메뉴 건너뛰기




Volumn 12, Issue 4, 2011, Pages 1248-1263

Reactive impurities in excipients: Profiling, identification and mitigation of drug-excipient incompatibility

Author keywords

excipients; impurities; interaction; mitigation; variability

Indexed keywords

ALDEHYDE; CARBOXYLIC ACID; CROSCARMELLOSE SODIUM; CROSPOVIDONE; EXCIPIENT; HEAVY METAL; HYDROGEN PEROXIDE; HYDROPEROXIDE; HYDROXYPROPYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; METAL; MICROCRYSTALLINE CELLULOSE; NITRATE; NITRITE; PEROXIDE; PIPERAZINE; POVIDONE; SILICON DIOXIDE; STARCH GLYCOLATE SODIUM; STEARIC ACID; SUGAR; TRACE METAL; VIGABATRIN;

EID: 83555168209     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9677-z     Document Type: Review
Times cited : (214)

References (95)
  • 1
    • 83555164420 scopus 로고    scopus 로고
    • Functionality and performance of excipients in a quality-by-design world: Part IV
    • Moreton C. Functionality and performance of excipients in a quality-by-design world: part IV. Am Pharm Rev. 2010; Suppl. p. 18-21.
    • (2010) Am Pharm Rev , Issue.SUPPL. , pp. 18-21
    • Moreton, C.1
  • 3
    • 0004188123 scopus 로고    scopus 로고
    • 3 American Pharmaceutical Association Washington
    • Kibbe A. Handbook of pharmaceutical excipients. 3rd ed. Washington: American Pharmaceutical Association; 2000. p. 102-6.
    • (2000) Handbook of Pharmaceutical Excipients , pp. 102-6
    • Kibbe, A.1
  • 4
    • 0030445828 scopus 로고    scopus 로고
    • Characterization of a solid state reaction product from a lyophilized formulation of a cyclic heptapeptide. A novel example of an excipient-induced oxidation
    • DOI 10.1023/A:1016024923002
    • DC Dubost MJ Kaufman JA Zimmerman MJ Bogusky AB Coddington SM Pitzenberger 1996 Characterization of a solid state reaction product from a lyophilized formulation of a cyclic heptapeptide. A novel example of an excipient-induced oxidation Pharm Res 13 12 1811 4 8987076 1:CAS:528: DyaK2sXkvF2gtw%3D%3D (Pubitemid 27034111)
    • (1996) Pharmaceutical Research , vol.13 , Issue.12 , pp. 1811-1814
    • Dubost, D.C.1    Kaufman, M.J.2    Zimmerman, J.A.3    Bogusky, M.J.4    Coddington, A.B.5    Pitzenberger, S.M.6
  • 7
    • 83555174159 scopus 로고    scopus 로고
    • Determination of formaldehyde and glucose in pharmaceutical excipients by HPLC with pre-column derivatization
    • Poster presentation
    • Huang G, Wu Y, Dali M. Determination of formaldehyde and glucose in pharmaceutical excipients by HPLC with pre-column derivatization. HPLC Conference 2007, San Francisco, CA. Poster presentation.
    • HPLC Conference 2007, San Francisco, CA
    • Huang, G.1    Wu, Y.2    Dali, M.3
  • 9
    • 70350656252 scopus 로고    scopus 로고
    • Understanding drug-excipient compatibility: Oxidation of compound A in a solid dosage form
    • 1:CAS:528:DC%2BD1MXhtFWhu7%2FK
    • Y Wu M Dali A Gupta K Raghavan 2009 Understanding drug-excipient compatibility: oxidation of compound A in a solid dosage form Pharmaceut Dev Tech 14 5 556 64 1:CAS:528:DC%2BD1MXhtFWhu7%2FK
    • (2009) Pharmaceut Dev Tech , vol.14 , Issue.5 , pp. 556-64
    • Wu, Y.1    Dali, M.2    Gupta, A.3    Raghavan, K.4
  • 10
    • 0024308611 scopus 로고
    • The chemistry of the Maillard reaction under physiological conditions: A review
    • 2675037 1:STN:280:DyaL1Mzos12rug%3D%3D
    • FG Njoroge VM Monnier 1989 The chemistry of the Maillard reaction under physiological conditions: a review Prog Clin Biol Res 304 85 107 2675037 1:STN:280:DyaL1Mzos12rug%3D%3D
    • (1989) Prog Clin Biol Res , vol.304 , pp. 85-107
    • Njoroge, F.G.1    Monnier, V.M.2
  • 11
    • 0001500697 scopus 로고
    • The Amadori rearrangement
    • JE Hodge 1966 The Amadori rearrangement Adv Carbohydr Chem 10 169 205
    • (1966) Adv Carbohydr Chem , vol.10 , pp. 169-205
    • Hodge, J.E.1
  • 12
    • 30744436305 scopus 로고    scopus 로고
    • Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography
    • DOI 10.1016/j.chroma.2005.10.084, PII S0021967305024039
    • Z Li LK Jacobus WP Wuelfing M Golden GP Martin RA Reed 2006 Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography J Chromatography A 1104 1 10 1:CAS:528:DC%2BD28XmsVKktA%3D%3D (Pubitemid 43099868)
    • (2006) Journal of Chromatography A , vol.1104 , Issue.1-2 , pp. 1-10
    • Li, Z.1    Jacobus, L.K.2    Wuelfing, W.P.3    Golden, M.4    Martin, G.P.5    Reed, R.A.6
  • 13
    • 33646436971 scopus 로고    scopus 로고
