Characterization Studies Albendazole Drug by Dissolution and DSC Correlation and DSC and DSC-Photovisual System

摘要

The present work proposes to evaluate the albendazole form present different in rawrnmaterials for analysis thermal, infrared spectra and dissolution. Albendazole drug substance isrnpoorly water soluble and has a show dissolution rate. Significant therapeutic differences havernbeen observed between the different forms, which supports the fact that the low solubility andrnpoor rate of solution of the drug are important factors limiting its use in the treatment of severalrndiseases. The polymorphs differ with respect to their infrared (IR) and differential scanningrncalorimeter (DSC). During this generic development study, four raw materials samples werernstudied in order to determine whether they contained polymorph. It has been shown that thernchanges in the crystalline and amorphous forms albendazole may be monitored by thermalrnanalytical techniques. The methodology employed correlation of the dissolution and DSC forrncharacterization of albendazole. Analysis of the data furnished by thermal analysis, infrared andrndissolution system confirmed differences between albendazole drug substance batches. Analysisrnof the data obtained from DSC coupled to the photovisual system showed different transitionrnphase processes between the different albendazole batches (Figure 1) The dissolution of batchrn01012 (Figure 2) was better than that of other batches. The comparison of samples from fourrndifferent batches revealed the value of dissolution/DSC photovisual system correlation in thernquality control of the raw material.