Stability of amorphous indomethacin in a solid dispersion using crospovidone prepared by a twin-screw kneader or extruder and application of aqueous film-coating to solid dispersion tablets

Shibata, Yusuke; Fujii, Makiko; Sugamura, Yuka; Nakanishi, Sayaka; Yamada, Masaki; Ouchi, Kiyohisa; Watanabe, Yoshihisa

doi:10.1016/s1773-2247(09)50037-8

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“…In these techniques, no solvent was used and no fusion of CrosPVP occurred; the materials always remained in a powder form. The obtained powder SD could be manufactured directly into tablets using the direct compression method (Shibata et al, , 2006(Shibata et al, , 2009a.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the physicochemical characteristics of crospovidone that influence solid dispersion preparation

Nakanishi

Fujii

Sugamura

et al. 2011

International Journal of Pharmaceutics

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Section: Introductionmentioning

confidence: 99%

Evaluation of the physicochemical characteristics of crospovidone that influence solid dispersion preparation

Nakanishi

Fujii

Sugamura

et al. 2011

International Journal of Pharmaceutics

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Effect of storage conditions on the recrystallization of drugs in solid dispersions with crospovidone

Shibata

Fujii

Suzuki

et al. 2013

Pharmaceutical Development and Technology

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The physical stability of amorphous solid dispersions (SDs) is influenced by their storage conditions. The goal of this work was to investigate the factors affecting the recrystallization of drugs in SDs after storage under conditions of high temperature and high humidity. SDs of three drugs (dipyridamole, nifedipine and indomethacin) with different functional groups (amino, carbonyl and hydroxyl) and onset times for crystallization of the amorphous state were prepared using crospovidone (CrosPVP). All of the drugs in the SDs remained in an amorphous state at 25 °C/50% relative humidity (RH) in closed glass bottles for at least six months. Under conditions of high temperature (40 °C/75%RH/closed and 60 °C/open), differences in interactions between the hydrogen bond donors of the drugs and the amide carbonyl group of CrosPVP are essential factors for recrystallization of the drugs in the SDs. On the other hand, under condition of high humidity (40 °C/75%RH/open), in addition to the difference in the interaction between the drug and CrosPVP, the rate of increase in moisture content affects their recrystallization in SDs.

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Stability of amorphous indomethacin in a solid dispersion using crospovidone prepared by a twin-screw kneader or extruder and application of aqueous film-coating to solid dispersion tablets

Cited by 2 publications

References 26 publications

Evaluation of the physicochemical characteristics of crospovidone that influence solid dispersion preparation

Evaluation of the physicochemical characteristics of crospovidone that influence solid dispersion preparation

Effect of storage conditions on the recrystallization of drugs in solid dispersions with crospovidone

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