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Drug release testing methods of polymeric particulate drug formulations

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Abstract

The long-term controlled delivery of drugs has been successfully achieved by biodegradable polymeric particulate systems. The drug release testing method is important for the characterization of dosage form performance under in vitro standardized conditions and can provide insight into the in vivo performance of the drug product. In vitro drug release testing methods for polymeric particulate systems are classified into sample and separate (SS), dialysis, and continuous flow (CF) methods. In the SS method, the drug-loaded microparticles are suspended in a vessel and the samples for the analysis are obtained by separating the particles using filtration or centrifugation. The dialysis method physically separates microparticles from the release media by a membrane, which eliminates the undesired loss of particles during sample preparation and handling. The CF method uses apparatus consisted of flow-through cell that holds the sample, pump and water bath in closed or open ends system. In this method, the release media is continuously circulated through a cell containing drug-loaded microparticles. This review summarizes the principles of the drug release testing methods and discusses their characteristics with the recent research results.

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Acknowledgments

This research was financially supported by the Ministry of Knowledge Economy (MKE) and Korea Institute for Advancement in Technology (KIAT) through the Research and Development for Regional Industry. This research was also supported by the leading industry and equipments of the ChungCheong Leading Industry Office of the Korean Ministry of Knowledge.

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Authors and Affiliations

  1. College of Pharmacy, Kyungsung University, Busan, 608-736, South Korea

    Sarmila Amatya & Young-Hee Shin

  2. College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, 702-701, South Korea

    Eun Ji Park & Dong Hee Na

  3. Peptron, Inc., Daejeon, 305-811, South Korea

    Jong Hoon Park, Joon Sik Kim, Eunyoung Seol, Heeyong Lee & Hoil Choi

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  1. Sarmila Amatya
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  5. Eunyoung Seol
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  6. Heeyong Lee
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  7. Hoil Choi
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  8. Young-Hee Shin
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Correspondence to Dong Hee Na.

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Sarmila Amatya and Eun Ji Park contributed equally to this study.

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Amatya, S., Park, E.J., Park, J.H. et al. Drug release testing methods of polymeric particulate drug formulations. Journal of Pharmaceutical Investigation 43, 259–266 (2013). https://doi.org/10.1007/s40005-013-0072-5

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