Drug release testing methods of polymeric particulate drug formulations

Journal of Pharmaceutical Investigation - Tập 43 - Trang 259-266 - 2013
Sarmila Amatya1, Eun Ji Park2, Jong Hoon Park3, Joon Sik Kim3, Eunyoung Seol3, Heeyong Lee3, Hoil Choi3, Young-Hee Shin1, Dong Hee Na2
1College of Pharmacy, Kyungsung University, Busan, South Korea
2College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, South Korea
3Peptron, Inc., Daejeon, South Korea

Tóm tắt

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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