In this paper, the quality evaluation and analysis of oral solid generic drugs were carried out by experiment, and the steps and methods of multiple dissolution curves in the evaluation of solid generic drugs were des...In this paper, the quality evaluation and analysis of oral solid generic drugs were carried out by experiment, and the steps and methods of multiple dissolution curves in the evaluation of solid generic drugs were described. The pharmaceutical quality evaluation results under the conditions of in vitro consistency, in vitro inconsistency, in vivo consistency, BE test success and failure were elaborated, which provided reference for the quality improvement of solid generic drugs in China.展开更多
Deferasirox is the first-line drug for iron overload due to thalassemia in adults and pediatric patients. It is classified as a type II compound in the Biopharmaceutics Classification System, and thus the particle siz...Deferasirox is the first-line drug for iron overload due to thalassemia in adults and pediatric patients. It is classified as a type II compound in the Biopharmaceutics Classification System, and thus the particle size of its active pharmaceutical ingredient(API) should be strictly controlled during the manufacturing process. In the present study, laser diffraction was adopted to measure the particle size distribution of deferasirox API. We also developed and validated an accurate and convenient method by investigating important optical parameters and sample dispersing conditions. The relative standard deviation values, namely, d(0.1), d(0.5), d(0.9), and d(4,3), measured via methodology validation and actual sample measurement were < 3%. The dissolution curves of several batches of dispersible tablets prepared using deferasirox with different particle sizes were compared in the four dissolved media to investigate the influence of particle size on drug dissolution in vitro. Results indicated that the particle size distribution of deferasirox API significantly affected the release of its dispersible tablet.展开更多
文摘In this paper, the quality evaluation and analysis of oral solid generic drugs were carried out by experiment, and the steps and methods of multiple dissolution curves in the evaluation of solid generic drugs were described. The pharmaceutical quality evaluation results under the conditions of in vitro consistency, in vitro inconsistency, in vivo consistency, BE test success and failure were elaborated, which provided reference for the quality improvement of solid generic drugs in China.
基金CAMS Innovation Fund for Medical Sciences(CIFMS No.2016-I2M-3-010 and CIFMS No.2017-I2M-1-011)。
文摘Deferasirox is the first-line drug for iron overload due to thalassemia in adults and pediatric patients. It is classified as a type II compound in the Biopharmaceutics Classification System, and thus the particle size of its active pharmaceutical ingredient(API) should be strictly controlled during the manufacturing process. In the present study, laser diffraction was adopted to measure the particle size distribution of deferasirox API. We also developed and validated an accurate and convenient method by investigating important optical parameters and sample dispersing conditions. The relative standard deviation values, namely, d(0.1), d(0.5), d(0.9), and d(4,3), measured via methodology validation and actual sample measurement were < 3%. The dissolution curves of several batches of dispersible tablets prepared using deferasirox with different particle sizes were compared in the four dissolved media to investigate the influence of particle size on drug dissolution in vitro. Results indicated that the particle size distribution of deferasirox API significantly affected the release of its dispersible tablet.
