메뉴 건너뛰기




Volumn 102, Issue 10, 2013, Pages 3748-3761

Development and evaluation of paclitaxel nanoparticles using a quality-by-design approach

Author keywords

Box Behnken; Design of experiments; Formulation; Mathematical model; Multivariate analysis; Nanoparticles; Paclitaxel; Plackett Burman; Polymeric drug delivery systems; Quality by design

Indexed keywords

NANOPARTICLE; PACLITAXEL;

EID: 84883748038     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23686     Document Type: Article
Times cited : (83)

References (40)
  • 1
    • 84883790525 scopus 로고    scopus 로고
    • US FDA. 2004. Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Silver Spring, Maryland: US FDA.
    • US FDA. 2004. Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Silver Spring, Maryland: US FDA.
  • 2
    • 84883751632 scopus 로고    scopus 로고
    • ICH. 2009. Q8(R2): Pharmaceutical Development. Geneva, Switzerland: ICH.
    • ICH. 2009. Q8(R2): Pharmaceutical Development. Geneva, Switzerland: ICH.
  • 3
    • 84862777856 scopus 로고    scopus 로고
    • Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate
    • Awotwe-Otoo D, Agarabi C, Faustino PJ, Habib MJ, Lee S, Khan MA, Shah RB. 2012. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. J Pharm Biomed Anal 62:61-67.
    • (2012) J Pharm Biomed Anal , vol.62 , pp. 61-67
    • Awotwe-Otoo, D.1    Agarabi, C.2    Faustino, P.J.3    Habib, M.J.4    Lee, S.5    Khan, M.A.6    Shah, R.B.7
  • 5
    • 34547106058 scopus 로고    scopus 로고
    • Quality by design: Characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology
    • Shah RB, Zidan AS, Funck T, Tawakkul MA, Nguyenpho A, Khan MA. 2007. Quality by design: Characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology. Int J Pharm 341(1-2):189-194.
    • (2007) Int J Pharm , vol.341 , Issue.1-2 , pp. 189-194
    • Shah, R.B.1    Zidan, A.S.2    Funck, T.3    Tawakkul, M.A.4    Nguyenpho, A.5    Khan, M.A.6
  • 6
    • 67649660193 scopus 로고    scopus 로고
    • Quality by design approach to understand the process of nanosuspension preparation
    • Verma S, Lan Y, Gokhale R, Burgess DJ. 2009. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm 377(1-2):185-198.
    • (2009) Int J Pharm , vol.377 , Issue.1-2 , pp. 185-198
    • Verma, S.1    Lan, Y.2    Gokhale, R.3    Burgess, D.J.4
  • 7
    • 68249125315 scopus 로고    scopus 로고
    • Quality-by-design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point
    • Wu H, Khan MA. 2009. Quality-by-design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point. J Pharm Sci 98(8):2784-2798.
    • (2009) J Pharm Sci , vol.98 , Issue.8 , pp. 2784-2798
    • Wu, H.1    Khan, M.A.2
  • 8
    • 76649117080 scopus 로고    scopus 로고
    • Quality-by-design (QbD): An integrated process analytical technology (PAT) approach for real-time monitoring and mapping the state of a pharmaceutical coprecipitation process
    • Wu H, Khan MA. 2010. Quality-by-design (QbD): An integrated process analytical technology (PAT) approach for real-time monitoring and mapping the state of a pharmaceutical coprecipitation process. J Pharm Sci 99(3):1516-1534.
    • (2010) J Pharm Sci , vol.99 , Issue.3 , pp. 1516-1534
    • Wu, H.1    Khan, M.A.2
  • 9
    • 64549088926 scopus 로고    scopus 로고
    • Quality-by-design (QbD): An integrated multivariate approach for the component quantification in powder blends
    • Wu H, Tawakkul M, White M, Khan MA. 2009. Quality-by-design (QbD): An integrated multivariate approach for the component quantification in powder blends. Int J Pharm 372(1-2):39-48.
