Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach
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...
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| Format: | Article |
| Language: | English |
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Sciendo
2017-03-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.1515/acph-2017-0009 |
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| author | Gavan Alexandru Porfire Alina Marina Cristina Tomuta Ioan |
| author_facet | Gavan Alexandru Porfire Alina Marina Cristina Tomuta Ioan |
| author_sort | Gavan Alexandru |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-dcafebb662f84fc78ea104f813142cd7 |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2017-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-dcafebb662f84fc78ea104f813142cd72025-02-02T08:32:25ZengSciendoActa Pharmaceutica1846-95582017-03-01671537010.1515/acph-2017-0009acph-2017-0009Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approachGavan Alexandru0Porfire Alina1Marina Cristina2Tomuta Ioan3University of Medicine and Pharmacy „Iuliu Hatieganu” Faculty of Pharmacy Department of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, RomaniaUniversity of Medicine and Pharmacy „Iuliu Hatieganu” Faculty of Pharmacy Department of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, RomaniaUniversity of Medicine and Pharmacy „Iuliu Hatieganu” Faculty of Pharmacy Department of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, RomaniaUniversity of Medicine and Pharmacy „Iuliu Hatieganu” Faculty of Pharmacy Department of Pharmaceutical Technology and Biopharmaceutics, Cluj-Napoca, RomaniaThe 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.https://doi.org/10.1515/acph-2017-0009quality by designdesign of experimentssustained releasehydrophilic matrixquetiapine |
| spellingShingle | Gavan Alexandru Porfire Alina Marina Cristina Tomuta Ioan Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach Acta Pharmaceutica quality by design design of experiments sustained release hydrophilic matrix quetiapine |
| title | Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach |
| title_full | Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach |
| title_fullStr | Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach |
| title_full_unstemmed | Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach |
| title_short | Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach |
| title_sort | formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a qbd approach |
| topic | quality by design design of experiments sustained release hydrophilic matrix quetiapine |
| url | https://doi.org/10.1515/acph-2017-0009 |
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