Quality Consistency Assessment In Pharmaceutical Research For Generic Drug—Parecoxib Sodium For Injection

Parecoxib Sodium researched by Pharmacia and pfizer Ltd, Europe officialy listed in 2002. N-[[4-(5-methyl-phenyl-isoxazolyl) phenyl] sulfonyl]-propionamide m, is the Water soluble non-activated prodrug for valdecoxib.It is the selective cyclooxygenase-2 inhibitors and can be injected intravenously or intramuscularly in clinical dose range. Clinical commonly used as an analgesic for short-term and acute postoperative pain. Its efficacy has been proved in the stomatologic, gynecologic, or orthopedicsurgery.Intravenous paricoxib can also reduce the morphine consumption and improve post operative analgesia.1、The fundamental research of parecoxib sodium for injectionThe fundamental research of intravenous paricoxib consists of the study of the reference preparation, parecoxib sodium for injection API and excipients used to the parecoxib sodium for injection. According to the reference preparation can available information on the composition of the preparation, dosage range etc. The research results can provide the references for the study on formulation. According to the synthetic route and the stress test we can understand the impurity profile and degradative pathways of API,which can not only indicate the stability of the API,but also prevent the formation of impurities. The compatibility between API and excipient can inspect the availability of excipients.2、Preparation process developmentIn the formulation development,we select the best formulation by pre-experiment, prescription variable initial risk assessment,analysising the reference preparation and testing the critical quality attributes(CQA) and the stability of the sample. In the preparation process,we study on preparing, filtering/sterilization, filling and freeze drying technology and packaging materials by initial risk assessment and DOE (Design Of Experiments).The result of the three batches of pilot-scale samples, factors affecting test, accelerated test and long-term test indicate that own product are all up to the standards.3、The quality study of parecoxib sodium for injectionReference to relevant literature and the import standards,we focused on studying related substances and content of the three batches of own product,we verify the standards by the stability test.4、Study of stabilityStudy the stability of self-products by stress testing, accelerated testing and long-term test,the results showed that the preparations were stable enough under these testing condition.5、Comparison of the reference preparation and own product qualityCompared with the physicochemical properties and stability under different conditions,the impurity and degradation between own products and reference preparation were basically identical,and can showed that the quality of own product were almost same as the reference preparation.