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Volumn 48, Issue 3, 2013, Pages 371-384

Hot melt extrusion (HME) for amorphous solid dispersions: Predictive tools for processing and impact of drug-polymer interactions on supersaturation

Author keywords

Amorphous; Hot melt extrusion; Interaction; Rheology; Solid dispersion; Supersaturation

Indexed keywords

EUDRAGIT; GRISEOFULVIN; HYDROXYPROPYLMETHYLCELLULOSE; INDOMETACIN; ITRACONAZOLE; POVIDONE; ACRYLIC ACID RESIN; ANTIFUNGAL AGENT; EUDRAGIT E PO; EUDRAGIT L100-55; EXCIPIENT; METHYLCELLULOSE; NONSTEROID ANTIINFLAMMATORY AGENT; POLYMETHACRYLIC ACID DERIVATIVE;

EID: 84872130842     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2012.12.012     Document Type: Article
Times cited : (218)

References (47)
  • 1
    • 26444591540 scopus 로고    scopus 로고
    • Inverse gas chromatographic determination of solubility parameters of excipients
    • Adamska, K., Voelkel, A., 2005. Inverse gas chromatographic determination of solubility parameters of excipients. Int. J. Pharm. 304, 11-17.
    • (2005) Int. J. Pharm. , vol.304 , pp. 11-17
    • Adamska, K.1    Voelkel, A.2
  • 2
    • 79958812380 scopus 로고    scopus 로고
    • Dissolution and precipitation behavior of amorphous solid dispersions
    • Alonzo, D.E., Gao, Y., Zhou, D., Mo, H., Zhang, G.G., Taylor, L.S., 2011. Dissolution and precipitation behavior of amorphous solid dispersions. J. Pharm. Sci. 100, 3316-3331.
    • (2011) J. Pharm. Sci. , vol.100 , pp. 3316-3331
    • Alonzo, D.E.1    Gao, Y.2    Zhou, D.3    Mo, H.4    Zhang, G.G.5    Taylor, L.S.6
  • 3
    • 77953171784 scopus 로고    scopus 로고
    • Understanding the behavior of amorphous pharmaceutical systems during dissolution
    • Alonzo, D.E., Zhang, G.G., Zhou, D., Gao, Y., Taylor, L.S., 2010. Understanding the behavior of amorphous pharmaceutical systems during dissolution. Pharm. Res. 27, 608-618.
    • (2010) Pharm. Res. , vol.27 , pp. 608-618
    • Alonzo, D.E.1    Zhang, G.G.2    Zhou, D.3    Gao, Y.4    Taylor, L.S.5
  • 4
    • 34547651036 scopus 로고    scopus 로고
    • Current perspectives in dissolution testing of conventional and novel dosage forms
    • Azarmi, S., Roa, W., Lobenberg, R., 2007. Current perspectives in dissolution testing of conventional and novel dosage forms. Int. J. Pharm. 328, 12-21.
    • (2007) Int. J. Pharm. , vol.328 , pp. 12-21
    • Azarmi, S.1    Roa, W.2    Lobenberg, R.3
  • 5
    • 0004229154 scopus 로고    scopus 로고
    • Cambrianprinters, University Of Wales, Aberystwyth
    • Barnes, H.A., 2001. A Handbook of Elementary Rheology. Cambrianprinters, University Of Wales, Aberystwyth, pp. 55-61.
    • (2001) A Handbook of Elementary Rheology. , pp. 55-61
    • Barnes, H.A.1
  • 6
    • 68249128120 scopus 로고    scopus 로고
    • Supersaturating drug delivery systems: The answer to solubility-limited oral bioavailability?
    • Brouwers, J., Brewster, M.E., Augustijns, P., 2009. Supersaturating drug delivery systems: The answer to solubility-limited oral bioavailability? J. Pharm. Sci. 98, 2549-2572.
    • (2009) J. Pharm. Sci. , vol.98 , pp. 2549-2572
    • Brouwers, J.1    Brewster, M.E.2    Augustijns, P.3
  • 7
    • 9644279429 scopus 로고    scopus 로고
    • Properties of hot-melt extruded tablet formulations for the colonic delivery of 5-aminosalicylic acid
    • Bruce, L.D., Shah, N.H., Malick, A.W., Infeld, M.H., McGinity, J.W., 2005. Properties of hot-melt extruded tablet formulations for the colonic delivery of 5-aminosalicylic acid. Eur. J. Pharm. Biopharm. 59, 85-97.
