메뉴 건너뛰기




Volumn 99, Issue 7, 2010, Pages 2941-2947

Drug-polymer solubility and miscibility: Stability consideration and practical challenges in amorphous solid dispersion development

Author keywords

Amorphous solid dispersion; Drug loading; Glass transition temperature; Miscibility; Physical stability; Solubility

Indexed keywords

DRUG CARRIER; POLYMER;

EID: 77953296607     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22074     Document Type: Note
Times cited : (371)

References (44)
  • 1
    • 0030638567 scopus 로고    scopus 로고
    • Characteristics and Significance of the Amorphous State in Pharmaceutical Systems
    • Hancock BC, Zografi G. 1997. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1-12. (Pubitemid 127489650)
    • (1997) Journal of Pharmaceutical Sciences , vol.86 , Issue.1
    • Hancock, B.C.1    Zografi, G.2
  • 2
    • 0035897584 scopus 로고    scopus 로고
    • Amorphous pharmaceutical solids: Preparation, characterization and stabilization
    • DOI 10.1016/S0169-409X(01)00098-9, PII S0169409X01000989
    • Yu L. 2001. Amorphous pharmaceutical solids: Preparation, characterization and stabilization. Adv Drug Deliv Rev 48:27-42. (Pubitemid 32454482)
    • (2001) Advanced Drug Delivery Reviews , vol.48 , Issue.1 , pp. 27-42
    • Yu, L.1
  • 3
    • 0029015405 scopus 로고
    • Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures
    • Hancock BC, Shamblin SL, Zografi G. 1995. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm Res 12:799-806.
    • (1995) Pharm Res , vol.12 , pp. 799-806
    • Hancock, B.C.1    Shamblin, S.L.2    Zografi, G.3
  • 4
    • 0035997888 scopus 로고    scopus 로고
    • Disordered drug delivery: Destiny, dynamics and the Deborah number
    • Hancock BC. 2002. Disordered drug delivery: Destiny, dynamics and the Deborah number. J Pharm Pharmacol 54: 737-746.
    • (2002) J Pharm Pharmacol , vol.54 , pp. 737-746
    • Hancock, B.C.1
  • 5
    • 85008071016 scopus 로고
    • Studies on absorption of eutectic mixture. I. A comparison of the behavior of eutectic mixture of sulfathiazole and that of ordinary sulfathiazole in man
    • Tokyo
    • Sekiguchi K, Obi N, Ueda Y. 1964. Studies on absorption of eutectic mixture. I. A comparison of the behavior of eutectic mixture of sulfathiazole and that of ordinary sulfathiazole in man. Chem Pharm Bull (Tokyo) 9:866-872.
    • (1964) Chem Pharm Bull , vol.9 , pp. 866-872
    • Sekiguchi, K.1    Obi, N.2    Ueda, Y.3
  • 6
    • 0001368366 scopus 로고
    • Studies on absorption of eutectic mixture. II. Absorption of fused conglomerates of chloramphenicol and urea in rabbits
    • Tokyo
    • Sekiguchi K, Obi N, Ueda Y. 1964. Studies on absorption of eutectic mixture. II. Absorption of fused conglomerates of chloramphenicol and urea in rabbits. Chem Pharm Bull (Tokyo) 12:134-144.
