyay S, Cone R, Ensign LM, Hanes J. Nanoparticles coated with high molecular weight PEG penetrate mucus and provide uniform vaginal and colorectal distribution in vivo. Nanomedicine. 2016;11(11):1337-43.

  19. Efentakis M, Politis S. Comparative evaluation of various structures in polymer controlled drug delivery systems and the effect of their morphology and characteristics on drug release. Eur Polym J. 2006;42(5):1183-95.

  20. Sharifi F, Nazir I, Asim MH, Jahangiri M, Ebrahimnejad P, Matuszczak B, Bernkop-Schnurch A. Zeta potential changing self-emulsifying drug delivery systems utilizing a novel Janus-headed surfactant: A promising strategy for enhanced mucus permeation. J Mol Liq. 2019;291:111285.

  21. Hauptstein S, Prufert F, Bernkop-Schnurch A. Self-nanoemulsifying drug delivery systems as novel approach for pDNA drug delivery. Int J Pharm. 2015;487(1-2):25-31.

  22. Joyce P, Dening TJ, Meola TR, Schultz HB, Holm R, Thomas N, Prestidge CA. Solidification to improve the biopharmaceutical performance of SEDDS: Opportunities and challenges. Adv Drug Deliv Rev. 2019;142:102-17.

  23. Rani ER, Radha GV. Insights into novel excipients of self-emulsifying drug delivery systems and their significance: An updated review. Crit Rev Ther Drug Carrier Syst. 2021;38(2):27-74.

  24. Laffleur F, Keckeis V. Advances in drug delivery systems: Work in progress still needed? Int J Pharm. 2020;590:119912.

  25. Krstic M, Medarevic B, Buris J, Ibric S. Self-nanoemulsifying drug delivery systems (SNEDDS) and self-microemulsifying drug delivery systems (SMEDDS) as lipid nanocarriers for improving dissolution rate and bioavailability of poorly soluble drugs. In: Grumezescu AM, editor. Lipid nanocarriers for drug targeting. Oxford: William Andrew; 2018. p. 473-508.

  26. Bahloul B, Lassoued MA, Sfar S. A novel approach for the development and optimization of self emulsifying drug delivery system using HLB and response surface methodology: Application to fenofibrate encapsulation. Int J Pharm. 2014;466(1-2):341-8.

  27. Ghazani SM, Marangoni AG. Healthy fats and oils. 2nd ed. In: Wrigley CW, Corke H, Seetharaman K, Faubion J, editors. Encyclopedia of food grains. Oxford: Elsevier; 2015. p. 257-67.

  28. Pandey V, Kohli S. Lipids and surfactants: The inside story of lipid-based drug delivery systems. Crit Rev Ther Drug Carrier Syst. 2018;35(2):99-155.

  29. Nardin I, Kollner S. Successful development of oral SEDDS: Screening of excipients from the industrial point of view. Adv Drug Deliv Rev. 2019;142:128-40.

  30. Arshad M, Pradhan RA, Zubair M, Ullah A. Lipid-derived renewable amphiphilic nanocarriers for drug delivery, biopolymer-based formulations: Biomedical and food applications. In: Pal K, Banerjee I, Sarkar P, Kim D, Deng WP, Dubey NK, Majumder K, editors. Biopolymer-based formulations: Biomedical and food applications. Amsterdam: Elsevier; 2020. p. 283-310.

  31. Raut S, Karzuon B, Atef E. Using in situ Raman spectroscopy to study the drug precipitation inhibition and supersaturation mechanism of Vitamin E TPGS from self-emulsifying drug delivery systems (SEDDS). J Pharm Biomed Anal. 2015;109:121-7.

  32. Nakamura MT, Yudell BE, Loor JJ. Regulation of energy metabolism by long-chain fatty acids. Prog Lipid Res. 2014;53:124-44.

  33. Carriere F. Impact of gastrointestinal lipolysis on oral lipid-based formulations and bioavailability of lipophilic drugs. Biochimie. 2016;125:297-305.

  34. Burdge GC. Adult mammals. In: Burdge GC, editor. Polyunsaturated fatty acid metabolism, vol. 9. London: Elsevier; 2018. p. 15-30.

  35. Desai HH, Bu P, Shah AV, Cheng X, Serajuddin ATM. Evaluation of cytotoxicity of self-emulsifying formulations containing long-chain lipids using Caco-2 cell model: Superior safety profile compared to medium-chain lipids. J Pharm Sci. 2020;109(5):1752-64.

