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...

Full description

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
Description
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.