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Volumn 12, Issue 3, 2011, Pages 799-810

Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: Development of controlled-release tablets

Author keywords

Box Behnken design; dissolution; felodipine; QbD; solid mixture

Indexed keywords

CARBOPOL 974P; FELODIPINE; HYDROXYPROPYLMETHYLCELLULOSE; POLOXAMER; POLYMER; SURFACTANT;

EID: 80052568927     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9646-6     Document Type: Article
Times cited : (66)

References (31)
  • 3
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding, and control
    • 18185986 10.1007/s11095-007-9511-1 1:CAS:528:DC%2BD1cXkt1Sntrg%3D
    • LX Yu 2008 Pharmaceutical quality by design: product and process development, understanding, and control Pharm Res 25 4 781 91 18185986 10.1007/s11095-007-9511-1 1:CAS:528:DC%2BD1cXkt1Sntrg%3D
    • (2008) Pharm Res , vol.25 , Issue.4 , pp. 781-91
    • Yu, L.X.1
  • 4
    • 51849157426 scopus 로고    scopus 로고
    • Effect of poloxamer on the dissolution of felodipine and preparation of controlled release matrix tablets containing felodipine
    • 18787792 10.1007/s12272-001-1263-9 1:CAS:528:DC%2BD1cXhtVClurrJ
    • KR Lee EJ Kim SW Seo HK Choi 2008 Effect of poloxamer on the dissolution of felodipine and preparation of controlled release matrix tablets containing felodipine Arch Pharm Res 31 8 1023 8 18787792 10.1007/s12272-001-1263-9 1:CAS:528:DC%2BD1cXhtVClurrJ
    • (2008) Arch Pharm Res , vol.31 , Issue.8 , pp. 1023-8
    • Lee, K.R.1    Kim, E.J.2    Seo, S.W.3    Choi, H.K.4
  • 5
    • 0344052670 scopus 로고    scopus 로고
    • Micronization of drugs using supercritical carbon dioxide
    • DOI 10.1016/S0378-5173(99)00063-0, PII S0378517399000630
    • J Kerc S Srcic Z Knez P Sencar-Bozic 1999 Micronization of drugs using supercritical carbon dioxide Int J Pharm 182 1 33 9 10332072 10.1016/S0378-5173(99)00063-0 1:CAS:528:DyaK1MXjtVyksr0%3D (Pubitemid 29229792)
    • (1999) International Journal of Pharmaceutics , vol.182 , Issue.1 , pp. 33-39
    • Kerc, J.1    Srcic, S.2    Knez, Z.3    Sencar-Bozic, P.4
  • 6
    • 24644474682 scopus 로고    scopus 로고
    • Miscibility behavior and formation mechanism of stabilized felodipine-polyvinylpyrrolidone amorphous solid dispersions
    • DOI 10.1080/03639040500215958
    • E Karavas G Ktistis A Xenakis E Georgarakis 2005 Miscibility behavior and formation mechanism of stabilized felodipine-polyvinylpyrrolidone amorphous solid dispersions Drug Dev Ind Pharm 31 6 473 89 16109621 10.1080/ 03639040500215958 1:CAS:528:DC%2BD2MXhtVCgu7zO (Pubitemid 41285726)
    • (2005) Drug Development and Industrial Pharmacy , vol.31 , Issue.6 , pp. 473-489
    • Karavas, E.1    Ktistis, G.2    Xenakis, A.3    Georgarakis, E.4
  • 7
    • 34249092945 scopus 로고    scopus 로고
    • Investigation of the release mechanism of a sparingly water-soluble drug from solid dispersions in hydrophilic carriers based on physical state of drug, particle size distribution and drug-polymer interactions
    • DOI 10.1016/j.ejpb.2006.11.020, PII S0939641106003390
    • E Karavas E Georgarakis MP Sigalas K Avgoustakis D Bikiaris 2007 Investigation of the release mechanism of a sparingly water-soluble drug from solid dispersions in hydrophilic carriers based on physical state of drug, particle size distribution and drug-polymer interactions Eur J Pharm Biopharm 66 3 334 47 17267194 10.1016/j.ejpb.2006.11.020 1:CAS:528:DC%2BD2sXlsFKmtLg%3D (Pubitemid 46778978)
    • (2007) European Journal of Pharmaceutics and Biopharmaceutics , vol.66 , Issue.3 , pp. 334-347