    • (2009) Int J Pharm , vol.372 , Issue.1-2 , pp. 39-48
    • Wu, H.1    Tawakkul, M.2    White, M.3    Khan, M.A.4
  • 10
    • 54949102425 scopus 로고    scopus 로고
    • Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester
    • Xie L, Wu H, Shen M, Augsburger LL, Lyon RC, Khan MA, Hussain AS, Hoag SW. 2008. Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester. J Pharm Sci 97(10):4485-4497.
    • (2008) J Pharm Sci , vol.97 , Issue.10 , pp. 4485-4497
    • Xie, L.1    Wu, H.2    Shen, M.3    Augsburger, L.L.4    Lyon, R.C.5    Khan, M.A.6    Hussain, A.S.7    Hoag, S.W.8
  • 11
    • 84864151120 scopus 로고    scopus 로고
    • Application of quality by design to formulation and processing of protein liposomes
    • Xu X, Costa AP, Khan MA, Burgess DJ. 2012. Application of quality by design to formulation and processing of protein liposomes. Int J Pharm 434(1-2):349-359.
    • (2012) Int J Pharm , vol.434 , Issue.1-2 , pp. 349-359
    • Xu, X.1    Costa, A.P.2    Khan, M.A.3    Burgess, D.J.4
  • 12
    • 84856558558 scopus 로고    scopus 로고
    • A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale
    • Xu X, Khan MA, Burgess DJ. 2012. A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale. Int J Pharm 423(2):543-553.
    • (2012) Int J Pharm , vol.423 , Issue.2 , pp. 543-553
    • Xu, X.1    Khan, M.A.2    Burgess, D.J.3
  • 13
    • 34748836023 scopus 로고    scopus 로고
    • Quality by design: Understanding the product variability of a self-nanoemulsified drug delivery system of cyclosporine A
    • Zidan AS, Sammour OA, Hammad MA, Megrab NA, Habib MJ, Khan MA. 2007. Quality by design: Understanding the product variability of a self-nanoemulsified drug delivery system of cyclosporine A. J Pharm Sci 96(9):2409-2423.
    • (2007) J Pharm Sci , vol.96 , Issue.9 , pp. 2409-2423
    • Zidan, A.S.1    Sammour, O.A.2    Hammad, M.A.3    Megrab, N.A.4    Habib, M.J.5    Khan, M.A.6
  • 14
    • 34249744715 scopus 로고    scopus 로고
    • Design of experiments: Concept and applications of Plackett-Burman design
    • Vanaja K, Shobha Rani RH 2007. Design of experiments: Concept and applications of Plackett-Burman design. Clin Res Regul Aff 24(1):1-23.
    • (2007) Clin Res Regul Aff , vol.24 , Issue.1 , pp. 1-23
    • Vanaja, K.1    Shobha Rani, R.H.2
  • 15
    • 84867397163 scopus 로고    scopus 로고
    • Quality by design: Impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody
    • Awotwe-Otoo D, Agarabi C, Wu GK, Casey E, Read E, Lute S, Brorson KA, Khan MA, Shah RB. 2012. Quality by design: Impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody. Int J Pharm 438(1-2):167-175.
    • (2012) Int J Pharm , vol.438 , Issue.1-2 , pp. 167-175
    • Awotwe-Otoo, D.1    Agarabi, C.2    Wu, G.K.3    Casey, E.4    Read, E.5    Lute, S.6    Brorson, K.A.7    Khan, M.A.8    Shah, R.B.9
  • 16
    • 84946657020 scopus 로고
    • Some new three level designs for the study of quantitative variables
    • Box GEP, Behnken DW. 1960. Some new three level designs for the study of quantitative variables. Technometrics 2(4):455-475.
    • (1960) Technometrics , vol.2 , Issue.4 , pp. 455-475
    • Box, G.E.P.1    Behnken, D.W.2
  • 17
    • 0033988302 scopus 로고    scopus 로고
    • Captopril gastrointestinal therapeutic system coated with cellulose acetate pseudolatex: Evaluation of main effects of several formulation variables
    • Khan MA, Sastry SV, Vaithiyalingam SR, Agarwal V, Nazzal S, Reddy IK. 2000. Captopril gastrointestinal therapeutic system coated with cellulose acetate pseudolatex: Evaluation of main effects of several formulation variables. Int J Pharm 193(2):147-156.
