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Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient

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Abstract

The SeDeM expert system is used to reveal direct compression (DC) suitability of the active ingredients and excipients in preformulation. In this study, the system was used to predict compressibility of rhodiola extract (RhE) and its mixture with excipients. The parameter index (IP), parameter profile index (IPP), and good compressibility index (IGC) of RhE mixtures with different fillers were investigated. The results showed that RhE and mixture with lactose or starch were not suitable for DC according to the values of IP, IPP, and IGC, which can be corrected by pregelatinized starch (P-STA). The quality of tablets corrected by P-STA all satisfied the USP monograph limit. The findings from this study showed that the system is a useful tool to predict DC suitability on the mixture of RhE and an excipient.

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Acknowledgements

We wish to thank Anhui Shanhe Medicinal Excipients Co., Ltd., China, and Meggle Pharma-Excipients & Technology Co., Ltd., Germany, for providing the necessary materials to carry out this study. This work has emanated from research conducted with the financial support of the National Science & Technology Major Project Key New Drug Creation and Manufacturing Program (2015ZX09303001002007), the Industrial Key Research and Development Project of the Chongqing Science & Technology Commission (cstc2017zdcy-cdyf193), and the Postgraduate Science and Technology Innovation Program of Chongqing University of Science and Technology (YKJCX1820507).

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Authors and Affiliations

  1. Chongqing University of Science and Technology, No. 20, University City East Road, Chongqing, 401331, China

    Shulin Wan, Han Zhang, Xuelian Li, Mingxian Gu, Tianbing Guan, Jianbing Ren & Chuanyun Dai

  2. National Institutes for Food and Drug Control, No. 2, Tiantan Xili Road, Beijing, 100050, China

    Rui Yang & Huimin Sun

  3. Chongqing LIYUN Nozzle Co., Ltd., No. 98, Xiyuan 2nd Road, Chongqing, 401332, China

    Jianbing Ren

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  1. Shulin Wan
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  3. Han Zhang
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Correspondence to Huimin Sun or Chuanyun Dai.

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Wan, S., Yang, R., Zhang, H. et al. Application of the SeDeM Expert System in Studies for Direct Compression Suitability on Mixture of Rhodiola Extract and an Excipient. AAPS PharmSciTech 20, 105 (2019). https://doi.org/10.1208/s12249-019-1320-4

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