Preparation and evaluation of diclofenac sodium orally disintegrating tablets

Open access


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. Pharmaburst™ 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 coprocessed excipient Pharmaburst™ 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.

If the inline PDF is not rendering correctly, you can download the PDF file here.

  • [1] S. E. Leucuța in Medicines modified release ed. House book of science Cluj - Napoca 2011 pp. 286-295 (in Romanian).

  • [2] A. Asthana S. Aggarwal and G. Asthana Int. J. Pharm. Sci. Rev. Res. 20 193 (2013).

  • [3] A.N. Cristea Pharmacology treaty first edition Medical Publishing House Bucharest 2013 (in Romanian).

  • [4] J. K. Tillotson SpiPharma Pharmaburst TM 500: optimized evolutionary ODT performance 2011.

  • [5] M. Guhmann M. Thommes F. Gerber N. Pöllinger S. Klein J. Breitkreutz and W. Weitschies Pharm. Res. 30 1483 (2013).

  • [6] C. A. Lipinski F. Lombardo B. W. Dominy and P. J. Feeney. Advanced Drug Delivery Reviews 23 3 (1997).

  • [7] *** Romanian Pharmacopoeia 10th edition Medical Publishing House Bucharest 2011 (in Romanian).

  • [8]

  • [9] K. Kashniyal A.N. Choudhary P. Kothiyal Int. J. Ph. Ch. Sci. 2 82 (2013).

  • [10] J. M. Suñé-Negre M. Roig R. Fuster C. Hernández R. Ruhí E. García-Montoya P. Pérez-Lozano M. Miñarro J.R. Ticó - International Journal of Pharmaceutics 470 15 (2014).

  • [11] D.S. Nikam and V. Kadam International Journal of Pharmacy & Pharmaceutical Research 5 82 (2015).

  • [12] *** European Pharmacopoeia 8.0. EDQM 2014.

  • [13] P. Khokhar V. Shukla - Formulation and evaluation of fast dissolving tablets of diclofenac sodium using PVP Int. J. of Pharma Res. & Rev. 3 12 (2014).

Journal information
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 257 159 1
PDF Downloads 140 110 1