Tanshinol sustained-release pellets with absorption enhancer: optimization, characterization, pharmacokinetics and pharmacodynamics

References

• Li W, Li ZW, Han JP, et al. Determination and pharmacokinetics of Danshensu in rat plasma after oral administration of Danshen extract using liquid chromatography/tandem mass spectrometry. Eur J Drug Metab Pharmacokinet 2008;33:9–16.
   PubMed Web of Science ®Google Scholar
• Jia W, Du F, Liu X, et al. Renal tubular secretion of tanshinol: molecular mechanisms, impact on its systemic exposure, and propensity for dose-related nephrotoxicity and for renal herb–drug interactions. Drug Metab Dispos 2015;43:669–78.
   PubMed Web of Science ®Google Scholar
• Yang G, Zhang HR, Wang W, et al. Down-regulation of CD40 gene expression and inhibition of apoptosis with Danshensu in endothelial cells. Basic Clin Pharmacol Toxicol 2009;104:87–92.
   PubMed Web of Science ®Google Scholar
• Zhou L, Chow MSS, Zuo Z. Effect of sodium caprate on the oral absorptions of Danshensu and salvianolic acid B. Int J Pharm 2009;379:109–18.
   PubMed Web of Science ®Google Scholar
• You C, Liang X, Sun J, et al. Blends of hydrophobic and swelling agents in the swelling layer in the preparation of delayed-release pellets of a hydrophilic drug with low MW: physicochemical characterizations and in-vivo evaluations. Asian J Pharm Sci 2014;9:199–207.
   Google Scholar
• Zhao X, Li G, Zhang L, et al. Preparation and evaluation of nicotinic acid sustained-release pellets combined with immediate release simvastatin. Int J Pharm 2010;400:42–8.
   PubMed Web of Science ®Google Scholar
• Albanez R, Nitz M, Taranto OP. Influence of the type of enteric coating suspension, coating layer and process conditions on dissolution profile and stability of coated pellets of diclofenac sodium. Powder Technol 2015;269:185–92.
   Web of Science ®Google Scholar
• Piao H, Liu S, Piao H, et al. Development of an osmotically-driven pellet coated with acrylic copolymers (Eudragit® RS 30 D) for the sustained release of oxymatrine, a freely water soluble drug used to treat stress ulcers (I): in vitro and in vivo evaluation in rabbits. Drug Dev Ind Pharm 2013;39:1230–7.
   PubMed Web of Science ®Google Scholar
• Dukić-Ott A, Remon JP, Foreman P, et al. Immediate release of poorly soluble drugs from starch-based pellets prepared via extrusion/spheronisation. Eur J Pharm Biopharm 2007;67:715–24.
   PubMed Web of Science ®Google Scholar
• Kim KS, Jin SG, Mustapha O, et al. Novel fenofibric acid-loaded controlled release pellet bioequivalent to choline fenofibrate-loaded commercial product in beagle dogs. Int J Pharm 2015;490:273–80.
   PubMed Web of Science ®Google Scholar
• Wang L, Wang J, Lin X, et al. Preparation and in vitro evaluation of gliclazide sustained-release matrix pellets: formulation and storage stability. Drug Dev Ind Pharm 2010;36:814–22.
   PubMed Web of Science ®Google Scholar
• Maher S, Leonard TW, Jacobsen J, et al. Safety and efficacy of sodium caprate in promoting oral drug absorption: from in vitro to the clinic. Adv Drug Deliv Rev 2009;61:1427–49.
   PubMed Web of Science ®Google Scholar
• Maher S, Brayden DJ. Overcoming poor permeability: translating permeation enhancers for oral peptide delivery. Drug Discov Today Technol 2012;9:e113–19.
   Google Scholar
• Krug SM, Amasheh M, Dittmann I, et al. Sodium caprate as an enhancer of macromolecule permeation across tricellular tight junctions of intestinal cells. Biomaterials 2013;34:275–82.
   PubMed Web of Science ®Google Scholar
• Dezani TM, Dezani AB, Junior JBDS, et al. Single-Pass Intestinal Perfusion (SPIP) and prediction of fraction absorbed and permeability in humans: a study with antiretroviral drugs. Eur J Pharm Biopharm 2016;104:131–9.
   PubMed Web of Science ®Google Scholar
• Sutton SC, Rinaldi MTS, McCarthy JM, et al. A statistical method for the determination of absorption rate constant estimated using the rat single pass intestinal perfusion model and multiple linear regression. J Pharm Sci 2002;91:1046–53.
   PubMed Web of Science ®Google Scholar
• O'Hara T, Dunne A, Butler J, et al. A review of methods used to compare dissolution profile data. Pharm Sci Technol Today 1998;1:214–23.
   Google Scholar
• Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13:123–33.
   PubMed Web of Science ®Google Scholar
• Liu Y, Sun Y, Sun J, et al. Preparation and in vitro/in vivo evaluation of sustained-release venlafaxine hydrochloride pellets. Int J Pharm 2012;426:21–8.
