Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization
Parenteral N-acetylcysteine has a wide variety of clinical applications, but its use can be limited by a poor chemical stability. We managed to control parenteral N-acetylcysteine stability, and to study the influence of additives on the decrease of N-acetylcysteine degradation. First, an HPLC-UV do...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-01-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/16/1/72 |
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| author | Nicolas Primas Guillaume Lano Damien Brun Christophe Curti Marion Sallée Emmanuelle Sampol-Manos Edouard Lamy Charleric Bornet Stéphane Burtey Patrice Vanelle |
| author_facet | Nicolas Primas Guillaume Lano Damien Brun Christophe Curti Marion Sallée Emmanuelle Sampol-Manos Edouard Lamy Charleric Bornet Stéphane Burtey Patrice Vanelle |
| author_sort | Nicolas Primas |
| collection | DOAJ |
| description | Parenteral N-acetylcysteine has a wide variety of clinical applications, but its use can be limited by a poor chemical stability. We managed to control parenteral N-acetylcysteine stability, and to study the influence of additives on the decrease of N-acetylcysteine degradation. First, an HPLC-UV dosing method of N-acetylcysteine and its main degradation product, a dimer, was validated and the stability without additive was studied. Then, the influence of several additives (ascorbic acid, sodium edetate, tocopherol and zinc) and of temperature on N-acetylcysteine dimerization was evaluated. Finally, the influence of zinc gluconate at different concentrations (administrable to patients) was investigated. Zinc gluconate at 62.5 µg·mL<sup>−1</sup> allows the stabilization of 25 mg·mL<sup>−1</sup> N-acetylcysteine solution for at least 8 days when stored at 5 ± 3 °C. |
| first_indexed | 2024-03-09T11:29:53Z |
| format | Article |
| id | doaj.art-d03a80ab525c40148c76b82a568fbfaf |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T11:29:53Z |
| publishDate | 2023-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-d03a80ab525c40148c76b82a568fbfaf2023-11-30T23:55:24ZengMDPI AGPharmaceuticals1424-82472023-01-011617210.3390/ph16010072Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its DimerizationNicolas Primas0Guillaume Lano1Damien Brun2Christophe Curti3Marion Sallée4Emmanuelle Sampol-Manos5Edouard Lamy6Charleric Bornet7Stéphane Burtey8Patrice Vanelle9Service Central de la Qualité et de L’information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique—Hôpitaux de Marseille (AP-HM), 13005 Marseille, FranceCentre of Nephrology and Renal Transplantation, Hôpital de la Conception, AP-HM, 13005 Marseille, FranceService Central de la Qualité et de L’information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique—Hôpitaux de Marseille (AP-HM), 13005 Marseille, FranceService Central de la Qualité et de L’information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique—Hôpitaux de Marseille (AP-HM), 13005 Marseille, FranceCentre of Nephrology and Renal Transplantation, Hôpital de la Conception, AP-HM, 13005 Marseille, FrancePharmacokinetics Department, Assistance Publique-Hôpitaux Marseille (AP-HM), 13005 Marseille, FranceService Central de la Qualité et de L’information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique—Hôpitaux de Marseille (AP-HM), 13005 Marseille, FrancePharmacie Usage Intérieur Hôpital Conception, Assistance Publique—Hôpitaux de Marseille (AP-HM), Hôpital de la Conception, 13005 Marseille, FranceCentre of Nephrology and Renal Transplantation, Hôpital de la Conception, AP-HM, 13005 Marseille, FranceService Central de la Qualité et de L’information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique—Hôpitaux de Marseille (AP-HM), 13005 Marseille, FranceParenteral N-acetylcysteine has a wide variety of clinical applications, but its use can be limited by a poor chemical stability. We managed to control parenteral N-acetylcysteine stability, and to study the influence of additives on the decrease of N-acetylcysteine degradation. First, an HPLC-UV dosing method of N-acetylcysteine and its main degradation product, a dimer, was validated and the stability without additive was studied. Then, the influence of several additives (ascorbic acid, sodium edetate, tocopherol and zinc) and of temperature on N-acetylcysteine dimerization was evaluated. Finally, the influence of zinc gluconate at different concentrations (administrable to patients) was investigated. Zinc gluconate at 62.5 µg·mL<sup>−1</sup> allows the stabilization of 25 mg·mL<sup>−1</sup> N-acetylcysteine solution for at least 8 days when stored at 5 ± 3 °C.https://www.mdpi.com/1424-8247/16/1/72N-acetylcysteinestability studyparenteral administration |
| spellingShingle | Nicolas Primas Guillaume Lano Damien Brun Christophe Curti Marion Sallée Emmanuelle Sampol-Manos Edouard Lamy Charleric Bornet Stéphane Burtey Patrice Vanelle Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization Pharmaceuticals N-acetylcysteine stability study parenteral administration |
| title | Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization |
| title_full | Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization |
| title_fullStr | Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization |
| title_full_unstemmed | Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization |
| title_short | Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization |
| title_sort | stability study of parenteral n acetylcysteine and chemical inhibition of its dimerization |
| topic | N-acetylcysteine stability study parenteral administration |
| url | https://www.mdpi.com/1424-8247/16/1/72 |
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