    • Simultaneous determination of formic acid and formaldehyde in pharmaceutical excipients using headspace GC/MS
    • 16464557
    • MA del Barrio J Hu P Zhou N Cauchon 2006 Simultaneous determination of formic acid and formaldehyde in pharmaceutical excipients using headspace GC/MS J Pharm Biomed Anal 41 738 43 16464557
    • (2006) J Pharm Biomed Anal , vol.41 , pp. 738-43
    • Del Barrio, M.A.1    Hu, J.2    Zhou, P.3    Cauchon, N.4
  • 14
    • 0030172535 scopus 로고    scopus 로고
    • Degradation of polyethylene glycol. A study of the reaction mechanism in a model molecule: Tetraethylene glycol
    • DOI 10.1016/0141-3910(95)00225-1
    • J Glastrup 1996 Degradation of polyethylene glycol. A study of the reaction mechanism in a model molecule: tetraethylene glycol Polym Degrad Stab 52 217 22 1:CAS:528:DyaK28XkvFajsLY%3D (Pubitemid 126362946)
    • (1996) Polymer Degradation and Stability , vol.52 , Issue.3 , pp. 217-222
    • Glastrup, J.1
  • 15
    • 0016634518 scopus 로고
    • Autoxidation of polyoxyethylenic nonionic surfactants and polyethylene glycols
    • 234621 1:CAS:528:DyaE2MXhsVCqsr0%3D
    • R Hamburger E Azaz M Donbro 1975 Autoxidation of polyoxyethylenic nonionic surfactants and polyethylene glycols Pharm Acta Helv 50 10 7 234621 1:CAS:528:DyaE2MXhsVCqsr0%3D
    • (1975) Pharm Acta Helv , vol.50 , pp. 10-7
    • Hamburger, R.1    Azaz, E.2    Donbro, M.3
  • 16
    • 43249094781 scopus 로고    scopus 로고
    • N-methylation and N-formylation of a secondary amine drug (Varenicline) in an osmotic tablet
    • 17879378 1:CAS:528:DC%2BD1cXkt1Cgsbs%3D
    • K Waterman WB Arikpo MB Fergione TW Graul BA Johnson BC MacDonald MC Roy RJ Timpano 2008 N-methylation and N-formylation of a secondary amine drug (Varenicline) in an osmotic tablet J Pharm Sci 97 4 1499 507 17879378 1:CAS:528:DC%2BD1cXkt1Cgsbs%3D
    • (2008) J Pharm Sci , vol.97 , Issue.4 , pp. 1499-507
    • Waterman, K.1    Arikpo, W.B.2    Fergione, M.B.3    Graul, T.W.4    Johnson, B.A.5    MacDonald, B.C.6    Roy, M.C.7    Timpano, R.J.8
  • 17
    • 0037563755 scopus 로고    scopus 로고
    • Catalytic oxidative deformylation of polyethylene glycols with the participation of molecular oxygen
    • DOI 10.1023/A:1012371630951
    • AM Sakharov LI Mazaletskaya IP Skibida 2001 Catalytic oxidative deformylation of polyethylene glycols with the participation of molecular oxygen Kinet Catal 42 662 8 1:CAS:528:DC%2BD3MXotFGlu7c%3D (Pubitemid 33617825)
    • (2001) Kinetics and Catalysis , vol.42 , Issue.5 , pp. 662-668
    • Sakharov, A.M.1    Mazaletskaya, L.I.2    Skibida, I.P.3
  • 18
    • 2942703943 scopus 로고    scopus 로고
    • Influence of formaldehyde impurity in polysorbate 80 and PEG-300 on the stability of a parenteral formulation of BMS-204352: Identification and control of the degradation product
    • DOI 10.1081/PDT-120030249
    • MN Nassar VN Nesarikar R Lozano WL Parker Y Huang V Palaniswamy W Xu N Khaselev 2004 Influence of formaldehyde impurity in Polysorbate 80 and PEG 300 on the stability of a parenteral formulation of BMS-204352: identification and control of the degradation product Pharmaceut Dev Tech 9 2 189 95 1:CAS:528:DC%2BD2cXltV2rtrc%3D (Pubitemid 38788646)
    • (2004) Pharmaceutical Development and Technology , vol.9 , Issue.2 , pp. 189-195
    • Nassar, M.N.1    Nesarikar, V.N.2    Lozano, R.3    Parker, W.L.4    Huang, Y.5    Palaniswamy, V.6    Xu, W.7    Khaselev, N.8
  • 19
    • 51949102878 scopus 로고    scopus 로고
    • Identification and control of a degradation product in Avapro film-coated tablet: Low dose formulation
    • 1:CAS:528:DC%2BD1cXhtFaisr3K
    • G Wang J Fiske S Jennings F Tomasella V Palaniswamy K Ray 2008 Identification and control of a degradation product in Avapro film-coated tablet: low dose formulation Pharm Dev Tech 13 393 9 1:CAS:528: DC%2BD1cXhtFaisr3K
    • (2008) Pharm Dev Tech , vol.13 , pp. 393-9
    • Wang, G.1    Fiske, J.2    Jennings, S.3    Tomasella, F.4    Palaniswamy, V.5    Ray, K.6
  • 21
    • 0028070599 scopus 로고
    • Effects of different types of lactose and disintegrant on dissolution stability of hydrochlorothiazide capsule formulations
    • DOI 10.1016/0378-5173(94)90248-8
    • DS Desai BA Rubitski JS Bergum SA Varia 1994 Effects of different types of lactose and disintegrant on dissolution stability of hydrochlorothiazide capsule formulations Int J Pharm 110 257 65 1:CAS:528:DyaK2cXls1ertLk%3D (Pubitemid 24274233)