  36. Bagheri Novir S, Tirandaz A, Lotfipour H. Quantum study of DHA, DPA and EPA anticancer fatty acids for microscopic explanation of their biological functions. J Mol Liq. 2021 ;325: 114646.

  37. So J, Wu D, Lichtenstein AH, Tai AK, Matthan NR, Maddipati KR, Lamon-Fava S. EPA and DHA differentially modulate monocyte inflammatory response in subjects with chronic inflammation in part via plasma specialized pro-resolving lipid mediators: A randomized, double-blind, crossover study. Atherosclerosis. 2021;316:90-8.

  38. Saneja A, Alam N, Dubey RD, Gupta PN. Recent advances in self-emulsifying drug-delivery systems for oral delivery of cancer therapeutics. In: Holban AM, Grumezescu A, editors. Nanoarchitectonics for smart delivery and drug targeting. Elsevier; 2016. p. 379-404.

  39. Psimadas D, Georgoulias P, Valotassiou V, Loudos G. Molecular nanomedicine towards cancer: mInlabeled nanoparticles. J Phaim Sci. 2012;101(7):2271-80.

  40. Chowdhury N, Singh M. Current development of oral taxane formulations: A review. Crit Rev Ther Drug Carrier Syst. 2020;37(3):205-27.

  41. Buyukozturk F, Benneyan JC, Carrier RL. Impact of emulsion-based drug delivery systems on intestinal permeability and drug release kinetics. J Control Release. 2010;142(1):22-30.

  42. Mazzeti AL, Oliveira LT, Gonjalves KR, Schaun GC, Mosqueira VCF, Bahia MT. Benznidazole self-emulsifying delivery system: A novel alternative dosage form for Chagas disease treatment. Eur J Pharm Sci. 2020;145:105234.

  43. Kommana N, Bharti K, Surekha DB, Thokala S, Mishra B. Development, optimization and evaluation of losartan potassium loaded self emulsifying drug delivery system. J Drug Deliv Sci Technol. 2020;60:102026.

  44. Charman SA, Charman WN, Rogge MC, Wilson TD, Dutko FJ, Pouton CW. Self-emulsifying drug delivery systems: Formulation and biopharmaceutic evaluation of an investigational lipophilic compound. Pharm Res. 1992 Jan;9(1):87-93.

  45. Tian B, Liu Y, Liu J. Smart stimuli-responsive drug delivery systems based on cyclodextrin: A review. Carbohydr Polym. 2021;251:116871.

  46. Hong IK, Kim SI, Lee SB. Effects of HLB value on oil-in-water emulsions: Droplet size, rheological behavior, zeta-potential, and creaming index. J Ind Eng Chem. 2018;67:123-31.

  47. Shakeel F, Haq N, Alanazi FK, Alsarra IA. Impact of various nonionic surfactants on self-nanoemulsification efficiency of two grades of Capryol (Capryol-90 and Capryol-PGMC). J Mol Liq. 2013;182:57-63.

  48. Anar K, Rahman M, Ray S, Karmakar S. Insights into the approach, fabrication, application, and lacunae of nanoemulsions in drug delivery systems. Crit Rev Ther Drug Carrier Syst. 2020;37(6):511-51.

  49. Rohrer J, Zupancic O, Hetenyi G, Kurpiers M, Bernkop-Schnurch A. Design and evaluation of SEDDS exhibiting high emulsifying properties. J Drug Deliv Sci Technol. 2018;44:366-72.

  50. Ujhelyi Z, Fenyvesi F, Varadi J, Feher P, Kiss T, Veszelka S, Deli M, Vecsernyes M, Bacskay I. Evaluation of cytotoxicity of surfactants used in self-micro emulsifying drug delivery systems and their effects on paracellular transport in Caco-2 cell monolayer. Eur J Pharm Sci. 2012;47(3):564-73.

  51. Cuine JF, McEvoy CL, Charman WN, Pouton CW, Edwards GA, Benameur H, Porter CJ. Evaluation of the impact of surfactant digestion on the bioavailability of danazol after oral administration of lipidic self-emulsifying formulations to dogs. J Pharm Sci. 2008;97(2):995-1012.

  52. da Silva Junior JB, Dezani TM, Dezani AB, dos Reis Serra CH. Evaluating potential P-gp substrates: Main aspects to choose the adequate permeability model for assessing gastrointestinal drug absorption. Mini Rev Med Chem. 2015;15(10):858-71.

