• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
LI Hui, ZHAO Yueqing, JIANG Niyanhan, CHENG Zeneng. A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets[J]. Journal of China Pharmaceutical University, 2018, 49(3): 301-309. DOI: 10.11665/j.issn.1000-5048.20180308
Citation: LI Hui, ZHAO Yueqing, JIANG Niyanhan, CHENG Zeneng. A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets[J]. Journal of China Pharmaceutical University, 2018, 49(3): 301-309. DOI: 10.11665/j.issn.1000-5048.20180308

A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets

More Information
  • A new method of dissolution test was established to better simulate the in vivo dissolution behavior of drugs from preparations and to distinguish the quality difference between drug preparations. With flow-through cell being chosen to be the dissolution apparatus and nimodipine tablet to be the model drugs, this study developed, on the basis of IVIVC theory, a new dissolution method which was subsequently used to evaluate the dissolution consistency of domestically produced nimodipine tablet as test preparation and its reference preparation. Meanwhile, conventional four-dissolution-curves method based on paddle apparatus was selected for comparison to evaluate the efficiency of the new dissolution method. The results indicated that the new dissolution method not only had a good correlation with the in vivo process of drugs, but also could reveal the internal quality differences between pharmaceutical preparations effectively. This research will provide further theoretical support for the application of flow-through cell apparatus in IVIVC study.
  • [1]
    Anand O,Lawrence XY,Conner DP,et al.Dissolution testing for generic drugs:an FDA perspective[J].AAPS J,2011,13(3):328.
    [2]
    Tsume Y,Matsui K,Searls AL,et al.The impact of supersaturation level for oral absorption of BCS class IIb drugs,dipyridamole and ketoconazole,using in vivo predictive dissolution system:gastrointestinal simulator(GIS)[J].Eur J Pharm Sci,2017,102(5):126-139.
    [3]
    Li ZQ,He X,Liu CX.Recent advances in drug dissolution/permeation synchronous evaluation technologies based on physiological characteristics of gastrointestinal tract [J].Acta Pharm Sin(药学学报),2016,51(10):1540-1550.
    [4]
    U. S. Food and Drug Administration. Guidance for industry,extended release oral dosage forms:development,evaluation,and application of in vitro/in vivo correlations[EB/OL].(1997-09)[2017-11-13] .https://www.fda.gov/downloads/dru-gs/guidAncecomplianceregulatoryinformation/guidances/ucm070239.pdf.
    [5]
    Gite S,Chogale M,Patravale V.Development and validation of a discriminating dissolution method for atorvastatin delayed-release nanoparticles using a flow through cell:a comparative study using USP apparatus 4 and 1[J].Dissolut Technol,2016,23(2):14-20.
    [6]
    Prajapat MD,Patel NJ,Bariya A,et al.Formulation and evaluation of self-emulsifying drug delivery system for nimodipine,a BCS class II drug[J].J Drug Deliv Sci Tec,2017,39(6):59-68.
    [7]
    Margolskee A,Darwich AS,Galetin A,et al.Deconvolution and IVIVC:exploring the role of rate-limiting conditions[J].AAPS J,2016,18(2):321-332.
    [8]
    Hardikar S, Bhosale AV, Budhawant RN. Establishment of in vivo-in vitro correlation:a cogent strategy in product development process[J].Indian J Pharm Edu,2014,48(4):66-73.
    [9]
    Tsume Y, Mudie DM, Langguth P, et al. The Biopharmaceutics classification system:subclasses for in vivo predictive dissolution(IPD)methodology and IVIVC[J].Eur J Pharm Sci,2014,57(1):152-163.
    [10]
    Kumar V,Lalit Kumar K,Shavej A,et al.Application of assumed IVIVC in product life cycle management:a case study of trimetazidine dihydrochloride extended release tablet[J].J Bioequiv Availab,2013,5(1):006-015.
    [11]
    Suarez-Sharp S,Li M,Duan J,et al.Regulatory experience with in vivo in vitro correlations(IVIVC)in new drug applications[J].AAPS J,2016,18(6):1379-1390.
    [12]
    Rämsch KD,Graefe KH,Scherling D,et al.Pharmacokinetics and metabolism of calcium-blocking agents nifedipine,nitrendipine,and nimodipine[J].Am J Nephrol,1986,6(Suppl 1):73-80.
    [13]
    Gualano V,Ntsikoussalabongui B,Mignot A,et al.Comparative bioavailability of two oral nimodipine formulations after administration to 24 healthy volunteers[J].Clin Drug Invest,1999,17(6):475-482.
    [14]
    Serban C,Sahebkar A,Ursoniu S,et al.A systematic review and meta-analysis of the effect of statins on plasma asymmetric dimethylarginine concentrations[J].Sci Rep,2015,5(1):9902.
    [15]
    González-García I,Mangas-Sanjuán V,Merino-Sanjuán M,et al.In vitro-in vivo correlations:general concepts,methodologies and regulatory applications[J].Drug Dev Ind Pharm,2015,41(12):1935-1947.
    [16]
    Liu J,Ma MC,Chow SC.Statistical evaluation of similarity factor f2 as a criterion for assessment of similarity between dissolution profiles[J].Drug Inf J,1997,31(4):1255-1271.
    [17]
    Shah VP,Tsong Y,Sathe P,et al.In vitro dissolution profile comparison-statistics and analysis of the similarity factor,f2[J].Pharm Res,1998,15(6):889-896.
    [18]
    Tsong Y,Hammerstrom T,Sathe P,et al.Statistical assessment of mean differences between two dissolution data sets[J].Ther Innov Regul Sci,1996,30(4):1105-1112.
    [19]
    Zhang Y,Huo M,Zhou J,et al.DDSolver:an add-in program for modeling and comparison of drug dissolution profiles[J].AAPS J,2010,12(3):263-271.
    [20]
    Chinese Pharmacopoeia Commission.Chinese Pharmacopoeia:part 2(中华人民共和国药典:二部)[S].Beijing:China Medical Science Press,2015:309-310.
    [21]
    U.S.Food and Drug Administration.Guidance for industry.dissolution testing of immediate release solid oral dosage forms[EB/OL].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf.
    [22]
    Cascone S,Lamberti G,Marra F,et al.Gastrointestinal behavior and ADME phenomena:I.In vitro simulation[J].J Drug Deliv Sci Technol,2016,35(5):272-283.
    [23]
    Xie MF.An understanding of "the quality consistency evaluation technique for oral solid pharmaceutical preparation"-multiple dissolution curves[J].Chin J Drug Eval(中国药物评价),2013,30(2):65-66.
  • Related Articles