    • Karavas, E.1    Georgarakis, E.2    Sigalas, M.P.3    Avgoustakis, K.4    Bikiaris, D.5
  • 9
    • 37849045222 scopus 로고    scopus 로고
    • Dissolution improvement of four poorly water soluble drugs by cogrinding with commonly used excipients
    • 17574401 10.1016/j.ejpb.2007.05.009 1:CAS:528:DC%2BD1cXlsF2rsQ%3D%3D
    • M Vogt K Kunath JB Dressman 2008 Dissolution improvement of four poorly water soluble drugs by cogrinding with commonly used excipients Eur J Pharm Biopharm 68 330 7 17574401 10.1016/j.ejpb.2007.05.009 1:CAS:528: DC%2BD1cXlsF2rsQ%3D%3D
    • (2008) Eur J Pharm Biopharm , vol.68 , pp. 330-7
    • Vogt, M.1    Kunath, K.2    Dressman, J.B.3
  • 10
    • 33846256269 scopus 로고    scopus 로고
    • Influence of different polymers on the crystallization tendency of molecularly dispersed amorphous felodipine
    • DOI 10.1002/jps.20697
    • H Konno LS Taylor 2006 Influence of different polymers on the crystallization tendency of molecularly dispersed amorphous felodipine J Pharm Sci 95 12 2692 705 16892209 10.1002/jps.20697 1:CAS:528:DC%2BD28XhtlSis7%2FE (Pubitemid 46093176)
    • (2006) Journal of Pharmaceutical Sciences , vol.95 , Issue.12 , pp. 2692-2705
    • Konno, H.1    Taylor, L.S.2
  • 11
    • 43349097105 scopus 로고    scopus 로고
    • Ability of different polymers to inhibit the crystallization of amorphous felodipine in the presence of moisture
    • DOI 10.1007/s11095-007-9331-3
    • H Konno LS Taylor 2007 Ability of different polymers to inhibit the crystallization of amorphous felodipine in the presence of moisture Pharm Res 25 4 969 78 17520180 10.1007/s11095-007-9331-3 (Pubitemid 351661822)
    • (2008) Pharmaceutical Research , vol.25 , Issue.4 , pp. 969-978
    • Konno, H.1    Taylor, L.S.2
  • 12
    • 52949150391 scopus 로고    scopus 로고
    • Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine
    • 18577451 10.1016/j.ejpb.2008.05.023 1:CAS:528:DC%2BD1cXhtFOmtbnE
    • H Konno T Handa DE Alonzo LS Taylor 2008 Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine Eur J Pharm Biopharm 70 493 9 18577451 10.1016/j.ejpb.2008.05.023 1:CAS:528: DC%2BD1cXhtFOmtbnE
    • (2008) Eur J Pharm Biopharm , vol.70 , pp. 493-9
    • Konno, H.1    Handa, T.2    Alonzo, D.E.3    Taylor, L.S.4
  • 13
    • 39849100697 scopus 로고    scopus 로고
    • Chitosan-sodium alginate nanoparticles as submicroscopic reservoirs for ocular delivery: Formulation, optimisation and in vitro characterisation
    • DOI 10.1016/j.ejpb.2007.09.009, PII S0939641107003086
    • SK Motwani S Chopra S Talegaonkar K Kohli FJ Ahmad RK Khar 2008 Chitosan-sodium alginate nanoparticles as submicroscopic reservoirs for ocular delivery: formulation, optimisation and in vitro characterisation Eur J Pharm Biopharm 68 3 513 25 17983737 1:CAS:528:DC%2BD1cXjtVeksLk%3D (Pubitemid 351318222)
    • (2008) European Journal of Pharmaceutics and Biopharmaceutics , vol.68 , Issue.3 , pp. 513-525
    • Motwani, S.K.1    Chopra, S.2    Talegaonkar, S.3    Kohli, K.4    Ahmad, F.J.5    Khar, R.K.6
  • 14
    • 23944480400 scopus 로고    scopus 로고
    • Improved physicochemical characteristics of felodipine solid dispersion particles by supercritical anti-solvent precipitation process
    • DOI 10.1016/j.ijpharm.2005.05.017, PII S0378517305003224
    • DH Won MS Kim S Lee JS Park SJ Hwang 2005 Improved physicochemical characteristics of felodipine solid dispersion particles by supercritical anti-solvent precipitation process Int J Pharm 301 1-2 199 208 16024189 10.1016/j.ijpharm.2005.05.017 1:CAS:528:DC%2BD2MXptVWhtr0%3D (Pubitemid 41206604)