    • (1964) Chem Pharm Bull , vol.12 , pp. 134-144
    • Sekiguchi, K.1    Obi, N.2    Ueda, Y.3
  • 8
    • 0034601240 scopus 로고    scopus 로고
    • Improving drug solubility for oral delivery using solid dispersions
    • DOI 10.1016/S0939-6411(00)00076-X, PII S093964110000076X
    • Leuner C, Dressman J. 2000. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 50:47-60. (Pubitemid 30326688)
    • (2000) European Journal of Pharmaceutics and Biopharmaceutics , vol.50 , Issue.1 , pp. 47-60
    • Leuner, C.1    Dressman, J.2
  • 10
    • 30344456981 scopus 로고    scopus 로고
    • Development of supersaturatable self-emulsifying drug delivery system formulations for improving the oral absorption of poorly soluble drugs
    • DOI 10.1517/17425247.3.1.97
    • Gao P, Morozowich W. 2006. Development of supersaturatable self-emulsifying drug delivery system formulations for improving the oral absorption of poorly soluble drugs. Expert Opin Drug Deliv 3:97-110. (Pubitemid 43056394)
    • (2006) Expert Opinion on Drug Delivery , vol.3 , Issue.1 , pp. 97-110
    • Gao, P.1    Morozowich, W.2
  • 12
    • 0034886795 scopus 로고    scopus 로고
    • Physicochemical considerations in the preparation of amorphous ritonavir-poly(ethylene glycol) 8000 solid dispersions
    • Law D, Krill SL, Schmitt EA, Fort JJ, Qiu Y, Wang W, Porter WR. 2001. Physicochemical considerations in the preparation of amorphous ritonavir-poly(ethylene glycol) 8000 solid dispersions. J Pharm Sci 90:1015-1025.
    • (2001) J Pharm Sci , vol.90 , pp. 1015-1025
    • Law, D.1    Krill, S.L.2    Schmitt, E.A.3    Fort, J.J.4    Qiu, Y.5    Wang, W.6    Porter, W.R.7
  • 13
    • 0035964465 scopus 로고    scopus 로고
    • In vitro and in vivo evaluation of carbamazepine-PEG 6000 solid dispersions
    • Zerrouk N, Chemtob C, Arnaud P, Toscani S, Dugue J. 2001. In vitro and in vivo evaluation of carbamazepine-PEG 6000 solid dispersions. Int J Pharm 225:49-62.
    • (2001) Int J Pharm , vol.225 , pp. 49-62
    • Zerrouk, N.1    Chemtob, C.2    Arnaud, P.3    Toscani, S.4    Dugue, J.5
  • 14
    • 34250799124 scopus 로고    scopus 로고
    • Mechanistic investigation of Pluronic based nano-crystalline drug-polymer solid dispersions
    • DOI 10.1007/s11095-007-9275-7
    • Qian F, Tao J, Desikan S, Hussain M, Smith RL. 2007. Mechanistic investigation of Pluronic based nano-crystalline drug-polymer solid dispersions. Pharm Res 24:1551-1560. (Pubitemid 46988222)
    • (2007) Pharmaceutical Research , vol.24 , Issue.8 , pp. 1551-1560
    • Qian, F.1    Tao, J.2    Desikan, S.3    Hussain, M.4    Smith, R.L.5
  • 15
    • 0009071257 scopus 로고
    • Formation of glasses from liquids and biopolymers
    • Angell CA. 1995. Formation of glasses from liquids and biopolymers. Science 267:1924-1935.
    • (1995) Science , vol.267 , pp. 1924-1935
    • Angell, C.A.1
  • 16
    • 70449107051 scopus 로고    scopus 로고
    • Effects of polymer type and storage relative humidity on the kinetics of felodipine crystallization from amorphous solid dispersions
    • Rumondor AC, Stanford LA, Taylor LS. 2009. Effects of polymer type and storage relative humidity on the kinetics of felodipine crystallization from amorphous solid dispersions. Pharm Res 26:2599-2606.
    • (2009) Pharm Res , vol.26 , pp. 2599-2606
    • Rumondor, A.C.1    Stanford, L.A.2    Taylor, L.S.3
  • 17
    • 70350220585 scopus 로고    scopus 로고
    • Evaluation of drug-polymer miscibility in amorphous solid dispersion systems
    • Rumondor AC, Ivanisevic I, Bates S, Alonzo DE, Taylor LS. 2009. Evaluation of drug-polymer miscibility in amorphous solid dispersion systems. Pharm Res 26:2523-2534.