    • (1994) International Journal of Pharmaceutics , vol.110 , Issue.3 , pp. 257-265
    • Desai, D.S.1    Rubitski, B.A.2    Bergum, J.S.3    Varia, S.A.4
  • 23
    • 0005515208 scopus 로고
    • Preliminary report on the comparative stability of certified colorants with lactose in aqueous solutions
    • 14016098 1:CAS:528:DyaF3sXks1WgsQ%3D%3D
    • CA Brownley Jr L Lachman 1963 Preliminary report on the comparative stability of certified colorants with lactose in aqueous solutions J Pharm Sci 52 1 86 93 14016098 1:CAS:528:DyaF3sXks1WgsQ%3D%3D
    • (1963) J Pharm Sci , vol.52 , Issue.1 , pp. 86-93
    • Brownley Jr., C.A.1    Lachman, L.2
  • 24
    • 0005457488 scopus 로고
    • Browning of spray-processed lactose
    • 14189949 1:CAS:528:DyaF2cXktFSks7g%3D
    • CA Brownley Jr L Lachman 1964 Browning of spray-processed lactose J Pharm Sci 53 4 452 4 14189949 1:CAS:528:DyaF2cXktFSks7g%3D
    • (1964) J Pharm Sci , vol.53 , Issue.4 , pp. 452-4
    • Brownley Jr., C.A.1    Lachman, L.2
  • 25
    • 0013779305 scopus 로고
    • Comparison of reactivity of amphetamine, methamphetamine, and dimethylamphetamine with lactose and related compounds
    • 5842351 1:CAS:528:DyaF2MXktVaksrs%3D
    • RN Duvall KT Koshy JW Pyles 1965 Comparison of reactivity of amphetamine, methamphetamine, and dimethylamphetamine with lactose and related compounds J Pharm Sci 54 4 607 11 5842351 1:CAS:528:DyaF2MXktVaksrs%3D
    • (1965) J Pharm Sci , vol.54 , Issue.4 , pp. 607-11
    • Duvall, R.N.1    Koshy, K.T.2    Pyles, J.W.3
  • 26
    • 0015424814 scopus 로고
    • Interaction of dextroamphetamine sulfate with spray-dried lactose
    • SM Bisug WT Huang 1972 Interaction of dextroamphetamine sulfate with spray-dried lactose J Pharm Sci 61 1770 5
    • (1972) J Pharm Sci , vol.61 , pp. 1770-5
    • Bisug, S.M.1    Huang, W.T.2
  • 27
    • 0015980854 scopus 로고
    • Reaction of Haloperidol with 5-(hydroxymethyl)-2-furfuraldehyde, an impurity in anhydrous lactose
    • 4811283 1:CAS:528:DyaE2cXnsVejsg%3D%3D
    • CA Janicki HR Almond 1974 Reaction of Haloperidol with 5-(hydroxymethyl)-2-furfuraldehyde, an impurity in anhydrous lactose J Pharm Sci 63 41 3 4811283 1:CAS:528:DyaE2cXnsVejsg%3D%3D
    • (1974) J Pharm Sci , vol.63 , pp. 41-3
    • Janicki, C.A.1    Almond, H.R.2
  • 28
    • 0029881476 scopus 로고    scopus 로고
    • Interactions between drug substances and excipients. 1. Fluorescence and HPLC studies of triazolophtalazine derivatives from Hydralazine Hydrochloride and starch
    • 8699338 1:CAS:528:DyaK28XpsFKgtQ%3D%3D
    • T Lessen Z Da-Chuan 1996 Interactions between drug substances and excipients. 1. Fluorescence and HPLC studies of triazolophtalazine derivatives from Hydralazine Hydrochloride and starch J Pharm Sci 85 326 9 8699338 1:CAS:528:DyaK28XpsFKgtQ%3D%3D
    • (1996) J Pharm Sci , vol.85 , pp. 326-9
    • Lessen, T.1    Da-Chuan, Z.2
  • 29
    • 0030901260 scopus 로고    scopus 로고
    • Adsorption of ketotifen onto some pharmaceutical excipients
    • DOI 10.1016/S0378-5173(96)04857-0, PII S0378517396048570
    • SS Al-Nimry SM Assaf MJ Ibrahim NM Najib 1997 Adsorption of Ketotifen onto some pharmaceutical excipients Int J Pharm 149 115 21 1:CAS:528: DyaK2sXjsVGhsLo%3D (Pubitemid 27193424)
    • (1997) International Journal of Pharmaceutics , vol.149 , Issue.1 , pp. 115-121
    • Al-Nimry, S.S.1    Assaf, S.M.2    Jalal, I.M.3    Najib, N.M.4
  • 30
    • 0023611750 scopus 로고
    • Drug excipient interaction. Effect of adsorption of oxytetracycline hydrochloride by some tablet excipients on the physiological availability of the tablets
    • SAS Aly SA Megwa 1987 Drug excipient interaction: effect of adsorption of oxytetracycline hydrochloride by some tablet excipients on the physiological availability of the tablets STP Pharma 3 652 7 1:CAS:528:DyaL1cXhtFyrtLo%3D (Pubitemid 18072536)
    • (1987) Sciences Techniques et Pratiques Pharmaceutiques , vol.3 , Issue.8 , pp. 652-657
    • Aly, S.A.S.1    Megwa, S.A.2
  • 31
    • 0035093096 scopus 로고    scopus 로고
    • Oxidative degradation of pharmaceuticals: Theory, mechanisms and inhibition
    • DOI 10.1002/1520-6017(200103)90:3<253::AID-JPS1>3.0.CO;2-W
    • S Hovorka C Schoneich 2001 Oxidative degradation of pharmaceuticals: theory, mechanisms and inhibition J Pharm Sci 90 253 69 11170019 1:CAS:528:DC%2BD3MXitVKksL0%3D (Pubitemid 32209888)
