Effect of Plasticizer on Release Kinetics of Diclofenac Sodium Pellets Coated with Eudragit RS 30 D |
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Authors: | Golam Kibria Monzurul Amin Roni Mohammad Shahriarul Absar Reza-ul Jalil |
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Institution: | (1) Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka, 1000, Bangladesh |
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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. |
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Keywords: | aqueous coating diclofenac sodium Eudragit RS 30 D plasticizer thermal analysis |
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