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 technolog...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2020-02-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/744 |
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| author | Yu. I. Poltavets S. V. Aleshin V. V. Zavarzina A. I. Murav’eva A. A. Soboleva I. A. Tubasheva S. L. Kuznetsov |
| author_facet | Yu. I. Poltavets S. V. Aleshin V. V. Zavarzina A. I. Murav’eva A. A. Soboleva I. A. Tubasheva S. L. Kuznetsov |
| author_sort | Yu. I. Poltavets |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ab1a89f8a65c45b39b35467c6d50b5c5 |
| institution | Matheson Library |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2020-02-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-ab1a89f8a65c45b39b35467c6d50b5c52025-08-03T19:23:55ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492020-02-0191667410.33380/2305-2066-2020-9-1-66-74715Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatmentYu. I. Poltavets0S. V. Aleshin1V. V. Zavarzina2A. I. Murav’eva3A. A. Soboleva4I. A. Tubasheva5S. L. Kuznetsov6Kurchatov InstituteKurchatov InstituteKurchatov InstituteKurchatov InstituteFederal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»Kurchatov InstituteKurchatov InstituteIntroduction. 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.https://www.pharmjournal.ru/jour/article/view/744docetaxelrelated substancesgamma-irradiationsterilizationpolymeric drugslyophilizate |
| spellingShingle | Yu. I. Poltavets S. V. Aleshin V. V. Zavarzina A. I. Murav’eva A. A. Soboleva I. A. Tubasheva S. L. Kuznetsov Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment Разработка и регистрация лекарственных средств docetaxel related substances gamma-irradiation sterilization polymeric drugs lyophilizate |
| title | Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment |
| title_full | Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment |
| title_fullStr | Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment |
| title_full_unstemmed | Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment |
| title_short | Formation of Docetaxel-related Substances in the Polymer Particles During Storage and Gamma-treatment |
| title_sort | formation of docetaxel related substances in the polymer particles during storage and gamma treatment |
| topic | docetaxel related substances gamma-irradiation sterilization polymeric drugs lyophilizate |
| url | https://www.pharmjournal.ru/jour/article/view/744 |
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