FORMULATION AND EVALUATION OF BILAYER TABLETS OF SUSTAINED RELEASE NSAID’s AND IMMEDIATE RELEASE PROTON PUMP INHIBITOR
Kishori Patel* Ashwini Rajendra and Swetha Gadhe
ABSTRACT
Aim of the present work was to develop bi-layer tablets of
Esomeprazole (IR) and Diclofenac sodium (SR) using bi-layer
technique. Esomeprazole immediate release layer was prepared by
using crospovidone, starch and microcrystalline cellulose. Diclofenac
sodium sustained release layer was prepared by using polymers such as
methocel K15M and guar gum in the ratio of [1:0.5]. The drug and
polymers were subjected for the compatibility studies using FT-IR
which indicated no interaction had taken place between the drug and
polymers. The pre-compression parameters and the post-compression
parameters of formulations were evaluated. The drug release studies of
Esomeprazole [IR] layer were performed in 0.1N HCl for 120 min and
Diclofenac sodium [SR] layer were performed in phosphate buffer pH 6.8 for 9 hrs.
Formulations F2 and F3 showed satisfactory % drug release among the prepared
formulations. In formulation F2, % drug release of Esomeprazole was 99.801±0.52% and %
drug release of Diclofenac sodium was 75.474±0.66%. In formulation F3, % drug release of
Esomeprazole was 99.461±0.88% and %drug release of Diclofenac sodium was
71.275±2.14%. The in vitro drug release data was fitted in kinetic models. It was found that
all the formulations followed zero order kinetics and non-Fickian/Anomalous diffusion
mechanism. MDT and %DE for formulations F2 and F3 were found to be 4.64hr & 4.64hr
and 48.37% & 48.40% respectively. From stability studies (at room temperature and at
40±2°C/75±5%RH for 2months), it was found that selected formulations F2 and F3 were
stable during study period.
Keywords: Bi-layer tablets, Diclofenac sodium, Esomeprazole, Crospovidone, HPMC K15M, Guar gum, Wet granulation.
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