  53. Buya AB, Ucakar B, Beloqui A, Memvanga PB, Preat V. Design and evaluation of self-nanoemulsifying drug delivery systems (SNEDDSs) for senicapoc. Int J Pharm. 2020;580:119180.

  54. Kommana N, Bharti K, Surekha DB, Thokala S, Mishra B. Development, optimization and evaluation of losartan potassium loaded self emulsifying drug delivery system. J Drug Deliv Sci Technol. 2020;60:102026.

  55. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413-20.

  56. Chaivichacharn P, Avihingsanon A, Manosuthi W, Ubolyam S, Tongkobpetch S, Shotelersuk V, Punyawudho B. Dosage optimization of efavirenz based on a population pharmacokinetic-pharmacogenetic model of HIV-infected patients in Thailand. Clin Ther. 2020;42(7):1234-45.

  57. Narang AS, Delmarre D, Gao D. Stable drug encapsulation in micelles and microemulsions. Int J Pharm. 2007;345(1-2):9-25.

  58. Mei L, Zhang Z, Zhao L, Huang L, Yang XL, Tang J, Feng SS. Pharmaceutical nanotechnology for oral delivery of anticancer drugs. Adv Drug Deliv Rev. 2013;65(6):880-90.

  59. Gonzalez SM, Rey D, Valderrama IH, de Araujo BV, Aragon DM. Development of a self-emulsifying drug delivery system (SEDDS) to improve the hypoglycemic activity of Passiflora ligularis leaves extract. J Drug Deliv Sci Technol. 2021;64:102604.

  60. Delavenne X, Dargaud Y. Pharmacokinetics for haemophilia treaters: Meaning of PK parameters, interpretation pitfalls, and use in the clinic. Thromb Res. 2020;192:52-60.

  61. Saha N. Clinical Pharmacokinetics and drug interactions. In: Vohara D, Singh G, editors. Pharmaceutical medicine and translational clinical research. Amsterdam: Elsevier; 2017. p. 81-106.

  62. Berezhkovskiy LM. Determination of mean residence time of drug in plasma and the influence of the initial drug elimination and distribution on the calculation of pharmacokinetic parameters. J Pharm Sci. 2008;98(2):748-62.

  63. Scutt G, Allen M, Waxman D. Estimating a drug's elimination rate-constant or half-life from a single blood sample: A practical approach with particular benefits for critically ill/vulnerable patients. Biosystems. 2019;184:103996.

  64. Nagilla R, Nord M, Mcatee JJ, Jolivette LJ. Cassette dosing for pharmacokinetic screening in drug discovery: Comparison of clearance, volume of distribution, half-life, mean residence time, and oral bioavailability obtained by cassette and discrete dosing in rats. J Pharm Sci. 2011;100(9):3862-74.

  65. AboulFotouh K, Allam AA, El-Badry M, El-Sayed AM. Role of self-emulsifying drug delivery systems in optimizing the oral delivery of hydrophilic macromolecules and reducing interindividual variability. Colloids Surf B Biointerfaces. 2018;167:82-92.

  66. Araya H, Nagao S, Tomita M, Hayashi M. The novel formulation design of self-emulsifying drug delivery systems (SEDDS) type O/W microemulsion I: Enhancing effects on oral bioavailability of poorly water soluble compounds in rats and beagle dogs. Drug Metab Pharmacokinet. 2005;20(4):244-56.

  67. Vasconcelos T, Araujo F, Lopes C, Loureiro A, das Neves J, Marques S, Sarmento B. Multicomponent self nano emulsifying delivery systems of resveratrol with enhanced pharmacokinetics profile. Eur J Pharm Sci. 2019;137:105011.

  68. Singhvi G, Singh M. In-vitro drug release characterization models. Int J Pharm Stud Res. 2011;2(1):77-84.

  69. Paarakh MP, Jose PANI, Setty CM, Peter G V. Release kinetics - concepts and applications. Int J Pharm Res Technol. 2019;8(l):12-20.

  70. Bernkop-Schnurch A, Jalil A. Do drug release studies from SEDDS make any sense? J Control Release. 2018;271:55-9.

ЦИТИРОВАНО В
  1. Salawi Ahmad, Self-emulsifying drug delivery systems: a novel approach to deliver drugs, Drug Delivery, 29, 1, 2022. Crossref

  2. Niu Xia, Meng Yanan, Wang Yucheng, Li Guiling, Established new compound IMB16-4 self-emulsifying drug delivery systems for increasing oral bioavailability and enhancing anti-hepatic fibrosis effect, Biomedicine & Pharmacotherapy, 154, 2022. Crossref

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