    • (2005) International Journal of Pharmaceutics , vol.301 , Issue.1-2 , pp. 199-208
    • Won, D.-H.1    Kim, M.-S.2    Lee, S.3    Park, J.-S.4    Hwang, S.-J.5
  • 15
    • 0016422844 scopus 로고
    • The concept of dissolution efficiency
    • 235616 10.1111/j.2042-7158.1975.tb09378.x 1:CAS:528:DyaE2MXhsVCru7o%3D
    • KA Khan 1975 The concept of dissolution efficiency J Pharm Pharmacol 27 1 48 9 235616 10.1111/j.2042-7158.1975.tb09378.x 1:CAS:528:DyaE2MXhsVCru7o%3D
    • (1975) J Pharm Pharmacol , vol.27 , Issue.1 , pp. 48-9
    • Khan, K.A.1
  • 16
    • 28444498145 scopus 로고    scopus 로고
    • Study of formulation variables influencing the drug release rate from matrix tablets by experimental design
    • DOI 10.1016/j.ejpb.2005.07.001, PII S0939641105001980
    • S Furlanetto M Cirri F Maestrelli G Corti P Mura 2006 Study of formulation variables influencing the drug release rate from matrix tablets by experimental design Eur J Pharm Biopharm 62 77 84 16154333 10.1016/j.ejpb.2005. 07.001 1:CAS:528:DC%2BD2MXht1Ontb%2FJ (Pubitemid 41736028)
    • (2006) European Journal of Pharmaceutics and Biopharmaceutics , vol.62 , Issue.1 , pp. 77-84
    • Furlanetto, S.1    Cirri, M.2    Maestrelli, F.3    Corti, G.4    Mura, P.5
  • 17
    • 52949134081 scopus 로고    scopus 로고
    • Evaluation of the formulation of solid dispersions by co-spray drying itraconazole with Inutec SP1, a polymeric surfactant, in combination with PVPVA 64
    • 18582567 10.1016/j.ejpb.2008.05.025 1:CAS:528:DC%2BD1cXhtFOmtbbM
    • S Janssens JV Humbeeck G Van den Mooter 2008 Evaluation of the formulation of solid dispersions by co-spray drying itraconazole with Inutec SP1, a polymeric surfactant, in combination with PVPVA 64 Eur J Pharm Biopharm 70 2 500 5 18582567 10.1016/j.ejpb.2008.05.025 1:CAS:528:DC%2BD1cXhtFOmtbbM
    • (2008) Eur J Pharm Biopharm , vol.70 , Issue.2 , pp. 500-5
    • Janssens, S.1    Humbeeck, J.V.2    Van Den Mooter, G.3
  • 18
    • 0033735234 scopus 로고    scopus 로고
    • Effect of water-soluble carriers on dissolution characteristics of nifedipine solid dispersions
    • 11068687 10.1081/DDC-100100985 1:CAS:528:DC%2BD3cXnvVSntbY%3D
    • S Chutimaworapan GC Ritthidej E Yonemochi T Oguchi K Yamamoto 2000 Effect of water-soluble carriers on dissolution characteristics of nifedipine solid dispersions Drug Dev Ind Pharm 26 11 1141 50 11068687 10.1081/DDC-100100985 1:CAS:528:DC%2BD3cXnvVSntbY%3D
    • (2000) Drug Dev Ind Pharm , vol.26 , Issue.11 , pp. 1141-50
    • Chutimaworapan, S.1    Ritthidej, G.C.2    Yonemochi, E.3    Oguchi, T.4    Yamamoto, K.5
  • 19
    • 45849092587 scopus 로고    scopus 로고
    • Preparation, characterization and in vitro evaluation of solid dispersions containing docetaxel
    • DOI 10.1080/03639040701831835, PII 792332639
    • J Chen L Qiu M Hu Y Jin J Han 2008 Preparation, characterization and in vitro evaluation of solid dispersions containing docetaxel Drug Dev Ind Pharm 34 6 588 94 18568908 10.1080/03639040701831835 1:CAS:528:DC%2BD1cXnsVSqsLw%3D (Pubitemid 351878675)
    • (2008) Drug Development and Industrial Pharmacy , vol.34 , Issue.6 , pp. 588-594
    • Chen, J.1    Qiu, L.2    Hu, M.3    Jin, Y.4    Han, J.5
  • 20
    • 33646799460 scopus 로고    scopus 로고
    • Evaluation of Inutec SP1 as a new carrier in the formulation of solid dispersions for poorly soluble drugs
    • DOI 10.1016/j.ijpharm.2006.02.025, PII S0378517306001499
