Formulation Optimization and Quality Verification of Bortezomib Lyophilized Powder Injection Based on the QbD Concept
(Objective)To optimize the formulation of bortezomib original research drug and verify its quality based on the quality by design(QbD)concept.(Methods)Tert-butanol was added as a co-solvent,the dosage of main drugs and auxiliary materials in the prescription was screened,the CPPS were designed and optimized.The methodology was validated by controlling CQA such as intermediate content.(Results)The determination of bortezomib content in the sample was conducted by employing ultraviolet-visible spectrophotometry at a wavelength of 270 nm,with methanol serving as the reference.This approach adhered to the regulations regarding product content preparation;liquor was stable when it was placed at room temperature.(Conclusion)The preparation process is feasible;After the prescription optimization,the cost of the product was reduced and the stability and quality of the product were better than the expectation of the original product.
Quality by Design(QbD)BortezomibLyophilized Powder InjectionPrescription OptimizationQuality Verification
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