    • (2001) Journal of Pharmaceutical Sciences , vol.90 , Issue.3 , pp. 253-269
    • Hovorka, S.W.1    Schoandneich, C.2
  • 32
    • 39049159804 scopus 로고    scopus 로고
    • The effect of crosslinker structure upon the rate of hydroperoxide formation in dried, crosslinked poly(vinylpyrrolidone)
    • DOI 10.1002/app.27449
    • MA Tallon EG Malawer NI Machnicki PJ Brush CS Wu JP Cullen 2008 The effect of crosslinker structure upon the rate of hydroperoxide formation in dried, crosslinked poly(vinylpyrrolidone) J Appl Polym Sci 107 2776 85 1:CAS:528:DC%2BD1cXhs1Gjsrw%3D (Pubitemid 351238704)
    • (2008) Journal of Applied Polymer Science , vol.107 , Issue.5 , pp. 2776-2785
    • Tallon, M.A.1    Malawer, E.G.2    Machnicki, N.I.3    Brush, P.J.4    Wu, C.S.5    Cullen, J.P.6
  • 34
    • 0037430827 scopus 로고    scopus 로고
    • Liquid chromatographic determination of residual hydrogen peroxide in pharmaceutical excipients using platinum and wired enzyme electrodes
    • DOI 10.1016/S0731-7085(03)00022-0
    • T Huang ME Garceau P Gao 2003 Liquid chromatographic determination of residual hydrogen peroxide in pharmaceutical excipients using platinum and wired enzyme electrodes J Pharm Biol Anal 31 1203 10 1:CAS:528:DC%2BD3sXit12gtb0%3D (Pubitemid 36349737)
    • (2003) Journal of Pharmaceutical and Biomedical Analysis , vol.31 , Issue.6 , pp. 1203-1210
    • Huang, T.1    Garceau, M.E.2    Gao, P.3
  • 35
    • 0025778781 scopus 로고
    • A simple assay for lipid hydroperoxides based on triphenylphosphine oxidation and high-performance liquid chromatography
    • 1:CAS:528:DyaK3MXmsFWgsrs%3D
    • T Nakamura H Maeda 1991 A simple assay for lipid hydroperoxides based on triphenylphosphine oxidation and high-performance liquid chromatography Lipids 26 765 8 1:CAS:528:DyaK3MXmsFWgsrs%3D
    • (1991) Lipids , vol.26 , pp. 765-8
    • Nakamura, T.1    Maeda, H.2
  • 36
  • 40
    • 33644807361 scopus 로고    scopus 로고
    • Urea- Hydrogen Peroxide (UHP) oxidation of thiols to the corresponding disulfides promoted by maleic anhydride as mediator
    • DOI 10.3390/10101385
    • K Bahador M Montazerozohori MH Habibi 2005 Urea-hydrogen peroxide (UHP) oxidation of thiols to the corresponding disulfides promoted by maleic anhydride as mediator Molecules 10 10 1358 63 (Pubitemid 43349759)
    • (2005) Molecules , vol.10 , Issue.10 , pp. 1358-1363
    • Karami, B.1    Montazerozohori, M.2    Habibi, M.H.3
  • 42
    • 0025095542 scopus 로고
    • Transition metals as catalysts of "autoxidation" reactions
    • 1:CAS:528:DyaK3MXltlSisrk%3D
    • DM Miller GR Buettner SD Aust 1990 Transition metals as catalysts of "autoxidation" reactions Free Radical Biol Med 8 1 95 108 1:CAS:528:DyaK3MXltlSisrk%3D
    • (1990) Free Radical Biol Med , vol.8 , Issue.1 , pp. 95-108
    • Miller, D.M.1    Buettner, G.R.2    Aust, S.D.3
  • 43
  • 44
    • 33947600311 scopus 로고    scopus 로고
    • Genotoxic and carcinogenic risk to humans of drug-nitrite interaction products
    • DOI 10.1016/j.mrrev.2006.09.003, PII S1383574206000937
    • G Brambilla A Martelli 2007 Genotoxic and carcinogenic risk to humans of drug-nitrite interaction products Mutat Res 635 17 52 17157055 1:CAS:528:DC%2BD2sXht1CntA%3D%3D (Pubitemid 46482377)
    • (2007) Mutation Research - Reviews in Mutation Research , vol.635 , Issue.1 , pp. 17-52
    • Brambilla, G.1    Martelli, A.2
  • 45
    • 83555164415 scopus 로고
    • Polyvinylpyrrolidone (PVP), its diagnostic, therapeutic and technical application and consequences thereof
    • W Wessel M Schoog E Winkler 1971 Polyvinylpyrrolidone (PVP), its diagnostic, therapeutic and technical application and consequences thereof Drug Research 10 1469 82
    • (1971) Drug Research , vol.10 , pp. 1469-82
    • Wessel, W.1    Schoog, M.2    Winkler, E.3
  • 46
    • 0023700692 scopus 로고
    • Inhibitors of endogenous nitrosation mechanisms and implications in human cancer prevention
    • 3057363 1:CAS:528:DyaL1MXjsVyntA%3D%3D
    • H Bartsch H Ohshima B Pignatelli 1988 Inhibitors of endogenous nitrosation mechanisms and implications in human cancer prevention Mutat Res 202 307 24 3057363 1:CAS:528:DyaL1MXjsVyntA%3D%3D
    • (1988) Mutat Res , vol.202 , pp. 307-24
    • Bartsch, H.1    Ohshima, H.2    Pignatelli, B.3
  • 47
    • 59449102286 scopus 로고    scopus 로고
    • Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals
    • 18845271 1:CAS:528:DC%2BD1MXhsFOltL4%3D
