【摘 要】
：
APIs polymorphic characteristics are crucial to their physicochemical behaviors such as solubility,dissolution rate,bioavailability,and stability.Acetaminophen,a representative NSAID drug,is known to
【机 构】
：
Department of Pharmaceutical Engineering,Inje University,Gimhae,Gyeongnam 621-749,South Korea
【出 处】
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The 6th International Conference on Separation and Technolog
论文部分内容阅读
APIs polymorphic characteristics are crucial to their physicochemical behaviors such as solubility,dissolution rate,bioavailability,and stability.Acetaminophen,a representative NSAID drug,is known to exist in three polymorphs; monoclinic (form-Ⅰ; stable),orthorhombic(form-Ⅱ; meta-stable),and form-Ⅲ.When a solid dosage form of acetaminophen is produced,the form-Ⅱ is preferred due to several advantages such as compactability,well-characterized plastic deformation upon compaction,and so forth.In general,the form-Ⅱ is produced by seeding technique or by melting the form-Ⅰ at elevated temperatures followed by cooling down to the room temperature.Recently it was reported that the polymorph of acetaminophen was greatly affected by the cooling rate with a supersaturated solution in methanol (5%)-ethanol solvent [1,2].In addition,it was found that the form-Ⅱ was formed as a transient polymorph in process of form-Ⅰ formation during the crystallization of acetaminophen.We examined the whole process using NIR in-line measurement combined with principal component analysis (PCA).The fast formation and disappearance of form-Ⅱ prior to the formation of form-Ⅰwas clearly monitored by PC score plots.This phenomenon was proved by XRD analysis as well.We will discuss the results from NIRS analysis with XRD data in the presentation [3,4,5].
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