    • (2005) Eur. J. Pharm. Biopharm. , vol.59 , pp. 85-97
    • Bruce, L.D.1    Shah, N.H.2    Malick, A.W.3    Infeld, M.H.4    McGinity, J.W.5
  • 8
    • 30544436192 scopus 로고    scopus 로고
    • Characterization of physico-mechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion process as a means to manufacture solid dispersion/solution
    • Chokshi, R.J., Sandhu, H.K., Iyer, R.M., Shah, N.H., Malick, A.W., Zia, H., 2005. Characterization of physico-mechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion process as a means to manufacture solid dispersion/solution. J. Pharm. Sci. 94, 2463-2474.
    • (2005) J. Pharm. Sci. , vol.94 , pp. 2463-2474
    • Chokshi, R.J.1    Sandhu, H.K.2    Iyer, R.M.3    Shah, N.H.4    Malick, A.W.5    Zia, H.6
  • 9
    • 85111386879 scopus 로고    scopus 로고
    • Hot-melt extrusion technique: A review. Iran
    • Chokshi, R.J., Zia, H., 2004. Hot-melt extrusion technique: A review. Iran. J. Pharm. Res. 3, 3-16.
    • (2004) J. Pharm. Res. , vol.3 , pp. 3-16
    • Chokshi, R.J.1    Zia, H.2
  • 11
    • 0034868680 scopus 로고    scopus 로고
    • The potential of small-scale fusion experiments and the Gordon-Taylor equation to predict the suitability of drug/polymer blends for melt extrusion
    • Forster, A., Hempenstall, J., Tucker, Rades, T., 2001a. The potential of small-scale fusion experiments and the Gordon-Taylor equation to predict the suitability of drug/polymer blends for melt extrusion. Drug Dev. Ind. Pharm. 27, 549-560.
    • (2001) Drug Dev. Ind. Pharm. , vol.27 , pp. 549-560
    • Forster, A.1    Hempenstall, J.2    Tucker Rades, T.3
  • 12
    • 0035845751 scopus 로고    scopus 로고
    • Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis
    • Forster, A., Hempenstall, J., Tucker, I., Rades, T., 2001b. Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis. Int. J. Pharm. 226, 147-161.
    • (2001) Int. J. Pharm. , vol.226 , pp. 147-161
    • Forster, A.1    Hempenstall, J.2    Tucker, I.3    Rades, T.4
  • 13
    • 84870356219 scopus 로고    scopus 로고
    • The amorphous solid dispersion of the poorly soluble ABT-102 forms nano/microparticulate structures in aqueous medium: Impact on solubility
    • Frank, K.J., Westedt, U., Rosenblatt, K.M., Holig, P., Rosenberg, J., Magerlein, M., Fricker, G., Brandl, M., 2012. The amorphous solid dispersion of the poorly soluble ABT-102 forms nano/microparticulate structures in aqueous medium: Impact on solubility. Int. J. Nanomed. 7, 5757-5768.
    • (2012) Int. J. Nanomed. , vol.7 , pp. 5757-5768
    • Frank, K.J.1    Westedt, U.2    Rosenblatt, K.M.3    Holig, P.4    Rosenberg, J.5    Magerlein, M.6    Fricker, G.7    Brandl, M.8
  • 14
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs
    • Galia, E., Nicolaides, E., Horter, D., Lobenberg, R., Reppas, C., Dressman, J.B., 1998. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 15, 698-705.
    • (1998) Pharm. Res. , vol.15 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Horter, D.3    Lobenberg, R.4    Reppas, C.5    Dressman, J.B.6
  • 15
    • 1842589355 scopus 로고    scopus 로고
    • Enhanced oral bioavailability of a poorly water soluble drug PNU-91325 by supersaturatable formulations
    • Gao, P., Guyton, M.E., Huang, T., Bauer, J.M., Stefanski, K.J., Lu, Q., 2004. Enhanced oral bioavailability of a poorly water soluble drug PNU-91325 by supersaturatable formulations. Drug Dev. Ind. Pharm. 30, 221-229.
    • (2004) Drug Dev. Ind. Pharm. , vol.30 , pp. 221-229
    • Gao, P.1    Guyton, M.E.2    Huang, T.3    Bauer, J.M.4    Stefanski, K.J.5    Lu, Q.6
  • 16
    • 0344012523 scopus 로고    scopus 로고
    • Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability
    • Gao, P., Rush, B.D., Pfund, W.P., Huang, T., Bauer, J.M., Morozowich, W., Kuo, M.S., Hageman, M.J., 2003. Development of a supersaturable SEDDS (S-SEDDS) formulation of paclitaxel with improved oral bioavailability. J. Pharm. Sci. 92, 2386-2398.
