메뉴 건너뛰기




Volumn 210, Issue , 2015, Pages 58-66

Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems

Author keywords

Absorption; Estradiol; In vitro in vivo correlation (IVIVC); Permeation; Transdermal; Validation

Indexed keywords

ABSORPTION; BODY FLUIDS; COMMERCE; PERMEATION; PRODUCT DESIGN;

EID: 84929581296     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2015.05.263     Document Type: Article
Times cited : (62)

References (38)
  • 1
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability
    • G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 1995 413 420
    • (1995) Pharm. Res. , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4
  • 2
    • 0027195325 scopus 로고
    • In vitro-in vivo correlation for modified-release formulations
    • J. Drewe, and P. Guitard In vitro-in vivo correlation for modified-release formulations J. Pharm. Sci. 82 1993 132 137
    • (1993) J. Pharm. Sci. , vol.82 , pp. 132-137
    • Drewe, J.1    Guitard, P.2
  • 5
    • 1242308254 scopus 로고    scopus 로고
    • Current status and future potential of transdermal drug delivery
    • M.R. Prausnitz, S. Mitragotri, and R. Langer Current status and future potential of transdermal drug delivery Nat. Rev. Drug Discov. 3 2004 115 124
    • (2004) Nat. Rev. Drug Discov. , vol.3 , pp. 115-124
    • Prausnitz, M.R.1    Mitragotri, S.2    Langer, R.3
  • 6
    • 48249100198 scopus 로고    scopus 로고
    • Delivering drugs by the transdermal route: review and comment
    • T. Tanner, and R. Marks Delivering drugs by the transdermal route: review and comment Skin Res. Technol. 14 2008 249 260
    • (2008) Skin Res. Technol. , vol.14 , pp. 249-260
    • Tanner, T.1    Marks, R.2
  • 9
    • 0026951478 scopus 로고
    • Transdermal estradiol. A review of its pharmacological profile, and therapeutic potential in the prevention of postmenopausal osteoporosis
    • J.A. Balfour, and D. McTavish Transdermal estradiol. A review of its pharmacological profile, and therapeutic potential in the prevention of postmenopausal osteoporosis Drugs Aging 2 1992 487 507
    • (1992) Drugs Aging , vol.2 , pp. 487-507
    • Balfour, J.A.1    McTavish, D.2
  • 10
    • 77952697219 scopus 로고    scopus 로고
    • Transdermal menopausal hormone therapy: delivery through skin changes the rules
    • J.E. Buster Transdermal menopausal hormone therapy: delivery through skin changes the rules Expert. Opin. Pharmacother. 11 2010 1489 1499
    • (2010) Expert. Opin. Pharmacother. , vol.11 , pp. 1489-1499
    • Buster, J.E.1
  • 12
    • 0034733478 scopus 로고    scopus 로고
    • Drug concentration effect relationship of estradiol from two matrix transdermal delivery systems: Menorest and Climara
    • T.L. Andersson, B. Stehle, B. Davidsson, and P. Hoglund Drug concentration effect relationship of estradiol from two matrix transdermal delivery systems: Menorest and Climara Maturitas 35 2000 245 252
    • (2000) Maturitas , vol.35 , pp. 245-252
    • Andersson, T.L.1    Stehle, B.2    Davidsson, B.3    Hoglund, P.4
  • 13
    • 0034650373 scopus 로고    scopus 로고
    • Bioavailability of estradiol from two matrix transdermal delivery systems: Menorest and Climara
    • T.L. Andersson, B. Stehle, B. Davidsson, and P. Hoglund Bioavailability of estradiol from two matrix transdermal delivery systems: Menorest and Climara Maturitas 34 2000 57 64
    • (2000) Maturitas , vol.34 , pp. 57-64
    • Andersson, T.L.1    Stehle, B.2    Davidsson, B.3    Hoglund, P.4
  • 15
    • 84929602775 scopus 로고    scopus 로고
    • Prescribing Information, Estradiol-Estradiol patch (http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=e7e6da3b-8485-1382-61c9-e9b369018b98&type=pdf&name=e7e6da3b-8485-1382-61c9-e9b369018b98) 2014
    • (2014) Prescribing Information, Estradiol-Estradiol patch
  • 16
    • 78651147390 scopus 로고
    • Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug
    • J.G. Wagner, and E. Nelson Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug J. Pharm. Sci. 53 1964 1392 1403
    • (1964) J. Pharm. Sci. , vol.53 , pp. 1392-1403
    • Wagner, J.G.1    Nelson, E.2
  • 17
    • 0028031838 scopus 로고
    • Pharmacokinetic characterization of transdermal delivery systems
    • B. Berner, and V.A. John Pharmacokinetic characterization of transdermal delivery systems Clin. Pharmacokinet. 26 1994 121 134
