메뉴 건너뛰기




Volumn 84, Issue 1, 2013, Pages 208-218

New formulation approaches to improve solubility and drug release from fixed dose combinations: Case examples pioglitazone/glimepiride and ezetimibe/simvastatin

Author keywords

Dissolution enhancement; Fixed dose combination; Solid dispersions; Solubility improvement; Ternary comlexes

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; COPOLYMER; EZETIMIBE PLUS SIMVASTATIN; GLIMEPIRIDE PLUS PIOGLITAZONE; MACROGOL;

EID: 84876927688     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2012.11.027     Document Type: Article
Times cited : (77)

References (43)
  • 1
    • 12844283957 scopus 로고    scopus 로고
    • High-throughput drug discovery: What can we exulect from HTS?
    • P. Gribbon, and A. Sewing High-throughput drug discovery: what can we exulect from HTS? Drug Discovery Today 10 1 2005 17 22
    • (2005) Drug Discovery Today , vol.10 , Issue.1 , pp. 17-22
    • Gribbon, P.1    Sewing, A.2
  • 2
    • 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 A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 3 1995 413 420
    • (1995) Pharm. Res. , vol.12 , Issue.3 , pp. 413-420
    • Amidon, G.L.1
  • 3
    • 0019309211 scopus 로고
    • Dependence of area under the curve on proquazone particle-size and in vitro dissolution rate
    • F. Nimmerfall, and J. Rosenthaler Dependence of area under the curve on proquazone particle-size and in vitro dissolution rate J. Pharm. Sci. 69 5 1980 605 607
    • (1980) J. Pharm. Sci. , vol.69 , Issue.5 , pp. 605-607
    • Nimmerfall, F.1    Rosenthaler, J.2
  • 4
    • 71049183092 scopus 로고    scopus 로고
    • Particle size reduction for improvement of oral absorption of the poorly soluble drug UG558 in rats during early development
    • K. Sigfridsson, A.J. Lundqvist, and M. Strimfors Particle size reduction for improvement of oral absorption of the poorly soluble drug UG558 in rats during early development Drug Dev. Ind. Pharm. 35 12 2009 1479 1486
    • (2009) Drug Dev. Ind. Pharm. , vol.35 , Issue.12 , pp. 1479-1486
    • Sigfridsson, K.1    Lundqvist, A.J.2    Strimfors, M.3
  • 5
    • 0030638567 scopus 로고    scopus 로고
    • Characteristics and significance of the amorphous state in pharmaceutical systems
    • B.C. Hancock, and G. Zograf Characteristics and significance of the amorphous state in pharmaceutical systems J. Pharm. Sci. 86 1 1997 1 12
    • (1997) J. Pharm. Sci. , vol.86 , Issue.1 , pp. 1-12
    • Hancock, B.C.1    Zograf, G.2
  • 6
    • 33947487639 scopus 로고
    • The rate of solution of solid substances in their own solutions
    • A.A. Noyes, and W.R. Whitney The rate of solution of solid substances in their own solutions J. Am. Chem. Soc. 19 1897 930 934
    • (1897) J. Am. Chem. Soc. , vol.19 , pp. 930-934
    • Noyes, A.A.1    Whitney, W.R.2
  • 7
    • 0002642747 scopus 로고
    • Theory on the reaction rate in heterogenous systems
    • N. Nernst Theory on the reaction rate in heterogenous systems Phys. Chem-Stoch 47 1904 52 55
    • (1904) Phys. Chem-Stoch , vol.47 , pp. 52-55
    • Nernst, N.1
  • 8
    • 0029819323 scopus 로고    scopus 로고
    • Pharmaceutical applications of cyclodextrins. 1. Drug solubilization and stabilization
    • T. Loftsson, and M.E. Brewster Pharmaceutical applications of cyclodextrins. 1. Drug solubilization and stabilization J. Pharm. Sci. 85 10 1996 1017 1025
    • (1996) J. Pharm. Sci. , vol.85 , Issue.10 , pp. 1017-1025
    • Loftsson, T.1    Brewster, M.E.2
  • 9
    • 10444279209 scopus 로고    scopus 로고
