Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach
Abstract The freeze-thaw (F/T) method is commonly employed during the processing and handling of drug substances to enhance their chemical and physical stability and obtain pharmaceutical applications such as hydrogels, emulsions, and nanosystems (e.g., supramolecular complexes of cyclodextrins and...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Journal of Biological Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13036-023-00353-9 |
| _version_ | 1797817931039506432 |
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| author | Sergio A. Bernal-Chávez Alejandra Romero-Montero Héctor Hernández-Parra Sheila I. Peña-Corona María L. Del Prado-Audelo Sergio Alcalá-Alcalá Hernán Cortés Lashyn Kiyekbayeva Javad Sharifi-Rad Gerardo Leyva-Gómez |
| author_facet | Sergio A. Bernal-Chávez Alejandra Romero-Montero Héctor Hernández-Parra Sheila I. Peña-Corona María L. Del Prado-Audelo Sergio Alcalá-Alcalá Hernán Cortés Lashyn Kiyekbayeva Javad Sharifi-Rad Gerardo Leyva-Gómez |
| author_sort | Sergio A. Bernal-Chávez |
| collection | DOAJ |
| description | Abstract The freeze-thaw (F/T) method is commonly employed during the processing and handling of drug substances to enhance their chemical and physical stability and obtain pharmaceutical applications such as hydrogels, emulsions, and nanosystems (e.g., supramolecular complexes of cyclodextrins and liposomes). Using F/T in manufacturing hydrogels successfully prevents the need for toxic cross-linking agents; moreover, their use promotes a concentrated product and better stability in emulsions. However, the use of F/T in these applications is limited by their characteristics (e.g., porosity, flexibility, swelling capacity, drug loading, and drug release capacity), which depend on the optimization of process conditions and the kind and ratio of polymers, temperature, time, and the number of cycles that involve high physical stress that could change properties associated to quality attributes. Therefore, is necessary the optimization of F/T conditions and variables. The current research regarding F/T is focused on enhancing the formulations, the process, and the use of this method in pharmaceutical, clinical, and biological areas. The present review aims to discuss different studies related to the impact and effects of the F/T process on the physical, mechanical, and chemical properties (porosity, swelling capacity) of diverse pharmaceutical applications with an emphasis on their formulation properties, the method and variables used, as well as challenges and opportunities in developing. Finally, we review the experimental approach for choosing the standard variables studied in the F/T method applying the systematic methodology of quality by design. |
| first_indexed | 2024-03-13T09:01:46Z |
| format | Article |
| id | doaj.art-8edb7ceba21342daa34e561488e701f2 |
| institution | Directory Open Access Journal |
| issn | 1754-1611 |
| language | English |
| last_indexed | 2024-03-13T09:01:46Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Biological Engineering |
| spelling | doaj.art-8edb7ceba21342daa34e561488e701f22023-05-28T11:19:08ZengBMCJournal of Biological Engineering1754-16112023-05-0117111810.1186/s13036-023-00353-9Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approachSergio A. Bernal-Chávez0Alejandra Romero-Montero1Héctor Hernández-Parra2Sheila I. Peña-Corona3María L. Del Prado-Audelo4Sergio Alcalá-Alcalá5Hernán Cortés6Lashyn Kiyekbayeva7Javad Sharifi-Rad8Gerardo Leyva-Gómez9Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de MéxicoDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de MéxicoDepartamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico NacionalDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de MéxicoTecnologico de Monterrey, Escuela de Ingeniería y Ciencias, Campus Ciudad de MéxicoLaboratorio de Tecnología Farmacéutica, Facultad de Farmacia, Universidad Autónoma del Estado de MorelosLaboratorio de Medicina Genómica, Departamento de Genómica, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra IbarraDepartment of Pharmaceutical Technology, Pharmaceutical School, Asfendiyarov Kazakh National Medical UniversityFacultad de Medicina, Universidad del AzuayDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de MéxicoAbstract The freeze-thaw (F/T) method is commonly employed during the processing and handling of drug substances to enhance their chemical and physical stability and obtain pharmaceutical applications such as hydrogels, emulsions, and nanosystems (e.g., supramolecular complexes of cyclodextrins and liposomes). Using F/T in manufacturing hydrogels successfully prevents the need for toxic cross-linking agents; moreover, their use promotes a concentrated product and better stability in emulsions. However, the use of F/T in these applications is limited by their characteristics (e.g., porosity, flexibility, swelling capacity, drug loading, and drug release capacity), which depend on the optimization of process conditions and the kind and ratio of polymers, temperature, time, and the number of cycles that involve high physical stress that could change properties associated to quality attributes. Therefore, is necessary the optimization of F/T conditions and variables. The current research regarding F/T is focused on enhancing the formulations, the process, and the use of this method in pharmaceutical, clinical, and biological areas. The present review aims to discuss different studies related to the impact and effects of the F/T process on the physical, mechanical, and chemical properties (porosity, swelling capacity) of diverse pharmaceutical applications with an emphasis on their formulation properties, the method and variables used, as well as challenges and opportunities in developing. Finally, we review the experimental approach for choosing the standard variables studied in the F/T method applying the systematic methodology of quality by design.https://doi.org/10.1186/s13036-023-00353-9Drug substancesChemical stabilityPhysical stabilityHydrogelsChemical propertiesPharmaceutical applications |
| spellingShingle | Sergio A. Bernal-Chávez Alejandra Romero-Montero Héctor Hernández-Parra Sheila I. Peña-Corona María L. Del Prado-Audelo Sergio Alcalá-Alcalá Hernán Cortés Lashyn Kiyekbayeva Javad Sharifi-Rad Gerardo Leyva-Gómez Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach Journal of Biological Engineering Drug substances Chemical stability Physical stability Hydrogels Chemical properties Pharmaceutical applications |
| title | Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach |
| title_full | Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach |
| title_fullStr | Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach |
| title_full_unstemmed | Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach |
| title_short | Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach |
| title_sort | enhancing chemical and physical stability of pharmaceuticals using freeze thaw method challenges and opportunities for process optimization through quality by design approach |
| topic | Drug substances Chemical stability Physical stability Hydrogels Chemical properties Pharmaceutical applications |
| url | https://doi.org/10.1186/s13036-023-00353-9 |
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