    • (2009) Pharm Res , vol.26 , pp. 2523-2534
    • Rumondor, A.C.1    Ivanisevic, I.2    Bates, S.3    Alonzo, D.E.4    Taylor, L.S.5
  • 18
    • 0031423468 scopus 로고    scopus 로고
    • Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions
    • DOI 10.1023/A:1012167410376
    • Taylor LS, Zografi G. 1997. Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions. Pharm Res 14:1691-1698. (Pubitemid 28062912)
    • (1997) Pharmaceutical Research , vol.14 , Issue.12 , pp. 1691-1698
    • Taylor, L.S.1    Zografi, G.2
  • 19
    • 0001242722 scopus 로고
    • Concentrations, total and partial vapor pressures, surface tensions and viscosities, in the systems phenol-water and phenol-water-4% succinic acid
    • Campbell AN, Campbell AJR. 1937. Concentrations, total and partial vapor pressures, surface tensions and viscosities, in the systems phenol-water and phenol-water-4% succinic acid. J Am Chem Soc 59:2481-2488.
    • (1937) J Am Chem Soc , vol.59 , pp. 2481-2488
    • Campbell, A.N.1    Campbell, A.J.R.2
  • 20
    • 85025135447 scopus 로고    scopus 로고
    • Thermodynamics of blends and solutions
    • New York: Oxford University Press Inc
    • Rubinstein M, Colby RH. 2003. Thermodynamics of blends and solutions. In: Polymer physics. New York: Oxford University Press Inc,. pp 137-170.
    • (2003) Polymer Physics , pp. 137-170
    • Rubinstein, M.1    Colby, R.H.2
  • 22
    • 0010831342 scopus 로고
    • Thermodynamics of high polymer solutions
    • Flory PJ. 1941. Thermodynamics of high polymer solutions. J Chem Phys 9:660-661.
    • (1941) J Chem Phys , vol.9 , pp. 660-661
    • Flory, P.J.1
  • 23
    • 84989989842 scopus 로고
    • Thermodynamic properties of solutions of long-chain compounds
    • Huggins ML. 1942. Thermodynamic properties of solutions of long-chain compounds. Ann N Y Acad Sci 43:1-32.
    • (1942) Ann N Y Acad Sci , vol.43 , pp. 1-32
    • Huggins, M.L.1
  • 24
    • 0036786457 scopus 로고    scopus 로고
    • Water vapor absorption into amorphous hydrophobic drug/ poly(vinylpyrrolidone) dispersions
    • Crowley KJ, Zografi G. 2002. Water vapor absorption into amorphous hydrophobic drug/poly(vinylpyrrolidone) dispersions. J Pharm Sci 91:2150-2165.
    • (2002) J Pharm Sci , vol.91 , pp. 2150-2165
    • Crowley, K.J.1    Zografi, G.2
  • 25
    • 33749442356 scopus 로고    scopus 로고
    • Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility
    • Marsac PJ, Shamblin SL, Taylor LS. 2006. Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility. Pharm Res 23:2417-2426.
    • (2006) Pharm Res , vol.23 , pp. 2417-2426
    • Marsac, P.J.1    Shamblin, S.L.2    Taylor, L.S.3
  • 26
    • 57749206650 scopus 로고    scopus 로고
    • Estimation of drug-polymer miscibility and solubility in amorphous solid dispersions using experimentally determined interaction parameters
    • Marsac PJ, Li T, Taylor LS. 2009. Estimation of drug-polymer miscibility and solubility in amorphous solid dispersions using experimentally determined interaction parameters. Pharm Res 26:139-151.
    • (2009) Pharm Res , vol.26 , pp. 139-151
    • Marsac, P.J.1    Li, T.2    Taylor, L.S.3
  • 27
    • 0001106314 scopus 로고
    • Ideal copolymers and the secondorder transitions of synthetic rubbers. I. Noncrystalline copolymers
    • Gordon M, Taylor J. 1952. Ideal copolymers and the secondorder transitions of synthetic rubbers. I. Noncrystalline copolymers. J Appl Chem 2:493-500.
