Preparation and characterization of simvastatin/DMβCD complex and its pharmacokinetics in rats

1. G. A. McClelland, R. J. Stubbs, J. A. Fix, S. A. Pogany and G. M. Zentner, Enhancement of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reducase inhibitor efficacy through administration of a controlled porosity osmotic pump dosage form, Pharm. Res. 8 (1991) 873–876; https://doi.org/10.1023/A:101589932810510.1023/A:1015899328105Search in Google Scholar

2. A. A. Anshuman, K. R. Mahadik and A. Paradkar, Spray-dried amorphous solid dispersions of simvastatin, a low T^g drug: In vitro and in vivo evaluations, Pharm. Res. 22 (2005) 990–998; https://doi.org/10.1007/s11095-005-4594-z10.1007/s11095-005-4594-z15948043Search in Google Scholar

3. M. Schachter, Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update, Fundam. Clin. Pharmacol. 19 (2005) 117–125; https://doi.org/10.1111/j.1472-8206.2004.00299.x10.1111/j.1472-8206.2004.00299.x15660968Search in Google Scholar

4. A. Fattahi, J. Karimi-Sabet, A. Keshavarz, A. Golzary, M. Rafiee-Tehrani and F. A. Dorkoosh, Preparation and characterization of simvastatin nanoparticles using rapid expansion of supercritical solution (RESS) with trifluoromethane, J. Supercrit. Fluids107 (2016) 469–478; https://doi.org/10.1016/j.supflu.2015.05.01310.1016/j.supflu.2015.05.013Search in Google Scholar

5. J. K. Patel and V. B. Sutariya, Micronisation of simvastatin by the supercritical antisolvent technique: in vitro-in vivo evaluation, J. Microencapsul. 32 (2015) 193–200; https://doi.org/10.3109/02652048.2014.99572610.3109/02652048.2014.99572625535989Search in Google Scholar

6. P. A. Sonar, A. L. Behera, S. K. Banerjee, D. D. Gaikwad and S. L. Harer, Preparation and characterization of simvastatin solid dispersion using skimmed milk, Drug Dev. Ind. Pharm. 41 (2015) 22–27; https://doi.org/10.3109/03639045.2013.84583610.3109/03639045.2013.84583624160569Search in Google Scholar

7. K. M. Hosny, A. Khames and S. S. A. Elhady, Preparation and evaluation of orodispersible tablets containing hydroxylbutyl-beta-cyclodextrin-simvastatin solid dispersion, Trop. J. Pharm. Res. 12 (2013) 469–476; https://doi.org/10.4314/tjpr.v12i4.410.4314/tjpr.v12i4.4Search in Google Scholar

8. S. D. Saoji, V. S. Belgamwar, S. S. Dharashivkar, A. A. Rode, C. Mack and V. S. Dave, The study of the influence of formulation and process variables on the functional attributes of simvastatin-phospholipid complex, J. Pharm. Innov.11 (2016) 264–278; https://doi.org/10.1007/s12247-016-9256-710.1007/s12247-016-9256-7Search in Google Scholar

9. G. Abdelbary, M. Amin and S. Salah, Self nano-emulsifying simvastatin based tablets: design and in vitro/in vivo evaluation, Pharm. Dev. Technol.18 (2013) 1294–1304; https://doi.org/10.3109/10837450.2012.67298910.3109/10837450.2012.67298922468935Search in Google Scholar

10. Z. W. Zhang, H. H. Bu, Z. W. Gao, Y. Huang, F. Gao and Y. P. Li, The characteristics and mechanism of simvastatin loaded lipid nanoparticles to increase oral bioavailability in rats, Int. J. Pharm. 394 (2010) 147–153; https://doi.org/10.1016/j.ijpharm.2010.04.03910.1016/j.ijpharm.2010.04.03920435111Search in Google Scholar

11. B. K. Kang, J. S. Lee, S. K. Chon, S. Y. Jeong, S. H. Yuk, G. Khang, H. B. Lee and S. H. Cho, Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs, Int. J. Pharm. 274 (2004) 65–73; https://doi.org/10.1016/j.ijpharm.2003.12.02810.1016/j.ijpharm.2003.12.028Search in Google Scholar

12. A. Porfire, D. Muntean, M. Achim, L. Vlase and I. Tomuta, Simultaneous quantification of simvastatin and excipients in liposomes using near infrared spectroscopy and chemometry, J. Pharm. Biomed. Anal.107 (2015) 40–49; https://doi.org/10.1016/j.jpba.2014.12.01310.1016/j.jpba.2014.12.013Search in Google Scholar

13. V. J. Stella and Q. He, Cyclodextrins, Toxicol. Pathol.36 (2008) 30–42; https://doi.org/10.1177/019262330731094510.1177/0192623307310945Search in Google Scholar

14. J. Pitha, J. Milecki, H. Fales, L. Pannell and K. Uekama, Hydroxypropyl-β-cyclodextrin: preparation and characterization; effect on solubility of drugs, Int. J. Pharm. 29 (1986) 73–82; https://doi.org/10.1016/0378-5173(86)90201-210.1016/0378-5173(86)90201-2Search in Google Scholar

