Purpose:
The objective of the study was to develop matrix tablets
for oral controlled release of aceclofenac using ethyl
cellulose, guar gum and various grades of cellulose
polymers.
Methods:
Possible drug-excipient interaction was evaluated by
high performance liquid chromatography (HPLC) and
Fourier infrared spectroscopy (FTIR). The tablets
prepared were assessed for their
physicochemical, in vitro drug release at pH1.2, 4.5, 6.8
and 7.5 and stability characteristics. Comparison with a
‘once daily’ commercial aceclofenac product was made in
the in vitro studies.
Results:
There was no interaction between aceclofenac and the
polymers used as excipients. Furthermore, the
physicochemical properties of the tablets were
satisfactory. The release profile of one of the
formulated aceclofenac tablets (F7), which contained
hydroxypropyl methyl cellulose (HPMC K4M), was
statistically similar (p < 0.05) to that of the
commercial aceclofenac brand in all the dissolution
media. The formulated products ware stable and
showed no changes in physical appearance, drug content,
or dissolution pattern after storage at 40 oC
/75 %RH for 6 months.
Conclusion:
The results indicate that it is feasible to achieve a
stable ‘once daily’ sustained release aceclofenac tablet
formulation by using HPMC K4M of 4000cps viscosity grade
as matrix material.
Keywords:
Aceclofenac, Sustained release, Matrix tablets,
Cellulose polymers, Stability studies.