    • Cyclodextrin-based pharmaceutics: Past, present and future
    • M.E. Davis, and M.E. Brewster Cyclodextrin-based pharmaceutics: past, present and future Nat. Rev. Drug Discovery 3 12 2004 1023 1035
    • (2004) Nat. Rev. Drug Discovery , vol.3 , Issue.12 , pp. 1023-1035
    • Davis, M.E.1    Brewster, M.E.2
  • 10
    • 1942434694 scopus 로고    scopus 로고
    • Self-association of cyclodextrins and cyclodextrin complexes
    • T. Loftsson, M. Masson, and M.E. Brewster Self-association of cyclodextrins and cyclodextrin complexes J. Pharm. Sci. 93 5 2004 1091 1099
    • (2004) J. Pharm. Sci. , vol.93 , Issue.5 , pp. 1091-1099
    • Loftsson, T.1    Masson, M.2    Brewster, M.E.3
  • 11
    • 0029852699 scopus 로고    scopus 로고
    • Pharmaceutical applications of cyclodextrins.2. in vivo drug delivery
    • R.A. Rajewski, and V.J. Stella Pharmaceutical applications of cyclodextrins.2. In vivo drug delivery J. Pharm. Sci. 85 11 1996 1142 1169
    • (1996) J. Pharm. Sci. , vol.85 , Issue.11 , pp. 1142-1169
    • Rajewski, R.A.1    Stella, V.J.2
  • 12
    • 79952314729 scopus 로고    scopus 로고
    • Self-assembly of cyclodextrin complexes: Aggregation of hydrocortisone/cyclodextrin complexes
    • T. Loftsson Self-assembly of cyclodextrin complexes: aggregation of hydrocortisone/cyclodextrin complexes Int. J. Pharm. 407 1-2 2011 174 183
    • (2011) Int. J. Pharm. , vol.407 , Issue.12 , pp. 174-183
    • Loftsson, T.1
  • 13
    • 84984082270 scopus 로고
    • Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures. 2. Experimental evaluation of a eutectic mixture-urea-acetaminophen system
    • A.H. Goldberg, M. Gibaldi, and J.L. Kanig Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures. 2. Experimental evaluation of a eutectic mixture-urea-acetaminophen system J. Pharm. Sci. 55 5 1966 482 484
    • (1966) J. Pharm. Sci. , vol.55 , Issue.5 , pp. 482-484
    • Goldberg, A.H.1    Gibaldi, M.2    Kanig, J.L.3
  • 14
    • 0034601240 scopus 로고    scopus 로고
    • Improving drug solubility for oral delivery using solid dispersions
    • C. Leuner, and J. Dressman Improving drug solubility for oral delivery using solid dispersions Eur. J. Pharm. Biopharm. 50 1 2000 47 60
    • (2000) Eur. J. Pharm. Biopharm. , vol.50 , Issue.1 , pp. 47-60
    • Leuner, C.1    Dressman, J.2
  • 15
    • 24144485837 scopus 로고    scopus 로고
    • Dissolution mechanism of poorly water-soluble drug from extended release solid dispersion system with ethylcellulose and hydroxypropylmethylcellulose
    • T. Ohara Dissolution mechanism of poorly water-soluble drug from extended release solid dispersion system with ethylcellulose and hydroxypropylmethylcellulose Int. J. Pharm. 302 1-2 2005 95 102
    • (2005) Int. J. Pharm. , vol.302 , Issue.12 , pp. 95-102
    • Ohara, T.1
  • 16
    • 33645758286 scopus 로고    scopus 로고
    • Development of novel sustained-release system, disintegration-controlled matrix tablet (DCMT) with solid dispersion granules of nilvadipine (II): In vivo evaluation
    • T. Kimura Development of novel sustained-release system, disintegration-controlled matrix tablet (DCMT) with solid dispersion granules of nilvadipine (II): in vivo evaluation J. Control. Rel. 112 1 2006 51 56
    • (2006) J. Control. Rel. , vol.112 , Issue.1 , pp. 51-56
    • Kimura, T.1
  • 17
    • 33646850912 scopus 로고    scopus 로고
    • Effect of hydrogen bonding interactions on the release mechanism of felodipine from nanodispersions with polyvinylpyrrolidone
