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Volumn 27, Issue 9, 2010, Pages 1869-1883

Characterisation and prediction of phase separation in hot-melt extruded solid dispersions: A thermal, microscopic and NMR relaxometry study

Author keywords

heat capacity; hot melt extrusion; miscibility; phase separation; supersaturation

Indexed keywords

EUDRAGIT; FELODIPINE;

EID: 77955471047     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-010-0185-8     Document Type: Article
Times cited : (72)

References (36)
  • 2
    • 0034601240 scopus 로고    scopus 로고
    • Improving drug solubility for oral delivery using solid dispersions
    • DOI 10.1016/S0939-6411(00)00076-X, PII S093964110000076X
    • C Leuner J Dressman 2000 Improving drug solubility for oral delivery using solid dispersions Eur J Pharm Biopharm 50 1 47 60 10.1016/S0939-6411(00) 00076-X 1:CAS:528:DC%2BD3cXjslyju7c%3D 10840192 (Pubitemid 30326688)
    • (2000) European Journal of Pharmaceutics and Biopharmaceutics , vol.50 , Issue.1 , pp. 47-60
    • Leuner, C.1    Dressman, J.2
  • 3
    • 1842865536 scopus 로고    scopus 로고
    • Melt extrusion: from process to drug delivery technology
    • DOI 10.1016/S0939-6411(02)00061-9, PII S0939641102000619
    • J Breitenbach 2002 Melt extrusion: from process to drug delivery technology Eur J Pharm Biopharm 54 2 107 17 10.1016/S0939-6411(02)00061-9 1:CAS:528:DC%2BD38XmtlKjtrg%3D 12191680 (Pubitemid 34919382)
    • (2002) European Journal of Pharmaceutics and Biopharmaceutics , vol.54 , Issue.2 , pp. 107-117
    • Breitenbach, J.1
  • 4
    • 0035845751 scopus 로고    scopus 로고
    • Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis
    • DOI 10.1016/S0378-5173(01)00801-8, PII S0378517301008018
    • A Forster J Hempenstall I Tucker T Rades 2001 Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis Int J Pharm 226 1-2 147 61 10.1016/S0378- 5173(01)00801-8 1:CAS:528:DC%2BD3MXmsV2jsbY%3D 11532578 (Pubitemid 32800790)
    • (2001) International Journal of Pharmaceutics , vol.226 , Issue.1-2 , pp. 147-161
    • Forster, A.1    Hempenstall, J.2    Tucker, I.3    Rades, T.4
  • 5
    • 64649088045 scopus 로고    scopus 로고
    • Application of melt extrusion in the development of a physically and chemically stable high-energy amorphous solid dispersion of a poorly water-soluble drug
    • 10.1021/mp8001073
    • JP Lalkshman Y Cao J Kowalski ATM Serajuddin 2008 Application of melt extrusion in the development of a physically and chemically stable high-energy amorphous solid dispersion of a poorly water-soluble drug Mol Pharm 5 6 994 1002 10.1021/mp8001073
    • (2008) Mol Pharm , vol.5 , Issue.6 , pp. 994-1002
    • Lalkshman, J.P.1    Cao, Y.2    Kowalski, J.3    Serajuddin, A.T.M.4
  • 6
    • 64649094850 scopus 로고    scopus 로고
    • Enhanced bioavailability of a poorly soluble VR1 antagonist using an amorphous solid dispersion approach: A case study
    • 10.1021/mp800061r 1:CAS:528:DC%2BD1cXhtlGqsL3E 19434920
    • M Kennedy J Hu P Gao L Li A Ali-Reynolds B Chal, et al. 2008 Enhanced bioavailability of a poorly soluble VR1 antagonist using an amorphous solid dispersion approach: a case study Mol Pharm 5 6 981 93 10.1021/mp800061r 1:CAS:528:DC%2BD1cXhtlGqsL3E 19434920