    • (1994) Clin. Pharmacokinet. , vol.26 , pp. 121-134
    • Berner, B.1    John, V.A.2
  • 18
    • 0032857381 scopus 로고    scopus 로고
    • In vitro percutaneous absorption enhancement of propranolol hydrochloride through porcine epidermis by terpenes/ethanol
    • K.D. Zhao, and J. Singh In vitro percutaneous absorption enhancement of propranolol hydrochloride through porcine epidermis by terpenes/ethanol J. Control. Release 62 1999 359 366
    • (1999) J. Control. Release , vol.62 , pp. 359-366
    • Zhao, K.D.1    Singh, J.2
  • 19
    • 33646470285 scopus 로고    scopus 로고
    • Effect of nerodilol and carvone on in vitro permeation of nicorandil across rat epidermal membrane
    • Y.S. Krishnaiah, S.M. Al-Saidan, D.V. Chandrasekhar, and B. Rama Effect of nerodilol and carvone on in vitro permeation of nicorandil across rat epidermal membrane Drug Dev. Ind. Pharm. 32 2006 423 435
    • (2006) Drug Dev. Ind. Pharm. , vol.32 , pp. 423-435
    • Krishnaiah, Y.S.1    Al-Saidan, S.M.2    Chandrasekhar, D.V.3    Rama, B.4
  • 20
    • 38049104374 scopus 로고    scopus 로고
    • Transepidermal water loss as an integrity test for skin barrier function in vitro: assay standardization
    • K.R. Brain, V.J. James, K.A. Walters, STS Cardiff
    • F. Benech-Kieffer, P. Wegrich, and H. Schaefer Transepidermal water loss as an integrity test for skin barrier function in vitro: assay standardization K.R. Brain, V.J. James, K.A. Walters, Perspectives in Percutaneous Penetration 1997 STS Cardiff 56
    • (1997) Perspectives in Percutaneous Penetration , pp. 56
    • Benech-Kieffer, F.1    Wegrich, P.2    Schaefer, H.3
  • 21
    • 0028861288 scopus 로고
    • Estradiol permeation across human skin, silastic and snake skin membranes - the effects of ethanol-water cosolvent systems
    • N.A. Megrab, A.C. Williams, and B.W. Barry Estradiol permeation across human skin, silastic and snake skin membranes - the effects of ethanol-water cosolvent systems Int. J. Pharm. 116 1995 101 112
    • (1995) Int. J. Pharm. , vol.116 , pp. 101-112
    • Megrab, N.A.1    Williams, A.C.2    Barry, B.W.3
  • 22
    • 0019976664 scopus 로고
    • Correction of perfusate concentration for sample removal
    • W.L. Hayton, and T. Chen Correction of perfusate concentration for sample removal J. Pharm. Sci. 71 1982 820 821
    • (1982) J. Pharm. Sci. , vol.71 , pp. 820-821
    • Hayton, W.L.1    Chen, T.2
  • 23
    • 33744938143 scopus 로고    scopus 로고
    • Determination of estradiol and its degradation products by liquid chromatography
    • L. Havlikova, L. Novakova, L. Matysova, J. Sicha, and P. Solich Determination of estradiol and its degradation products by liquid chromatography J. Chromatogr. A 1119 2006 216 223
    • (2006) J. Chromatogr. A , vol.1119 , pp. 216-223
    • Havlikova, L.1    Novakova, L.2    Matysova, L.3    Sicha, J.4    Solich, P.5
  • 24
    • 33845423927 scopus 로고    scopus 로고
    • Near infrared spectrometry for the quantification of human dermal absorption of econazole nitrate and estradiol
    • J.P. Medendorp, K.S. Paudel, R.A. Lodder, and A.L. Stinchcomb Near infrared spectrometry for the quantification of human dermal absorption of econazole nitrate and estradiol Pharm. Res. 24 2007 186 193
    • (2007) Pharm. Res. , vol.24 , pp. 186-193
    • Medendorp, J.P.1    Paudel, K.S.2    Lodder, R.A.3    Stinchcomb, A.L.4
  • 25
    • 84929602776 scopus 로고    scopus 로고
    • The United States Pharmacopoeia Rockville, MD, USA
    • USP37-NF32, General Chapter <621> Chromatography 2014 The United States Pharmacopoeia Rockville, MD, USA 6376 6386
    • (2014) USP37-NF32, General Chapter <621> Chromatography , pp. 6376-6386
  • 27
    • 84929581703 scopus 로고    scopus 로고
    • Irish Pharmaceutical Healthcare Association (IPHA) Ireland
    • Summary of Product Characteristics, Climara Transdermal Patch (http://www.medicines.ie/medicine/2742/SPC/Climara+50+micrograms+24+hours+Transdermal+Patch/) 2014 Irish Pharmaceutical Healthcare Association (IPHA) Ireland
    • (2014) Summary of Product Characteristics, Climara Transdermal Patch
  • 28
    • 33745616771 scopus 로고    scopus 로고
    • In vitro-in vivo correlation: from theory to applications
    • J. Emami In vitro-in vivo correlation: from theory to applications J. Pharm. Pharm. Sci. 9 2006 169 189
    • (2006) J. Pharm. Pharm. Sci. , vol.9 , pp. 169-189
