A Proposed Methodology for a Risk Assessment-Based Liposome Development Process
The requirements of a liposomal formulation vary depending on the pharmaceutical indication, the target patient population, and the corresponding route of administration. Different preparation methods require various material attributes (MAs) (properties and characteristics of the components) and pr...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-11-01
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| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/12/12/1164 |
| _version_ | 1797546236186722304 |
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| author | Zsófia Németh Edina Pallagi Dorina Gabriella Dobó Ildikó Csóka |
| author_facet | Zsófia Németh Edina Pallagi Dorina Gabriella Dobó Ildikó Csóka |
| author_sort | Zsófia Németh |
| collection | DOAJ |
| description | The requirements of a liposomal formulation vary depending on the pharmaceutical indication, the target patient population, and the corresponding route of administration. Different preparation methods require various material attributes (MAs) (properties and characteristics of the components) and process parameters (PPs) (settings of the preparation method). The identification of the quality target product profile for a liposome-based formulation, the critical quality attributes of the liposomes, and the possible MAs and PPs that may influence the key characteristics of the vesicles facilitates pharmaceutical research. Researchers can systematise their knowledge by using the quality by design (QbD) approach. The potential factors that influence the quality of the product can be collected and studied through a risk assessment process. In this paper, the requirements of a liposome formulation prepared via the thin-film hydration preparation technique are presented; furthermore, the possible factors that have an impact on the quality of the final product and have to be considered and specified during the development of a liposomal formulation are herein identified and collected. The understanding and the application of these elements of QbD in the pharmaceutical developments help to influence the quality, the achievements, and the success of the formulated product. |
| first_indexed | 2024-03-10T14:27:14Z |
| format | Article |
| id | doaj.art-7f1d87539f2646de9cb0f6e7f79ca7e7 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T14:27:14Z |
| publishDate | 2020-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-7f1d87539f2646de9cb0f6e7f79ca7e72023-11-20T22:52:59ZengMDPI AGPharmaceutics1999-49232020-11-011212116410.3390/pharmaceutics12121164A Proposed Methodology for a Risk Assessment-Based Liposome Development ProcessZsófia Németh0Edina Pallagi1Dorina Gabriella Dobó2Ildikó Csóka3Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, HungaryFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, HungaryFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, HungaryFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, HungaryThe requirements of a liposomal formulation vary depending on the pharmaceutical indication, the target patient population, and the corresponding route of administration. Different preparation methods require various material attributes (MAs) (properties and characteristics of the components) and process parameters (PPs) (settings of the preparation method). The identification of the quality target product profile for a liposome-based formulation, the critical quality attributes of the liposomes, and the possible MAs and PPs that may influence the key characteristics of the vesicles facilitates pharmaceutical research. Researchers can systematise their knowledge by using the quality by design (QbD) approach. The potential factors that influence the quality of the product can be collected and studied through a risk assessment process. In this paper, the requirements of a liposome formulation prepared via the thin-film hydration preparation technique are presented; furthermore, the possible factors that have an impact on the quality of the final product and have to be considered and specified during the development of a liposomal formulation are herein identified and collected. The understanding and the application of these elements of QbD in the pharmaceutical developments help to influence the quality, the achievements, and the success of the formulated product.https://www.mdpi.com/1999-4923/12/12/1164quality by designquality planningrisk assessmentcritical factorsliposome formulationthin-film hydration method |
| spellingShingle | Zsófia Németh Edina Pallagi Dorina Gabriella Dobó Ildikó Csóka A Proposed Methodology for a Risk Assessment-Based Liposome Development Process Pharmaceutics quality by design quality planning risk assessment critical factors liposome formulation thin-film hydration method |
| title | A Proposed Methodology for a Risk Assessment-Based Liposome Development Process |
| title_full | A Proposed Methodology for a Risk Assessment-Based Liposome Development Process |
| title_fullStr | A Proposed Methodology for a Risk Assessment-Based Liposome Development Process |
| title_full_unstemmed | A Proposed Methodology for a Risk Assessment-Based Liposome Development Process |
| title_short | A Proposed Methodology for a Risk Assessment-Based Liposome Development Process |
| title_sort | proposed methodology for a risk assessment based liposome development process |
| topic | quality by design quality planning risk assessment critical factors liposome formulation thin-film hydration method |
| url | https://www.mdpi.com/1999-4923/12/12/1164 |
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