   PubMed Web of Science ®Google Scholar
• Siepmann J, Peppas NA. Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv Drug Deliv Rev 2001;48:139–57.
   PubMed Web of Science ®Google Scholar
• Wang S, Wang Y, Luo Y, et al. In vitro and in vivo evaluation of naringin sustained-release pellets compared with immediate-release tablets. J Drug Deliv Sci Technol 2013;23:459–64.
   Web of Science ®Google Scholar
• Zhang Y, Huo M, Zhou J, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J 2010;12:263–71.
   PubMed Web of Science ®Google Scholar
• Yan HX, Li J, Li ZH, et al. Tanshinone IIA – loaded pellets developed for angina chronotherapy: deconvolution-based formulation design and optimization, pharmacokinetic and pharmacodynamic evaluation. Eur J Pharm Sci 2015;76:156–64.
   PubMed Web of Science ®Google Scholar
• Pappenheimer JR. Physiological regulation of transepithelial impedance in the intestinal mucosa of rats and hamsters. J Membr Biol 1987;100:137–48.
   PubMed Web of Science ®Google Scholar
• Anderberg EK, Lindmark T, Artursson P. Sodium caprate elicits dilatations in human intestinal tight junctions and enhances drug absorption by the paracellular route. Pharm Res 1993;10:857–64.
   PubMed Web of Science ®Google Scholar
• Tavakoli N, Minaiyan M, Tabbakhian M, et al. Preparation and evaluation of a controlled drug release of repaglinide through matrix pellets: in vitro and in vivo studies. J Microencapsul 2014;31:529–34.
   PubMed Web of Science ®Google Scholar
• Qiao M, Luo Y, Zhang L, et al. Sustained release coating of tablets with Eudragit(®) RS/RL using a novel electrostatic dry powder coating process. Int J Pharm 2010;399:37–43.
   PubMed Web of Science ®Google Scholar
• Dashevsky A, Wagner K, Kolter K, et al. Physicochemical and release properties of pellets coated with Kollicoat® SR 30 D, a new aqueous polyvinyl acetate dispersion for extended release. Int J Pharm 2005;290:15–23.
   PubMed Web of Science ®Google Scholar
• Bodmeier R, Paeratakul O. Leaching of water-soluble plasticizers from polymeric films prepared from aqueous colloidal polymer dispersions. Drug Dev Ind Pharm 1992;18:1865–82.
   Web of Science ®Google Scholar
• Kramar A, Turk S, Vrečer F. Statistical optimisation of diclofenac sustained release pellets coated with polymethacrylic films. Int J Pharm 2003;256:43–52.
   PubMed Web of Science ®Google Scholar
• Sun YM, Hsu SC, Lai JY. Transport properties of ionic drugs in the ammonio methacrylate copolymer membranes. Pharm Res 2001;18:304–10.
   PubMed Web of Science ®Google Scholar
• Yan HX, Zhang SS, He JH, et al. Application of ethyl cellulose, microcrystalline cellulose and octadecanol for wax based floating solid dispersion pellets. Carbohydr Polym 2016;148:143–52.
   PubMed Web of Science ®Google Scholar
• Meng Z, Zhang M, Wei S, et al. Amorphous solid dispersion of berberine with absorption enhancer demonstrates a remarkable hypoglycemic effect via improving its bioavailability. Int J Pharm 2014;467:50–9.
   PubMed Web of Science ®Google Scholar
• Tang Y, Wang M, Chen C, et al. Cardiovascular protection with Danshensu in spontaneously hypertensive rats. Biol Pharm Bull 2011;34:1596–601.
   PubMed Web of Science ®Google Scholar
• Yang R, Huang S, Yan F, et al. Danshensu protects vascular endothelia in a rat model of hyperhomocysteinemia. Acta Pharmacol Sin 2010;31:1395–400.
   PubMed Web of Science ®Google Scholar
• Le XY, Chen CL, Ma L, et al. Effects of Danshensu on the incidence of ischemia-reperfusion induced arrhythmia in hypertrophy rat heart. Chin J Nat Med 2008;6:461–5.
   Google Scholar
• Louizos C, Yáñez JA, Forrest L, et al. Understanding the hysteresis loop conundrum in pharmacokinetic/pharmacodynamic relationships. J Pharm Pharm Sci 2014;17:34–91.
   PubMed Web of Science ®Google Scholar
• Kan SL, Li J, Liu JP, et al. Evaluation of pharmacokinetics and pharmacodynamics relationships for salvianolic acid B micro-porous osmotic pump pellets in angina pectoris rabbit. Asian J Pharm Sci 2014;9:137–45.
   Google Scholar
• Jia J, Dong C, Zhang W, et al. Evaluation of pharmacokinetic and pharmacodynamic relationship for oral sustained-release atenolol pellets in rats. J Pharm Biomed Anal 2011;55:342–8.
   PubMed Web of Science ®Google Scholar
• Hoffman A. Pharmacodynamic aspects of sustained release preparations. Adv Drug Deliv Rev 1998;33:185–99.
   PubMed Web of Science ®Google Scholar