    • Emami, J.1
  • 29
    • 0029064591 scopus 로고
    • Dual-controlled transdermal delivery of levonorgestrel and estradiol-enhanced permeation and modulated delivery
    • G.S. Chen, D.D. Kim, and Y.W. Chien Dual-controlled transdermal delivery of levonorgestrel and estradiol-enhanced permeation and modulated delivery J. Control. Release 34 1995 129 143
    • (1995) J. Control. Release , vol.34 , pp. 129-143
    • Chen, G.S.1    Kim, D.D.2    Chien, Y.W.3
  • 30
    • 85027926011 scopus 로고    scopus 로고
    • Use of in vitro-in vivo correlation to predict the pharmacokinetics of several products containing a BCS class 1 drug in extended release matrices
    • T. Mirza, S.A. Bykadi, C.D. Ellison, Y. Yang, B.M. Davit, and M.A. Khan Use of in vitro-in vivo correlation to predict the pharmacokinetics of several products containing a BCS class 1 drug in extended release matrices Pharm. Res. 30 2013 179 190
    • (2013) Pharm. Res. , vol.30 , pp. 179-190
    • Mirza, T.1    Bykadi, S.A.2    Ellison, C.D.3    Yang, Y.4    Davit, B.M.5    Khan, M.A.6
  • 31
    • 0030847133 scopus 로고    scopus 로고
    • The role of in vitro-in vivo correlations (IVIVC) to regulatory agencies
    • H.J. Malinowski The role of in vitro-in vivo correlations (IVIVC) to regulatory agencies Adv. Exp. Med. Biol. 423 1997 261 268
    • (1997) Adv. Exp. Med. Biol. , vol.423 , pp. 261-268
    • Malinowski, H.J.1
  • 32
    • 77954073585 scopus 로고    scopus 로고
    • Use of in vitro-in vivo Correlation (IVIVC) to facilitate the development of polymer-based controlled release injectable formulation
    • A. Mitra, and Y. Wu Use of in vitro-in vivo Correlation (IVIVC) to facilitate the development of polymer-based controlled release injectable formulation Recent Pat. Drug Deliv. Formul. 4 2010 94 104
    • (2010) Recent Pat. Drug Deliv. Formul. , vol.4 , pp. 94-104
    • Mitra, A.1    Wu, Y.2
  • 33
    • 78751487071 scopus 로고    scopus 로고
    • Biowaiver extension potential and IVIVC for BCS Class II drugs by formulation design: case study for cyclosporine self-microemulsifying formulation
    • S.G. Yang Biowaiver extension potential and IVIVC for BCS Class II drugs by formulation design: case study for cyclosporine self-microemulsifying formulation Arch. Pharm. Res. 33 2010 1835 1842
    • (2010) Arch. Pharm. Res. , vol.33 , pp. 1835-1842
    • Yang, S.G.1
  • 35
    • 0036891932 scopus 로고    scopus 로고
    • Polymers effect on estradiol partition coefficient between powdered human stratum corneum and water
    • R.C. Wester, X. Hui, P.G. Hewitt, J. Hostynek, S. Krauser, T. Chan, and H.I. Maibach Polymers effect on estradiol partition coefficient between powdered human stratum corneum and water J. Pharm. Sci. 91 2002 2642 2645
    • (2002) J. Pharm. Sci. , vol.91 , pp. 2642-2645
    • Wester, R.C.1    Hui, X.2    Hewitt, P.G.3    Hostynek, J.4    Krauser, S.5    Chan, T.6    Maibach, H.I.7
  • 36
    • 0029844908 scopus 로고    scopus 로고
    • Mutual hairless rat skin permeation-enhancing effect of ethanol/water system and oleic acid
    • D.D. Kim, J.L. Kim, and Y.W. Chien Mutual hairless rat skin permeation-enhancing effect of ethanol/water system and oleic acid J. Pharm. Sci. 85 1996 1191 1195
    • (1996) J. Pharm. Sci. , vol.85 , pp. 1191-1195
    • Kim, D.D.1    Kim, J.L.2    Chien, Y.W.3
  • 37
    • 0025100879 scopus 로고
    • Solvent-mediated alterations of the stratum-corneum
    • K. Knutson, S.L. Krill, and J. Zhang Solvent-mediated alterations of the stratum-corneum J. Control. Release 11 1990 93 103
    • (1990) J. Control. Release , vol.11 , pp. 93-103
    • Knutson, K.1    Krill, S.L.2    Zhang, J.3
  • 38
    • 0023606009 scopus 로고
    • The effects of ethanol on the transport of β-estradiol and other permeants in hairless mouse skin. II. A new quantitative approach
    • A.-H. Ghanem, H. Mahmoud, W.l. Higuchi, U.D. Rohr, S. Borsadia, P. Liu, J.L. Fox, and W.R. Good The effects of ethanol on the transport of β-estradiol and other permeants in hairless mouse skin. II. A new quantitative approach J. Control. Release 6 1987 75 83
    • (1987) J. Control. Release , vol.6 , pp. 75-83
    • Ghanem, A.-H.1    Mahmoud, H.2    Higuchi, W.L.3    Rohr, U.D.4    Borsadia, S.5    Liu, P.6    Fox, J.L.7    Good, W.R.8


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.