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Volumn 15, Issue 2, 2014, Pages 407-416

From bench to humans: Formulation development of a poorly water soluble drug to mitigate food effect

Author keywords

bioavailability; food effect; in vivo in vitro models; vitamin E TPGS; wet granulation

Indexed keywords

LIPID; SURFACTANT; TOCOFERSOLAN;

EID: 84898040916     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-013-0069-4     Document Type: Article
Times cited : (23)

References (27)
  • 1
    • 39149115065 scopus 로고    scopus 로고
    • Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption
    • 2292816 18199522 10.1016/j.addr.2007.08.043
    • Custodio JM, Wu C-Y, Benet LZ. Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev. 2008;60(6):717-33.
    • (2008) Adv Drug Deliv Rev , vol.60 , Issue.6 , pp. 717-733
    • Custodio, J.M.1    Wu, C.-Y.2    Benet, L.Z.3
  • 2
    • 0032927254 scopus 로고    scopus 로고
    • Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications
    • 10223170 10.2165/00003088-199936030-00004
    • Fleisher D, Li C, Zhou Y, Pao LH, Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet. 1999;36(3):233-54.
    • (1999) Clin Pharmacokinet. , vol.36 , Issue.3 , pp. 233-254
    • Fleisher, D.1    Li, C.2    Zhou, Y.3    Pao, L.H.4    Karim, A.5
  • 3
    • 34249037098 scopus 로고    scopus 로고
    • Predicting effect of food on extent of drug absorption based on physicochemical properties
    • 17385020 10.1007/s11095-007-9236-1
    • Gu CH, Li H, Levons J, Lentz K, Gandhi RB, Raghavan K, et al. Predicting effect of food on extent of drug absorption based on physicochemical properties. Pharm Res. 2007;24(6):1118-30.
    • (2007) Pharm Res , vol.24 , Issue.6 , pp. 1118-1130
    • Gu, C.H.1    Li, H.2    Levons, J.3    Lentz, K.4    Gandhi, R.B.5    Raghavan, K.6
  • 4
    • 72649106871 scopus 로고    scopus 로고
    • FDA. Guidance for Industry: Food-effect bioavailability and fed bioequivalence studies 2002;Rockville, MD
    • FDA. Guidance for Industry: Food-effect bioavailability and fed bioequivalence studies. Food and Drug Administration. 2002;Rockville, MD.
    • Food and Drug Administration
  • 5
    • 0030614844 scopus 로고    scopus 로고
    • Physiochemical and physiological mechanisms for the effects of food on drug absorption: The role of lipids and pH
    • 9050793 10.1021/js960085v
    • Charman WN, Porter CJ, Mithani S, Dressman JB. Physiochemical and physiological mechanisms for the effects of food on drug absorption: the role of lipids and pH. J Pharm Sci. 1997;86(3):269-82.
    • (1997) J Pharm Sci , vol.86 , Issue.3 , pp. 269-282
    • Charman, W.N.1    Porter, C.J.2    Mithani, S.3    Dressman, J.B.4
  • 6
    • 53849134465 scopus 로고    scopus 로고
    • Current methods for predicting human food effect
    • 2751375 18500565 10.1208/s12248-008-9025-8
    • Lentz KA. Current methods for predicting human food effect. AAPS J. 2008;10(2):282-8.
    • (2008) AAPS J , vol.10 , Issue.2 , pp. 282-288
    • Lentz, K.A.1
  • 7
    • 65549103408 scopus 로고    scopus 로고
    • Predicting pharmacokinetics of drugs using physiologically based modeling - Application to food effects
    • 2664880 19184451 10.1208/s12248-008-9079-7
    • Parrott N, Lukacova V, Fraczkiewicz G, Bolger MB. Predicting pharmacokinetics of drugs using physiologically based modeling - application to food effects. The AAPS Journal. 2009;11(1):45-53.
    • (2009) The AAPS Journal , vol.11 , Issue.1 , pp. 45-53
    • Parrott, N.1    Lukacova, V.2    Fraczkiewicz, G.3    Bolger, M.B.4
  • 8
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • 7617530 10.1023/A:1016212804288
    • Amidon GL, Lennernas 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):413-20.
    • (1995) Pharm Res , vol.12 , Issue.3 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4
  • 9
    • 72949123710 scopus 로고    scopus 로고
    • Prediction of solubility and permeability class membership: Provisional BCS classification of the world's top oral drugs
    • 2782078 19876745 10.1208/s12248-009-9144-x
    • Dahan A, Miller JM, Amidon GL. Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs. AAPS J. 2009;11(4):740-6.
    • (2009) AAPS J , vol.11 , Issue.4 , pp. 740-746
    • Dahan, A.1    Miller, J.M.2    Amidon, G.L.3
  • 10
    • 17644380257 scopus 로고    scopus 로고