    • (2003) J. Pharm. Sci. , vol.92 , pp. 2386-2398
    • Gao, P.1    Rush, B.D.2    Pfund, W.P.3    Huang, T.4    Bauer, J.M.5    Morozowich, W.6    Kuo, M.S.7    Hageman, M.J.8
  • 17
    • 33845409810 scopus 로고    scopus 로고
    • Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: Selection of polymer-surfactant combinations using solubility parameters and testing the processability
    • Ghebremeskel, A.N., Vemavarapu, C., Lodaya, M., 2007. Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: Selection of polymer-surfactant combinations using solubility parameters and testing the processability. Int. J. Pharm. 328, 119-129.
    • (2007) Int. J. Pharm. , vol.328 , pp. 119-129
    • Ghebremeskel, A.N.1    Vemavarapu, C.2    Lodaya, M.3
  • 18
    • 65549101635 scopus 로고    scopus 로고
    • The science of USP 1 and 2 dissolution: Present challenges and future relevance
    • Gray, V., Kelly, G., Xia, M., Butler, C., Thomas, S., Mayock, S., 2009. The science of USP 1 and 2 dissolution: Present challenges and future relevance. Pharm. Res. 26, 1289-1302.
    • (2009) Pharm. Res. , vol.26 , pp. 1289-1302
    • Gray, V.1    Kelly, G.2    Xia, M.3    Butler, C.4    Thomas, S.5    Mayock, S.6
  • 19
    • 0032726595 scopus 로고    scopus 로고
    • Solubility parameters as predictors of miscibility in solid dispersions
    • Greenhalgh, D.J., Williams, A.C., Timmins, P., York, P., 1999. Solubility parameters as predictors of miscibility in solid dispersions. J. Pharm. Sci. 88, 1182-1190.
    • (1999) J. Pharm. Sci. , vol.88 , pp. 1182-1190
    • Greenhalgh, D.J.1    Williams, A.C.2    Timmins, P.3    York, P.4
  • 20
    • 79952259745 scopus 로고    scopus 로고
    • Prediction of solubility parameters and miscibility of pharmaceutical compounds by molecular dynamics simulations
    • Gupta, J., Nunes, C., Vyas, S., Jonnalagadda, S., 2011. Prediction of solubility parameters and miscibility of pharmaceutical compounds by molecular dynamics simulations. J. Phys. Chem. B 115, 2014-2023.
    • (2011) J. Phys. Chem. B , vol.115 , pp. 2014-2023
    • Gupta, J.1    Nunes, C.2    Vyas, S.3    Jonnalagadda, S.4
  • 21
    • 0030896467 scopus 로고    scopus 로고
    • The use of solubility parameters in pharmaceutical dosage form design
    • Hancock, B.C., York, P., Rowe, R.C., 1997. The use of solubility parameters in pharmaceutical dosage form design. Int. J. Pharm. 148, 1-21.
    • (1997) Int. J. Pharm. , vol.148 , pp. 1-21
    • Hancock, B.C.1    York, P.2    Rowe, R.C.3
  • 23
    • 84866728928 scopus 로고    scopus 로고
    • Stabilization of a supersaturated solution of mefenamic acid from a solid dispersion with EUDRAGIT((R)) EPO
    • Kojima, T., Higashi, K., Suzuki, T., Tomono, K., Moribe, K., Yamamoto, K., 2012. Stabilization of a supersaturated solution of mefenamic acid from a solid dispersion with EUDRAGIT((R)) EPO. Pharm. Res. 29, 2777-2791.
    • (2012) Pharm. Res. , vol.29 , pp. 2777-2791
    • Kojima, T.1    Higashi, K.2    Suzuki, T.3    Tomono, K.4    Moribe, K.5    Yamamoto, K.6
  • 24
    • 52949150391 scopus 로고    scopus 로고
    • Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine
    • Konno, H., Handa, T., Alonzo, D.E., Taylor, L.S., 2008. Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine. Eur. J. Pharm. Biopharm. 70, 493-499.