    • (2008) Mol Pharm , vol.5 , Issue.6 , pp. 981-93
    • Kennedy, M.1    Hu, J.2    Gao, P.3    Li, L.4    Ali-Reynolds, A.5    Chal, B.6
  • 7
    • 59649083142 scopus 로고    scopus 로고
    • Mechanism of drug release from polymethacrylate-based extrudates and milled strands prepared by hot-melt extrusion
    • 10.1016/j.ejpb.2008.10.002 1:CAS:528:DC%2BD1MXitVShtrY%3D 18951978
    • J Albers R Alles K Matthée K Knop JS Nahrup P Kleinebudde 2009 Mechanism of drug release from polymethacrylate-based extrudates and milled strands prepared by hot-melt extrusion Eur J Pharm Biopharm 71 2 387 94 10.1016/j.ejpb.2008.10.002 1:CAS:528:DC%2BD1MXitVShtrY%3D 18951978
    • (2009) Eur J Pharm Biopharm , vol.71 , Issue.2 , pp. 387-94
    • Albers, J.1    Alles, R.2    Matthée, K.3    Knop, K.4    Nahrup, J.S.5    Kleinebudde, P.6
  • 8
    • 0342804284 scopus 로고    scopus 로고
    • Melt extrusion - An alternative method for enhancing the dissolution rate of 17β-estradiol hemihydrate
    • DOI 10.1016/S0939-6411(00)00077-1, PII S0939641100000771
    • S Hülsmann T Backensfeld S Keitel R Bodmeier 2000 Melt extrusion-an alternative method for enhancing the dissolution rate of 17β-estradiol hemihydrate Eur J Pharm Biopharm 49 3 237 42 10.1016/S0939-6411(00)00077-1 10799815 (Pubitemid 30229872)
    • (2000) European Journal of Pharmaceutics and Biopharmaceutics , vol.49 , Issue.3 , pp. 237-242
    • Hulsmann, S.1    Backensfeld, T.2    Keitel, S.3    Bodmeier, R.4
  • 9
    • 21644462238 scopus 로고    scopus 로고
    • A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions, part II: Molecular mobility and activation thermodynamic parameters
    • DOI 10.1023/B:PHAM.0000048194.54538.ca
    • RA Shmeis ZR Wang SL Krill 2004 A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions, part II: molecular mobility and activation thermodynamic parameters Pharm Res 21 11 2031 9 10.1023/B:PHAM.0000048194.54538.ca 1:CAS:528:DC%2BD2cXpvVertbc%3D 15587925 (Pubitemid 40941223)
    • (2004) Pharmaceutical Research , vol.21 , Issue.11 , pp. 2031-2039
    • Shmeis, R.A.1    Wang, Z.2    Krill, S.L.3
  • 10
    • 0346494421 scopus 로고    scopus 로고
    • Increased Physical Stability and Improved Dissolution Properties of Itraconazole, a Class II Drug, by Solid Dispersions that Combine Fast- and Slow-Dissolving Polymers
    • DOI 10.1002/jps.10522
    • K Six G Verreck J Peeters M Brewster G Van den Mooter 2004 Increased physical stability and improved dissolution properties of itraconazole, a class II drug, by solid dispersions that combine fast- and slow-dissolving polymers J Pharm Sci 93 1 124 31 10.1002/jps.10522 1:CAS:528:DC%2BD2cXjvFWnsg%3D%3D 14648642 (Pubitemid 38081820)
    • (2004) Journal of Pharmaceutical Sciences , vol.93 , Issue.1 , pp. 124-131
    • Six, K.1    Verreck, G.2    Peeters, J.3    Brewster, M.4    Van Den Mooter, G.5
  • 11
    • 0034886795 scopus 로고    scopus 로고
    • Physicochemical considerations in the preparation of amorphous ritonavir-poly(ethylene glycol) 8000 solid dispersions
