Research And Development Of Nimesulide Orally Disintegrating Tablet

Orally disintegrating tablet as a new dosage form appears abroad medicine market in recent years .Because the patient use it without water, it can dissolve in a minute. Because of facility, fast and high bioavailability characteristic , so it become a study hot point in medical world.In this paper, prescription and preparation technology of nimesulide orally disintegrating tablet have been proposed. with the indes of the appearance of photograph ,disintegration time limit, bursting strength and dissolution rate, combine with the property of nimesulide physical chemistry ,the ingredient of prescription were selected by orthogonal design. Then granule preparation by the wet method were experimentally determined. Based on the above results dissolution rate and content measurement method and conditions were elementally determined , criterion of nimesulide orally disintegrating tablet's quality control also was investigated . By comparing dissolution rate of nimesulide orally disintegrating tablet's with that of other orally dosage. Nimesulide orally disintegrating tablet's prescription was indicated reasonable .In addition, the stability of nimesulide orally disintegrating tablet was investigated in detail. Through the test of air oxidation light shinning , high temperature and heavy humidity ,it was proved that nimesulide was insensitive to the above–mentioned factors. Meanwhile, high stability of nimesulide was certified by the accelerated test.Finally ,the scale-up experiment for industrial production was carried out . The experimental results showed that the nimesulide orally disintegrating tablets produced after scale-up experiment were in accordance with Chinese pharmacopoeia in appearance, weight difference, ingredient and dissolution rate. It indicated that production technology in this study had a high recurrence and production quality was easily controlled, so it could be industrially produced.In conclusion, this study established reliable academic foundation and experimental basis for next optimizing orally disintegrating tablet .it has an important significance in theoretical guide and relatively high practical value.