Patent · US Active

Method of testing crystallinity in amorphous pharmaceutical compositions

US12313613B2 · kind B2 · utility

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16Claims
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Key dates

Filing dateJan 29, 2020
Grant dateMay 27, 2025
Priority date
Expiry dateJun 26, 2042

Classification

  • Technology area (CPC G)Physics
  • CPC primaryG01N2201/129
  • WIPO fieldMeasurement
  • WIPO sectorInstruments

Abstract

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.

Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.