    • DOI 10.1002/jps.1054
    • D Law SL Krill EA Schmitt JJ Fort YH Qiu WL Wang, et al. 2001 Physicochemical considerations in the preparation of amorphous ritonavir-poly(ethylene glycol) 8000 solid dispersions J Pharm Sci 90 8 1015 25 10.1002/jps.1054 1:CAS:528:DC%2BD3MXmtFKlu7w%3D 11536205 (Pubitemid 32776982)
    • (2001) Journal of Pharmaceutical Sciences , vol.90 , Issue.8 , pp. 1015-1025
    • Funasaki, N.1    Okuda, T.2    Neya, S.3
  • 12
    • 33746889126 scopus 로고    scopus 로고
    • Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: Stability testing of selected solid dispersions
    • DOI 10.1007/s11095-006-9034-1
    • AN Ghebremeskel C Vemavarapu M Lodaya 2006 Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: stability testing of selected solid dispersions Pharm Res 23 8 1928 36 10.1007/s11095-006-9034-1 1:CAS:528:DC%2BD28XnvVymtrk%3D 16871443 (Pubitemid 44200557)
    • (2006) Pharmaceutical Research , vol.23 , Issue.8 , pp. 1928-1936
    • Ghebremeskel, A.N.1    Vemavarapu, C.2    Lodaya, M.3
  • 13
    • 38349182320 scopus 로고    scopus 로고
    • Drug-polymer interaction and its significance on the physical stability of nifedipine amorphous dispersion in microparticles of an ammonio methacrylate copolymer and ethylcellulose binary blend
    • 10.1002/jps.21072 1:CAS:528:DC%2BD1cXkslyjsA%3D%3D 17724668
    • JJ Huang RJ Wigent JB Schwartz 2008 Drug-polymer interaction and its significance on the physical stability of nifedipine amorphous dispersion in microparticles of an ammonio methacrylate copolymer and ethylcellulose binary blend J Pharm Sci 97 1 251 62 10.1002/jps.21072 1:CAS:528:DC%2BD1cXkslyjsA%3D%3D 17724668
    • (2008) J Pharm Sci , vol.97 , Issue.1 , pp. 251-62
    • Huang, J.J.1    Wigent, R.J.2    Schwartz, J.B.3
  • 14
    • 0034826034 scopus 로고    scopus 로고
    • Influence of processing parameters on the degradation of poly(L-lactide) during extrusion
    • DOI 10.1002/1097-4628(20010321)79:12<2128::AID-APP1020>3.0.CO;2-#
    • V Taubner R Shishoo 2001 Influence of processing parameters on the degradation of poly(L-lactide) during extrusion J Appl Polym Sci 79 128 2135 10.1002/1097-4628(20010321)79:12<2128::AID-APP1020>3.0.CO;2-# (Pubitemid 32873004)
    • (2001) Journal of Applied Polymer Science , vol.79 , Issue.12 , pp. 2128-2135
    • Taubner, V.1    Shishoo, R.2
  • 15
    • 0035940345 scopus 로고    scopus 로고
    • Influence of hot-melt extrusion and compression molding on polymer structure organization, investigated by differential scanning calorimetry
    • DOI 10.1002/app.1764
    • AG Sarraf H Tissot P Tissot D Alfonso R Gurny E Doelker 2001 Influence of hot-melt extrusion and compression molding on polymer structure organization. Investigated by Differential Scanning Calorimetry J Appl Polym Sci 81 3124 32 10.1002/app.1764 1:CAS:528:DC%2BD3MXltlejtbo%3D (Pubitemid 32732531)
    • (2001) Journal of Applied Polymer Science , vol.81 , Issue.13 , pp. 3124-3132
    • Sarraf, A.G.1    Tissot, H.2    Tissot, P.3    Alfonso, D.4    Gurny, R.5    Doelker, E.6
  • 16
    • 41549168295 scopus 로고    scopus 로고