    • Predicting drug disposition via application of BCS: Transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system
    • 15771225 10.1007/s11095-004-9004-4
    • Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11-23.
    • (2005) Pharm Res , vol.22 , Issue.1 , pp. 11-23
    • Wu, C.Y.1    Benet, L.Z.2
  • 11
    • 0033805179 scopus 로고    scopus 로고
    • In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs
    • 11033429 10.1016/S0928-0987(00)00181-0
    • Dressman JB, Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. European Journal of Pharmaceutical Sciences. 2000;11(2):S73-80.
    • (2000) European Journal of Pharmaceutical Sciences , vol.11 , Issue.2 , pp. 73-80
    • Dressman, J.B.1    Reppas, C.2
  • 12
    • 33748936522 scopus 로고    scopus 로고
    • Effect of food intake on the oral absorption of poorly water-soluble drugs: In vitro assessment of drug dissolution and permeation assay system
    • 16850428 10.1002/jps.20691
    • Kataoka M, Masaoka Y, Sakuma S, Yamashita S. Effect of food intake on the oral absorption of poorly water-soluble drugs: in vitro assessment of drug dissolution and permeation assay system. J Pharm Sci. 2006;95(9):2051-61.
    • (2006) J Pharm Sci , vol.95 , Issue.9 , pp. 2051-2061
    • Kataoka, M.1    Masaoka, Y.2    Sakuma, S.3    Yamashita, S.4
  • 13
    • 29244445764 scopus 로고    scopus 로고
    • The effects of food on the dissolution of poorly soluble drugs in human and in model small intestinal fluids
    • 16247711 10.1007/s11095-005-8192-x
    • Persson E, Gustafsson A-S, Carlsson A, Nilsson R, Knutson L, Forsell P, et al. The effects of food on the dissolution of poorly soluble drugs in human and in model small intestinal fluids. Pharm Res. 2005;22(12):2141-51.
    • (2005) Pharm Res , vol.22 , Issue.12 , pp. 2141-2151
    • Persson, E.1    Gustafsson, A.-S.2    Carlsson, A.3    Nilsson, R.4    Knutson, L.5    Forsell, P.6
  • 14
    • 77955656443 scopus 로고    scopus 로고
    • Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans
    • 20576487 10.1016/j.ejpb.2010.05.009
    • Shono Y, Jantratid E, Kesisoglou F, Reppas C, Dressman JB. Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans. Eur J Pharm Biopharm. 2010;76(1):95-104.
    • (2010) Eur J Pharm Biopharm , vol.76 , Issue.1 , pp. 95-104
    • Shono, Y.1    Jantratid, E.2    Kesisoglou, F.3    Reppas, C.4    Dressman, J.B.5
  • 15
    • 20844446627 scopus 로고    scopus 로고
    • The role of biopharmaceutics in the development of a clinical nanoparticle formulation of MK-0869: A Beagle dog model predicts improved bioavailability and diminished food effect on absorption in human
    • 15488686 10.1016/j.ijpharm.2004.08.001
    • Wu Y, Loper A, Landis E, Hettrick L, Novak L, Lynn K, et al. The role of biopharmaceutics in the development of a clinical nanoparticle formulation of MK-0869: a Beagle dog model predicts improved bioavailability and diminished food effect on absorption in human. Int J Pharm. 2004;285(1-2):135-46.
    • (2004) Int J Pharm , vol.285 , Issue.1-2 , pp. 135-146
    • Wu, Y.1    Loper, A.2    Landis, E.3    Hettrick, L.4    Novak, L.5    Lynn, K.6
  • 16
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of class i and II drugs
    • 9619777 10.1023/A:1011910801212
    • Galia E, Nicolaides E, Horter D, Lobenberg 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.
    • (1998) Pharm Res , vol.15 , Issue.5 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Horter, D.3    Lobenberg, R.4    Reppas, C.5    Dressman, J.B.6
  • 17
    • 77955947927 scopus 로고    scopus 로고
    • The use of biorelevant dissolution media to forecast the in vivo performance of a drug
    • 2895438 20458565 10.1208/s12248-010-9203-3
    • Klein S. The use of biorelevant dissolution media to forecast the in vivo performance of a drug. The AAPS Journal. 2010;12(3):397-406.
    • (2010) The AAPS Journal , vol.12 , Issue.3 , pp. 397-406
    • Klein, S.1
  • 18
    • 33947276437 scopus 로고    scopus 로고
    • Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system
    • 11741200 10.1208/ps010203
    • Ginski MJ, Taneja R, Polli JE. Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system. AAPS PharmSci. 1999;1(2):E3.
    • (1999) AAPS PharmSci , vol.1 , Issue.2 , pp. 3
    • Ginski, M.J.1    Taneja, R.2    Polli, J.E.3
  • 19
    • 34247516835 scopus 로고    scopus 로고
    • Permeability assessment for solid oral drug formulations based on Caco-2 monolayer in combination with a flow through dissolution cell
