METHOD OF TESTING CRYSTALLINITY IN AMORPHOUS PHARMACEUTICAL COMPOSITIONS

METHOD OF TESTING CRYSTALLINITY IN AMORPHOUS PHARMACEUTICAL COMPOSITIONS

Methods of testing pharmaceutical compositions for the presence or absence of active pharmaceutical ingredient (API) crystallinity in an amorphous solid dispersion or solid-state solution using UV/vis spectrometry is provided. Testing may be performed standalone or during manufacturing of a pharmace...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: SPANGENBERG ANGELA, BERGHAUS ANDREAS
Format: Patent
Sprache:chi ; eng
Schlagworte:
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
Online-Zugang:Volltext bestellen
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:Methods of testing pharmaceutical compositions for the presence or absence of active pharmaceutical ingredient (API) crystallinity in an amorphous solid dispersion or solid-state solution using UV/vis spectrometry is provided. Testing may be performed standalone or during manufacturing of a pharmaceutical composition. A predictive model provides for quantitative analysis of the amount of crystalline API based on UV/vis data of corresponding reference samples. Also provided is an apparatus for manufacturing a pharmaceutical composition. 提供了使用UV/vis光谱针对在无定形固体分散体或固态溶液中存在或不存在活性药物成分(API)结晶度而对药物组合物进行测试的方法。测试可以独立进行或在药物组合物的制造过程中进行。预测模型提供了基于相应参考样品的UV/vis数据的结晶API量的定量分析。还提供了一种用于制造药物组合物的设备。