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Volumn 96, Issue 9, 2007, Pages 2409-2423

Quality by design: Understanding the product variability of a self-nanoemulsified drug delivery system of cyclosporine A

Author keywords

Cyclosporine; Permeability and near infrared; Self nanoemulsification; Variability

Indexed keywords

ALKAMULS EL 620; CAPMUL MCM C8; CYCLOSPORIN A; OCTANOIN; OIL; RICINOMACROGOL; SURFACTANT; UNCLASSIFIED DRUG;

EID: 34748836023     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20824     Document Type: Article
Times cited : (35)

References (32)
  • 1
    • 0028335905 scopus 로고
    • Reduced inter- and intraindividual variability in cyclosporine pharmacokinetics from a microemulsion formulation
    • Kovarik JM, Mueller EA, Van Bree JB, Tetzloff W, Kutz K. 1994. Reduced inter- and intraindividual variability in cyclosporine pharmacokinetics from a microemulsion formulation. J Pharm Sci 83:444-446.
    • (1994) J Pharm Sci , vol.83 , pp. 444-446
    • Kovarik, J.M.1    Mueller, E.A.2    Van Bree, J.B.3    Tetzloff, W.4    Kutz, K.5
  • 2
    • 3242673239 scopus 로고    scopus 로고
    • pH-sensitive nanoparticles for improving the oral bioavailability of cyclosporine A
    • Dai J, Nagai T, Wang X, Zhang T, Meng M, Zhang Q. 2004. pH-sensitive nanoparticles for improving the oral bioavailability of cyclosporine A. Int J Pharm 280:229-240.
    • (2004) Int J Pharm , vol.280 , pp. 229-240
    • Dai, J.1    Nagai, T.2    Wang, X.3    Zhang, T.4    Meng, M.5    Zhang, Q.6
  • 3
    • 3042551382 scopus 로고    scopus 로고
    • Bioavailability and pharmacokinetics of cyclosporine A loaded pH-sensitive nanoparticles for oral administration
    • Wang X, Dai J, Chen Z, Zhang T, Xia G, Nagai T, Zhang Q. 2004. Bioavailability and pharmacokinetics of cyclosporine A loaded pH-sensitive nanoparticles for oral administration. J Cont Rel 97:421-429.
    • (2004) J Cont Rel , vol.97 , pp. 421-429
    • Wang, X.1    Dai, J.2    Chen, Z.3    Zhang, T.4    Xia, G.5    Nagai, T.6    Zhang, Q.7
  • 4
    • 0027301116 scopus 로고
    • An investigation into the physico-chemical properties of self-emulsifying systems using low frequency dielectric spectroscopy, surface tension measurements and article size analysis
    • Craig DQM, Lievens HSR, Pitt KG, Storey DE. 1993. An investigation into the physico-chemical properties of self-emulsifying systems using low frequency dielectric spectroscopy, surface tension measurements and article size analysis. Int J Pharm 96:147-155.
    • (1993) Int J Pharm , vol.96 , pp. 147-155
    • Craig, D.Q.M.1    Lievens, H.S.R.2    Pitt, K.G.3    Storey, D.E.4
  • 5
    • 0034714866 scopus 로고    scopus 로고
    • Physicochemical studies of lidocaine-menthol binary systems for enhanced membrane transport
    • Kang L, Jun HW, McCall JW. 2000. Physicochemical studies of lidocaine-menthol binary systems for enhanced membrane transport. Int J Pharm 206:35-42.
    • (2000) Int J Pharm , vol.206 , pp. 35-42
    • Kang, L.1    Jun, H.W.2    McCall, J.W.3
  • 6
    • 0035895309 scopus 로고    scopus 로고
    • Self-emulsifying drug delivery systems (SEDDS) of coenzyme Q10: Formulation development and bioavailability assessment
    • Kommuru TR, Gurley B, Khan MA, Reddy IK. 2001. Self-emulsifying drug delivery systems (SEDDS) of coenzyme Q10: Formulation development and bioavailability assessment. Int J Pharm 212:233-246.
    • (2001) Int J Pharm , vol.212 , pp. 233-246
    • Kommuru, T.R.1    Gurley, B.2    Khan, M.A.3    Reddy, I.K.4