    • The manufacture and characterisation of hot-melt extruded enteric tablets
    • 10.1016/j.ejpb.2007.11.001 1:CAS:528:DC%2BD1cXktlGltbw%3D 18164604
    • GP Andrews DS Jones OA Diak CP McCoy AB Watts JW McGinity 2008 The manufacture and characterisation of hot-melt extruded enteric tablets Eur J Pharm Biopharm 69 264 73 10.1016/j.ejpb.2007.11.001 1:CAS:528: DC%2BD1cXktlGltbw%3D 18164604
    • (2008) Eur J Pharm Biopharm , vol.69 , pp. 264-73
    • Andrews, G.P.1    Jones, D.S.2    Diak, O.A.3    McCoy, C.P.4    Watts, A.B.5    McGinity, J.W.6
  • 17
    • 28044442973 scopus 로고    scopus 로고
    • Physicochemical studies on solid dispersions of poorly water-soluble drugs: Evaluation of capabilities and limitations of thermal analysis techniques
    • DOI 10.1016/j.tca.2005.09.011, PII S0040603105004934
    • D Bikiaris GZ Papageorgiou A Stergiou E Pavlidou E Karavas F Kanaze, et al. 2005 Physicochemical studies on solid dispersions of poorly water-soluble drugs: evaluation of capabilities and limitations of thermal analysis techniques Thermochim Acta 439 58 67 10.1016/j.tca.2005.09.011 1:CAS:528: DC%2BD2MXht1GlsrfM (Pubitemid 41688353)
    • (2005) Thermochimica Acta , vol.439 , Issue.1-2 , pp. 58-67
    • Bikiaris, D.1    Papageorgiou, G.Z.2    Stergiou, A.3    Pavlidou, E.4    Karavas, E.5    Kanaze, F.6    Georgarakis, M.7
  • 18
    • 40849119736 scopus 로고    scopus 로고
    • Characterisation of solid dispersions of paracetamol and EUDRAGIT® e prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis
    • 10.1016/j.ijpharm.2007.11.048 1:CAS:528:DC%2BD1cXjsFOqt78%3D 18242020
    • S Qi A Gryczke P Belton DQM Craig 2008 Characterisation of solid dispersions of paracetamol and EUDRAGIT® E prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis Int J Pharm 354 1-2 158 67 10.1016/j.ijpharm.2007.11.048 1:CAS:528:DC%2BD1cXjsFOqt78%3D 18242020
    • (2008) Int J Pharm , vol.354 , Issue.12 , pp. 158-67
    • Qi, S.1    Gryczke, A.2    Belton, P.3    Craig, D.Q.M.4
  • 21
    • 0001533698 scopus 로고
    • The effects of diffusive exchange in heterogeneous systems on N.M.R. line shapes and relaxation processes
    • 10.1080/00268978700101611 1:CAS:528:DyaL1cXivVKl
    • PS Belton BP Hills 1987 The effects of diffusive exchange in heterogeneous systems on N.M.R. line shapes and relaxation processes Mol Phys 61 999 1018 10.1080/00268978700101611 1:CAS:528:DyaL1cXivVKl
    • (1987) Mol Phys , vol.61 , pp. 999-1018
    • Belton, P.S.1    Hills, B.P.2
  • 22
    • 3643117787 scopus 로고
    • Melting-point depression and kinetic effects of cooling on crystallisation in poly (vinylidene fluoride) poly (methyl methacrylate) mixtures
    • 10.1021/ma60048a040 1:CAS:528:DyaE2MXmtVKktrk%3D
    • T Nishi TT Wang 1975 Melting-point depression and kinetic effects of cooling on crystallisation in poly (vinylidene fluoride) poly (methyl methacrylate) mixtures Macromolecules 8 909 15 10.1021/ma60048a040 1:CAS:528:DyaE2MXmtVKktrk%3D
    • (1975) Macromolecules , vol.8 , pp. 909-15
    • Nishi, T.1    Wang, T.T.2
  • 23
    • 14644407432 scopus 로고    scopus 로고
