Research Progress on Detection Methods for Amorphous Content in Active Pharmaceutical Ingredients and Excipients of Inhalation Preparations
In recent years,with the frequent occurrence of respiratory diseases such as chronic obstructive pulmonary disease and asthma,pulmonary administration has gradually become a new trend in the treatment of these diseases.And inhalation administration is one of the more widely used ways.In the development of inhalation,there is often a certain amount of amorphous material present in the active pharmaceutical ingredients,excipients,and intermediates due to the processes such as micronization and grinding.Amorphous material has poor thermal stability and can easily transform into the crystalline under certain conditions,which can potentially cause many issues,such as affecting the stability of the final products.Therefore,whether it is a single compound or an intermediate obtained according to a prescription,a mature drug development process must include the detection and quantitative analysis of amorphous material in the drug.This review mainly elaborates on the detection methods commonly used in the pharmaceutical field for the amorphous content.
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