* If you want to update the article please login/register
The anti-cancer drug pazopanib hydrochloride has a very low aqueous solubility and a variable oral bioavailability. A new pharmaceutical formulation with a greater solubility may increase the bioavailability and decrease the variability. Of the tested mixture formulations, the one containing co-block polymer Soluplus® in a 8:1 ratio with PZH did the best in terms of in vitro dissolution characteristics, according to the table below. 300 mg of the approved formulation yielded similar coverage and a lower variation than previously reported values for the standard PZH formulation in the approved dose of 800 mg.
Source link: https://doi.org/10.1016/j.ijpharm.2018.04.037
A selective stability showing a validated procedure was created with a Waters Acquity UPLC T3 column in gradient mode with ammonium acetate buffer and acetonitrile was obtained in a selective mode. All of the TPs were identified and described by liquid chromatography/atmospheric pressure chemical ionization-quadrupole-time of flight mass spectrometry experiments in combination with accurate mass measurements. The TP, N4-methylpyrimidine-2,4-diamine, was discovered to be genotoxic, but all other sulfonamide TPs were hepatotoxic. The results here are expected to be of importance as this report predicts the emergence of one potential genotoxic and five hepatotoxic degradation/transformation products.
Source link: https://doi.org/10.1002/jms.3602
An essential part of drug quality control is knowing the origins and fate of organic impurities in the manufacturing process as well as a robust control process is a vital component of drug quality control. Following the underlying principles of quality by design's fundamentals, a comprehensive approach to quantitative monitoring of process impurities by impurity fate mapping has been applied to the investigation and monitoring of impurities in the manufacturing process of Pazopanib hydrochloride, an anticancer drug that was recently approved by the US FDA. Comprehensive IFM can demonstrate impurities control plans. This paper discusses the central roles that analytical sciences play in the IFM process and impurity control. Pazopanib hydrochloride's complete control program includes qualitative testing of impurities with'meaningful' specifications and the 'right' analytical techniques.
Source link: https://doi.org/10.1016/j.jpba.2010.01.043
Manufacturer control companies are becoming increasingly concerned about trace-level genotoxic impurities in drug drugs, requiring manufacturers to provide new methods for monitoring and monitoring. Given the largely reactive and labile nature of genotoxic impurities, it is difficult to determine the majority genotoxic impurities in the low ppm level relative to the active pharmaceutical ingredient, it poses significant analytical difficulties. Product quality should be factored into the manufacturing process from a quality-by-design perspective. We provide concrete examples for the analytical evaluation of five genotoxic impurities in the production of pazopanib hydrochloride, an anticancer drug that is currently in Phase III clinical trials, which may be a model for other products in development. This allows the control limits to be set at percentage rather than ppm levels, thereby reducing the analytical testing and the analytical toolkits to be used in quality control labs.
Source link: https://doi.org/10.1016/j.jpba.2009.04.002
* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions