Study On The Finasteride Tablets Quality Consistency Evaluation

Finasteride was developed by Merck in the United States.It was approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia.It was approved to import into China in 2002.Combined with production practice,this paper conducted a systematic quality consistency evaluation study on finasteride tablets and the reference drugs(Proscar(?)),aiming to achieve similar in vitro dissolution behavior of the original drug and consistent product quality indicators.The basis of the pharmaceutical research data for the conformity evaluation of the generic drug declaration for this drug is as follows:1.Existing process evaluationIn the present process evaluation,the dissolution method of finasteride tablets in vitro was studied,and the dissolution curve of the marketed products and reference drugs was analyzed according to the method,and the similarity of the dissolution behavior of finasteride tablets in vitro was investigated.The comparison of dissolution behavior provides reference for prescription and process optimization.The comparison of the key quality properties of finasteride tablets provides a basis for the study of quality standard methodology.2.Prescription and process researchThe study of physical and chemical properties of API provides guidance for prescription and process research.The types of excipients in the prescription were determined by the compatibility test of raw materials.According to the existing process evaluation results,the reference drugs was analyzed,the prescription was screened and optimized,and the process parameters were compared to determine the optimal prescription and process parameters.After the pilot test,the product quality is controllable and reproducibility is good.3.Research on quality standardsThrough the verification of analytical methods,the key quality control items of finasteride tablets,the detection methods of dissolution,related substances and contents were established and determined,and the comparison tests of reference drugs and self-made drugs were carried out.The analytical methods determined can effectively control the product quality of finasteride tablets.4.In vitro consistency evaluationThe results of sample test and dissolution curve determination of the three batches of verified samples showed that the key quality properties of the self-made drugs and the reference drugs were consistent,and the dissolution behavior was similar in the four pH dissolution media.Through the influence factor test,6-months accelerated test and 18-months long-term test investigation,the stability of the homemade preparation is good.In summary,on the basis of the existing production process of finasteride tablets,this article carried out the research on the formulation process and quality standard of the product,and compared the product quality,dissolution behavior and stability of the self-made and the reference drugs.Confirmed that the quality of the self-made and the reference drugs were consistent,and the stability of self-made drugs was good,which provided a reliable basis for the pharmaceutical data declared for the consistency evaluation of finasteride tablets.