Development and Assessment of the Stability of Hospital Derivation of Tacrolimus
Tacrolimus is an immunosuppressive drug widely used in hospitals for the treatment of transplant patients. Often, hospitalized patients undergo the administration of tacrolimus in liquid pharmaceutical forms. However, this drug has been marketed only in solid form for oral use. This work aimed to d...
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| Format: | Article |
| Language: | English |
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Universidade Federal do Rio Grande do Sul
2024-01-01
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| Series: | Drug Analytical Research |
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| Online Access: | https://seer.ufrgs.br/Po/index.php/dar/article/view/137468 |
| _version_ | 1797354684452700160 |
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| author | Caroline Venturi Gabriele Primieri Márcio Vinícius Ayres Silvia Helena Oliveira de Almeida |
| author_facet | Caroline Venturi Gabriele Primieri Márcio Vinícius Ayres Silvia Helena Oliveira de Almeida |
| author_sort | Caroline Venturi |
| collection | DOAJ |
| description |
Tacrolimus is an immunosuppressive drug widely used in hospitals for the treatment of transplant patients. Often, hospitalized patients undergo the administration of tacrolimus in liquid pharmaceutical forms. However, this drug has been marketed only in solid form for oral use. This work aimed to develop and evaluate the stability of tacrolimus in a simple liquid formulation with comparable efficacy, safety, and stability. The analyzes were developed according to the USP method (2018), being co-validated, guaranteeing its accuracy, precision, and specificity. Based on the analyzed analyses, the derivation of tacrolimus in suspension was determined, as well as the wetting agent in its ideal proportion to obtain drug content in HPLC within acceptable limits, this being 8% polyethylene glycol 400. The formulation was observed for the evaluation of physical-chemical parameters, being grown, pH, sedimentation volume, and organoleptic characteristics. Dosing was carried out for 30 days at room temperature and a temperature of 40°C. The formulation maintained its integrity during the 30 days of storage at room temperature with content between 90 – 110%, growth above 200 cP, neutral pH, and sedimentation volume below 3 mL. However, tacrolimus is controlled sensitively to heat, observing degradation in the first ten days of analysis at 40°C, with possible formation of degradation products. Based on this work, the tacrolimus formulation developed has adequate dosage and homogeneity for 30 days and should be kept away from light and at room temperature.
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| first_indexed | 2024-03-08T13:53:54Z |
| format | Article |
| id | doaj.art-1e68a884d2c049b2949b53bd52925409 |
| institution | Directory Open Access Journal |
| issn | 2527-2616 |
| language | English |
| last_indexed | 2024-03-08T13:53:54Z |
| publishDate | 2024-01-01 |
| publisher | Universidade Federal do Rio Grande do Sul |
| record_format | Article |
| series | Drug Analytical Research |
| spelling | doaj.art-1e68a884d2c049b2949b53bd529254092024-01-15T18:13:51ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162024-01-017210.22456/2527-2616.137468Development and Assessment of the Stability of Hospital Derivation of TacrolimusCaroline Venturi0Gabriele PrimieriMárcio Vinícius Ayres1Silvia Helena Oliveira de Almeida2UFRGSHCPAHCPA Tacrolimus is an immunosuppressive drug widely used in hospitals for the treatment of transplant patients. Often, hospitalized patients undergo the administration of tacrolimus in liquid pharmaceutical forms. However, this drug has been marketed only in solid form for oral use. This work aimed to develop and evaluate the stability of tacrolimus in a simple liquid formulation with comparable efficacy, safety, and stability. The analyzes were developed according to the USP method (2018), being co-validated, guaranteeing its accuracy, precision, and specificity. Based on the analyzed analyses, the derivation of tacrolimus in suspension was determined, as well as the wetting agent in its ideal proportion to obtain drug content in HPLC within acceptable limits, this being 8% polyethylene glycol 400. The formulation was observed for the evaluation of physical-chemical parameters, being grown, pH, sedimentation volume, and organoleptic characteristics. Dosing was carried out for 30 days at room temperature and a temperature of 40°C. The formulation maintained its integrity during the 30 days of storage at room temperature with content between 90 – 110%, growth above 200 cP, neutral pH, and sedimentation volume below 3 mL. However, tacrolimus is controlled sensitively to heat, observing degradation in the first ten days of analysis at 40°C, with possible formation of degradation products. Based on this work, the tacrolimus formulation developed has adequate dosage and homogeneity for 30 days and should be kept away from light and at room temperature. https://seer.ufrgs.br/Po/index.php/dar/article/view/137468TacrolimusSuspensionsDosage FormsValidation StudyDrug Stability |
| spellingShingle | Caroline Venturi Gabriele Primieri Márcio Vinícius Ayres Silvia Helena Oliveira de Almeida Development and Assessment of the Stability of Hospital Derivation of Tacrolimus Drug Analytical Research Tacrolimus Suspensions Dosage Forms Validation Study Drug Stability |
| title | Development and Assessment of the Stability of Hospital Derivation of Tacrolimus |
| title_full | Development and Assessment of the Stability of Hospital Derivation of Tacrolimus |
| title_fullStr | Development and Assessment of the Stability of Hospital Derivation of Tacrolimus |
| title_full_unstemmed | Development and Assessment of the Stability of Hospital Derivation of Tacrolimus |
| title_short | Development and Assessment of the Stability of Hospital Derivation of Tacrolimus |
| title_sort | development and assessment of the stability of hospital derivation of tacrolimus |
| topic | Tacrolimus Suspensions Dosage Forms Validation Study Drug Stability |
| url | https://seer.ufrgs.br/Po/index.php/dar/article/view/137468 |
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