Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system

Dissolution profiles of four carbamazepine immediate-release generic products (200mg tablets) and the reference product Tegretol® were evaluated using the USP paddles method and an alternative method with the flow-through cell system, USP Apparatus 4. Under official conditions all products met the Q...

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Veröffentlicht in:Saudi pharmaceutical journal 2014-04, Vol.22 (2), p.141-147
Hauptverfasser: Medina, José Raúl, Salazar, Dulce Karina, Hurtado, Marcela, Cortés, Alma Rosa, Domínguez-Ramírez, Adriana Miriam
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Sprache:eng
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Zusammenfassung:Dissolution profiles of four carbamazepine immediate-release generic products (200mg tablets) and the reference product Tegretol® were evaluated using the USP paddles method and an alternative method with the flow-through cell system, USP Apparatus 4. Under official conditions all products met the Q specification, dissolution profiles of generic products were similar to the dissolution profile of the reference product (f2>50) and model-independent parameters showed non significant differences to the reference product except mean dissolution time for product A (p
ISSN:1319-0164
2213-7475
DOI:10.1016/j.jsps.2013.02.001