Discussion on Crystal Type Research in the Development of Chemical Generic Drugs
Objective To discuss crystal type studies and control strategies during preparations process and stability of chemical generic drug.Methods Based on the idea that the quality by design,discuss the types of drug substance crystal patterns present in the pharmaceutical preparation.Results Different crystal forms in pharmaceutical preparations require different control strategies,and maintaining crystal form stability is one of the important bases for drug safety and effectiveness.Good crystal control strategy can ensure the quality reproducibility.Conclusion During the formulation development process,in addition to the conventional powder X-ray diffraction method(PXRD),alternative methods(such as dissolution)can also be used as a means of crystal control which especially for the solubility varies widely between different crystal forms.
Chemical generic drugPharmaceutic preparationCrystal type research
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