    • (2008) Eur. J. Pharm. Biopharm. , vol.70 , pp. 493-499
    • Konno, H.1    Handa, T.2    Alonzo, D.E.3    Taylor, L.S.4
  • 25
    • 70149118117 scopus 로고    scopus 로고
    • Influence of molecular properties on oral bioavailability of lipophilic drugs-mapping of bulkiness and different measures of polarity
    • Kuentz, M.T., Arnold, Y., 2009. Influence of molecular properties on oral bioavailability of lipophilic drugs-mapping of bulkiness and different measures of polarity. Pharm. Dev. Technol., 1-9.
    • (2009) Pharm. Dev. Technol. , pp. 1-9
    • Kuentz, M.T.1    Arnold, Y.2
  • 26
    • 0037452415 scopus 로고    scopus 로고
    • Investigations on the predictability of the formation of glassy solid solutions of drugs in sugar alcohols
    • Langer, M., Holtje, M., Urbanetz, N.A., Brandt, B., Holtje, H.D., Lippold, B.C., 2003. Investigations on the predictability of the formation of glassy solid solutions of drugs in sugar alcohols. Int. J. Pharm. 252, 167-179.
    • (2003) Int. J. Pharm. , vol.252 , pp. 167-179
    • Langer, M.1    Holtje, M.2    Urbanetz, N.A.3    Brandt, B.4    Holtje, H.D.5    Lippold, B.C.6
  • 28
    • 33845581285 scopus 로고    scopus 로고
    • Preparation of monolithic matrices for oral drug delivery using a supercritical fluid assisted hot melt extrusion process
    • Lyons, J.G., Hallinan, M., Kennedy, J.E., Devine, D.M., Geever, L.M., Blackie, P., Higginbotham, C.L., 2007. Preparation of monolithic matrices for oral drug delivery using a supercritical fluid assisted hot melt extrusion process. Int. J. Pharm. 329, 62-71.
    • (2007) Int. J. Pharm. , vol.329 , pp. 62-71
    • Lyons, J.G.1    Hallinan, M.2    Kennedy, J.E.3    Devine, D.M.4    Geever, L.M.5    Blackie, P.6    Higginbotham, C.L.7
  • 31
    • 64649086750 scopus 로고    scopus 로고
    • Highly supersaturated solutions from dissolution of amorphous itraconazole microparticles at pH 6.8
    • Matteucci, M.E., Paguio, J.C., Miller, M.A., Williams 3rd, R.O., Johnston, K.P., 2009. Highly supersaturated solutions from dissolution of amorphous itraconazole microparticles at pH 6.8. Mol. Pharm. 6, 375-385.
    • (2009) Mol. Pharm. , vol.6 , pp. 375-385
    • Matteucci, M.E.1    Paguio, J.C.2    Miller, M.A.3    Williams III, R.O.4    Johnston, K.P.5
  • 32
    • 43049151043 scopus 로고    scopus 로고
    • Targeted intestinal delivery of supersaturated itraconazole for improved oral absorption
    • Miller, D.A., DiNunzio, J.C., Yang, W., McGinity, J.W., Williams 3rd, R.O., 2008. Targeted intestinal delivery of supersaturated itraconazole for improved oral absorption. Pharm. Res. 25, 1450-1459.
    • (2008) Pharm. Res. , vol.25 , pp. 1450-1459
    • Miller, D.A.1    DiNunzio, J.C.2    Yang, W.3    McGinity, J.W.4    Williams III, R.O.5
  • 33
    • 0031768843 scopus 로고    scopus 로고
    • Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy
    • Mura, P., Faucci, M.T., Manderioli, A., Bramanti, G., Ceccarelli, L., 1998a. Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy. J. Pharm. Biomed. Anal. 18, 151-163.
    • (1998) J. Pharm. Biomed. Anal. , vol.18 , pp. 151-163
    • Mura, P.1    Faucci, M.T.2    Manderioli, A.3    Bramanti, G.4    Ceccarelli, L.5
  • 34
    • 0031845544 scopus 로고    scopus 로고
    • Thermal analysis as a screening technique in preformulation studies of picotamide solid dosage forms
    • Mura, P., Faucci, M.T., Manderioli, A., Furlanetto, S., Pinzauti, S., 1998b. Thermal analysis as a screening technique in preformulation studies of picotamide solid dosage forms. Drug Dev. Ind. Pharm. 24, 747-756.
