메뉴 건너뛰기




Volumn 15, Issue 2, 2014, Pages 400-406

Application of physiologically based absorption modeling to formulation development of a low solubility, low permeability weak base: Mechanistic investigation of food effect

Author keywords

GastroPlus; particle size; physiologically based pharmacokinetics; precipitation; solubility

Indexed keywords

BASE; ALKALI;

EID: 84898036483     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-014-0075-1     Document Type: Article
Times cited : (34)

References (21)
  • 1
    • 0030580951 scopus 로고    scopus 로고
    • Transport approaches to the biopharmaceutical design of oral drug delivery systems: Prediction of intestinal absorption
    • 11540095 10.1016/0169-409X(96)00009-9
    • Yu LX, Lipka E, Crison JR, Amidon GL. Transport approaches to the biopharmaceutical design of oral drug delivery systems: prediction of intestinal absorption. Adv Drug Deliv Rev. 1996;19(3):359-76.
    • (1996) Adv Drug Deliv Rev , vol.19 , Issue.3 , pp. 359-376
    • Yu, L.X.1    Lipka, E.2    Crison, J.R.3    Amidon, G.L.4
  • 2
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • 11576695 10.1016/S0169-409X(01)00179-X
    • Agoram B, Woltosz WS, Bolger MB. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev. 2001;50 Suppl 1:S41-67.
    • (2001) Adv Drug Deliv Rev , vol.50 , Issue.SUPPL.. 1
    • Agoram, B.1    Woltosz, W.S.2    Bolger, M.B.3
  • 3
    • 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
  • 4
    • 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 L-H, 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
  • 5
    • 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. AAPS J. 2009;11(1):45-53.
    • (2009) AAPS J , vol.11 , Issue.1 , pp. 45-53
    • Parrott, N.1    Lukacova, V.2    Fraczkiewicz, G.3    Bolger, M.B.4
  • 6
    • 43349100699 scopus 로고    scopus 로고
    • Predicting effect of food on extent of drug absorption based on physicochemical properties (Pharmaceutical Research (2007) DOI: 10.1007/s11095-007-9236-1)
    • 10.1007/s11095-007-9337-x
    • Gu C-H, 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 (Pharmaceutical Research (2007) DOI: 10.1007/s11095-007-9236-1). Pharm Res. 2008;25(4):979.
    • (2008) Pharm Res , vol.25 , Issue.4 , pp. 979
    • Gu, C.-H.1    Li, H.2    Levons, J.3    Lentz, K.4    Gandhi, R.B.5    Raghavan, K.6
  • 7
    • 84871957696 scopus 로고    scopus 로고
    • Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data
    • 3535115 23139017 10.1208/s12248-012-9419-5
    • Heimbach T, Xia BF, Lin TH, He HD. Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data. AAPS J. 2013;15(1):143-58.
    • (2013) AAPS J , vol.15 , Issue.1 , pp. 143-158
    • Heimbach, T.1    Xia, B.F.2    Lin, T.H.3    He, H.D.4
  • 8
    • 84866037370 scopus 로고    scopus 로고
    • Predicting the oral absorption of a poorly soluble, poorly permeable weak base using biorelevant dissolution and transfer model tests coupled with a physiologically based pharmacokinetic model
    • 22652546 10.1016/j.ejpb.2012.05.008
    • Wagner C, Jantratid E, Kesisoglou F, Vertzoni M, Reppas C, Dressman JB. Predicting the oral absorption of a poorly soluble, poorly permeable weak base using biorelevant dissolution and transfer model tests coupled with a physiologically based pharmacokinetic model. Eur J Pharm Biopharm. 2012;82(1):127-38.
    • (2012) Eur J Pharm Biopharm , vol.82 , Issue.1 , pp. 127-138
    • Wagner, C.1    Jantratid, E.2    Kesisoglou, F.3    Vertzoni, M.4    Reppas, C.5    Dressman, J.B.6
  • 9
    • 84890192826 scopus 로고    scopus 로고
    • Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound
    • 23955148 10.1208/s12249-013-0018-2
    • Xia BF, Heimbach T, Lin TH, Li SF, Zhang HF, Sheng J, et al. Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound. AAPS Pharmscitech. 2013;14(3):1255-66.
    • (2013) AAPS Pharmscitech , vol.14 , Issue.3 , pp. 1255-1266
    • Xia, B.F.1    Heimbach, T.2    Lin, T.H.3    Li, S.F.4    Zhang, H.F.5    Sheng, J.6
  • 10
    • 23044469809 scopus 로고    scopus 로고
    • Estimating human drug oral absorption kinetics from Caco-2 permeability using an absorption-disposition model: Model development and evaluation and derivation of analytical solutions for k(a) and F(a)