    • G. Ktistis Effect of hydrogen bonding interactions on the release mechanism of felodipine from nanodispersions with polyvinylpyrrolidone Eur. J. Pharm. Biopharm. 63 2 2006 103 114
    • (2006) Eur. J. Pharm. Biopharm. , vol.63 , Issue.2 , pp. 103-114
    • Ktistis, G.1
  • 18
    • 33747033371 scopus 로고    scopus 로고
    • Development, characterization and stabilization of amorphous form of a low T-g drug
    • A. Paradkar Development, characterization and stabilization of amorphous form of a low T-g drug Powder Technol. 167 1 2006 20 25
    • (2006) Powder Technol. , vol.167 , Issue.1 , pp. 20-25
    • Paradkar, A.1
  • 19
    • 0032989612 scopus 로고    scopus 로고
    • A calorimetric investigation into the interaction between paracetamol and polyethlene glycol 4000 in physical mixes and solid dispersions
    • G.R. Lloyd, D.Q.M. Craig, and A. Smith A calorimetric investigation into the interaction between paracetamol and polyethlene glycol 4000 in physical mixes and solid dispersions Eur. J. Pharm. Biopharm. 48 1 1999 59 65
    • (1999) Eur. J. Pharm. Biopharm. , vol.48 , Issue.1 , pp. 59-65
    • Lloyd, G.R.1    Craig, D.Q.M.2    Smith, A.3
  • 20
    • 0028111609 scopus 로고
    • The effect of water-soluble polymers on drug-cyclodextrin complexation
    • T. Loftsson The effect of water-soluble polymers on drug-cyclodextrin complexation Int. J. Pharm. 110 2 1994 169 177
    • (1994) Int. J. Pharm. , vol.110 , Issue.2 , pp. 169-177
    • Loftsson, T.1
  • 21
    • 0031728704 scopus 로고    scopus 로고
    • Increasing the cyclodextrin complexation of drugs and drug bioavailability through addition of water-soluble polymers
    • T. Loftsson Increasing the cyclodextrin complexation of drugs and drug bioavailability through addition of water-soluble polymers Pharmazie 53 11 1998 733 740
    • (1998) Pharmazie , vol.53 , Issue.11 , pp. 733-740
    • Loftsson, T.1
  • 22
    • 0032214518 scopus 로고    scopus 로고
    • Biopharmaceutical characterization of oral immediate release drug products. in vitro in vivo comparison of phenoxymethylpenicillin potassium, glimepiride and levofloxacin
    • A. Frick, H. Moller, and E. Wirbitzki Biopharmaceutical characterization of oral immediate release drug products. In vitro in vivo comparison of phenoxymethylpenicillin potassium, glimepiride and levofloxacin Eur. J. Pharm. Biopharm. 46 3 1998 305 311
    • (1998) Eur. J. Pharm. Biopharm. , vol.46 , Issue.3 , pp. 305-311
    • Frick, A.1    Moller, H.2    Wirbitzki, E.3
  • 23
    • 77149165406 scopus 로고    scopus 로고
    • Predicting drug disposition via application of a biopharmaceutics drug disposition classification system
    • L.Z. Benet Predicting drug disposition via application of a biopharmaceutics drug disposition classification system Basic Clin. Pharmacol. Toxicol. 106 3 2010 162 167
    • (2010) Basic Clin. Pharmacol. Toxicol. , vol.106 , Issue.3 , pp. 162-167
    • Benet, L.Z.1
  • 24
    • 12844258788 scopus 로고    scopus 로고
    • The efficacy and safety of glimepiride in the management of type 2 diabetes in Muslim patients during Ramadan
    • T. Rohban The efficacy and safety of glimepiride in the management of type 2 diabetes in Muslim patients during Ramadan Diabetes Care 28 2 2005 421 422
    • (2005) Diabetes Care , vol.28 , Issue.2 , pp. 421-422
    • Rohban, T.1
  • 25
    • 0344061039 scopus 로고    scopus 로고
    • Addition of rosiglitazone to metformin is most effective in obese, insulin-resistant patients with type 2 diabetes