15. C. Jullian, Improvement of galangin solubility using native and derivative cyclodextrin. An UV-vis and NMR study, J. Chil. Chem. Soc.54 (2009) 201–203; https://doi.org/10.4067/S0717-9707200900020002510.4067/S0717-97072009000200025Search in Google Scholar

16. Y. Kwon, H. Kim, S. Park and S. Jung, Enhancement of solubility and antioxidant activity of some flavonoids based on the inclusion complexation with sulfobutylether beta-cyclodextrin, Bull. Korean Chem. Soc. 31 (2010) 3035–3037; https://doi.org/10.5012/bkcs.2010.31.10.303510.5012/bkcs.2010.31.10.3035Search in Google Scholar

17. X. H. Wen, Z. Y. Liu and T. Q. Zhu, Mass spectrometry and molecular modeling studies on the inclusion complexes between α, β-cyclodextrins and simvastatin, Chem. Phys. Lett.405 (2005) 114–117; https://doi.org/10.1016/j.cplett.2005.01.10310.1016/j.cplett.2005.01.103Search in Google Scholar

18. F. Csempesz, A. Süle and I. Puskás, Induced surface activity of supramolecular cyclodextrin-statin complexes: Relevance in drug delivery, Coll. Surf. A.354 (2010) 308–313; https://doi.org/10.1016/j.colsurfa.2009.09.00810.1016/j.colsurfa.2009.09.008Search in Google Scholar

19. S. W. Jun, M. S. Kim, J. S. Kim, H. J. Park, S. Lee, J. S. Woo and S. J. Hwang, Preparation and characterization of simvastatin/hydroxylpropyl-β-cyclodextrin inclusion complex using supercritical antisolvent (SAS) process, Eur. J. Pharm. Biopharm. 66 (2007) 413–421; https://doi.org/10.1016/j.ejpb.2006.11.01310.1016/j.ejpb.2006.11.01317240129Search in Google Scholar

20. L. X. Zhang, Y. X. Zhang, L. Zhang and Y. H. Chen, Preparation of simvastatin orally disintegrating tablets and its quality evaluation, Chin. J. New Drugs17 (2008) 766–768; https://doi.org/10.3321/j.issn:1003-3734.2008.09.013Search in Google Scholar

21. T. Higuchi and K. A. Connors, Phase solubility techniques, Adv. Anal. Chem. Instrum. 4 (1965) 117–212.Search in Google Scholar

22. C. Mendes, A. Buttchevitz, J. H. Kruger, J. M. Kratz, C. M. O. Simoes, P. D. Benedet, P. R. Oliveira and M. A. S. Silva, Inclusion complexes of hydrochlorothiazide and beta-cyclodextrin: Physicochemical characteristics, in vitro and in vivo studies, Eur. J. Pharm. Sci.83 (2016) 71–78; https://doi.org/10.1016/j.ejps.2015.12.01510.1016/j.ejps.2015.12.01526687444Search in Google Scholar

23. Y. M. Liu, X. F. Wang and D. Wang, Preparation and pharmacokinetics in rats of simvastatin solid lipid nanoparticles, Chin. Pharmacist. 19 (2016) 50–53; https://doi.org/10.3969/j.issn.1008-049X.2016.01.014Search in Google Scholar

24. L. Tan, L. L. Yang, X. Zhang, Y. S. Yuan and S. S. Ling, Determination of simvastatin in human plasma by high performance liquid chromatography, Chin. J. Chromatogr. 18 (2000) 232–234; https://doi.org/10.3321/j.issn:1000-8713.2000.03.010Search in Google Scholar

25. F. Ungaro, C. Giovino, O. Catanzano, A. Miro, A. Mele, F. Quaglia and M. I. La Rotonda, Use of cyclodextrins as solubilizing agents for simvastatin: Effect of hydroxylpropyl-β-cyclodextrin on lactone/hydroxyacid aqueous equilibrium, Int. J. Pharm. 404 (2011) 49–56. https://doi.org/10.1016/j.ijpharm.2010.10.05010.1016/j.ijpharm.2010.10.050Search in Google Scholar

26. M. Yamamoto, F. Hirayama and K. Uekama, Improvement of stability and dissolusion of prostaglandin E₁ by maltosyl-β-cyclodexrtin in lyophilized formulation, Chem. Pharm. Bull. 40 (1992) 747–751; https://doi.org/10.1248/cpb.40.74710.1248/cpb.40.747Search in Google Scholar

27. A. Sule, L. Szente and F. Csempesz, Enhancement of drug solubility in supramolecular and colloidal systems, J. Pharm. Sci. 98 (2009) 484–494; https://doi.org/10.1002/jps.2143710.1002/jps.21437Search in Google Scholar

28. M. J. Arias, J. R. Moyano and J. M. Ginés, Investigation of the triamterene-β-cyclodextrin system prepared by co-grinding, Int. J. Pharm.153 (1997) 181–189; https://doi.org/10.1016/S0378-5173(97)00101-410.1016/S0378-5173(97)00101-4Search in Google Scholar