    • Miscibility and specific interactions in blends of poly(L-lactide) with poly(vinylphenol)
    • DOI 10.1021/ma047818f
    • E Meaurio E Zuza JR Sarasua 2005 Miscibility and specific interactions in blends of poly (L-lactide) with poly(vinylphenol) Macromolecules 38 1207 15 10.1021/ma047818f 1:CAS:528:DC%2BD2MXntFGjtw%3D%3D (Pubitemid 40308179)
    • (2005) Macromolecules , vol.38 , Issue.4 , pp. 1207-1215
    • Meaurio, E.1    Zuza, E.2    Sarasua, J.-R.3
  • 24
    • 33749442356 scopus 로고    scopus 로고
    • Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility
    • DOI 10.1007/s11095-006-9063-9
    • PJ Marsac SL Shamblin LS Taylor 2006 Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility Pharm Res 23 10 2417 26 10.1007/s11095-006-9063-9 1:CAS:528:DC%2BD28XhtVeqsbvK 16933098 (Pubitemid 44511522)
    • (2006) Pharmaceutical Research , vol.23 , Issue.10 , pp. 2417-2426
    • Marsac, P.J.1    Shamblin, S.L.2    Taylor, L.S.3
  • 25
    • 0015949763 scopus 로고
    • Quantitative analytical method for determination of drugs dispersed in polymers using differential scanning calorimetry
    • 10.1002/jps.2600630325 1:CAS:528:DyaE2cXhtlOhs7Y%3D 4820377
    • F Theeuwes A Hussain T Higuchi 1974 Quantitative analytical method for determination of drugs dispersed in polymers using differential scanning calorimetry J Pharm Sci 63 3 427 9 10.1002/jps.2600630325 1:CAS:528: DyaE2cXhtlOhs7Y%3D 4820377
    • (1974) J Pharm Sci , vol.63 , Issue.3 , pp. 427-9
    • Theeuwes, F.1    Hussain, A.2    Higuchi, T.3
  • 26
    • 23944515791 scopus 로고    scopus 로고
    • High speed DSC (hyper-DSC) as a tool to measure the solubility of a drug within a solid or semi-solid matrix
    • DOI 10.1016/j.ijpharm.2005.04.038, PII S0378517305002954
    • D Gramaglia BR Conway VL Kett RK Malcolm HK Batchelor 2005 High speed DSC (hyper-DSC) as a tool to measure the solubility of a drug within a solid or semi-solid matrix Int J Pharm 301 1 5 10.1016/j.ijpharm.2005.04.038 1:CAS:528:DC%2BD2MXptVWhsb8%3D 16061335 (Pubitemid 41206584)
    • (2005) International Journal of Pharmaceutics , vol.301 , Issue.1-2 , pp. 1-5
    • Gramaglia, D.1    Conway, B.R.2    Kett, V.L.3    Malcolm, R.K.4    Batchelor, H.K.5
  • 27
    • 0025994822 scopus 로고
    • Characterisation of polyethylene glycol solid dispersions using differential scanning calorimetry and solution calorimetry
    • 10.1016/0378-5173(91)90339-P 1:CAS:528:DyaK3MXmvVOjtr0%3D
    • DQM Craig JM Newton 1991 Characterisation of polyethylene glycol solid dispersions using differential scanning calorimetry and solution calorimetry Int J Pharm 76 17 24 10.1016/0378-5173(91)90339-P 1:CAS:528:DyaK3MXmvVOjtr0%3D
    • (1991) Int J Pharm , vol.76 , pp. 17-24
    • Craig, D.Q.M.1    Newton, J.M.2
  • 28
    • 77955469357 scopus 로고    scopus 로고
    • Modulated temperature differential scanning calorimetry
    • D.Q.M. Craig M. Reading (eds). CRC London
    • Reading M, Craig DQM, Murphy JR, Kett VL. Modulated temperature differential scanning calorimetry. In: Craig DQM, Reading M, editors. Thermal analysis of pharmaceuticals. London: CRC; 2007. p. 103-29.