    • G Van den Mooter I Weuts T De Ridder N Blaton 2006 Evaluation of Inutec SP1 as a new carrier in the formulation of solid dispersions for poorly soluble drugs Int J Pharm 316 1-2 1 6 16563676 10.1016/j.ijpharm.2006.02.025 (Pubitemid 43765697)
    • (2006) International Journal of Pharmaceutics , vol.316 , Issue.1-2 , pp. 1-6
    • Van Den Mooter, G.1    Weuts, I.2    De Ridder, T.3    Blaton, N.4
  • 21
    • 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
    • DOI 10.1016/j.ijpharm.2006.08.010, PII S0378517306006491
    • AN Ghebremeskel C Vemavarapu M Lodaya 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 2 119 29 16968659 10.1016/j.ijpharm.2006.08.010 1:CAS:528:DC%2BD28XhtlWqurnF (Pubitemid 44895482)
    • (2007) International Journal of Pharmaceutics , vol.328 , Issue.2 , pp. 119-129
    • Ghebremeskel, A.N.1    Vemavarapu, C.2    Lodaya, M.3
  • 22
    • 0032756138 scopus 로고    scopus 로고
    • Physical properties of solid molecular dispersions of indomethacin with poly(vinylpyrrolidone) and poly(vinylpyrrolidone-co-vinyl-acetate) in relation to indomethacin crystallization
    • DOI 10.1023/A:1018906132279
    • T Matsumoto G Zografi 1999 Physical properties of solid molecular dispersions of indomethacin with poly(vinylpyrrolidone) and poly(vinylpyrrolidone-co-vinyl-acetate) in relation to indomethacin crystallization Pharm Res 16 11 1722 8 10571278 10.1023/A:1018906132279 1:CAS:528:DyaK1MXnt1GgsL4%3D (Pubitemid 29530405)
    • (1999) Pharmaceutical Research , vol.16 , Issue.11 , pp. 1722-1728
    • Matsumoto, T.1    Zografi, G.2
  • 23
    • 0017235421 scopus 로고
    • Dissolution rates of high energy sulfathiazole-povidone coprecipitates II: Characterization of form of drug controlling its dissolution rate via solubility studies
    • 1263082 10.1002/jps.2600650310 1:CAS:528:DyaE28XhvVCrsLY%3D
    • AP Simonelli SC Mehta WI Higuchi 1976 Dissolution rates of high energy sulfathiazole-povidone coprecipitates II: characterization of form of drug controlling its dissolution rate via solubility studies J Pharm Sci 65 3 355 61 1263082 10.1002/jps.2600650310 1:CAS:528:DyaE28XhvVCrsLY%3D
    • (1976) J Pharm Sci , vol.65 , Issue.3 , pp. 355-61
    • Simonelli, A.P.1    Mehta, S.C.2    Higuchi, W.I.3
  • 24
    • 0031958399 scopus 로고    scopus 로고
    • Influence of water-soluble polymers on the dissolution of Nifedipine solid dispersions with combined carriers
    • H Suzuki H Sunada 1998 Influence of water-soluble polymers on the dissolution of nifedipine solid dispersions with combined carriers Chem Pharm Bull (Tokyo) 46 3 482 7 1:CAS:528:DyaK1cXit1Kms7k%3D (Pubitemid 28188567)
    • (1998) Chemical and Pharmaceutical Bulletin , vol.46 , Issue.3 , pp. 482-487
    • Suzuki, H.1    Sunada, H.2
  • 25
    • 0035895236 scopus 로고    scopus 로고
    • Crystallization of hydrocortisone acetate: Influence of polymers
    • DOI 10.1016/S0378-5173(00)00610-4, PII S0378517300006104
    • SL Raghavan A Trividic AF Davis J Hadgraft 2001 Crystallization of hydrocortisone acetate: influence of polymers Int J Pharm 212 2 213 21 11165079 10.1016/S0378-5173(00)00610-4 1:CAS:528:DC%2BD3MXmvFKktw%3D%3D (Pubitemid 32119447)
    • (2001) International Journal of Pharmaceutics , vol.212 , Issue.2 , pp. 213-221
    • Raghavan, S.L.1    Trividic, A.2    Davis, A.F.3    Hadgraft, J.4
  • 26
    • 0030805738 scopus 로고    scopus 로고
    • Inhibitory effects of water-soluble polymers on precipitation of RS-8359
    • DOI 10.1016/S0378-5173(97)00129-4, PII S0378517397001294
    • F Usui K Maeda A Kusai K Nishimura K Yamamoto 1997 Inhibitory effects of water-soluble polymers on precipitation of RS-8359 Int J Pharm 154 59 66 10.1016/S0378-5173(97)00129-4 1:CAS:528:DyaK2sXltl2lur0%3D (Pubitemid 27326820)