    • G Brambilla A Martelli 2009 Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals Mutat Res 681 2-3 209 29 18845271 1:CAS:528:DC%2BD1MXhsFOltL4%3D
    • (2009) Mutat Res , vol.681 , Issue.23 , pp. 209-29
    • Brambilla, G.1    Martelli, A.2
  • 49
    • 38849162730 scopus 로고    scopus 로고
    • The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics
    • DOI 10.1038/nrd2466, PII NRD2466
    • JO Lundberg E Weitzberg MT Gladwin 2008 The nitrate nitriteenitric oxide pathway in physiology and therapeutics Nat Rev Drug Discov 7 156 67 18167491 1:CAS:528:DC%2BD1cXhs1Khsrw%3D (Pubitemid 351194063)
    • (2008) Nature Reviews Drug Discovery , vol.7 , Issue.2 , pp. 156-167
    • Lundberg, J.O.1    Weitzberg, E.2    Gladwin, M.T.3
  • 52
    • 0019521719 scopus 로고
    • Drug-disintegrant interactions: Binding of oxymorphone derivatives
    • DOI 10.1002/jps.2600700641
    • YW Chien P Van Nostrand AR Hurwitz EG Shami 1981 Drug-disintegrant interactions: binding of oxymorphone derivatives J Pharm Sci 70 709 10 6166740 1:CAS:528:DyaL3MXks1Oru7s%3D (Pubitemid 11035318)
    • (1981) Journal of Pharmaceutical Sciences , vol.70 , Issue.6 , pp. 709-710
    • Chien, Y.W.1    Van Nostrand, P.2    Hurwitz, A.R.3    Shami, E.G.4
  • 53
    • 5444239252 scopus 로고    scopus 로고
    • Is it the method or the process - Separating the causes of low recovery
    • DOI 10.1081/DDC-200034588
    • W Cory K Field D Wu-Linhares 2004 Is it the method or the process-separating the causes of low recovery Drug Dev Ind Pharm 30 891 9 15521334 1:CAS:528:DC%2BD2cXotVektLs%3D (Pubitemid 39362872)
    • (2004) Drug Development and Industrial Pharmacy , vol.30 , Issue.8 , pp. 891-899
    • Cory, W.1    Field, K.2    Wu-Linhares, D.3
  • 54
    • 0033403992 scopus 로고    scopus 로고
    • Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant
    • BR Rohrs TJ Thamann P Gao DJ Stelzer MS Bergren RS Chao 1999 Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant Pharm Res 16 1850 6 10644073 1:CAS:528:DC%2BD3cXkt1eguw%3D%3D (Pubitemid 30040701)
    • (1999) Pharmaceutical Research , vol.16 , Issue.12 , pp. 1850-1856
    • Rohrs, B.R.1    Thamann, T.J.2    Gao, P.3    Stelzer, D.J.4    Bergren, M.S.5    Chao, R.S.6
  • 55
    • 77954862553 scopus 로고    scopus 로고
    • Reaction between drug substances and pharmaceutical excipients: Formation of esters between cetirizine and polyols
    • 1:CAS:528:DC%2BC3cXptVSqsrY%3D
    • H Yu C Cornett J Larsen JH Hansen 2010 Reaction between drug substances and pharmaceutical excipients: formation of esters between cetirizine and polyols J Pharm and Biomed Anal 53 3 745 50 1:CAS:528:DC%2BC3cXptVSqsrY%3D
    • (2010) J Pharm and Biomed Anal , vol.53 , Issue.3 , pp. 745-50
    • Yu, H.1    Cornett, C.2    Larsen, J.3    Hansen, J.H.4
  • 56
    • 0027942642 scopus 로고
    • Mechanism of optical isomerization of (S)-N-[1-(2-fluorophenyl)-3,4,6,7- tetrahydro-4-oxopyrrolo[3,2,1-jk] [1,4]-benzodiazepine-3-yl]-1H-indole-2- carboxamide (FK480) in soft capsules containing polyethylene glycol 400 and glycerol
    • DOI 10.1023/A:1018998813296
    • S Fukuyama N Kihara K Naksashima N Morokoshi S Koda T Yasuda 1994 Mechanism of optical isomerization of (S)-N-[1-(2-fluorophenyl)-3,4,6,7- tetrahydro-4-oxopyrrolo[3,2,1-jk][1,4]-benzodiazepine-3-yl]-1H-indole-2- carboxamide (FK480) in soft capsules containing polyethylene glycol 400 and glycerol Pharm Res 11 1704 6 7899231 1:CAS:528:DyaK2MXis1Cgtro%3D (Pubitemid 24377078)
    • (1994) Pharmaceutical Research , vol.11 , Issue.12 , pp. 1704-1706
    • Fukuyama, S.1    Kihara, N.2    Nakashima, K.3    Morokoshi, N.4    Koda, S.5    Yasuda, T.6
  • 57
    • 0025943901 scopus 로고
    • Effect of autoxidation of hydrogenated castor oil containing 60 oxyethylene groups on degradation of miconazole
    • 1:CAS:528:DyaK3MXms1egs7w%3D
    • M Nishikawa K Fuji 1991 Effect of autoxidation of hydrogenated castor oil containing 60 oxyethylene groups on degradation of miconazole Chem Pharm Bull 39 2408 11 1:CAS:528:DyaK3MXms1egs7w%3D
    • (1991) Chem Pharm Bull , vol.39 , pp. 2408-11
    • Nishikawa, M.1    Fuji, K.2
  • 58
    • 0013104656 scopus 로고    scopus 로고
    • The effects of residual water on solid-state stability of drugs and drug products, Water Manage
    • Zografi G, Byrn SR. The effects of residual water on solid-state stability of drugs and drug products, Water Manage. Des Distrib Qual Foods. 1999. p. 397-410.
