In Silico Modelling and Prediction of Pharmaceutical Stability
Pharmaceutical stability studies continue to be a key parameter in the development and manufacture of both drug substance and drug pruducts. The data collected from stability studies across the entire life cycle of drug development can be used to identify optimum formulation and manufacturing strate...
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| Tipo de recurso: | tesis doctoral |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Universidad Complutense de Madrid (UCM) |
| Repositorio: | Docta Complutense |
| Idioma: | inglés |
| OAI Identifier: | oai:docta.ucm.es:20.500.14352/95372 |
| Acceso en línea: | https://hdl.handle.net/20.500.14352/95372 |
| Access Level: | acceso abierto |
| Palabra clave: | 615.2(043.2) Medicamentos 3209 Farmacología |
| Sumario: | Pharmaceutical stability studies continue to be a key parameter in the development and manufacture of both drug substance and drug pruducts. The data collected from stability studies across the entire life cycle of drug development can be used to identify optimum formulation and manufacturing strategies, determine packaging and storage requirements, assign shelf-life or retest dates. Currently this information serves as both a key learning tool for industry as well as fulfilling a regulatory requirement for drug approval.Predictive modelling tools such as Accelerated Predictive Stability (APS), Risk Based Predictive Stability (RBPS) and the Accelerated Stability Assessment Program (ASAP) have gained prominence in the pharmaceutical industry as a means to improve understanding of drug degradation mechanisms and other key stability characteristics. Amorphous solid dispersions are currently one of the most common approaches utilised by the pharmaceutical industry to overcome solubility and dissolution issues when tackling the formulation of a poorly water-soluble drug for oral administration. Enhancing the solubility of hydrophobic drugs remains a challenge for oral delivery as their low solubility often results in reduced bioavailability being required for the administration of higher doses to ensure that a therapeutic dose is delivered to the target organ. Dispersing an active pharmaceutical ingredient (API) within an amorphous carrier – namely a polymer that controls drug release is one of the most common strategies to increase the dissolution rate of hydrophobic drugs. Several methods exist that may be used to produce amorphous solid dispersions but only a few, such as spray drying (SD) and hot melt extrusion (HME), are easily scalable... |
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