AAPS PharmSciTech

, Volume 9, Issue 4, pp 1240–1246 | Cite as

Effect of Plasticizer on Release Kinetics of Diclofenac Sodium Pellets Coated with Eudragit RS 30 D

  • Golam Kibria
  • Monzurul Amin Roni
  • Mohammad Shahriarul Absar
  • Reza-ul Jalil
Research Article

Abstract

The present study was designed to investigate the effect of two plasticizers, i.e., triethyl citrate (TEC) and polyethylene glycol 6000 (PEG 6000) on the in vitro release kinetics of diclofenac sodium from sustained-release pellets. Ammonio methacrylate copolymer type B (Eudragit RS 30 D) is used as the release-retarding polymer. Both plasticizers were used at 10% and 15% (w/w) of Eudragit RS 30 D. Pellets were prepared by powder layering technology and coated with Eudragit RS 30 D by air suspension technique. Thermal properties of drug and drug-loaded beads were studied using differential scanning calorimeter (DSC). DSC thermogram represented the identity of raw materials and exhibited no interaction or complexation between the active and excipients used in the pelletization process. Dissolution study was performed by using USP apparatus 1. No significant difference was observed among the physical properties of the coated pellets of different batches. When dissolution was performed as pure drug, about 8.22% and 90% drug was dissolved at 2 h in 0.1 N HCl and at 30 min in buffer (pH 6.8), respectively. From all formulations, the release of drug in acid media was very negligible (maximum 1.8 ± 0.08% at 2 h) but in buffer only 12% and 30% drug was released at 10 h from coated pellets containing TEC and PEG 6000, respectively, indicating that Eudragit RS 30 D significantly retards the drug release rate and that drug release was varied according to the type and amount of plasticizers used. The amount of TEC in coating formulation significantly effected drug release (p < 0.001), but the effect of PEG 6000 was not significant. Formulations containing PEG 6000 released more drug (98.35 ± 2.35%) than TEC (68.01 ± 1.04%) after 24 h. Different kinetic models like zero order, first order, and Higuchi were used for fitting drug release pattern. Zero order model fitted best for diclofenac release in all formulations. Drug release mechanism was derived with Korsmeyer equation.

Key words

aqueous coating diclofenac sodium Eudragit RS 30 D plasticizer thermal analysis 

Notes

Acknowledgements

The authors would like to thank Eskayef Bangladesh Ltd. (formerly, SmithKline & French, UK) for providing the raw materials as well as manufacturing facilities, Bangladesh Council of Scientific and Industrial Research (BCSIR), and Renata Ltd. Bangladesh (formerly, Pfizer, USA) for providing the scanning electron micrograph and the DSC thermogram, respectively.

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Copyright information

© American Association of Pharmaceutical Scientists 2008

Authors and Affiliations

  • Golam Kibria
    • 1
  • Monzurul Amin Roni
    • 1
  • Mohammad Shahriarul Absar
    • 1
  • Reza-ul Jalil
    • 1
  1. 1.Department of Pharmaceutical Technology, Faculty of PharmacyUniversity of DhakaDhakaBangladesh

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