  • 7
    • 0033805858 scopus 로고    scopus 로고
    • Lipid formulations for oral administration of drug non-emulsifying, self-emulsifying and self-microemulsifying drug delivery system
    • Pouton CW. 2000. Lipid formulations for oral administration of drug non-emulsifying, self-emulsifying and self-microemulsifying drug delivery system. Eur J Pharm Sci 2:S93-S98.
    • (2000) Eur J Pharm Sci , vol.2
    • Pouton, C.W.1
  • 8
    • 85030578966 scopus 로고    scopus 로고
    • Guidance for Industry. 2004. PAT - A framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, FDA/CDER/CVM/ORA/CGMPs, http://www.fda.gov/cder/guidance/6419fnl.pdf.
    • Guidance for Industry. 2004. PAT - A framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, FDA/CDER/CVM/ORA/CGMPs, http://www.fda.gov/cder/guidance/6419fnl.pdf.
  • 9
    • 0036812998 scopus 로고    scopus 로고
    • Transdermal delivery of nicardipine: An approach to in vitro permeation enhancement
    • Aboofazeli R, Zia H, Needham TE. 2002. Transdermal delivery of nicardipine: An approach to in vitro permeation enhancement. Drug Deliv 9:239-247.
    • (2002) Drug Deliv , vol.9 , pp. 239-247
    • Aboofazeli, R.1    Zia, H.2    Needham, T.E.3
  • 10
    • 0028949717 scopus 로고
    • An investigation into the mechanisms of self-emulsification using particle size analysis and low frequency dielectric spectroscopy
    • Craig DQM, Barker SA, Banning D, Booth SW. 1995. An investigation into the mechanisms of self-emulsification using particle size analysis and low frequency dielectric spectroscopy. Int J Pharm 114:103-110.
    • (1995) Int J Pharm , vol.114 , pp. 103-110
    • Craig, D.Q.M.1    Barker, S.A.2    Banning, D.3    Booth, S.W.4
  • 11
    • 0004199268 scopus 로고    scopus 로고
    • Turbidity Science
    • Booklet No. 11. HACH Company, Loveland, CO, USA
    • Sadar MJ. 1998. Turbidity Science. HACH Technical Information Series. Booklet No. 11. HACH Company, Loveland, CO, USA.
    • (1998) HACH Technical Information Series
    • Sadar, M.J.1
  • 12
    • 5644250472 scopus 로고    scopus 로고
    • Preparation and in vitro characterization of self-nanoemulsified drug delivery systems of coenzyme Q10 using chiral essential oil components
    • Palamakula A, Soliman M, Reddy IK, Khan MA. 2004. Preparation and in vitro characterization of self-nanoemulsified drug delivery systems of coenzyme Q10 using chiral essential oil components. Pharm Tech 10:74-88.
    • (2004) Pharm Tech , vol.10 , pp. 74-88
    • Palamakula, A.1    Soliman, M.2    Reddy, I.K.3    Khan, M.A.4
  • 13
    • 0033974937 scopus 로고    scopus 로고
    • Lecithin vesicular carriers for transdermal delivery of cyclosporin A
    • Guo J, Ping Q, Sun G, Jiao C. 2000. Lecithin vesicular carriers for transdermal delivery of cyclosporin A. Int J Pharm 194:201-207.
    • (2000) Int J Pharm , vol.194 , pp. 201-207
    • Guo, J.1    Ping, Q.2    Sun, G.3    Jiao, C.4
  • 14
    • 0038641721 scopus 로고    scopus 로고
    • Solubilization of (d)-Limonene by anionic-cationic mixed surfactant systems
    • Saito Y, Hashizaki K, Taguchi H, Ogawa N. 2003. Solubilization of (d)-Limonene by anionic-cationic mixed surfactant systems. Drug Dev Ind Pharm 29:345-348.
    • (2003) Drug Dev Ind Pharm , vol.29 , pp. 345-348
    • Saito, Y.1    Hashizaki, K.2    Taguchi, H.3    Ogawa, N.4
  • 15
    • 0037427224 scopus 로고    scopus 로고
    • Self-diffusion nuclear magnetic resonance, microstructure transitions, and solubilization capacity of phytosterols and cholesterol in Winsor IV Food-Grade microemulsions
