Article
Design Space and Critical Points in Solid Dosage Forms
Author/s | Aguilar de Leyva, Mercedes Ángela
Campiñez, María Dolores Casas Delgado, Marta Caraballo Rodríguez, Isidoro |
Department | Universidad de Sevilla. Departamento de Farmacia y Tecnología Farmacéutica |
Publication Date | 2017 |
Deposit Date | 2024-09-24 |
Published in |
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Abstract | The current regulatory environment based on the ICH guidelines encourages a systematic and science-based approach in the pharmaceutical development, required by the “Quality by design” concept. This methodology implies ... The current regulatory environment based on the ICH guidelines encourages a systematic and science-based approach in the pharmaceutical development, required by the “Quality by design” concept. This methodology implies that the quality of a product must be designed instead of assayed in the final dosage form. For this purpose, a deep knowledge of the factors affecting the quality of the product is needed to establish the design space. This design space is limited by critical points of the formulation whose knowledge is essential in order to develop a robust dosage form. This papers deals with the main critical points that must be taken into account in the design of solid dosage forms such as inert and hydrophilic matrices as well as controlled released systems based in new biopolymers. The influence of factors such as the particle size or the rheology of powders in these critical points has been analysed. Moreover, in silico simulation software has been employed to elucidate the release mechanism leading to unexpectedly low critical points in sustained release matrices prepared with two new polyurethanes. |
Funding agencies | Ministerio de Economía y Competitividad (MINECO). España Junta de Andalucía |
Project ID. | MAT2012- 38044-C03-02
MAT2016-77345-C3-3-P P12-FQM-1553 |
Citation | Aguilar de Leyva, M.Á., Campiñez, M.D., Casas Delgado, M. y Caraballo Rodríguez, I. (2017). Design Space and Critical Points in Solid Dosage Forms. Journal of Drug Delivery Science and Technology, 42, 134-143. https://doi.org/10.1016/j.jddst.2017.06.004. |
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