    • T.A. Jones Addition of rosiglitazone to metformin is most effective in obese, insulin-resistant patients with type 2 diabetes Diabetes Obes. Metab. 5 3 2003 163 170
    • (2003) Diabetes Obes. Metab. , vol.5 , Issue.3 , pp. 163-170
    • Jones, T.A.1
  • 26
    • 69249219332 scopus 로고    scopus 로고
    • Co-solvent solubilization of some poorly-soluble antidiabetic drugs
    • N. Seedher, and M. Kanojia Co-solvent solubilization of some poorly-soluble antidiabetic drugs Pharm. Dev. Technol. 14 2 2009 185 192
    • (2009) Pharm. Dev. Technol. , vol.14 , Issue.2 , pp. 185-192
    • Seedher, N.1    Kanojia, M.2
  • 27
    • 0027435363 scopus 로고
    • Evaluation of sustained controlled-release dosage forms of 3-hydroxy-3-methylglutaryl coenzyme a (Hmg-Coa) reductase inhibitors in dogs and humans
    • H.Y. Cheng Evaluation of sustained controlled-release dosage forms of 3-hydroxy-3-methylglutaryl coenzyme a (Hmg-Coa) reductase inhibitors in dogs and humans Pharm. Res. 10 11 1993 1683 1687
    • (1993) Pharm. Res. , vol.10 , Issue.11 , pp. 1683-1687
    • Cheng, H.Y.1
  • 28
    • 21244445440 scopus 로고    scopus 로고
    • Spray-dried amorphous solid dispersions of simvastatin, a low T-g drug: In vitro and in vivo evaluations
    • A. Paradkar, A.A. Ambike, and K.R. Mahadik Spray-dried amorphous solid dispersions of simvastatin, a low T-g drug: in vitro and in vivo evaluations Pharm. Res. 22 6 2005 990 998
    • (2005) Pharm. Res. , vol.22 , Issue.6 , pp. 990-998
    • Paradkar, A.1    Ambike, A.A.2    Mahadik, K.R.3
  • 29
    • 1842609789 scopus 로고    scopus 로고
    • Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs
    • S.H. Cho Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs Int. J. Pharm. 274 1-2 2004 65 73
    • (2004) Int. J. Pharm. , vol.274 , Issue.12 , pp. 65-73
    • Cho, S.H.1
  • 30
    • 78650830392 scopus 로고    scopus 로고
    • Design and characterization of nanocrystal formulations containing ezetimibe
    • L. Oner, T. Gulsun, and R.N. Gursoy Design and characterization of nanocrystal formulations containing ezetimibe Chem. Pharm. Bull. 59 1 2011 41 45
    • (2011) Chem. Pharm. Bull. , vol.59 , Issue.1 , pp. 41-45
    • Oner, L.1    Gulsun, T.2    Gursoy, R.N.3
  • 31
    • 1842576537 scopus 로고    scopus 로고
    • Dissolution media simulating the intralumenal composition of the small intestine: Physiological issues and practical aspects
    • M. Vertzoni Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects J. Pharm. Pharmacol. 56 4 2004 453 462
    • (2004) J. Pharm. Pharmacol. , vol.56 , Issue.4 , pp. 453-462
    • Vertzoni, M.1
  • 32
    • 12244263506 scopus 로고    scopus 로고
    • Comparison of a miniaturized shake-flask solubility method with automated potentiometric acid/base titrations and calculated solubilities
    • A. Glomme, J. Marz, and J.B. Dressman Comparison of a miniaturized shake-flask solubility method with automated potentiometric acid/base titrations and calculated solubilities J. Pharm. Sci. 94 1 2005 1 16
    • (2005) J. Pharm. Sci. , vol.94 , Issue.1 , pp. 1-16
    • Glomme, A.1    Marz, J.2    Dressman, J.B.3
  • 33
    • 84876915425 scopus 로고    scopus 로고
    • USP, USP 34/NF 29 Rockville MD: United States Pharmacopeia Convention, Inc
    • USP, USP 34/NF 29, I. United States Pharmacopeia Convention. 2011, Rockville MD: United States Pharmacopeia Convention, Inc.
    • (2011) I. United States Pharmacopeia Convention
  • 34
    • 84876916668 scopus 로고    scopus 로고
    • seventh ed. Council of Europe
    • PhEur, European Pharmacopoeia, seventh ed., vol. 7, Council of Europe, 2011.