    • Spernath A, Yaghmur A, Aserin A, Hoffman RE, Garti N. 2003. Self-diffusion nuclear magnetic resonance, microstructure transitions, and solubilization capacity of phytosterols and cholesterol in Winsor IV Food-Grade microemulsions. J Agric Food Chem 51:2359-2364.
    • (2003) J Agric Food Chem , vol.51 , pp. 2359-2364
    • Spernath, A.1    Yaghmur, A.2    Aserin, A.3    Hoffman, R.E.4    Garti, N.5
  • 16
    • 0011379669 scopus 로고
    • Entropy-induced dispersion of bulk liquids
    • Reiss H. 1975. Entropy-induced dispersion of bulk liquids. J Colloid Interface Sci 53:61-70.
    • (1975) J Colloid Interface Sci , vol.53 , pp. 61-70
    • Reiss, H.1
  • 17
    • 0030834788 scopus 로고    scopus 로고
    • Formulation and physical characterization of water-in-oil microemulsions containing long- versus medium-chain glycerides
    • Constantinides PP, Scalart JP. 1997. Formulation and physical characterization of water-in-oil microemulsions containing long- versus medium-chain glycerides. Int J Pharm 158:57-68.
    • (1997) Int J Pharm , vol.158 , pp. 57-68
    • Constantinides, P.P.1    Scalart, J.P.2
  • 18
    • 18844450421 scopus 로고    scopus 로고
    • In vitro release of diclofenac diethylamine from caprylocaproyl macrogolglycerides based microemulsions
    • Djordjevic L, Primorac M, Stupar M. 2005. In vitro release of diclofenac diethylamine from caprylocaproyl macrogolglycerides based microemulsions. Int J Pharm 296:73-79.
    • (2005) Int J Pharm , vol.296 , pp. 73-79
    • Djordjevic, L.1    Primorac, M.2    Stupar, M.3
  • 19
    • 0032498581 scopus 로고    scopus 로고
    • Physicochemical characterization and evaluation of a microemulsion system for oral delivery of cyclosporin A
    • Gao ZG, Choi HG, Shin HJ, Park KM, Lim SJ, Hwang KJ, Kim CK. 1998. Physicochemical characterization and evaluation of a microemulsion system for oral delivery of cyclosporin A. Int J Pharm 161:75-86.
    • (1998) Int J Pharm , vol.161 , pp. 75-86
    • Gao, Z.G.1    Choi, H.G.2    Shin, H.J.3    Park, K.M.4    Lim, S.J.5    Hwang, K.J.6    Kim, C.K.7
  • 20
    • 0021954099 scopus 로고
    • Drug targeting: Current aspects and future prospects
    • Pouton CW. 1985. Drug targeting: Current aspects and future prospects. J Clin Hosp Pharm 10:45-58.
    • (1985) J Clin Hosp Pharm , vol.10 , pp. 45-58
    • Pouton, C.W.1
  • 21
    • 0032189892 scopus 로고    scopus 로고
    • Comparison of nephelometric turbidity measurements using wavelengths 400-600 and 860 nm
    • Hongve D, Akesson G. 1998. Comparison of nephelometric turbidity measurements using wavelengths 400-600 and 860 nm. Water Res 32:3143-3145.
    • (1998) Water Res , vol.32 , pp. 3143-3145
    • Hongve, D.1    Akesson, G.2
  • 22
    • 4644335531 scopus 로고    scopus 로고
    • Polymeric micelles for oral drug delivery: Why and how
    • Francis M, Cristea M, Winnik FM. 2004. Polymeric micelles for oral drug delivery: Why and how. Pure Appl Chem 76:1321-1335.
    • (2004) Pure Appl Chem , vol.76 , pp. 1321-1335
    • Francis, M.1    Cristea, M.2    Winnik, F.M.3
  • 23
    • 0029969387 scopus 로고    scopus 로고
    • An investigation into physical and chemical properties of semi-solid self emulsifying systems for hard gelatin capsules
    • Halbaut L, Berbe C, Del Pozo A. 1996. An investigation into physical and chemical properties of semi-solid self emulsifying systems for hard gelatin capsules. Int J Pharm 130:203-212.
    • (1996) Int J Pharm , vol.130 , pp. 203-212