    • 15833900 10.1124/jpet.104.076182
    • Usansky HH, Sinko PJ. Estimating human drug oral absorption kinetics from Caco-2 permeability using an absorption-disposition model: model development and evaluation and derivation of analytical solutions for k(a) and F(a). J Pharmacol Exp Ther. 2005;314(1):391-9.
    • (2005) J Pharmacol Exp Ther , vol.314 , Issue.1 , pp. 391-399
    • Usansky, H.H.1    Sinko, P.J.2
  • 11
    • 0027275798 scopus 로고
    • Dissolution modeling: Factors affecting the dissolution rates of polydisperse powders
    • 8234168 10.1023/A:1018917729477
    • Lu AT, Frisella ME, Johnson KC. Dissolution modeling: factors affecting the dissolution rates of polydisperse powders. Pharm Res. 1993;10(9):1308-14.
    • (1993) Pharm Res , vol.10 , Issue.9 , pp. 1308-1314
    • Lu, A.T.1    Frisella, M.E.2    Johnson, K.C.3
  • 12
    • 0036092934 scopus 로고    scopus 로고
    • Measurement of meal-stimulated gastric acid secretion by in vivo gastric autotitration
    • 11796648
    • Gardner JD, Ciociola AA, Robinson M. Measurement of meal-stimulated gastric acid secretion by in vivo gastric autotitration. J Appl Physiol. 2002;92(2):427-34.
    • (2002) J Appl Physiol , vol.92 , Issue.2 , pp. 427-434
    • Gardner, J.D.1    Ciociola, A.A.2    Robinson, M.3
  • 14
    • 0342897023 scopus 로고    scopus 로고
    • Nanosuspensions for the formulation of poorly soluble drugs: I. Preparation by a size-reduction technique
    • 10.1016/S0378-5173(97)00311-6
    • Muller RH, Peters K. Nanosuspensions for the formulation of poorly soluble drugs: I. Preparation by a size-reduction technique. Int J Pharm. 1998;160(2):229-37.
    • (1998) Int J Pharm , vol.160 , Issue.2 , pp. 229-237
    • Muller, R.H.1    Peters, K.2
  • 15
    • 83555174958 scopus 로고    scopus 로고
    • BDDCS applied to over 900 drugs
    • 3231854 21818695 10.1208/s12248-011-9290-9
    • Benet LZ, Broccatelli F, Oprea TI. BDDCS applied to over 900 drugs. AAPS J. 2011;13(4):519-47.
    • (2011) AAPS J , vol.13 , Issue.4 , pp. 519-547
    • Benet, L.Z.1    Broccatelli, F.2    Oprea, T.I.3
  • 16
    • 80054989486 scopus 로고    scopus 로고
    • Precipitation in the small intestine may play a more important role in the in vivo performance of poorly soluble weak bases in the fasted state: Case example nelfinavir
    • 21527341 10.1016/j.ejpb.2011.04.005
    • Shono Y, Jantratid E, Dressman JB. Precipitation in the small intestine may play a more important role in the in vivo performance of poorly soluble weak bases in the fasted state: case example nelfinavir. Eur J Pharm Biopharm. 2011;79(2):349-56.
    • (2011) Eur J Pharm Biopharm , vol.79 , Issue.2 , pp. 349-356
    • Shono, Y.1    Jantratid, E.2    Dressman, J.B.3
  • 17
    • 0030003789 scopus 로고    scopus 로고
    • Estimation of the increase in solubility of drugs as a function of bile salt concentration
    • 8668668 10.1023/A:1016062224568
    • 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(1):163-7.
    • (1996) Pharm Res , vol.13 , Issue.1 , pp. 163-167
    • Mithani, S.D.1    Bakatselou, V.2    Tenhoor, C.N.3    Dressman, J.B.4
  • 18
    • 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
  • 19
    • 33344478634 scopus 로고    scopus 로고
    • Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs
    • 16410029 10.1016/j.jconrel.2005.11.013
    • Jinno J, Kamada N, Miyake M, Yamada K, Mukai T, Odomi M, et al. Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs. J Control Release. 2006;111(1-2):56-64.
    • (2006) J Control Release , vol.111 , Issue.1-2 , pp. 56-64
    • Jinno, J.1    Kamada, N.2    Miyake, M.3    Yamada, K.4    Mukai, T.5    Odomi, M.6
  • 20
    • 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
  • 21
    • 65549146053 scopus 로고    scopus 로고
    • Understanding the effect of API properties on bioavailability through absorption modeling
    • 2628211 19002590 10.1208/s12248-008-9061-4
    • Kesisoglou F, Wu YH. Understanding the effect of API properties on bioavailability through absorption modeling. AAPS J. 2008;10(4):516-25.
    • (2008) AAPS J , vol.10 , Issue.4 , pp. 516-525
    • Kesisoglou, F.1    Wu, Y.H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.