    [1]LI Zhenming, HUO Meirong, DENG Qidan, CHEN Dengjun, SUN Hongzhang. In vitro evaluation of saxagliptin and metformin hydrochloride sustained-release tablets[J]. Journal of China Pharmaceutical University, 2021, 52(5): 541-546. DOI: 10.11665/j.issn.1000-5048.20210505
    [2]ZHANG Jinlin, YUAN Yaozuo, ZHANG Ya, ZHAO Shuqiang, ZHAO Xun, ZHANG Mei. Consistency evaluation of domestic generic rifampicin capsules and reference drug in vitro[J]. Journal of China Pharmaceutical University, 2018, 49(5): 603-609. DOI: 10.11665/j.issn.1000-5048.20180513
    [3]Study on Optimize the Preparation and Formulation of Nimodipine-Containing Nanoliposome[J]. Journal of China Pharmaceutical University, 2003, (1): 27-30.
    [4]Distribution of Nimodipine Microemulsion in Mice In vivo and Evaluation on Its Targeting Performance[J]. Journal of China Pharmaceutical University, 2002, (4): 31-34.
    [5]Study on Transdermal Therapeutic System for Nimodipine[J]. Journal of China Pharmaceutical University, 2000, (5): 28-31.
    [6]Development of Nimodipine Sustained Release Capsules[J]. Journal of China Pharmaceutical University, 1999, (5): 346-349.
    [7]The Factors Influencing Nimodipine Release from Hydroxypropyl Methylcellulose Matrix Tablet[J]. Journal of China Pharmaceutical University, 1998, (6): 418-421.
    [8]Improved Process of Nimodipine[J]. Journal of China Pharmaceutical University, 1998, (3): 82-83.
    [9]Study on Penetration Enhancers for Nimodipine[J]. Journal of China Pharmaceutical University, 1994, (3): 149-152.
    [10]CORRELATION BETWEEN THE ABSORPTION IN VIVO AND THE RELEASE IN VITRO OF TWO CONTROLLED-RELEASE TABLETS OF AMINOPHYLLINE[J]. Journal of China Pharmaceutical University, 1986, (1): 18-23.

Catalog

    Article views (979) PDF downloads (1652) Cited by()

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return