    • (1998) Drug Dev. Ind. Pharm. , vol.24 , pp. 747-756
    • Mura, P.1    Faucci, M.T.2    Manderioli, A.3    Furlanetto, S.4    Pinzauti, S.5
  • 35
    • 0037173515 scopus 로고    scopus 로고
    • The role of the kneading paddle and the effects of screw revolution speed and water content on the preparation of solid dispersions using a twin-screw extruder
    • Nakamichi, K., Nakano, T., Yasuura, H., Izumi, S., Kawashima, Y., 2002. The role of the kneading paddle and the effects of screw revolution speed and water content on the preparation of solid dispersions using a twin-screw extruder. Int. J. Pharm. 241, 203-211.
    • (2002) Int. J. Pharm. , vol.241 , pp. 203-211
    • Nakamichi, K.1    Nakano, T.2    Yasuura, H.3    Izumi, S.4    Kawashima, Y.5
  • 36
    • 0035895236 scopus 로고    scopus 로고
    • Crystallization of hydrocortisone acetate: Influence of polymers
    • Raghavan, S.L., Trividic, A., Davis, A.F., Hadgraft, J., 2001. Crystallization of hydrocortisone acetate: Influence of polymers. Int. J. Pharm. 212, 213-221.
    • (2001) Int. J. Pharm. , vol.212 , pp. 213-221
    • Raghavan, S.L.1    Trividic, A.2    Davis, A.F.3    Hadgraft, J.4
  • 40
    • 15244341878 scopus 로고    scopus 로고
    • Identification of biowaivers among class II drugs: Theoretical justification and practical examples
    • Rinaki, E., Dokoumetzidis, A., Valsami, G., Macheras, P., 2004. Identification of biowaivers among class II drugs: Theoretical justification and practical examples. Pharm. Res. 21, 1567-1572.
    • (2004) Pharm. Res. , vol.21 , pp. 1567-1572
    • Rinaki, E.1    Dokoumetzidis, A.2    Valsami, G.3    Macheras, P.4
  • 41
    • 0035940345 scopus 로고    scopus 로고
    • Influence of hot-melt extrusion and compression molding on polymer structure organization, investigated by differential scanning calorimetry
    • Sarraf, A.G., Tissot, H., Tissot, P., Alfonso, D., Gurny, R., Doelker, E., 2001. Influence of hot-melt extrusion and compression molding on polymer structure organization, investigated by differential scanning calorimetry. J. Appl. Polym. Sci. 81, 3124-3132.
    • (2001) J. Appl. Polym. Sci. , vol.81 , pp. 3124-3132
    • Sarraf, A.G.1    Tissot, H.2    Tissot, P.3    Alfonso, D.4    Gurny, R.5    Doelker, E.6
  • 42
    • 0035253402 scopus 로고    scopus 로고
    • Characterization of glassy itraconazole: A comparative study of its molecular mobility below T(g) with that of structural analogues using MTDSC
    • Six, K., Verreck, G., Peeters, J., Augustijns, P., Kinget, R., Van den Mooter, G., 2001. Characterization of glassy itraconazole: A comparative study of its molecular mobility below T(g) with that of structural analogues using MTDSC. Int. J. Pharm. 213, 163-173.
    • (2001) Int. J. Pharm. , vol.213 , pp. 163-173
    • Six, K.1    Verreck, G.2    Peeters, J.3    Augustijns, P.4    Kinget, R.5    Van Den Mooter, G.6
  • 43
    • 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
    • Six, K., Verreck, G., Peeters, J., Brewster, M., Van Den Mooter, G., 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, 124-131.
    • (2004) J. Pharm. Sci. , vol.93 , pp. 124-131
    • Six, K.1    Verreck, G.2    Peeters, J.3    Brewster, M.4    Van Den Mooter, G.5
  • 45
    • 0035834181 scopus 로고    scopus 로고
    • Determination of partial solubility parameters of five benzodiazepines in individual solvents
    • Verheyen, S., Augustijns, P., Kinget, R., Van den Mooter, G., 2001. Determination of partial solubility parameters of five benzodiazepines in individual solvents. Int. J. Pharm. 228, 199-207.
    • (2001) Int. J. Pharm. , vol.228 , pp. 199-207
    • Verheyen, S.1    Augustijns, P.2    Kinget, R.3    Van Den Mooter, G.4
  • 47
    • 64649086799 scopus 로고    scopus 로고
    • Solid state amorphization of pharmaceuticals
    • Willart, J.F., Descamps, M., 2008. Solid state amorphization of pharmaceuticals. Mol. Pharm. 5, 905-920.
    • (2008) Mol. Pharm. , vol.5 , pp. 905-920
    • Willart, J.F.1    Descamps, M.2


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