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A Quality-by-Control Approach in Pharmaceutical Continuous Manufacturing of Oral Solid Dosage via Direct Compaction.
Su, Qinglin; Ganesh, Sudarshan; Le Vo, Dan Bao; Nukala, Anushaa; Bommireddy, Yasasvi; Gonzalez, Marcial; Reklaitis, Gintaras V; Nagy, Zoltan K.
Afiliación
  • Su Q; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Ganesh S; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Le Vo DB; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Nukala A; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Bommireddy Y; School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Gonzalez M; School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Reklaitis GV; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
  • Nagy ZK; Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, United States.
ESCAPE ; 46: 1327-1332, 2019.
Article en En | MEDLINE | ID: mdl-36790944
The pharmaceutical industry has been undergoing a paradigm shift towards continuous manufacturing, under which novel approaches to real-time product quality assurance have been investigated. A new perspective, entitled Quality-by-Control (QbC), has recently been proposed as an important extension and complementary approach to enable comprehensive Quality-by-Design (QbD) implementation. In this study, a QbC approach was demonstrated for a commercial scale tablet press in a continuous direct compaction process. First, the necessary understanding of the compressibility of a model formulation was obtained under QbD guidance using a pilot scale tablet press, Natoli BLP-16. Second, a data reconciliation strategy was used to reconcile the tablet weight measurement based on this understanding on a commercial scale tablet press, Natoli NP-400. Parameter estimation to monitor and update the material property variance was also considered. Third, a hierarchical three-level control strategy, which addressed the fast process dynamics of the commercial scale tablet press was designed. The strategy consisted of the Level 0 built-in machine control, Level 1 decoupled Proportional Integral Derivative (PID) control loops for tablet weight, pre-compression force, main compression force, and production rate control, and Level 2 data reconciliation of sensor measurements. The effective and reliable performance, which could be demonstrated on the rotary tablet press, confirmed that a QbC approach, based on product and process knowledge and advanced model-based techniques, can ensure robustness and efficiency in pharmaceutical continuous manufacturing.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: ESCAPE Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: ESCAPE Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido