In drug development, reproducibility in terms of the biological, chemical and physical characteristics of the product is crucial. The presence of the amorphous phase can have a profound effect on the physical and chemical properties of both drug and excipient samples. This new approach demonstrates how the perturbation that follows deuteration of blended samples of amorphous and crystalline material results in a marked enhancement in the sensitivity with which the amorphous phase can be detected.

 

In the application detailed in the poster, amorphous lactose was generated by spray drying a 10% w/v solution using a Buchi mini spray drier 190. Deuterium oxide vapour (25% RH) was generated and controlled using a Triton Humidity Generator. Spectra were recorded using a Bruker RFS 100/S FT-Raman spectrometer. Results of the application demonstrate a non-destructive method that is capable of providing reproducible quantitative measurements of low levels of amorphous material in lactose.

 

This method resulted from a Knowledge Transfer Partnership (KTP) with the University of Nottingham and Molecular Profiles, funded by the DTI. The KTP Associate involved in this project, Dr. Paul Whiteside, has been awarded the inaugral Duncan Bryant Memorial Prize in recognition of the work he undertook, in particular the deuteration methods in spectroscopy. Dr. Paul Whiteside is now Project Scientist for Molecular Profiles. The Duncan Bryant Memorial Prize is awarded to young analytical chemists working or studying in the pharmaceutical sector and is awarded by the Analytical Division of The Royal Society of Chemistry, Molecular Spectroscopy Group. The aim of a KTP is to strengthen the competitiveness, wealth creation and economic performance of the UK by the enhancement of knowledge and skills, as well as innovation through collaborative projects between business and the knowledge base. Over the past 30 years, KTPs have given British firms new opportunities to break into new production methodologies and technologies. A KTP serves to meet a core strategic need and identify innovative solutions to help that business grow. The output of this particular KTP was a new methodology using FT-Raman spectroscopy. This methodology will be an effective tool for the detection and quantification of amorphous materials in the pharmaceutical industry.

 

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