DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM
Aim. To study the stability of biocompatible microemulsion composition-based bromokain transdermal therapeutic systems (TTS) in order to confi rm the original shelf life and to identify the most appropriate TTS composition for storage.Materials and methods. The stability test using accelerated aging...
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| Format: | Article |
| Language: | Russian |
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Federal Research Center of Transplantology and Artificial Organs named after V.I.Shumakov
2014-12-01
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| Series: | Vestnik Transplantologii i Iskusstvennyh Organov |
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| Online Access: | https://journal.transpl.ru/vtio/article/view/477 |
| _version_ | 1797872077799161856 |
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| author | V. A. Ryzhikova E. G. Kuznetsova V. Yu. Belov L. A. Salomatina V. I. Sevastianov |
| author_facet | V. A. Ryzhikova E. G. Kuznetsova V. Yu. Belov L. A. Salomatina V. I. Sevastianov |
| author_sort | V. A. Ryzhikova |
| collection | DOAJ |
| description | Aim. To study the stability of biocompatible microemulsion composition-based bromokain transdermal therapeutic systems (TTS) in order to confi rm the original shelf life and to identify the most appropriate TTS composition for storage.Materials and methods. The stability test using accelerated aging method was performed on the samples of TTS containing 50 and 100 mg of bromokain. Physicochemical properties of TTS were analyzed at the end of the 1st, 2nd, 3rd, and 6th month of storage. The physical confi guration of the dosage form, the content of bromokain in TTS, and drug release were evaluated at each stage of the study. The content of bromokain in the samples was recorded using high performance liquid chromatography (HPLC). As a control for each method, the newly manufactured TTS forms were used.Results. Unlike the samples containing 50 mg of bromokain, TTS with 100 mg of the anesthetic demonstrated changes in the physical confi guration and deterioration of the functional properties after the 6th month of storage. The quantitative content of the substance in TTS containing 50 and 100 mg of bromokain met the requirements of regulatory documentation (RD) at allphases of the experiment and was within 50,0 ± 5,0 mg and 100,0 ± 10,0 mg, respectively. The release profi le of TTS with 50 mg of bromokain has remained unchanged during storage and complies with the RD. TTS with 100 mg of bromokain after the 3rd month of storage had a deviation from the release profi le indicated in the RD.Conclusion. The shelf life of 2 years at t = 25 °C preset by us for samples of TTS containing 50 mg of bromokain has been confi rmed. According to the test results, samples of TTS with the content of bromokain of 100 mg were declared unstable and unfi t for storage under the selected storage conditions. |
| first_indexed | 2024-04-10T00:53:06Z |
| format | Article |
| id | doaj.art-8290e2fa9a55486492a2982173b701c7 |
| institution | Directory Open Access Journal |
| issn | 1995-1191 |
| language | Russian |
| last_indexed | 2024-04-10T00:53:06Z |
| publishDate | 2014-12-01 |
| publisher | Federal Research Center of Transplantology and Artificial Organs named after V.I.Shumakov |
| record_format | Article |
| series | Vestnik Transplantologii i Iskusstvennyh Organov |
| spelling | doaj.art-8290e2fa9a55486492a2982173b701c72023-03-13T10:37:22ZrusFederal Research Center of Transplantology and Artificial Organs named after V.I.ShumakovVestnik Transplantologii i Iskusstvennyh Organov1995-11912014-12-01164899510.15825/1995-1191-2014-4-89-95415DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEMV. A. Ryzhikova0E. G. Kuznetsova1V. Yu. Belov2L. A. Salomatina3V. I. Sevastianov4Laboratory of tissue engineering and delivery systems of department of biomedical technologies and tissue engineering, V.I. Shumakov Federal Research Center of Transplantology and Artifi cial Organs, Ministry of Healthcare of the Russian Federation, Moscow, Russian FederationLaboratory of tissue engineering and delivery systems of department of biomedical technologies and tissue engineering, V.I. Shumakov Federal Research Center of Transplantology and Artifi cial Organs, Ministry of Healthcare of the Russian Federation, Moscow, Russian FederationTesting laboratory of preclinical research «BIOMIR», ANO «Institute of Biomedical Research and Technology», Moscow, Russian FederationLaboratory of tissue engineering and delivery systems of department of biomedical technologies and tissue engineering, V.I. Shumakov Federal Research Center of Transplantology and Artifi cial Organs, Ministry of Healthcare of the Russian Federation, Moscow, Russian FederationLaboratory of tissue engineering and delivery systems of department of biomedical technologies and tissue engineering, V.I. Shumakov Federal Research Center of Transplantology and Artifi cial Organs, Ministry of Healthcare of the Russian Federation, Moscow, Russian FederationAim. To study the stability of biocompatible microemulsion composition-based bromokain transdermal therapeutic systems (TTS) in order to confi rm the original shelf life and to identify the most appropriate TTS composition for storage.Materials and methods. The stability test using accelerated aging method was performed on the samples of TTS containing 50 and 100 mg of bromokain. Physicochemical properties of TTS were analyzed at the end of the 1st, 2nd, 3rd, and 6th month of storage. The physical confi guration of the dosage form, the content of bromokain in TTS, and drug release were evaluated at each stage of the study. The content of bromokain in the samples was recorded using high performance liquid chromatography (HPLC). As a control for each method, the newly manufactured TTS forms were used.Results. Unlike the samples containing 50 mg of bromokain, TTS with 100 mg of the anesthetic demonstrated changes in the physical confi guration and deterioration of the functional properties after the 6th month of storage. The quantitative content of the substance in TTS containing 50 and 100 mg of bromokain met the requirements of regulatory documentation (RD) at allphases of the experiment and was within 50,0 ± 5,0 mg and 100,0 ± 10,0 mg, respectively. The release profi le of TTS with 50 mg of bromokain has remained unchanged during storage and complies with the RD. TTS with 100 mg of bromokain after the 3rd month of storage had a deviation from the release profi le indicated in the RD.Conclusion. The shelf life of 2 years at t = 25 °C preset by us for samples of TTS containing 50 mg of bromokain has been confi rmed. According to the test results, samples of TTS with the content of bromokain of 100 mg were declared unstable and unfi t for storage under the selected storage conditions.https://journal.transpl.ru/vtio/article/view/477drug stabilitydrug shelf lifehigh performance liquid chromatographytransdermal therapeutic systembromocain |
| spellingShingle | V. A. Ryzhikova E. G. Kuznetsova V. Yu. Belov L. A. Salomatina V. I. Sevastianov DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM Vestnik Transplantologii i Iskusstvennyh Organov drug stability drug shelf life high performance liquid chromatography transdermal therapeutic system bromocain |
| title | DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM |
| title_full | DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM |
| title_fullStr | DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM |
| title_full_unstemmed | DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM |
| title_short | DETERMINATION OF THE STABILITY OF A LOCAL ANESTHETIC BROMOKAIN TRANSDERMAL THERAPEUTIC SYSTEM |
| title_sort | determination of the stability of a local anesthetic bromokain transdermal therapeutic system |
| topic | drug stability drug shelf life high performance liquid chromatography transdermal therapeutic system bromocain |
| url | https://journal.transpl.ru/vtio/article/view/477 |
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