    • (1999) Des Distrib Qual Foods , pp. 397-410
    • Zografi, G.1    Byrn, S.R.2
  • 59
    • 0035979419 scopus 로고    scopus 로고
    • Effect of salt formation on chemical stability of an ester prodrug of a glycoprotein IIb/IIIa receptor antagonist in solid dosage forms
    • 11451634 1:STN:280:DC%2BD3MvgtVGktg%3D%3D
    • SIF Badawy 2001 Effect of salt formation on chemical stability of an ester prodrug of a glycoprotein IIb/IIIa receptor antagonist in solid dosage forms Int J Pharm 223 81 7 11451634 1:STN:280:DC%2BD3MvgtVGktg%3D%3D
    • (2001) Int J Pharm , vol.223 , pp. 81-7
    • Badawy, S.I.F.1
  • 60
    • 0032937684 scopus 로고    scopus 로고
    • Chemical stability of an ester prodrug of a glycoprotein IIb/IIIa receptor antagonist in solid dosage forms
    • DOI 10.1021/js9803297
    • SIF Badawy RC Williams D Gilbert 1999 Chemical stability of an ester prodrug of a IIb/IIIa antagonist in solid dosage forms J Pharm Sci 8 428 33 (Pubitemid 29180767)
    • (1999) Journal of Pharmaceutical Sciences , vol.88 , Issue.4 , pp. 428-433
    • Badawy, S.I.F.1    Williams, R.C.2    Gilbert, D.L.3
  • 63
    • 72149109006 scopus 로고    scopus 로고
    • Quantitative study of solid-state acid-base reactions between polymorphs of flufenamic acid and magnesium oxide using X-ray powder diffraction
    • 19906502 1:CAS:528:DC%2BD1MXhs1WgsbbM
    • X Chen JG Stowell KR Morris SR Byrn 2010 Quantitative study of solid-state acid-base reactions between polymorphs of flufenamic acid and magnesium oxide using X-ray powder diffraction J Pharm Biomed Anal 51 866 74 19906502 1:CAS:528:DC%2BD1MXhs1WgsbbM
    • (2010) J Pharm Biomed Anal , vol.51 , pp. 866-74
    • Chen, X.1    Stowell, J.G.2    Morris, K.R.3    Byrn, S.R.4
  • 64
    • 83555166959 scopus 로고    scopus 로고
    • An active film-coating approach to enhance chemical stability of a potent drug molecule
    • Desai D, Rao VM, Guo H, Li D, Stein D, Hu F, Kiesnowski C. An active film-coating approach to enhance chemical stability of a potent drug molecule. Pharm Dev Tech. 2010;1-9.
    • (2010) Pharm Dev Tech , pp. 1-9
    • Desai, D.1    Rao, V.M.2    Guo, H.3    Li, D.4    Stein, D.5    Hu, F.6    Kiesnowski, C.7
  • 65
    • 0020180618 scopus 로고
    • Antioxidants in pharmaceutical products
    • 1:CAS:528:DyaL2cXptFWrtA%3D%3D
    • M Akers 1982 Antioxidants in pharmaceutical products J Parenteral Sci and Tech 36 5 222 8 1:CAS:528:DyaL2cXptFWrtA%3D%3D
    • (1982) J Parenteral Sci and Tech , vol.36 , Issue.5 , pp. 222-8
    • Akers, M.1
  • 66
    • 0029031191 scopus 로고
    • Photolytic and oxidative degradation of an antiemetic agent, RG 12915
    • 1:CAS:528:DyaK2MXmtVymtb4%3D
    • CM Won SY Tang CL Strohbeck 1995 Photolytic and oxidative degradation of an antiemetic agent, RG 12915 Int J Pharm 121 95 105 1:CAS:528: DyaK2MXmtVymtb4%3D
    • (1995) Int J Pharm , vol.121 , pp. 95-105
    • Won, C.M.1    Tang, S.Y.2    Strohbeck, C.L.3
  • 67
    • 0025352909 scopus 로고
    • Applications of oxygen polarography to drug stability testing and formulation development: Solution-phase oxidation of hydroxymethylglutaryl coenzyme a (HMG-CoA) reductase inhibitors
    • DOI 10.1023/A:1015886415210
    • MJ Kaufman 1990 Applications of oxygen polarography to drug stability testing and formulation development: solution-phase oxidation of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors Pharm Res 7 289 92 2339104 1:CAS:528:DyaK3cXisVSgtLc%3D (Pubitemid 20228572)
    • (1990) Pharmaceutical Research , vol.7 , Issue.3 , pp. 289-292
    • Kaufman, M.J.1
  • 68
    • 0013645071 scopus 로고
    • Inhibition of hydrolysis of esters in solution by formation of complexes I. Stabilization of benzocaine with caffeine
    • T Higuchi L Lachman 1995 Inhibition of hydrolysis of esters in solution by formation of complexes I. Stabilization of benzocaine with caffeine J Ame Pharm Asso 44 521 6
    • (1995) J Ame Pharm Asso , vol.44 , pp. 521-6
    • Higuchi, T.1    Lachman, L.2
  • 69
    • 34248189392 scopus 로고
    • Inhibition of hydrolysis of esters in solution by formation of complexes II. Stabilization of procaine with caffeine
    • 1:CAS:528:DyaG28XlsVWhtA%3D%3D
    • L Lachman LJ Ravin T Higuchi 1956 Inhibition of hydrolysis of esters in solution by formation of complexes II. Stabilization of procaine with caffeine J Am Pharm Assoc 45 290 5 1:CAS:528:DyaG28XlsVWhtA%3D%3D
