Formulation and evaluation of olanzapine sustained release matrix tablets for the treatment of schizophrenia

The present study was undertaken to design sustained release matrix tablets of olanzapine(OZ) for the treatment of schizophrenia. The tablets were prepared by wet granulation method along with benecel and HPMC K4M polymer as release retardant polymer. The amount remains fixed(10mg) for all the batches of formulation. All the batches were evaluated for the precompression parameters and post compression parameters. The release kinetics of tablets using hydrophilic matrix of benecel alone could not control the olanzapine release effectively for 12 hr whereas when combined with HPMC K4M could slow down the release of drug. The dosage regimen of olanzapine is 10mg tablet once in a day. It was chosen as a model drug with an aim to develop a sustained release system for a period of 12 hrs. The batch(OZ4) formulation containing 140mg of benecel and 26mg of HPMCK4M considered as overall best formulation (with an in vitro release of 98.63%).This sustained release system was found to deliver olanzapine at a zero-order rate for 12 hrs. Short term stability study (at 40±2ºC/ 75±5% RH for three months) on the best formulation indicated that there no significant changes in drug content. IR spectroscopic study indicated that there are no drug excipient interactions.

Author(s): ChinmayaKeshariSahoo, KokkulaSatyanarayana, GudeBhargaviand NaliniKantaSahoo

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