    • 17156983 10.1016/j.ejpb.2006.10.015
    • Motz SA, Schaefer UF, Balbach S, Eichinger T, Lehr CM. Permeability assessment for solid oral drug formulations based on Caco-2 monolayer in combination with a flow through dissolution cell. Eur J Pharm Biopharm. 2007;66(2):286-95.
    • (2007) Eur J Pharm Biopharm , vol.66 , Issue.2 , pp. 286-295
    • Motz, S.A.1    Schaefer, U.F.2    Balbach, S.3    Eichinger, T.4    Lehr, C.M.5
  • 20
    • 20144387782 scopus 로고    scopus 로고
    • PH-dependent dissolution in vitro and absorption in vivo of weakly basic drugs: Development of a canine model
    • 15783065 10.1007/s11095-004-1185-3
    • Zhou R, Moench P, Heran C, Lu X, Mathias N, Faria TN, et al. pH-dependent dissolution in vitro and absorption in vivo of weakly basic drugs: development of a canine model. Pharm Res. 2005;22(2):188-92.
    • (2005) Pharm Res , vol.22 , Issue.2 , pp. 188-192
    • Zhou, R.1    Moench, P.2    Heran, C.3    Lu, X.4    Mathias, N.5    Faria, T.N.6
  • 21
    • 24644431507 scopus 로고    scopus 로고
    • Canine versus in vitro data for predicting input profiles of l-sulpiride after oral administration
    • 16139490 10.1016/j.ejps.2005.07.004
    • Fotaki N, Symillides M, Reppas C. Canine versus in vitro data for predicting input profiles of l-sulpiride after oral administration. Eur J Pharm Sci. 2005;26(3-4):324-33.
    • (2005) Eur J Pharm Sci , vol.26 , Issue.3-4 , pp. 324-333
    • Fotaki, N.1    Symillides, M.2    Reppas, C.3
  • 22
    • 79951765993 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetics in drug development and regulatory science
    • 20854171 10.1146/annurev-pharmtox-010510-100540
    • Rowland M, Peck C, Tucker G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol. 2011;51:45-73.
    • (2011) Annu Rev Pharmacol Toxicol , vol.51 , pp. 45-73
    • Rowland, M.1    Peck, C.2    Tucker, G.3
  • 23
    • 33845467297 scopus 로고    scopus 로고
    • Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modelling
    • 17112297 10.2165/00003088-200645120-00006
    • Jones HM, Parrott N, Ohlenbusch G, Lave T. Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modelling. Clin Pharmacokinet. 2006;45(12):1213-26.
    • (2006) Clin Pharmacokinet , vol.45 , Issue.12 , pp. 1213-1226
    • Jones, H.M.1    Parrott, N.2    Ohlenbusch, G.3    Lave, T.4
  • 24
    • 0033452575 scopus 로고    scopus 로고
    • Forecasting the in vivo performance of four low solubility drugs from their in vitro dissolution data
    • 10644077 10.1023/A:1018959511323
    • Nicolaides E, Galia E, Efthymiopoulos C, Dressman JB, Reppas C. Forecasting the in vivo performance of four low solubility drugs from their in vitro dissolution data. Pharm Res. 1999;16(12):1876-82.
    • (1999) Pharm Res , vol.16 , Issue.12 , pp. 1876-1882
    • Nicolaides, E.1    Galia, E.2    Efthymiopoulos, C.3    Dressman, J.B.4    Reppas, C.5
  • 25
    • 84862764756 scopus 로고    scopus 로고
    • The use of modeling tools to drive efficient oral product design
    • 3385810 22644702 10.1208/s12248-012-9372-3
    • Mathias NR, Crison J. The use of modeling tools to drive efficient oral product design. AAPS J. 2012;14(3):591-600.
    • (2012) AAPS J , vol.14 , Issue.3 , pp. 591-600
    • Mathias, N.R.1    Crison, J.2
  • 26
    • 77349112650 scopus 로고    scopus 로고
    • Tabletability assessment of conventional formulations containing vitamin e tocopheryl polyethylene glycol succinate
    • 20083178 10.1016/j.ijpharm.2010.01.017
    • Jin F, Tatavarti A. Tabletability assessment of conventional formulations containing vitamin E tocopheryl polyethylene glycol succinate. Int J Pharm. 2010;389(1-2):58-65.
    • (2010) Int J Pharm , vol.389 , Issue.1-2 , pp. 58-65
    • Jin, F.1    Tatavarti, A.2
  • 27
    • 84870885071 scopus 로고    scopus 로고
    • Processing challenges with solid dosage formulations containing vitamin e TPGS
    • 23136832 10.3109/10837450.2012.737807
    • Pandey P, Sinko PD, Bindra DS, Hamey R, Gour S, Vema-Varapu C. Processing challenges with solid dosage formulations containing vitamin E TPGS. Pharm Dev Technol. 2013;18(1):296-304.
    • (2013) Pharm Dev Technol , vol.18 , Issue.1 , pp. 296-304
    • Pandey, P.1    Sinko, P.D.2    Bindra, D.S.3    Hamey, R.4    Gour, S.5    Vema-Varapu, C.6


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