    • (1956) J Am Pharm Assoc , vol.45 , pp. 290-5
    • Lachman, L.1    Ravin, L.J.2    Higuchi, T.3
  • 70
    • 70449191074 scopus 로고
    • Inhibition of hydrolysis of esters in solution by formation of complexes. I. Stabilization of tetracaine with caffeine
    • 1:CAS:528:DyaG2sXislekug%3D%3D
    • L Lachman T Higuchi 1957 Inhibition of hydrolysis of esters in solution by formation of complexes. I. Stabilization of tetracaine with caffeine J Am Pharm Assoc 46 32 6 1:CAS:528:DyaG2sXislekug%3D%3D
    • (1957) J Am Pharm Assoc , vol.46 , pp. 32-6
    • Lachman, L.1    Higuchi, T.2
  • 71
    • 0003086001 scopus 로고
    • Complex formation influence on reaction rate. I. Effect of caffeine on riboflavin base-catalyzed degradation
    • 1:CAS:528:DyaF3sXjvFeltA%3D%3D
    • DE Guttman 1962 Complex formation influence on reaction rate. I. Effect of caffeine on riboflavin base-catalyzed degradation J Am Pharm Assoc 51 1162 6 1:CAS:528:DyaF3sXjvFeltA%3D%3D
    • (1962) J Am Pharm Assoc , vol.51 , pp. 1162-6
    • Guttman, D.E.1
  • 72
    • 0347598197 scopus 로고    scopus 로고
    • Studies of reactions within molecular complexes: Alkaline hydrolysis of substituted phenyl benzoates in the presence of xanthines
    • N Pirinccioglu A Williams 1998 Studies of reactions within molecular complexes: alkaline hydrolysis of substituted phenyl benzoates in the presence of xanthines J Chem Society, Perkin Transactions 2: Phys Org Chem 1 37 40 (Pubitemid 128434854)
    • (1998) Journal of the Chemical Society. Perkin Transactions 2 , Issue.1 , pp. 37-40
    • Pirinccioglu, N.1    Williams, A.2
  • 73
    • 0023145393 scopus 로고
    • Improvement of chemical instability of prostacyclin in aqueous solution by complexation with methylated cyclodextrins
    • DOI 10.1016/0378-5173(87)90130-X
    • F Hirayama M Kurihara K Uekama 1987 Improvement of chemical instability of prostacyclin in aqueous solution by complexation with methylated cyclodextrins Int J Pharm 35 193 9 1:CAS:528:DyaL2sXhvVamt70%3D (Pubitemid 17018981)
    • (1987) International Journal of Pharmaceutics , vol.35 , Issue.3 , pp. 193-199
    • Hirayama, F.1    Kurihara, M.2    Uekama, K.3
  • 74
    • 0028280544 scopus 로고
    • 2 in solution
    • DOI 10.1016/0378-5173(94)90311-5
    • IJ Oh HM Song M Hyun KC Lee 1994 Effect of 2-hydroxypropyl-beta- cyclodextrin on the stability of prostaglandin E2 in solution Int J Pharm 106 135 40 1:CAS:528:DyaK2cXktFOrtL0%3D (Pubitemid 24136531)
    • (1994) International Journal of Pharmaceutics , vol.106 , Issue.2 , pp. 135-140
    • Oh, J.1    Song, H.M.2    Lee, K.C.3
  • 75
    • 0026583130 scopus 로고
    • 1 by maltosyl-β-cyclodextrin in lyophilized formulation
    • 1:CAS:528:DyaK38Xktlems7Y%3D
    • 1 by maltosyl-β-cyclodextrin in lyophilized formulation Chem Pharm Bulletin 40 747 51 1:CAS:528: DyaK38Xktlems7Y%3D
    • (1992) Chem Pharm Bulletin , vol.40 , pp. 747-51
    • Yamamoto, M.1    Hirayama, F.2    Uekama, K.3
  • 76
    • 0025908311 scopus 로고
    • Effect of cyclodextrin complexation on the chemical stability of doxorubicin and daunorubicin in aqueous solutions
    • 1:CAS:528:DyaK3MXls1Kmsrs%3D
    • O Bekers JH Beijnen BJ Vis A Suenaga M Otagiri A Bult WJM Underberg 1991 Effect of cyclodextrin complexation on the chemical stability of doxorubicin and daunorubicin in aqueous solutions Int J Pharm 72 123 30 1:CAS:528: DyaK3MXls1Kmsrs%3D
    • (1991) Int J Pharm , vol.72 , pp. 123-30
    • Bekers, O.1    Beijnen, J.H.2    Vis, B.J.3    Suenaga, A.4    Otagiri, M.5    Bult, A.6    Underberg, W.J.M.7
  • 77
    • 0025974255 scopus 로고
    • Effects of cyclodextrins on N-trifluoroacetyldoxorubicin-14-valerate (AD-32) stability and solubility in aqueous media
    • 1:CAS:528:DyaK3MXht1yqt7g%3D
    • O Bekers JH Beijnen YAG Kempers A Bult WJM Underberg 1991 Effects of cyclodextrins on N-trifluoroacetyldoxorubicin-14-valerate (AD-32) stability and solubility in aqueous media Int J Pharm 68 271 6 1:CAS:528:DyaK3MXht1yqt7g%3D
    • (1991) Int J Pharm , vol.68 , pp. 271-6
    • Bekers, O.1    Beijnen, J.H.2    Kempers, Y.A.G.3    Bult, A.4    Underberg, W.J.M.5
  • 78
    • 0025024417 scopus 로고
    • Drug-excipient incompatibility studies of the dipeptide angiotensin-converting enzyme inhibitor, moexipril hydrochloride: Dry powder vs wet granulation
