World Journal of
Pharmaceutical and Life Sciences

PREPARATION OF MIRTAZAPINE ORALLY DISINTEGRATING TABLETS WITH IMPROVED FORMULATION CHARACTERISTICS

Mahesh Kumar T.* and Gowsalya K.

ABSTRACT

The present work aimed to formulate the taste-masked mirtazapine granular blend into a solid oral tablet dosage form which disintegrates in the mouth quickly and effectively releases the drug for its systemic absorption with immediate action for the treatment of depressive disorders. The taste-masked blend of mirtazapine containing different types of disintegrants prepared in our previous study was compressed by direct compression method using a rotary tablet compression machine with optimum parameters. The formulated tablets were evaluated for various quality parameters including appearance, thickness, hardness, disintegration time, weight variation, drug content, wetting time, water absorption ratio, in-vitro dispersion time, fineness of dispersion and dissolution. There was no significant difference in physical parameters for all the formulations F1-F3, F4-F6, F7-F9, F10-F12 and F13-F15, which contained pregelatinized starch, sodium starch glycolate, croscarmellose sodium, polacrilin potassium and crospovidone respectively in three concentration levels of 1.5%, 3.0% and 4.5%. Formulations containing croscarmellose sodium, polacrilin potassium and crospovidone (F7-F15) were observed to be having less disintegration time, wetting time, in-vitro dispersion time with increased water absorption ratio in compared to formulations with pregelatinized starch and sodium starch glycolate (F1-F6). The optimized formulation containing polacrilin potassium (F10-F12) shows the least disintegration time and increased rate of drug release compared to other formulations and market products. A compatibility study performed between mirtazapine and tablet excipients used in this study by FT-IR spectroscopy showed no interactions. Further stability studies were conducted as per ICH-described accelerated storage conditions. It can be concluded that the developed formulation of mirtazapine orally disintegrating tablets was stable to possess improved quality characteristics and the process of preparation was easily scalable for its commercial manufacturing.

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