Preparation and evaluation of diclofenac sodium orally disintegrating tablets

Orally disintegrating tablets (ODTs) are dosage forms which disintegrate in mouth within seconds without need of water. This type of quality in dosage form can be attained by addition of different varieties of excipients. PharmaburstTM 500 is a co-processed excipient system which allows rapid disintegration and low adhesion to punches. The aim of the present study was to develop and evaluate 25 mg diclofenac sodium ODTs (orodispersible tablets) batches by direct compression method at different compression forces 10 kN (F1) and 20 kN (F2) and directly compressible excipients used in different ratio (Avicel PH 102, magnesium stearate and co-processed excipient PharmaburstTM 500, 70% and 80% w/w). The obtained batches were analyzed for appearance, tablet thickness, uniformity of weight, hardness, friability, disintegration time, and non-compendial methods (wetting time). Co-processed Pharmaburst™ 500 excipient 70% used for sodium diclofenac ODT obtaining determined good results for quality control tests evaluation.

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Preparation and evaluation of diclofenac sodium orally disintegrating tablets
Valeriu Iancu1 / Florentina Roncea1 / Radu George Cazacincu2 / Dumitru Lupuleasa3
1Ovidius University of Constanta, Faculty of Pharmacy, 1 University Alley, Campus, Corp B, Constanta, Romania
2Magistra C&C, 82A Aurel Vlaicu Blvd., Constanta, Romania
3Carol Davila University of Medicine and Pharmacy, Faculty of Pharmacy, 6 Traian Vuia, Bucharest, Romania
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