    • DOI 10.1023/A:1015871406549
    • L Gu RG Strickley LH Chi ZT Chowhan 1990 Drug-excipient incompatibility studies of the dipeptide angiotensin-converting enzyme inhibitor, moexipril hydrochloride: dry powder vs wet granulation Pharm Res 7 379 83 2362911 1:CAS:528:DyaK3cXksVKitbY%3D (Pubitemid 20266593)
    • (1990) Pharmaceutical Research , vol.7 , Issue.4 , pp. 379-383
    • Gu, L.1    Strickley, R.G.2    Chi, L.-H.3    Chowhan, Z.T.4
  • 79
    • 0016426449 scopus 로고
    • Wet granulation of acetylsalicylic acid. Effect of pH and stabilization agents
    • 1:CAS:528:DyaE2MXltlKku7s%3D
    • H Delonca J Joachim G Joachim A Cantos 1975 Wet granulation of acetylsalicylic acid. Effect of pH and stabilization agents Farmaco Ed Prat 30 89 97 1:CAS:528:DyaE2MXltlKku7s%3D
    • (1975) Farmaco Ed Prat , vol.30 , pp. 89-97
    • Delonca, H.1    Joachim, J.2    Joachim, G.3    Cantos, A.4
  • 82
    • 54949085448 scopus 로고    scopus 로고
    • Mechanoradical-induced degradation in a pharmaceutical blend during high-shear processing
    • 1:CAS:528:DC%2BD1cXht1ymsrbP
    • MA Polizzi D Singhal J Colvin 2008 Mechanoradical-induced degradation in a pharmaceutical blend during high-shear processing Pharm Dev Tech 13 457 62 1:CAS:528:DC%2BD1cXht1ymsrbP
    • (2008) Pharm Dev Tech , vol.13 , pp. 457-62
    • Polizzi, M.A.1    Singhal, D.2    Colvin, J.3
  • 84
    • 0035979420 scopus 로고    scopus 로고
    • Application of sorption-desorption moisture transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations
    • DOI 10.1016/S0378-5173(01)00693-7, PII S0378517301006937
    • SI Badawy AJ Gawronski FJ Alvarez 2001 Application of sorption-desorption moisture transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations Int J Pharm 223 1 13 11451627 1:CAS:528:DC%2BD3MXkvFygu7s%3D (Pubitemid 32640873)
    • (2001) International Journal of Pharmaceutics , vol.223 , Issue.1-2 , pp. 1-13
    • Badawy, S.I.F.1    Gawronski, A.J.2    Alvarez, F.J.3
  • 85
    • 0037436995 scopus 로고    scopus 로고
    • A new model for predicting moisture uptake by packaged solid pharmaceuticals
    • DOI 10.1016/S0378-5173(03)00089-9
    • Y Chen Y Li 2003 A new model for predicting moisture uptake by packaged solid pharmaceuticals Int J Pharm 255 217 25 12672617 1:CAS:528: DC%2BD3sXisVGksLc%3D (Pubitemid 36369605)
    • (2003) International Journal of Pharmaceutics , vol.255 , Issue.1-2 , pp. 217-225
    • Chen, Y.1    Li, Y.2
  • 86
    • 0036266749 scopus 로고    scopus 로고
    • Use of oxygen scavengers to stabilize solid pharmaceutical dosage forms: A case study
    • DOI 10.1081/PDT-120003490
    • KC Waterman MC Roy 2002 Use of oxygen scavengers to stabilize solid pharmaceutical dosage forms: a case study Pharm Dev Tech 7 2 227 34 1:CAS:528:DC%2BD38XksVGhu7o%3D (Pubitemid 34595003)
    • (2002) Pharmaceutical Development and Technology , vol.7 , Issue.2 , pp. 227-234
    • Waterman, K.C.1    Roy, M.C.2
  • 91
    • 33746904780 scopus 로고    scopus 로고
    • Removal of peroxides in polyethylene glycols by vacuum drying: Implications in the stability of biotech and pharmaceutical formulations
    • 17025243
    • V Kumar S Kalonia, et al. 2006 Removal of peroxides in polyethylene glycols by vacuum drying: implications in the stability of biotech and pharmaceutical formulations AAPS PharmSciTech 7 62 17025243
    • (2006) AAPS PharmSciTech , vol.7 , pp. 62
    • Kumar, V.1    Kalonia, S.2
  • 93
    • 84957015566 scopus 로고    scopus 로고
    • Control excipient reactivity. with packaging and aluminum lakes
    • PharmaTechnologist.com
    • Taylor N. Control excipient reactivity with packaging and aluminum lakes, in: product news, ingredients, excipients, and raw materials. PharmaTechnologist.com; 2010.
    • (2010) Product News, Ingredients, Excipients, and Raw Materials
    • Taylor, N.1
  • 94
    • 53849145301 scopus 로고    scopus 로고
    • Lactose contaminant as steroid degradation enhancer
    • 18670867 1:CAS:528:DC%2BD1cXht1aisb3E
    • F Nieuwmeyer K van der Voort Maarschalk H Vromans 2008 Lactose contaminant as steroid degradation enhancer Pharm Res 25 11 2666 72 18670867 1:CAS:528:DC%2BD1cXht1aisb3E
    • (2008) Pharm Res , vol.25 , Issue.11 , pp. 2666-72
    • Nieuwmeyer, F.1    Van Der Voort Maarschalk, K.2    Vromans, H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.