Abstract:
The aim of present study was to formulate, develop and Characterize the
Geomatrix tablets containing Haloperidol in order to achieve zero order controlled
drug release to reduce the dose dependent toxicity of Haloperidol and to have better
patient compliance. The core tablet is prepared by using different grades of HPMC
in different proportions and along with other excipients like Lactose monohydrate
magnesium Stearate, PVP K30 by wet granulation technique. The granules for outer
layer were prepared by using mixture of HPMC K4M and HPMC K100LV in
different proportion and along with other excipients like lactose monohydrate and
PVP K30 by wet granulation method. Core tablet is placed in between the outer
layer granules and compressed to get geomatrix tablet. The granules were evaluated
for their flow properties and the finished tablets were evaluated for their physical
parameters and % Cumulative drug release. The drug release study of haloperidol
were done by using USP-II paddle type dissolution apparatus. The release rate of
Haloperidol was studied for 24 hours. The release rate of Haloperidol from all the
formulations was more than 85% at 24 hours. In case of HPMC K4M and HPMC
K100LV based tablets with the increasing of polymer concentration the release was
decreased. Total 9 batches have been manufactured to optimize and develop a
robust and stable formulation. The stability studies of the Geomatrix tablets were
also comply with ICH guidelines.