    • Halbaut, L.1    Berbe, C.2    Del Pozo, A.3
  • 24
    • 0021092024 scopus 로고
    • Some factors affecting the droplet size and charge of dilute oil-in-water emulsions prepared by self-emulsification
    • Iranloye TA, Pilpel N, Groves MJ. 1983. Some factors affecting the droplet size and charge of dilute oil-in-water emulsions prepared by self-emulsification. J Disp Sci Technol 4:109-121.
    • (1983) J Disp Sci Technol , vol.4 , pp. 109-121
    • Iranloye, T.A.1    Pilpel, N.2    Groves, M.J.3
  • 25
    • 0000009718 scopus 로고
    • Microemulsions
    • Swarbrich J, Boylan JC, editors, New York: Marcel Dekker
    • Eccleston GM. 1992. Microemulsions. In: Swarbrich J, Boylan JC, editors. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker. Vol. 9, pp 375-421.
    • (1992) Encyclopedia of Pharmaceutical Technology , vol.9 , pp. 375-421
    • Eccleston, G.M.1
  • 26
    • 0037139412 scopus 로고    scopus 로고
    • Preparation and in vitro characterization of a eutectic based semisolid self-nanoemulsified drug delivery system (SNEDDS) of ubiquinone: Mechanism and progress of emulsion formation
    • Nazzal S, Smalyukh II, Lavrentovich OD, Mansoor AK. 2002. Preparation and in vitro characterization of a eutectic based semisolid self-nanoemulsified drug delivery system (SNEDDS) of ubiquinone: Mechanism and progress of emulsion formation. Int J Pharm 235:247-265.
    • (2002) Int J Pharm , vol.235 , pp. 247-265
    • Nazzal, S.1    Smalyukh, I.I.2    Lavrentovich, O.D.3    Mansoor, A.K.4
  • 27
    • 0030875017 scopus 로고    scopus 로고
    • Factors affecting the efficiency of a self-emulsifying oral delivery system
    • Bachynsky MO, Shah NH, Patel CI, Malick AW. 1997. Factors affecting the efficiency of a self-emulsifying oral delivery system. Drug Dev Ind Pharm 23:809-816.
    • (1997) Drug Dev Ind Pharm , vol.23 , pp. 809-816
    • Bachynsky, M.O.1    Shah, N.H.2    Patel, C.I.3    Malick, A.W.4
  • 28
    • 0028194817 scopus 로고
    • Self-emulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs
    • Shah NH, Carvajal MT, Patel CI, Infeld NH, Malick AW. 1994. Self-emulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs. Int J Pharm 106:15-23.
    • (1994) Int J Pharm , vol.106 , pp. 15-23
    • Shah, N.H.1    Carvajal, M.T.2    Patel, C.I.3    Infeld, N.H.4    Malick, A.W.5
  • 29
    • 0037625782 scopus 로고    scopus 로고
    • Analysis of water in food by near infrared spectroscopy
    • Buning-Pfaue H. 2003. Analysis of water in food by near infrared spectroscopy. Food Chem 82:107-115.
    • (2003) Food Chem , vol.82 , pp. 107-115
    • Buning-Pfaue, H.1
  • 30
    • 0019476977 scopus 로고
    • Optical properties of the clearest natural waters (200-800 nm)
    • Smith RC, Baker KS. 1981. Optical properties of the clearest natural waters (200-800 nm). Appl Opt 20:177-184.
    • (1981) Appl Opt , vol.20 , pp. 177-184
    • Smith, R.C.1    Baker, K.S.2
  • 32
    • 0031727877 scopus 로고    scopus 로고
    • Near-infrared mass median particle size determination of lactose monohydrate: Evaluating several chemometric approaches
    • Franke P, Gill I, Luscombe CN, Rudd DR, Waterhouse J, Jayasooriya A. 1998. Near-infrared mass median particle size determination of lactose monohydrate: Evaluating several chemometric approaches. Analyst 123:2043-2046.
    • (1998) Analyst , vol.123 , pp. 2043-2046
    • Franke, P.1    Gill, I.2    Luscombe, C.N.3    Rudd, D.R.4    Waterhouse, J.5    Jayasooriya, A.6


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