Journal of Pharmaceutical Science and Technology, Japan
Online ISSN : 2188-3149
Print ISSN : 0372-7629
ISSN-L : 0372-7629
Volume 66, Issue 2
Displaying 1-18 of 18 articles from this issue
Foreword
20th Anniversary Commemorative Articles: Toward the Establishment of Corporate Jurid
Colloquium
Research Laboratory
Young Researchers
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Introduction
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Regular Articles
  • Koh Konishi, Hisakazu Sunada, Yorinobu Yonezawa, Kazumi Danjo
    2006 Volume 66 Issue 2 Pages 151-159
    Published: 2006
    Released on J-STAGE: April 13, 2019
    JOURNAL FREE ACCESS

    Crude drug powders have various particle shapes and properties leading to poor fluidity and strong adhesiveness and those properties make the handling in processing the powders and controlling the qualities of products difficult. The granulation of crude drug seems to be a good procedure to solve the problem.

    In this study, we looked at the pharmaceutical manufacturing of crude drug powder by the dry compacting method. Senna powder was chosen as a model crude drug powder and granulated by roller compactor. The effects of granulating conditions, such as roller pressure or lactose/micro crystalline cellulose (MCC) mixing ratio, on mean diameter, strength and disintegration time of granules was examined and evaluated by multiple regression analysis. The physical properties of tablets made with various granules, binders and disintegrants were also examined and evaluated by multiple regression analysis.

    As a result, we found that the lactose/MCC ratio strongly affected the granule properties, but the roller pressure did not, especially granule disintegration time. We could achieve our goals, about 2.0 kg hardness and less than 1000 sec. disintegration time, by using a formulation of Senna granules consisting of just MCC as an excipient, MCC as a binder and crospovidone (Kollidon CL) as a disintegrant and by tableting at more than 200 MPa.

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  • Noboru Sekiya, Masanobu Yamamoto, Atsushi Nishiwaki, Akio Nishiura, Ka ...
    2006 Volume 66 Issue 2 Pages 160-166
    Published: 2006
    Released on J-STAGE: April 13, 2019
    JOURNAL FREE ACCESS

    The stability of OPALMON® tablets, which contain the active ingredient Limaprostalfadex, a PGE1 derivative, is known to be affected by humidity. In this study, we sought to investigate methods to improve the stability of OPALMON® tablets under humid conditions. Polysaccharide additives, such as dextran, exhibited a stabilizing effect under humid conditions, while disaccharide additives, such as lactose, had no effect. Under humid conditions, the lyophilized drug product containing a disaccharide additive was liquefied. In contrast, the appearance of the product containing dextran was unchanged. Dextran and dextrin provided the best stabilization of this drug product in comparison with other saccharide and cellulose additives.

    The pH of the lyophilized product mixed with various additives did not affect stability, regardless of the additives used. The moisture content of the product containing dextran or dextrin was higher than that of the product mixed with other additives, suggesting that the moisture content of the lyophilized product does not affect the stability of Limaprost-alfadex. Therefore, the mechanism of stabilization by dextran and dextrin remains to be elucidated. Differences in the mobility of water molecules between dextran and dextrin and other additives are likely to play a role in the stabilization of Limaprost-alfadex.

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