The apparent solubilizing capacity of simulated intestinal fluids for poorly water-soluble drugs

References

• Bakatselou V, Oppenheim RC, Dressman JB. Solubilization and wetting effects of bile salts on the dissolution of steroids. Pharm Res 1991;8:1461–1469.
   PubMed Web of Science ®Google Scholar
• Mithani SD, Bakatselou V, TenHoor CN, Dressman JB. Estimation of the increase in solubility of drugs as a function of bile salt concentration. Pharm Res 1996;13:163–167.
   PubMed Web of Science ®Google Scholar
• Dressman JB, Vertzoni M, Goumas K, Reppas C. Estimating drug solubility in the gastrointestinal tract. Adv Drug Deliv Rev 2007;59:591–602.
   PubMed Web of Science ®Google Scholar
• Amidon GL, Lennernaes 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):413–420.
   PubMed Web of Science ®Google Scholar
• Kuentz M. Drug absorption modeling as a tool to define the strategy in clinical formulation development. AAPS J 2008;10(3):473–479.
   PubMed Web of Science ®Google Scholar
• Takano R, Sugano K, Higashida A, Hayashi Y, Machida M, Aso Y, Yamashida S. Oral absorption of poorly water-soluble drugs: Computer simulation of fraction absorbed in humans from a miniscale dissolution test. Pharm Res 2006;23(6):1144–1156.
   PubMed Web of Science ®Google Scholar
• Okumu A, DiMaso M, Löbenberg R. Dynamic dissolution testing to establish in vitro/in vivo correlations for montelukast sodium, a poorly soluble drug. Pharm Res 2008;25(12):2778–2785.
   PubMed Web of Science ®Google Scholar
• Sunesen VH, Pedersen BL, Kristensen HG, Müllertz A. In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur J Pharm Biopharm 2005;24:305–313.
   Google Scholar
• Galia E, Nicolaides E, Hörter D, Löbenberg R, Reppas C, Dressman JB. Evaluation of various dissolution media for predicting in vivo performance of Class I and II drugs. Pharm Res 1998;15(5):698–705.
   PubMed Web of Science ®Google Scholar
• Nicolaides E, Symillides M, Dressman J, Reppas Ch. Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration. Pharm Res 2001;18(3):380–388.
   PubMed Web of Science ®Google Scholar
• Jantratid E, Janssen N, Reppas Ch, Dressman JB. Dissolution media simulating conditions in the proximal human gastrointestinal tract: An update. Pharm Res 2008;25(7):1663–1676.
   PubMed Web of Science ®Google Scholar
• Jantratid E, Dressman JB. Biorelevant dissolution media simulating the proximal human gastrointestinal tract: An update. Diss Technol 2009;16:21–25.
   Web of Science ®Google Scholar
• Vertzoni M, Fotaki N, Kostewicz A, Stippler E, Leuner Ch Nicolaides E, Dressman J, Reppas Ch. Dissolution media simulating the intraluminal composition of the small intestine: Physiological issues and practical aspects. J Pharm Pharmacol 2004;56:453–462.
   PubMed Web of Science ®Google Scholar
• Boni JE, Brickl, RS, Dressman J, Pfefferle, ML. Instant FaSSIF and FeSSIF- biorelevance meets practicality. Dissolut Technol 2009;16(3):41–45.
   Web of Science ®Google Scholar
• Alsenz J, Kansy M. High throughput solubility measurement in drug discovery and development. Adv Drug Deliv Rev 2007;59:546–567.
   PubMed Web of Science ®Google Scholar
• Alsenz J, Meister E, Haenel E. Development of a partially automated solubility screening (PASS) assay for early drug development. J Pharm Sci 2007;96(7):1748–1762.
   PubMed Web of Science ®Google Scholar
• Bard B, Martel S, Carrupt PA. High throughput UV method for the estimation of thermodynamic solubility and the determination of the solubility in biorelevant media. Eur J Pharm Sci 2008;33:230–240.
   PubMed Web of Science ®Google Scholar
• Nielsen FS, Gibault E, Ljusberg-Wahren H, Arleth L, Pedersen JS, Müllertz A. Characterization of prototype self-nanoemulsifying formulations of lipophilic compounds. J Pharm Sci 2007;96(4):876–982.
   PubMed Web of Science ®Google Scholar
• Ertl P, Rohde B, Selzer P. Fast calculation of molecular polar surface area as a sum of fragment-based contributions and its application to the prediction of drug transport properties. J Med Chem 2000;43:3714–3717.
