速崩壊性錠剤の口腔内崩壊時間と In Vitro 崩壊試験法の評価  [in Japanese] Evaluation of Oral Disintegration Time of Rapidly Disintegrating Tablets (RDTs) by In Vivo and In Vitro Disintegration Testing  [in Japanese]

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Author(s)

Abstract

The purpose of this study was to evaluate the oral (<i>in vivo</i>) disintegration time of commercially available rapidly disintegrating tablets (RDTs), and to establish an <i>in vitro</i> disintegration test that may be used to predict <i>in vivo</i> disintegration times.<br>The <i>in vivo</i> disintegration time for the tablets tested ranged from a minimum of 8.32 sec to a maximum of 44.27 sec, information that will be useful for medication counseling and in the selection of products that will maintain high patient compliance. The <i>in vitro</i> disintegration times were determined using the JP XIV disintegration test apparatus in which the attached Distopper<sup>®</sup> electronic sensor automatically determines <i>in vitro</i> disintegration time. The results were well correlated with the <i>in vivo</i> disintegration times (r<sup>2</sup>=0.88), and the slope was close to 1 for the majority of RDTs (30 of 43 products tested). In the case of the RDTs that showed poor correlation, the <i>in vitro</i> disintegration time became virtually equal to <i>in vivo</i> disintegration time when the Distopper<sup>®</sup> sensor was modified so that the mechanical stress generated by the tongue could be simulated. Thus the optimization of the Distopper<sup>®</sup> to more closely simulate the disintegration mechanism in the mouth enabled the <i>in vitro</i> testing apparatus to be applied to a greater number of RDTs. This testing method should be useful in evaluating RDT quality at the sites of manufacturing, development and medical treatment.

Journal

  • Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences)

    Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) 32(11), 1124-1132, 2006-11-10

    Japanese Society of Pharmaceutical Health Care and Sciences

References:  5

Codes

  • NII Article ID (NAID)
    110005518960
  • NII NACSIS-CAT ID (NCID)
    AA11527197
  • Text Lang
    JPN
  • Article Type
    NOT
  • ISSN
    1346342X
  • Data Source
    CJP  NII-ELS  J-STAGE  NDL-Digital 
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