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Category:WindowsFormulation of dosage form of Venetoclax monohydrate: evaluation of quality, safety and stability.
Venetoclax is a new Bcl-2 inhibitor for treatment of B-cell lymphoid malignancies. The objective of the current study was to develop and formulate a dosage form of Venetoclax monohydrate with a long shelf life, which is effective, safe and well tolerated. Formulations of Venetoclax monohydrate were prepared by direct compression, and the in-vitro dissolution, dissolution rate, tablet hardness, disintegration time, friability, drug content uniformity, in vitro drug release were assessed and compared with the reference product. Pharmacokinetic parameters were calculated using Therapeutic Drug Monitoring in human healthy volunteers. A stable dosage form was developed by the incorporation of an immediate-release layer of methyl cellulose (MH) and an enteric-coated sustained-release layer of HPC with vinylpyrrolidone-polyethylene glycol polymer (VP-PPG). The proposed dosage form was stable for 3 months at different temperatures. The dissolution rate of Venetoclax was enhanced by increasing the concentration of polymers of HPC and VP-PPG. The enteric coating technique was used to sustain the release of Venetoclax. The results showed that the modified dosage form achieved a similar dissolution profile to the reference product. The dissolution rate of Venetoclax monohydrate was successfully increased by decreasing the amount of MH. The combination of VP-PPG and HPC significantly improved the oral bioavailability of Venetoclax. The in-vivo data showed that the bioavailability of Venetoclax monohydrate achieved was in the range of 95-134%. The results of the current study showed that the combination of HPC and VP-PPG was able to modulate the pharmacokinetics of Venetoclax monohydrate and the dosage form of Venetoclax developed in the current study has the potential to increase patient compliance and to improve the

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