Purpose: To
formulate extended-release tablets of diclofenac sodium
based on ispaghula husk
Methods:
Tablets with varying proportions of diclofenac
sodium and ispaghula husk were formulated by wet
granulation technique at a fixed compression force of 10
kN. The formulated tablets were evaluated for
physicochemical parameters
as well as by
Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and
x-ray diffraction (XRD).
Results: Content uniformity, weight
variation, thickness and friability of the formulated
tablets were within acceptable limits. The hardness of
the tablet decreased from 5.4 to 4.2 kg/cm2
with increasing quantity of ispaghula husk in the
formulation. In contrast, disintegration time increased
from 12 to 70 min with increasing amount of husk.
Tablets formulated with 1:0.25 and 1:0.5 drug/husk ratio
failed to extend drug release whereas tablets prepared
with 1:0.75 and 1:1 ratio extended release up to 5 and 6
h, respectively. FTIR, DSC and XRD analysis of tablets
revealed the absence of diclofenac–ispaghula interaction
and crystalline nature of diclofenac sodium. Drug
release data fitted well with Korsmeyar-Peppas and the n
value of 0.98 indicate non-Fickian diffusion. The
tablets were stable on storage and retained its
physicochemical properties within acceptable limits.
Conclusion: The
results indicate the possibility
of formulating
extended-release tablets based on ispaghula husk. The
tablets were stable during storage and free from drug-excipient
interactions. However further studies are required to
ascertain the safety of the husk and to optimize the
release properties of the tablets.
Keywords: Ispaghula husk, Extended
release tablet, Diclofenac sodium, Release kinetics.