    • (2000) Int J Pharm , vol.193 , Issue.2 , pp. 147-156
    • Khan, M.A.1    Sastry, S.V.2    Vaithiyalingam, S.R.3    Agarwal, V.4    Nazzal, S.5    Reddy, I.K.6
  • 18
    • 0001131698 scopus 로고
    • The design of optimum multifactorial experiments
    • Plackett RL, Burman JP. 1946. The design of optimum multifactorial experiments. Biometrika 33(4):305-325.
    • (1946) Biometrika , vol.33 , Issue.4 , pp. 305-325
    • Plackett, R.L.1    Burman, J.P.2
  • 19
    • 77349122289 scopus 로고    scopus 로고
    • Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design
    • Rahman Z, Zidan AS, Habib MJ, Khan MA. 2010. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm 389(1-2):186-194.
    • (2010) Int J Pharm , vol.389 , Issue.1-2 , pp. 186-194
    • Rahman, Z.1    Zidan, A.S.2    Habib, M.J.3    Khan, M.A.4
  • 20
    • 33846852628 scopus 로고    scopus 로고
    • Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function
    • Zidan AS, Sammour OA, Hammad MA, Megrab NA, Habib MJ, Khan MA. 2007. Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. Int J Pharm 332(1-2):55-63.
    • (2007) Int J Pharm , vol.332 , Issue.1-2 , pp. 55-63
    • Zidan, A.S.1    Sammour, O.A.2    Hammad, M.A.3    Megrab, N.A.4    Habib, M.J.5    Khan, M.A.6
  • 21
    • 79959770668 scopus 로고    scopus 로고
    • Characterization, pharmacokinetics and disposition of novel nanoscale preparations of paclitaxel
    • Wang C, Wang Y, Wang Y, Fan M, Luo F, Qian Z. 2011. Characterization, pharmacokinetics and disposition of novel nanoscale preparations of paclitaxel. Int J Pharm 414(1-2):251-259.
    • (2011) Int J Pharm , vol.414 , Issue.1-2 , pp. 251-259
    • Wang, C.1    Wang, Y.2    Wang, Y.3    Fan, M.4    Luo, F.5    Qian, Z.6
  • 22
    • 78650697312 scopus 로고    scopus 로고
    • High loading efficiency and sustained release of siRNA encapsulated in PLGA nanoparticles: Quality by design optimization and characterization
    • Cun D, Jensen DK, Maltesen MJ, Bunker M, Whiteside P, Scurr D, Foged C, Nielsen HM. 2011. High loading efficiency and sustained release of siRNA encapsulated in PLGA nanoparticles: Quality by design optimization and characterization. Eur J Pharm Biopharm 77(1):26-35.
    • (2011) Eur J Pharm Biopharm , vol.77 , Issue.1 , pp. 26-35
    • Cun, D.1    Jensen, D.K.2    Maltesen, M.J.3    Bunker, M.4    Whiteside, P.5    Scurr, D.6    Foged, C.7    Nielsen, H.M.8
  • 23
    • 67650115442 scopus 로고    scopus 로고
    • Preparation and characterization of negatively charged poly(lactic-co-glycolic acid) microspheres
    • Xu Q, Crossley A, Czernuszka J. 2009. Preparation and characterization of negatively charged poly(lactic-co-glycolic acid) microspheres. J Pharm Sci 98(7):2377-2389.
    • (2009) J Pharm Sci , vol.98 , Issue.7 , pp. 2377-2389
    • Xu, Q.1    Crossley, A.2    Czernuszka, J.3
  • 24
    • 70350244685 scopus 로고    scopus 로고
    • PLGA nanoparticles stabilized with cationic surfactant: Safety studies and application in oral delivery of paclitaxel to treat chemical-induced breast cancer in rat
    • Bhardwaj V, Ankola DD, Gupta SC, Schneider M, Lehr CM, Kumar MNVR. 2009. PLGA nanoparticles stabilized with cationic surfactant: Safety studies and application in oral delivery of paclitaxel to treat chemical-induced breast cancer in rat. Pharm Res 26(11):2495-2503.
