Study On The Dispersible Tablets Of Aniracetam

Aniracetam(1-p-anisoyl-2-pyrrolidinone) is a member of a group of cognition enhancers with a pyrrolidinone moiety; it is a derivative of piracetam.Aniracetam is a pyrrolidinone-type cognition enhancer thathas been clinically used in the treatment of behavioral and psychological symptoms of dementia following stroke and in Alzheimer's disease as well in the treatment of various CNS disorders or disease states.In this paper, Aniracetam dispersible tablets were prepared. First of all, we determined the content and the related substances of Aniracetam dispersible tablets by high-performance liquid chromatography, determined the dissolution of Aniracetam dispersible tablets by ultraviolet spectrophotometry. The results of HPLC showed that, Aniracetam in the concentration from 20.04μg/ml to 200.4μg/ml is in a good linear relationship, the regression equation is A=57711.5C-15841.0,r=0.9999 (n=7), the average recovery rate is between 99% and 101%,RSD<1.70%, The RSD of gauge factor, repeatability and daily stability were 0.08%,0.90%,which is consistent with the determination requirements of Aniracetam dispersible tablets.The lowest limit of quantification is 18ng, the minimum detection limit of 5ng. After destroyed with acid, alkali,oxidizing agents, high temperature test, the peak separation of the foreign matter peak and the main component peak is consistent with the assaying request. The results of UV showed that, in 0.1mol/L HCl,between the concentration 2.0μg/ml and 12.0μg/ml, is a linear relationship between the absorption of Aniracetam and concentration,A=0.0495C-7.33×10-4,r=0.9999,the solution is stable in 8 hours, the average recovery is between 99% and 102%, RSD<1.60%, in line with the requirements of dissolution. Secondly, we carried out a series of test evaluated the effects of type and dosage of disintegrating agents,type and dosage of lubricants and particles siza, granulation method and pressure,join approach of disintegrating agents.Also,we evaluated the effects release medium and rotation speed on the release rate of the Aniracetam dispersible tablets Results show, the release rate of Aniracetam dispersible tablets was mainly effected by the amount of PVPP.Granulation method,particles siza,pressure,join approach of disintegrating agents also had significant effect on the release rate of Aniracetam dispersible tablets. The reproducibility results show that the prescription of the Aniracetam dispersible tablets is optimal, and the preparation technology is stable, the in vitro dissolution property is in line with listed products.Secondly,the stability of Aniracetam dispersible tablets was investigated in detail.By the tests of strong light shinning,high temperatureand and heavy humidity,it was proved that Aniracetam dispersible tablets were insensitive to the above factors.Meanwhile,Further high stability of the product was certified by the acceleration test and long term storage at room temperature test(18months).In conclusion, established reliable academic foundation and industrial basis for next optimizing Aniracetam dispersible tables prescription have important significancein theoretical guide and practical application value for developing the dispersible tablets.