    • (2011) PhEur, European Pharmacopoeia , vol.7
  • 35
    • 84962061517 scopus 로고    scopus 로고
    • The mini paddle apparatus-a useful tool in the early developmental stage? Experiences with immediate-release dosage forms
    • S. Klein The mini paddle apparatus-a useful tool in the early developmental stage? Experiences with immediate-release dosage forms Dissol. Technol. 13 4 2006 6 11
    • (2006) Dissol. Technol. , vol.13 , Issue.4 , pp. 6-11
    • Klein, S.1
  • 36
    • 63649144572 scopus 로고    scopus 로고
    • A standardized mini paddle apparatus as an alternative to the standard paddle
    • S. Klein, and V. Shah A standardized mini paddle apparatus as an alternative to the standard paddle AAPS. PharmSiTech. 9 4 2008 1179 1184
    • (2008) AAPS. PharmSiTech. , vol.9 , Issue.4 , pp. 1179-1184
    • Klein, S.1    Shah, V.2
  • 37
    • 19544371758 scopus 로고    scopus 로고
    • Ezetimibe-a review of its metabolism, pharmacokinetics and drug interactions
    • T. Kosoglou Ezetimibe-a review of its metabolism, pharmacokinetics and drug interactions Clin. Pharmacokinet. 44 5 2005 467 494
    • (2005) Clin. Pharmacokinet. , vol.44 , Issue.5 , pp. 467-494
    • Kosoglou, T.1
  • 38
    • 0037422375 scopus 로고    scopus 로고
    • Effect of PVPK-25 on the formation of the naproxen: Beta-ciclodextrin complex
    • M. Valero, B.I. Perez-Revuelta, and L.J. Rodriguez Effect of PVPK-25 on the formation of the naproxen: beta-ciclodextrin complex Int. J. Pharm. 253 1-2 2003 97 110
    • (2003) Int. J. Pharm. , vol.253 , Issue.12 , pp. 97-110
    • Valero, M.1    Perez-Revuelta, B.I.2    Rodriguez, L.J.3
  • 39
    • 33746444733 scopus 로고    scopus 로고
    • Implication of inclusion complexation of glimepiride in cyclodextrin-polymer systems on its dissolution, stability and therapeutic efficacy
    • H.O. Ammar Implication of inclusion complexation of glimepiride in cyclodextrin-polymer systems on its dissolution, stability and therapeutic efficacy Int. J. Pharmaceut. 320 1-2 2006 53 57
    • (2006) Int. J. Pharmaceut. , vol.320 , Issue.12 , pp. 53-57
    • Ammar, H.O.1
  • 40
    • 68249128120 scopus 로고    scopus 로고
    • Supersaturating drug delivery systems: The answer to solubility-limited oral bioavailability?
    • P. Augustijns, J. Brouwers, and M.E. Brewster Supersaturating drug delivery systems: the answer to solubility-limited oral bioavailability? J. Pharm. Sci. 98 8 2009 2549 2572
    • (2009) J. Pharm. Sci. , vol.98 , Issue.8 , pp. 2549-2572
    • Augustijns, P.1    Brouwers, J.2    Brewster, M.E.3
  • 41
    • 84860745465 scopus 로고    scopus 로고
    • Application of a ternary HP-beta-CD-complex approach to improve the dissolution performance of a poorly soluble weak acid under biorelevant conditions
    • T. Zoeller, J.B. Dressman, and S. Klein Application of a ternary HP-beta-CD-complex approach to improve the dissolution performance of a poorly soluble weak acid under biorelevant conditions Int. J. Pharm. 430 1-2 2012 176 183
    • (2012) Int. J. Pharm. , vol.430 , Issue.12 , pp. 176-183
    • Zoeller, T.1    Dressman, J.B.2    Klein, S.3
  • 42
    • 44749087279 scopus 로고    scopus 로고
    • Dissolution media simulating conditions in the proximal human gastrointestinal tract: An update
    • E. Jantratid Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update Pharm. Res. 25 7 2008 1663 1676
    • (2008) Pharm. Res. , vol.25 , Issue.7 , pp. 1663-1676
    • Jantratid, E.1
  • 43
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of classes i and II drugs
    • J.B. Dressman Evaluation of various dissolution media for predicting in vivo performance of classes I and II drugs Pharm. Res. 15 5 1998 698 705
    • (1998) Pharm. Res. , vol.15 , Issue.5 , pp. 698-705
    • Dressman, J.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.