    • (2009) Pharm Res , vol.26 , Issue.11 , pp. 2495-2503
    • Bhardwaj, V.1    Ankola, D.D.2    Gupta, S.C.3    Schneider, M.4    Lehr, C.M.5    Kumar, M.N.V.R.6
  • 25
    • 77956934839 scopus 로고    scopus 로고
    • Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel
    • Kollipara S, Bende G, Movva S, Saha R. 2010. Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel. Drug Dev Ind Pharm 36(11):1377-1387.
    • (2010) Drug Dev Ind Pharm , vol.36 , Issue.11 , pp. 1377-1387
    • Kollipara, S.1    Bende, G.2    Movva, S.3    Saha, R.4
  • 26
    • 0023557345 scopus 로고
    • The preparation and evaluation of drug-containing poly(dl-lactide) microspheres formed by the solvent evaporation method
    • Bodmeier R, McGinity JW. 1987. The preparation and evaluation of drug-containing poly(dl-lactide) microspheres formed by the solvent evaporation method. Pharm Res 4(6):465-471.
    • (1987) Pharm Res , vol.4 , Issue.6 , pp. 465-471
    • Bodmeier, R.1    McGinity, J.W.2
  • 27
    • 80053568116 scopus 로고    scopus 로고
    • A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment
    • Xu X, Khan MA, Burgess DJ. 2011. A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment. Int J Pharm 419(1-2):52-59.
    • (2011) Int J Pharm , vol.419 , Issue.1-2 , pp. 52-59
    • Xu, X.1    Khan, M.A.2    Burgess, D.J.3
  • 28
    • 34248638766 scopus 로고    scopus 로고
    • Enhanced solubility and stability of PEGylated liposomal paclitaxel: In vitro and in vivo evaluation
    • Yang T, Cui FD, Choi MK, Cho JW, Chung SJ, Shim CK, Kim DD. 2007. Enhanced solubility and stability of PEGylated liposomal paclitaxel: In vitro and in vivo evaluation. Int J Pharm 338(1-2):317-326.
    • (2007) Int J Pharm , vol.338 , Issue.1-2 , pp. 317-326
    • Yang, T.1    Cui, F.D.2    Choi, M.K.3    Cho, J.W.4    Chung, S.J.5    Shim, C.K.6    Kim, D.D.7
  • 29
    • 70349137110 scopus 로고    scopus 로고
    • In-vitro evaluation of paclitaxel-loaded MPEG-PLGA nanoparticles on laryngeal cancer cells
    • Gao CL, Pan J, Lu WY, Zhang M, Zhou L, Tian J. 2009. In-vitro evaluation of paclitaxel-loaded MPEG-PLGA nanoparticles on laryngeal cancer cells. Anticancer Drug 20(9):807-814.
    • (2009) Anticancer Drug , vol.20 , Issue.9 , pp. 807-814
    • Gao, C.L.1    Pan, J.2    Lu, W.Y.3    Zhang, M.4    Zhou, L.5    Tian, J.6
  • 30
    • 84861812126 scopus 로고    scopus 로고
    • PEG-PE-based micelles co-loaded with paclitaxel and cyclosporine A or loaded with paclitaxel and targeted by anticancer antibody overcome drug resistance in cancer cells
    • Sarisozen C, Vural I, Levchenko T, Hincal AA, Torchilin VP. 2012. PEG-PE-based micelles co-loaded with paclitaxel and cyclosporine A or loaded with paclitaxel and targeted by anticancer antibody overcome drug resistance in cancer cells. Drug Deliv 19(4):169-176.
    • (2012) Drug Deliv , vol.19 , Issue.4 , pp. 169-176
    • Sarisozen, C.1    Vural, I.2    Levchenko, T.3    Hincal, A.A.4    Torchilin, V.P.5
  • 31
    • 77956647233 scopus 로고    scopus 로고
    • Preparation and characterization of biodegradable paclitaxel loaded alginate microparticles for pulmonary delivery
    • Alipour S, Montaseri H, Tafaghodi M. 2010. Preparation and characterization of biodegradable paclitaxel loaded alginate microparticles for pulmonary delivery. Colloids Surf B Biointerfaces 81(2):521-529.
