<abstract xmlns="http://www.w3.org/1999/xhtml"><p>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.</p></abstract>

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.

Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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...

Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology

Published Online: Jul 20, 2020

Page range: 81 - 98

Accepted: Apr 05, 2020

DOI: https://doi.org/10.2478/acph-2021-0010

Keywords
design space, response surface method, lyophilization, ibuprofen

© 2021 Maja Preskar et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Investigation of design space for freeze-drying injectable ibuprofen using response surface methodology

Published Online: Jul 20, 2020

Page range: 81 - 98

Accepted: Apr 05, 2020

DOI: https://doi.org/10.2478/acph-2021-0010

Keywordsdesign space, response surface method, lyophilization, ibuprofen

© 2021 Maja Preskar et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
design space, response surface method, lyophilization, ibuprofen