The Study On Prepartion Technology And Quality Assessment Of Lurasidone Hydrochloride

According to the nature of the lurasidone,this paper was designed to take the formulation screening through selecting excipients screened by excipient compatibility testing and those with good compatibility after referring to the RLD formulation and considering the usage of recipients in our country.Using mannitol as filler,pregelatine starch for ball mill mixture,cross linking carboxymethyl cellulose sodium as disintegrating agent,magnesium stearate as lubricant,hydroxypropyl methyl cellulose as adhesive.Based on continuous optimization of ball grinding process,we solved the problem of the indissolvable of lurasidone.Single factor test was adopted to screen out the disintegrant content and the way it joins,the amount of lubricant,the concentration of adhesive,the different preesure to tablet respectively.Particle fluidity,appearance of tablet,hardness,friabibity,disintegration time and dissolution curve were taken as indicators.Formula 12 was determined,namely,a lurasidone tablet contains 40 mg lurasidone,71.2 mg mannitol,40mg pregelatine starch,17.5 mg starch,4 mg sodium starch glycolate,1 mg colloidal silicon dioxide and 1 mg magnesium stearate,8mg crosslinking carboxymethyl cellulose sodium,a moderate amount of 2%hydroxypropyl methyl cellulose,0.8mg magnesium stearate.Single factor test was adopted to optimize the preparation technology,including addition amount of adhesive,tablet hardness,coating weight and particle size.The production process of the Lurasidone hydrochloride was developed,from laboratory scale to industrial scale.The production process includes following major steps:mixing,preparing the damp mass,granulating,drying,milling,general mixing,tabletting,coating and packaging.Process steps which may have impact on the preparation quality during the preparing process are also investigated in this paper.