    • (1952) J Appl Chem , vol.2 , pp. 493-500
    • Gordon, M.1    Taylor, J.2
  • 28
    • 40549086641 scopus 로고    scopus 로고
    • Recrystallization of nifedipine and felodipine from amorphous molecular level solid dispersions containing poly(vinylpyrrolidone) and sorbed water
    • DOI 10.1007/s11095-007-9420-3
    • Marsac PJ, Konno H, Rumondor AC, Taylor LS. 2008. Recrystallization of nifedipine and felodipine from amorphous molecular level solid dispersions containing poly(vinylpyrrolidone) and sorbed water. Pharm Res 25:647-656. (Pubitemid 351357733)
    • (2008) Pharmaceutical Research , vol.25 , Issue.3 , pp. 647-656
    • Marsac, P.J.1    Konno, H.2    Rumondor, A.C.F.3    Taylor, L.S.4
  • 29
    • 61449135800 scopus 로고    scopus 로고
    • Solubility of small-molecule crystals in polymers: D-mannitol in PVP, indomethacin in PVP/VA, and nifedipine in PVP/VA
    • Tao J, Sun Y, Zhang GG, Yu L. 2009. Solubility of small-molecule crystals in polymers: D-mannitol in PVP, indomethacin in PVP/VA, and nifedipine in PVP/VA. Pharm Res 26:855-864.
    • (2009) Pharm Res , vol.26 , pp. 855-864
    • Tao, J.1    Sun, Y.2    Zhang, G.G.3    Yu, L.4
  • 30
    • 17644414570 scopus 로고    scopus 로고
    • Phase behavior of amorphous molecular dispersions. I: Determination of the degree and mechanism of solid solubility
    • Vasanthavada M, Tong WQ, Joshi Y, Kislalioglu MS. 2004. Phase behavior of amorphous molecular dispersions. I: Determination of the degree and mechanism of solid solubility. Pharm Res 21:1598-1606.
    • (2004) Pharm Res , vol.21 , pp. 1598-1606
    • Vasanthavada, M.1    Tong, W.Q.2    Joshi, Y.3    Kislalioglu, M.S.4
  • 31
    • 17644395269 scopus 로고    scopus 로고
    • Phase behavior of amorphous molecular dispersions. II: Role of hydrogen bonding in solid solubility and phase separation kinetics
    • Vasanthavada M, Tong WQ, Joshi Y, Kislalioglu MS. 2005. Phase behavior of amorphous molecular dispersions. II: Role of hydrogen bonding in solid solubility and phase separation kinetics. Pharm Res 22:440-448.
    • (2005) Pharm Res , vol.22 , pp. 440-448
    • Vasanthavada, M.1    Tong, W.Q.2    Joshi, Y.3    Kislalioglu, M.S.4
  • 32
    • 0017632367 scopus 로고
    • Phase separation in styrene-a-methyl styrene block copolymers
    • Klempner D, Frisch K, editors. New York: Plenum Pub Corp 10th edition
    • Krause S, Iskander M. 1977. Phase separation in styrene-a-methyl styrene block copolymers. In: Klempner D, Frisch K, editors. Polymer science and technology. New York: Plenum Pub Corp 10th edition. pp 231-243.
