n vitro Release kinetics and Bio availability of Layered Matrix tablets of Diclofenac Sodium
Keywords:
Diclofenac sodium, Matrix and layered matrix tablets, Controlled releasedAbstract
Controlled release tablets having near zero-order release of diclofenac sodium water soluble drug were prepared using guar gum (GG) in matrix core and Hydroxy Propyl Cellulose (HPC), Hydroxy Propyl Methyl Cellulose (HPMCK4M) and Sodium Carboxy Methyl Cellulose (Na CMC) as barrier layers. The optimum ratio of drug: guar gum was found to be 1:1, anionic GG in the matrix core and anionic Na CMC as barrier layers resulted in near zero order release of diclofenac sodium. Different dissolution models were applied to drug release data in order to evaluate release mechanisms and kinetics. The nature of drug release from matrix tablets and layered matrix tablets followed non-Fickian diffusion and super case II mechanism respectively. Mean dissolution time (MDT) for the formulations MT-GG and MLT-06 were found to be 3.65h and 16.57h, while Dissolution Efficiency (DE8%) decreases, indicating that the release of drug is slower from layered matrix tablets. On the basis of in vitro release data, MLT-06 was subjected to bioavailability studies. The in-vivo characterization of diclofenac sodium in human volunteers from formulation MLT-06 showed delayed Tmax unaltered bio availability indicating a slow and controlled release of the drug from layered matrix tablets.
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