Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology
This study explores the use of a statistical model to build a design space for freeze-drying two formulations with ibuprofen. A 2 × 3 factorial experimental design was used to evaluate independent variables (filling volume and annealing time) and responses as residual moisture content, specific surf...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Sciendo
2021-03-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.2478/acph-2021-0010 |
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| _version_ | 1832569692215050240 |
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| author | Preskar Maja Videc Danijel Vrečer Franc Gašperlin Mirjana |
| author_facet | Preskar Maja Videc Danijel Vrečer Franc Gašperlin Mirjana |
| author_sort | Preskar Maja |
| collection | DOAJ |
| description | This study explores the use of a statistical model to build a design space for freeze-drying two formulations with ibuprofen. A 2 × 3 factorial experimental design was used to evaluate independent variables (filling volume and annealing time) and responses as residual moisture content, specific surface area and reconstitution time. A statistical model and response surface plots were generated to define the interactions among the selected variables. The models constructed for both formulations suggest that 1 mL of filled volume and no annealing should be used to achieve optimal residual moisture content, specific surface area and reconstitution time. The proposed models were validated with additional experiments, in which the responses observed were mainly in close agreement with the predicted ones. Additionally, the established models demonstrate the reliability of the evaluation procedure in predicting the selected responses. |
| format | Article |
| id | doaj-art-d28a1b248da44b4bb8527d3bf16e00eb |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2021-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-d28a1b248da44b4bb8527d3bf16e00eb2025-02-02T19:57:25ZengSciendoActa Pharmaceutica1846-95582021-03-01711819810.2478/acph-2021-0010acph-2021-0010Investigation of design space for freeze-drying injectable ibuprofen using response surface methodologyPreskar Maja0Videc Danijel1Vrečer Franc2Gašperlin Mirjana3Krka d.d. SI-8000Novo mesto, SloveniaKrka d.d. SI-8000Novo mesto, SloveniaKrka d.d. SI-8000Novo mesto, SloveniaUniversity of Ljubljana, Faculty of Pharmacy, SI-1000, Ljubljana, SloveniaThis study explores the use of a statistical model to build a design space for freeze-drying two formulations with ibuprofen. A 2 × 3 factorial experimental design was used to evaluate independent variables (filling volume and annealing time) and responses as residual moisture content, specific surface area and reconstitution time. A statistical model and response surface plots were generated to define the interactions among the selected variables. The models constructed for both formulations suggest that 1 mL of filled volume and no annealing should be used to achieve optimal residual moisture content, specific surface area and reconstitution time. The proposed models were validated with additional experiments, in which the responses observed were mainly in close agreement with the predicted ones. Additionally, the established models demonstrate the reliability of the evaluation procedure in predicting the selected responses.https://doi.org/10.2478/acph-2021-0010design spaceresponse surface methodlyophilizationibuprofen |
| spellingShingle | Preskar Maja Videc Danijel Vrečer Franc Gašperlin Mirjana Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology Acta Pharmaceutica design space response surface method lyophilization ibuprofen |
| title | Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology |
| title_full | Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology |
| title_fullStr | Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology |
| title_full_unstemmed | Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology |
| title_short | Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology |
| title_sort | investigation of design space for freeze drying injectable ibuprofen using response surface methodology |
| topic | design space response surface method lyophilization ibuprofen |
| url | https://doi.org/10.2478/acph-2021-0010 |
| work_keys_str_mv | AT preskarmaja investigationofdesignspaceforfreezedryinginjectableibuprofenusingresponsesurfacemethodology AT videcdanijel investigationofdesignspaceforfreezedryinginjectableibuprofenusingresponsesurfacemethodology AT vrecerfranc investigationofdesignspaceforfreezedryinginjectableibuprofenusingresponsesurfacemethodology AT gasperlinmirjana investigationofdesignspaceforfreezedryinginjectableibuprofenusingresponsesurfacemethodology |