   PubMed Web of Science ®Google Scholar
• Van Krevelen DW. Properties of polymers: Their correlation with chemical structure; their numerical estimation and prediction from additive group contributions. Amsterdam: Elsevier; 1997:898.
   Google Scholar
• Glomme A, Maerz J, Dressman JB. Comparison of a miniaturized shake-flask solubility method with automated potentionmetric acid/base titrations and calculated solubilities. J Pharm Sci 2005;94(1):1–16.
   PubMed Web of Science ®Google Scholar
• Lehto P, Aaltonen J, Tenho M, Rantanen J, Hirvonen J, Tanninen VP, Peltonen L. Solvent-mediated solid phase transformations of carbamazepine: Effects of simulated intestinal fluid and fasted state simulated intestinal fluid. J Pharm Sci 2009;98(3):985–996.
   PubMed Web of Science ®Google Scholar
• Agoram B, Woltosz W, Bolger M. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev 2001;50(S1):S41–67.
   Web of Science ®Google Scholar
• Willmann S, Schmitt W, Keldenich J, Lippert J, Dressman J. A physiological model for the estimation of the fraction dose absorbed in humans. J Med Chem 2004;47(16):4022–4031.
   PubMed Web of Science ®Google Scholar
• Jamei M, Turner D, Yang J, Neuhoff S, Polak S, Rostami-Hodjegan A, Tucker G. Population-based mechanistic prediction of oral drug absorption. AAPS J 2009;11(2):225–237.
   PubMed Web of Science ®Google Scholar
• Yang G, Jain N, Yalkowsky SH. Combined effects of SLS and (SBE)7M-β-CD on the solubilization of NSC-639829. Int J Pharm 2004;269:141–148.
   PubMed Web of Science ®Google Scholar
• Mazer NA, Benedek GB, Carey MC. Quasielastic light-scattering studies of aqueous biliary lipid systems. Mixed micelle formation in bile salt-lecithin solutions. Biochemistry 1980;19:601–615.
   PubMed Web of Science ®Google Scholar
• Schurtenberger P, Mazer N, Känzig W. Micelle to vesicle transition in aqueous solutions of bile salt and lecithin. J Phys Chem 1985;89:1042–1049.
   Web of Science ®Google Scholar
• Dörfler HD. Chirality, twist and structures of micellar lyotropic cholesteric liquid crystals in comparison to the properties of chiralic thermotropic phases. Adv Coll Interf Sci 2002;98:285–340.
   PubMed Web of Science ®Google Scholar
• Reis S, Moutinho CG, Pereira E, Castro B, Gameiro P, Lima J. β-blockers and benzodiazepines location in SDS and bile salt micellar systems. An ESR study. J Pharm Biomed Anal 2007;45:62–69.
   PubMed Web of Science ®Google Scholar
• Glomme A. Biorelevante Löslichkeit schwerlöslicher Arzneistoffe. PhD Thesis, 2003. Johann Wolfgang Goethe-Universität Frankfurt, Germany. pp 134–139.
   Google Scholar
• Ilardia-Arana D, Kristensen HG, Müllertz A. Biorelevant dissolution media: Aggregation of amphiphiles and solubility of estradiol. J Pharm Sci 2006;95(2):248–255.
   PubMed Web of Science ®Google Scholar
• Patel AR, Vavia PR. Preparation and in vivo evaluation of SMEDDS (self-microemulsifying drug delivery system) containing fenofibrate. AAPS J 2007;9(3):E344–352.
   PubMed Web of Science ®Google Scholar
• Sonet B, Vanderbist F, Streel, B, Houin G. Randomised crossover studies of the bioequivalence of two fenofibrate formulations after administration of a single oral dose in healthy volunteers. Belg Arzneimittel-Forschung 2002;52(3):200–204.
   PubMed Web of Science ®Google Scholar
• Tziomalos K, Athyros VG. Fenofibrate: A novel formulation (Triglide) in the treatment of lipid disorders: A review. Int J Nanomed 2006;1(2):129–147.
   PubMed Web of Science ®Google Scholar
• Guivarch PH, Vachon MG, Fordyce D. A new fenofibrate formulation: Results of six single-dose, clinical studies of bioavailability under fed and fasting conditions. Clin Therapeut 2004;26(9):1456–1469.
   PubMed Web of Science ®Google Scholar