Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment

Introduction . Docetaxel is widely used for cancer treatment. Actual issue for newly developed polymer-based Docetaxel formulations is applicability of current quality requirements. The technology of polymeric forms, including gamma-sterilization, are differ from actual Docetaxel injections technolo...

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Published inRazrabotka i registraciâ lekarstvennyh sredstv (Online) Vol. 9; no. 1; pp. 66 - 74
Main Authors Poltavets, Yu. I., Aleshin, S. V., Zavarzina, V. V., Murav’eva, A. I., Soboleva, A. A., Tubasheva, I. A., Kuznetsov, S. L.
Format Journal Article
LanguageEnglish
Russian
Published LLC Center of Pharmaceutical Analytics (LLC «CPHA») 26.02.2020
Subjects
docetaxel
gamma-irradiation
lyophilizate
polymeric drugs
related substances
sterilization
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Summary:Introduction . Docetaxel is widely used for cancer treatment. Actual issue for newly developed polymer-based Docetaxel formulations is applicability of current quality requirements. The technology of polymeric forms, including gamma-sterilization, are differ from actual Docetaxel injections technology. In this study were used PLGA-based particles with Docetaxel. The main attention was directed to studying qualitative and quantitative content of related impurities in polymeric forms during long-term storage and gamma-sterilization in comparison with pharmacopoeial requirements for Docetaxel injections. Aim . Studying of possible patterns of Docetaxel-related impurities formation between intact and gamma-irradiated batches. Materials and methods . Objects of study – lyophilizates of Docetaxel polymeric forms was previously obtained by the authors. Qualitative and quantitative analysis was performed by high pressure liquid chromatography. Results and discussion . Docetaxel-related impurities was determined and evaluated in the intact and gamma-treated batches. It was cleared, that related substances in the gamma-treated batches was different in comparison with non-treated but after vary storage periods. Conclusion . Docetaxel-loaded polymeric drugs shown proper stability during long term storage. The influence of gamma-treatment to Docetaxelrelated impurities content was found. Gamma sterilization can be promising method for novel drugs, but it needs individual study in the each case.
ISSN:2305-2066
2658-5049
DOI:10.33380/2305-2066-2020-9-1-66-74