    • (2010) Colloids Surf B Biointerfaces , vol.81 , Issue.2 , pp. 521-529
    • Alipour, S.1    Montaseri, H.2    Tafaghodi, M.3
  • 32
    • 0015453518 scopus 로고
    • Linearization of dissolution rate curves by the Weibull distribution
    • Langenbucher F. 1972. Linearization of dissolution rate curves by the Weibull distribution. J Pharm Pharmacol 24(12):979-981.
    • (1972) J Pharm Pharmacol , vol.24 , Issue.12 , pp. 979-981
    • Langenbucher, F.1
  • 33
    • 0033969801 scopus 로고    scopus 로고
    • Biodegradable progesterone microsphere delivery system for osteoporosis therapy
    • Yang Q, Owusu-Ababio G 2000. Biodegradable progesterone microsphere delivery system for osteoporosis therapy. Drug Dev Ind Pharm 26(1):61-70.
    • (2000) Drug Dev Ind Pharm , vol.26 , Issue.1 , pp. 61-70
    • Yang, Q.1    Owusu-Ababio, G.2
  • 34
    • 34547903625 scopus 로고    scopus 로고
    • The characterization of paclitaxel-loaded microspheres manufactured from blends of poly(lactic-co-glycolic acid) (PLGA) and low molecular weight diblock copolymers
    • Jackson JK, Hung T, Letchford K, Burt HM. 2007. The characterization of paclitaxel-loaded microspheres manufactured from blends of poly(lactic-co-glycolic acid) (PLGA) and low molecular weight diblock copolymers. Int J Pharm 342(1-2):6-17.
    • (2007) Int J Pharm , vol.342 , Issue.1-2 , pp. 6-17
    • Jackson, J.K.1    Hung, T.2    Letchford, K.3    Burt, H.M.4
  • 35
    • 55649104973 scopus 로고    scopus 로고
    • Principles of encapsulating hydrophobic drugs in PLA/PLGA microparticles
    • Wischke C, Schwendeman SP. 2008. Principles of encapsulating hydrophobic drugs in PLA/PLGA microparticles. Int J Pharm 364(2):298-327.
    • (2008) Int J Pharm , vol.364 , Issue.2 , pp. 298-327
    • Wischke, C.1    Schwendeman, S.P.2
  • 36
    • 0035073301 scopus 로고    scopus 로고
    • Modeling and comparison of dissolution profiles
    • Costa P, Manuel J, Lobo S. 2001. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 13(2):123-133.
    • (2001) Eur J Pharm Sci , vol.13 , Issue.2 , pp. 123-133
    • Costa, P.1    Manuel, J.2    Lobo, S.3
  • 37
    • 0035848417 scopus 로고    scopus 로고
    • Effects of emulsifiers on the controlled release of paclitaxel (Taxol (R)) from nanospheres of biodegradable polymers
    • Feng SS, Huang GF. 2001. Effects of emulsifiers on the controlled release of paclitaxel (Taxol (R)) from nanospheres of biodegradable polymers. J Control Release 71(1):53-69.
    • (2001) J Control Release , vol.71 , Issue.1 , pp. 53-69
    • Feng, S.S.1    Huang, G.F.2
  • 38
    • 84883817898 scopus 로고    scopus 로고
    • ICH. 2009. Q3C(R4) Impurities: Guideline for residual solvents. Geneva, Switzerland: ICH.
    • ICH. 2009. Q3C(R4) Impurities: Guideline for residual solvents. Geneva, Switzerland: ICH.
  • 39
    • 65949120534 scopus 로고    scopus 로고
    • Doxorubicin and paclitaxel-loaded lipid-based nanoparticles overcome multidrug resistance by inhibiting P-glycoprotein and depleting ATP
    • Dong X, Mattingly CA, Tseng MT, Cho MJ, Liu Y, Adams VR, Mumper RJ. 2009. Doxorubicin and paclitaxel-loaded lipid-based nanoparticles overcome multidrug resistance by inhibiting P-glycoprotein and depleting ATP Cancer Res 69(9):3918-3926.
    • (2009) Cancer Res , vol.69 , Issue.9 , pp. 3918-3926
    • Dong, X.1    Mattingly, C.A.2    Tseng, M.T.3    Cho, M.J.4    Liu, Y.5    Adams, V.R.6    Mumper, R.J.7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.