<abstract xmlns="http://www.w3.org/1999/xhtml"><p> The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics and a dissolution profile similar to the innovator product, with f<sub>2</sub> values of 74.53 and 83.74. It was concluded that the QbD approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.</p></abstract>

The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics and a dissolution profile similar to the innovator product, with f2 values of 74.53 and 83.74. It was concluded that the QbD approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target...

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

Article Category: Original research paper

Publicado en línea: 21 feb 2017

Páginas: 53 - 70

Aceptado: 03 dic 2016

DOI: https://doi.org/10.1515/acph-2017-0009

Palabras clave
quality by design, design of experiments, sustained release, hydrophilic matrix, quetiapine

© by Alina Porfire

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach

Article Category: Original research paper

Publicado en línea: 21 feb 2017

Páginas: 53 - 70

Aceptado: 03 dic 2016

DOI: https://doi.org/10.1515/acph-2017-0009

Palabras clavequality by design, design of experiments, sustained release, hydrophilic matrix, quetiapine

© by Alina Porfire

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Palabras clave
quality by design, design of experiments, sustained release, hydrophilic matrix, quetiapine