Solid self-nanoemulsifying drug delivery system (SNEDDS) for enhanced oral bioavailability of poorly water-soluble tacrolimus: physicochemical characterisation and pharmacokinetics

References

• Balakrishnan P, Lee BJ, Oh DH, Kim JO, Hong MJ, Jee JP, Kim JA, Yoo BK, Woo JS, Yong CS, Choi HG. Enhanced oral bioavailability of dexibuprofen by a novel solid self-nanoemulsifying drug delivery system (SEDDS). Eur J Pharm Biopharm, 2009a;72:539–45
   PubMed Web of Science ®Google Scholar
• Balakrishnan P, Lee BJ, Oh DH, Kim JO, Lee YI, Kim DD, Jee JP, Lee YB, Woo JS, Yong CS, Choi HG. Enhanced oral bioavailability of Coenzyme Q10 by self-emulsifying drug delivery systems. Int J Pharm, 2009b;374:66–72
   PubMed Web of Science ®Google Scholar
• Borhade V, Nair H, Hegde D. Design and evaluation of self-microemulsifying drug delivery system (SMEDDS) of tacrolimus. AAPS Pharm Sci Tech, 2008;9:13–21
   PubMed Web of Science ®Google Scholar
• Cho KH, Choi YK, Kang JH, Choi HG, Yong CS, Park YJ. Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia. Int J Pharm, 2010;400:145–52
   PubMed Web of Science ®Google Scholar
• Chung Y, Cho H. Preparation of highly water soluble tacrolimus derivatives: poly(ethylene glycol) esters as potential prodrugs. Arch Pharm Res, 2004;27:878–83
   PubMed Web of Science ®Google Scholar
• Craig DQM, Barker SA, Banning D, Booth SW. An investigation into the mechanisms of self-emulsification using particle size analysis and low frequency dielectric spectroscopy. Int J Pharm, 1995;114:103–10
   Web of Science ®Google Scholar
• Gao S, Sun J, Fu D, Zhao H, Lan M, Gao F. Preparation, characterisation and pharmacokinetic studies of tacrolimus-dimethyl-β-cyclodextrin inclusion complex-loaded albumin nanoparticles. Int J Pharm, 2012;427:410–16
   PubMed Web of Science ®Google Scholar
• Han J, Beeton A, Long P, Wong I, Tuleu C. Physical and microbiological stability of an extemporaneous tacrolimus suspension for paediatric use. J Clin Pharm Ther, 2006;31:167–72
   PubMed Web of Science ®Google Scholar
• Joe JH, Lee WM, Park YJ, Joe KH, Oh DH, Seo YG, Woo JS, Yong CS, Choi HG. Effect of the solid-dispersion method on the solubility and crystalline property of tacrolimus. Int J Pharm, 2010;395:161–6
   PubMed Web of Science ®Google Scholar
• Kang JH, Oh DH, Oh YK, Yong CS, Choi HG. Effects of solid carriers on the crystalline properties, dissolution and bioavailability of flurbiprofen in solid self-nanoemulsifying drug delivery system (solid SNEDDS). Eur J Pharm Biopharm, 2012;80(2):289–97
   PubMed Web of Science ®Google Scholar
• Kim YI, Kim KS, Suh KH, Shanmugam S, Woo JS, Yong CS, Choi HG. New clopidogrel napadisilate salt and its solid dispersion with improved stability and bioequivalence to the commercial clopidogrel bisulphate salt in beagle dogs. Int J Pharm, 2011;415:129–39
   PubMed Web of Science ®Google Scholar
• Lee SN, Poudel BK, Tran TH, Marasini N, Pradhan R, Lee YI, Lee DW, Woo JS, Choi HG, Yong CS, Kim JO. A novel surface-attached carvedilol solid dispersion with enhanced solubility and dissolution. Arch Pharm Res, 2013;36(1):79–85
   PubMed Web of Science ®Google Scholar
• Marasini N, Tran TH, Poudel BK, Cho HJ, Choi YK, Chi SC, Choi HG, Yong CS, Kim JO. Fabrication and evaluation of pH-modulated solid dispersion for telmisartan by spray-drying technique. Int J Pharm, 2013;441:424–32
   PubMed Web of Science ®Google Scholar
• Nassar T, Rom A, Nyska A, Benita S. A novel nanocapsule delivery system to overcome intestinal degradation and drug transport limited absorption of P-glycoprotein substrate drugs. Pharm Res, 2008;25:2019–29
   PubMed Web of Science ®Google Scholar
• Oh DH, Balakrishnan P, Oh YK, Kim DD, Yong CS, Choi HG. Effect of process parameters on nanoemulsion droplet size and distribution in SPG membrane emulsification. Int J Pharm, 2011;14:191–7
   Web of Science ®Google Scholar
• Oh DH, Kang JH, Kim DW, Lee BJ, Kim JO, Yong CS, Choi HG. Comparison of solid self-microemulsifying drug delivery system (solid SMEDDS) prepared with hydrophilic and hydrophobic solid carrier. Int J Pharm, 2012;420:412–18
   Web of Science ®Google Scholar
• Park SI, Felipe CR, Pinheiro-Machado PG, Garcia R, Tedesco-Silva Jr H, Medina-Pestana JO. Circadian and time-dependent variability in tacrolimus pharmacokinetics. Fundam Clin Pharmacol, 2007;21:191–7
   PubMed Web of Science ®Google Scholar
• Park YJ, Ryu DS, Li DX, Quan QZ, Oh DH, Kim JO, Seo YG, Lee YI, Yong CS, Woo JS, Choi HG. Physicochemical characterisation of tacrolimus-loaded solid dispersion with sodium carboxylmethyl cellulose and sodium lauryl sulphate. Arch Pharm Res, 2009;32(6):893–8
   PubMed Web of Science ®Google Scholar
• Pouton C. Self-emulsifying drug delivery systems: assessment of the efficiency of emulsification. Int J Pharm, 1985;27:335–48
   Web of Science ®Google Scholar
• Rane SS, Anderson BD. What determines drug solubility in lipid vehicles: Is it predictable? Adv Drug Deliv Rev, 2008;60:638–56
   PubMed Web of Science ®Google Scholar
• Shapiro R. Tacrolimus in solid organ transplantation: An update. Transplant Proc, 1999;31:2203–5
   PubMed Web of Science ®Google Scholar
• Shimomura M, Masuda S, Saito H, Sakamoto S, Uemoto S, Tanaka K, Inui K. Roles of the jejunum and ileum in the first-pass effect as absorptive barriers for orally administered tacrolimus. J Surg Res, 2002;103:215–22
   PubMed Web of Science ®Google Scholar
• Shin SB, Cho HY, Kim DD, Choi HG, Lee YB. Preparation and evaluation of tacrolimus-loaded nanoparticles for lymphatic delivery. Eur J Pharm Biopharm, 2010;74:164–71
   PubMed Web of Science ®Google Scholar
• Sinswat P, Overhoff KA, McConville JT, Johnston KP, Williams 3rd RO. Nebulisation of nanoparticulate amorphous or crystalline tacrolimus-single-dose pharmacokinetics study in mice. Eur J Pharm Biopharm, 2008;69(3):1057–66
   PubMed Web of Science ®Google Scholar
• Society of Toxicology (SOT). 2008. Guiding principles in the use of animals in toxicology. Available at www.toxicology.org/AI/FA/guidingprinciples.pdf. Accessed December
   Google Scholar
• Spencer CM, Goa KL, Gillis JC. Tacrolimus. An update of its pharmacology and clinical efficacy in the management of organ transplantation. Drugs, 1997;54:925–75
   PubMed Web of Science ®Google Scholar
• Tran TH, Poudel BK, Marasini N, Chi SC, Choi HG, Yong CS, Kim JO. Preparation and evaluation of raloxifene-loaded solid dispersion nanoparticle by spray-drying technique without an organic solvent. Int J Pharm, 2013;443:50–7
   PubMed Web of Science ®Google Scholar
• Tuleu C, Newton M, Rose J, Euler D, Saklatvala R, Clarke A, Booth S. Comparative bioavailability study in dogs of a self-emulsifying formulation of progesterone presented in a pellet and liquid form compared with an aqueous suspension of progesterone. J Pharm Sci, 2004;93:1495–502
   PubMed Web of Science ®Google Scholar
• Wang Y, Sun J, Zhang T, Liu H, He F, He Z. Enhanced oral bioavailability of tacrolimus in rats by self-microemulsifying drug delivery systems. Drug Dev Ind Pharm, 2011;37(10):1225–30
   PubMed Web of Science ®Google Scholar
• Watts AB, Cline AM, Saad AR, Johnson SB, Peters JI, Williams 3rd RO. Characterisation and pharmacokinetic analysis of tacrolimus dispersion for nebulisation in a lung transplanted rodent model. Int J Pharm, 2010;384:46–52
   PubMed Web of Science ®Google Scholar
• Watts AB, Williams 3rd RO, Peters JI. Recent developments in drug delivery to prolong allograft survival in lung transplant patients. Drug Dev Ind Pharm, 2009;35(3):259–71
   PubMed Web of Science ®Google Scholar
• Yan YD, Sung JH, Kim KK, Kim DW, Kim JO, Lee BJ, Yong CS, Choi HG. Novel valsartan-loaded solid dispersion with enhanced bioavailability and no crystalline changes. Int J Pharm, 2012;422:202–10
   PubMed Web of Science ®Google Scholar
• Yoshida T, Kurimoto I, Yoshihara K, Umejima H, Ito N, Watanabe S, Sako K, Kikuchi A. Aminoalkyl methacrylate copolymers for improving the solubility of tacrolimus. I: Evaluation of solid dispersion formulations. Int J Pharm, 2012;428:18–24
   PubMed Web of Science ®Google Scholar