    • (1977) Polymer Science and Technology , pp. 231-243
    • Krause, S.1    Iskander, M.2
  • 34
    • 33750509190 scopus 로고    scopus 로고
    • Solid-state NMR spectroscopy in pharmaceutical research and analysis
    • DOI 10.1016/j.trac.2006.07.006, PII S0165993606001671
    • Berendt RT, Sperger DM, Munson EJ, Isbester PK. 2006. Solid-state NMR spectroscopy in pharmaceutical research and analysis. TrAC Trends Anal Chem 25:977-984. (Pubitemid 44666187)
    • (2006) TrAC - Trends in Analytical Chemistry , vol.25 , Issue.10 , pp. 977-984
    • Berendt, R.T.1    Sperger, D.M.2    Munson, E.J.3    Isbester, P.K.4
  • 37
    • 24044499657 scopus 로고    scopus 로고
    • Molecular properties of ibuprofen and its solid dispersions with Eudragit RL100 studied by solid-state nuclear magnetic resonance
    • DOI 10.1007/s11095-005-6249-5
    • Geppi M, Guccione S, Mollica G, Pignatello R, Veracini CA. 2005. Molecular properties of ibuprofen and its solid dispersions with Eudragit RL100 studied by solid-state nuclear magnetic resonance. Pharm Res 22:1544-1555. (Pubitemid 41215896)
    • (2005) Pharmaceutical Research , vol.22 , Issue.9 , pp. 1544-1555
    • Geppi, M.1    Guccione, S.2    Mollica, G.3    Pignatello, R.4    Veracini, C.A.5
  • 38
    • 55749088198 scopus 로고    scopus 로고
    • Characterization of amorphous API:Polymer mixtures using X-ray powder diffraction
    • Newman A, Engers D, Bates S, Ivanisevic I, Kelly RC, Zografi G. 2008. Characterization of amorphous API:polymer mixtures using X-ray powder diffraction. J Pharm Sci 97:4840-4856.
    • (2008) J Pharm Sci , vol.97 , pp. 4840-4856
    • Newman, A.1    Engers, D.2    Bates, S.3    Ivanisevic, I.4    Kelly, R.C.5    Zografi, G.6
  • 39
    • 68949089977 scopus 로고    scopus 로고
    • Novel methods for the assessment of miscibility of amorphous drug-polymer dispersions
    • Ivanisevic I, Bates S, Chen P. 2009. Novel methods for the assessment of miscibility of amorphous drug-polymer dispersions. J Pharm Sci 98:3373-3386.
    • (2009) J Pharm Sci , vol.98 , pp. 3373-3386
    • Ivanisevic, I.1    Bates, S.2    Chen, P.3
  • 40
    • 21644476482 scopus 로고    scopus 로고
    • A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions. Part I: A comparative analysis by thermally stimulated depolarization current and differential scanning calorimetry
    • Shmeis RA, Wang Z, Krill SL. 2004. A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions. Part I: A comparative analysis by thermally stimulated depolarization current and differential scanning calorimetry. Pharm Res 21:2025-2030.
    • (2004) Pharm Res , vol.21 , pp. 2025-2030
    • Shmeis, R.A.1    Wang, Z.2    Krill, S.L.3
  • 41
    • 21644462238 scopus 로고    scopus 로고
    • A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions. Part II: Molecular mobility and activation thermodynamic parameters
    • Shmeis RA, Wang Z, Krill SL. 2004. A mechanistic investigation of an amorphous pharmaceutical and its solid dispersions. Part II: Molecular mobility and activation thermodynamic parameters. Pharm Res 21:2031-2039.
    • (2004) Pharm Res , vol.21 , pp. 2031-2039
    • Shmeis, R.A.1    Wang, Z.2    Krill, S.L.3
  • 42
    • 37049137698 scopus 로고
    • Liquid-liquid equilibria in multi-component polymer systems
    • Koningsveld R. 1970. Liquid-liquid equilibria in multi-component polymer systems. Discuss Faraday Soc 49:144-161.
    • (1970) Discuss Faraday Soc , vol.49 , pp. 144-161
    • Koningsveld, R.1
  • 44
    • 0035861453 scopus 로고    scopus 로고
    • The glass transition of water, based on hyperquenching experiments
    • DOI 10.1126/science.1061757
    • Velikov V, Borick S, Angell C. 2001. The glass transition of water, based on hyperquenching. Science 294:2335-2338. (Pubitemid 33140553)
    • (2001) Science , vol.294 , Issue.5550 , pp. 2335-2338
    • Velikov, V.1    Borick, S.2    Angell, C.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.