    • (1997) International Journal of Pharmaceutics , vol.154 , Issue.1 , pp. 59-66
    • Usui, F.1    Maeda, K.2    Kusai, A.3    Nishimura, K.4    Yamamoto, K.5
  • 27
    • 0031856830 scopus 로고    scopus 로고
    • Formulation and in vitro evaluation of ibuprofen-carbopol 974P-NF controlled release matrix tablets III: Influence of co-excipients on release rate of the drug
    • DOI 10.1016/S0168-3659(97)00225-3, PII S0168365997002253
    • GM Khan Z Jiabi 1998 Formulation and in vitro evaluation of ibuprofen-Carbopol 974P-NF controlled release matrix tablets III: influence of co-excipients on release rate of the drug J Control Release 54 2 185 90 9724905 10.1016/S0168-3659(97)00225-3 1:CAS:528:DyaK1cXksVWntrc%3D (Pubitemid 28342697)
    • (1998) Journal of Controlled Release , vol.54 , Issue.2 , pp. 185-190
    • Khan, G.M.1    Jiabi, Z.2
  • 28
    • 0001918207 scopus 로고    scopus 로고
    • Hydrophilic cellulose derivatives as drug delivery carriers: Influence of the substitution type on the properties of compressed matrix tablets
    • D.L. Wise (eds). Marcell Dekker New York, USA
    • Rodriguez CF, Bruneau N, Barra J, Alfonso D, Doelker E. Hydrophilic cellulose derivatives as drug delivery carriers: influence of the substitution type on the properties of compressed matrix tablets. In: Wise DL, editor. Handbook of pharmaceutical controlled release technology. New York, USA: Marcell Dekker; 2000. p. 1-30.
    • (2000) Handbook of Pharmaceutical Controlled Release Technology , pp. 1-30
    • Rodriguez, C.F.1    Bruneau, N.2    Barra, J.3    Alfonso, D.4    Doelker, E.5
  • 29
    • 0033952741 scopus 로고    scopus 로고
    • High molecular weight polyethylene oxides (PEOs) as an alternative to HPMC in controlled release dosage forms
    • DOI 10.1016/S0378-5173(99)00402-0, PII S0378517399004020
    • L Maggi R Bruni U Conte 2000 High molecular weight polyethylene oxides (PEOs) as an alternative to HPMC in controlled release dosage forms Int J Pharm 195 1-2 229 38 10675700 10.1016/S0378-5173(99)00402-0 1:CAS:528: DC%2BD3cXhtV2ht7w%3D (Pubitemid 30089507)
    • (2000) International Journal of Pharmaceutics , vol.195 , Issue.1-2 , pp. 229-238
    • Maggi, L.1    Bruni, R.2    Conte, U.3
  • 30
    • 0033991012 scopus 로고    scopus 로고
    • Controlled release from solid dispersion composed of poly(ethylene oxide)-carbopol interpolymer complex with various cross-linking degrees of carbopol
    • 10601724 10.1016/S0168-3659(99)00202-3 1:CAS:528:DyaK1MXnvFSmu7s%3D
    • T Ozeki H Yuasa Y Kanaya 2000 Controlled release from solid dispersion composed of poly(ethylene oxide)-carbopol interpolymer complex with various cross-linking degrees of carbopol J Control Release 63 3 287 95 10601724 10.1016/S0168-3659(99)00202-3 1:CAS:528:DyaK1MXnvFSmu7s%3D
    • (2000) J Control Release , vol.63 , Issue.3 , pp. 287-95
    • Ozeki, T.1    Yuasa, H.2    Kanaya, Y.3
  • 31
    • 78649904090 scopus 로고    scopus 로고
    • Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet
    • 10.1208/s12249-010-9467-z 1:CAS:528:DC%2BC3cXhsFemsb7E
    • AA Aboelwafa EB Basalious 2010 Optimization and in vivo pharmacokinetic study of a novel controlled release venlafaxine hydrochloride three-layer tablet AAPS Pharm Sci Tech 11 3 1026 37 10.1208/s12249-010-9467-z 1:CAS:528: DC%2BC3cXhsFemsb7E
    • (2010) AAPS Pharm Sci Tech , vol.11 , Issue.3 , pp. 1026-37
    • Aboelwafa, A.A.1    Basalious, E.B.2


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