    • (2007) Thermal Analysis of Pharmaceuticals , pp. 103-29
    • Reading, M.1    Craig, D.Q.M.2    Murphy, J.R.3    Kett, V.L.4
  • 29
    • 0026595350 scopus 로고
    • Investigation of felodipine polymorphism and its glassy state
    • 10.1016/0378-5173(92)90221-M
    • S Srčič J Kerč U Urleb I Zupančič G Lahajnar B Kofler, et al. 1992 Investigation of felodipine polymorphism and its glassy state Int J Pharm 87 1 10 10.1016/0378-5173(92)90221-M
    • (1992) Int J Pharm , vol.87 , pp. 1-10
    • Srčič, S.1    Kerč, J.2    Urleb, U.3    Zupančič, I.4    Lahajnar, G.5    Kofler, B.6
  • 30
    • 65249119294 scopus 로고    scopus 로고
    • Polymorph control of Felodipine form II in an attempted cocrystallization
    • 10.1021/cg8009749
    • MM Parmar O Khan L Seton JL Ford 2009 Polymorph control of Felodipine form II in an attempted cocrystallization Cryst Growth Des 9 3 1254 7 10.1021/cg8009749
    • (2009) Cryst Growth des , vol.9 , Issue.3 , pp. 1254-7
    • Parmar, M.M.1    Khan, O.2    Seton, L.3    Ford, J.L.4
  • 31
    • 0034942279 scopus 로고    scopus 로고
    • Polymorphism of racemic felodipine and the unusual series of solid solutions in the binary system of its enantiomers
    • DOI 10.1002/jps.1046
    • JM Rollinger A Burger 2001 Polymorphism of racemic felodipine and the unusual series of solid solutions in the binary system of its enantiomers J Pharm Sci 90 949 59 10.1002/jps.1046 1:CAS:528:DC%2BD3MXlt1Gjsro%3D 11458342 (Pubitemid 32645951)
    • (2001) Journal of Pharmaceutical Sciences , vol.90 , Issue.7 , pp. 949-959
    • Rollinger, J.M.1    Burger, A.2
  • 32
    • 0026090094 scopus 로고
    • Some physico-chemical properties of glassy felodipine
    • 10.1016/0378-5173(91)90123-6
    • J Kerč S Srčič M Mohar J Smid-Korbar 1991 Some physico-chemical properties of glassy felodipine Int J Pharm 68 25 33 10.1016/0378-5173(91)90123-6
    • (1991) Int J Pharm , vol.68 , pp. 25-33
    • Kerč, J.1    Srčič, S.2    Mohar, M.3    Smid-Korbar, J.4
  • 34
    • 0542374226 scopus 로고    scopus 로고
    • Low temperature thermal properties of amorphous materials
    • 10.1351/pac199870030599 1:CAS:528:DyaK1cXksV2gsL4%3D
    • T Matsuo 1998 Low temperature thermal properties of amorphous materials Pure Appl Chem 70 3 599 602 10.1351/pac199870030599 1:CAS:528:DyaK1cXksV2gsL4%3D
    • (1998) Pure Appl Chem , vol.70 , Issue.3 , pp. 599-602
    • Matsuo, T.1
  • 35
    • 2342645520 scopus 로고    scopus 로고
    • Heat capacity study of isotactic polystyrene: Dual reversible crystal melting and relaxation of rigid amorphous fraction
    • 10.1021/ma035961n 1:CAS:528:DC%2BD2cXitlKksbk%3D
    • H Xu P Cebe 2004 Heat capacity study of isotactic polystyrene: dual reversible crystal melting and relaxation of rigid amorphous fraction Macromolecules 37 8 2797 806 10.1021/ma035961n 1:CAS:528:DC%2BD2cXitlKksbk%3D
    • (2004) Macromolecules , vol.37 , Issue.8 , pp. 2797-806
    • Xu, H.1    Cebe, P.2


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