Application of quality by design (qbd) to reformulation of chewable tablets
This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study. In this way, product formulation and preparation procedure were reformulated. The starting point was the definition of t...
- Autores:
-
Rocha Saleme, Héctor
Cuadro Julio, Jorge Enrique
Mora Huertas, Claudia Elizabeth
- Tipo de recurso:
- Article of journal
- Fecha de publicación:
- 2013
- Institución:
- Universidad Nacional de Colombia
- Repositorio:
- Universidad Nacional de Colombia
- Idioma:
- spa
- OAI Identifier:
- oai:repositorio.unal.edu.co:unal/49326
- Acceso en línea:
- https://repositorio.unal.edu.co/handle/unal/49326
http://bdigital.unal.edu.co/42783/
http://bdigital.unal.edu.co/42783/2/
- Palabra clave:
- calidad basada en el diseño
gestión del riesgo
diseño estadístico experimental
formulación
tabletas masticables
Quality by Design (QbD)
risk management
statistical experimental design
formulation
chewable tablets
- Rights
- openAccess
- License
- Atribución-NoComercial 4.0 Internacional
Summary: | This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study. In this way, product formulation and preparation procedure were reformulated. The starting point was the definition of the product quality profile from which the critical quality attributes were identified. Also, the impact and the criticality of each stage of manufacture for the product were examined regarding to their influence in achieving the critical quality attributes. Risk assessment was made for critical manufacture stages and considering the results, mitigation strategies were proposed and implemented. This leads to a formulation satisfying the requirements for the organoleptic properties like the 25% reduction in the production time. |
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