1. Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach
- Author
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Alina Porfire, Ioan Tomuta, Cristina Marina, and Alexandru Gavan
- Subjects
hydrophilic matrix ,quality by design ,Pharmaceutical Science ,design of experiments ,sustained release ,quetiapine ,02 engineering and technology ,030226 pharmacology & pharmacy ,Matrix (chemical analysis) ,03 medical and health sciences ,0302 clinical medicine ,Innovator ,Quetiapine Fumarate ,Process engineering ,Pharmaceutical industry ,Mathematics ,Pharmacology ,business.industry ,Product profile ,General Medicine ,021001 nanoscience & nanotechnology ,Product (mathematics) ,HD9665-9675 ,0210 nano-technology ,business ,Critical quality attributes ,Drug carrier ,Design space - 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.
- Published
- 2017