New Method from Molecular Profiles For Efficient Detection of Amorphous Material Using H D Exchange and FT-Raman Spectroscopy

Released on: June 3, 2008, 3:18 am

Press Release Author: The Scott Partnership

Industry:

Press Release Summary: (Nottingham UK, 2 June, 2008) - Molecular Profiles, a global
leader in the provision of innovative contract research services to the
pharmaceutical, biopharmaceutical and biomedical sectors worldwide, announces a new
method to demonstrate the use of hydrogen/deuterium (H/D) exchange and FT-Raman
spectroscopy for the detection of low levels of amorphous material. The sensitivity
of this novel approach has been shown to be superior to conventional FT-Raman. The
method is described in a new poster entitled \"Detection of low levels of amorphous
lactose using H/D exchange and FT-Raman spectroscopy.\" The work will also be
published soon, in a peer reviewed journal.

Press Release Body: Contact Information:
Fiona Robinson
The Scott Partnership
Phone: +44 (0) 1477 539539
E-mail: molecular@scottpr.com

Claire Madden-Smith
Molecular Profiles Ltd
Phone: +44 (0)115 871 8888
Email: cmadden@molprofiles.co.uk

New Method from Molecular Profiles For Efficient Detection of Amorphous Material
Using H/D Exchange and FT-Raman Spectroscopy

(Nottingham UK, 2 June, 2008) - Molecular Profiles, a global leader in the provision
of innovative contract research services to the pharmaceutical, biopharmaceutical
and biomedical sectors worldwide, announces a new method to demonstrate the use of
hydrogen/deuterium (H/D) exchange and FT-Raman spectroscopy for the detection of low
levels of amorphous material. The sensitivity of this novel approach has been shown
to be superior to conventional FT-Raman. The method is described in a new poster
entitled \"Detection of low levels of amorphous lactose using H/D exchange and
FT-Raman spectroscopy.\" The work will also be published soon, in a peer reviewed
journal.

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.

For more information on Molecular Profiles\' contract research services or to obtain
a copy of this poster, please visit www.molprofiles.co.uk or e-mail
enquiry@molprofiles.co.uk

About Molecular Profiles
Molecular Profiles is a leader in the provision of innovative contract research
services to the pharmaceutical, biopharmaceutical and biomedical sectors worldwide.
The company is a recipient of a Queen\'s Award for Enterprise in the Continuous
Innovation and Development category. The award saw the company and its complete
range of services recognised as one of the UK\'s most innovative during 2007. The
services include nanoscreening technology for predicting the ease of development of
a new medicine, a deformulation service for identifying problems with a product down
to the nanoscale, and advanced imaging for viewing and optimising the internal
structure of products.

For further press information please contact: Fiona Robinson, The Scott Partnership,
1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom Tel: + 44
1477 539539 Fax: +44 1477 539540 mail to:
molecular@scottpr.com



Web Site: http://

Contact Details: Contact Information:
Fiona Robinson
The Scott Partnership
Phone: +44 (0) 1477 539539
E-mail: molecular@scottpr.com

Claire Madden-Smith
Molecular Profiles Ltd
Phone: +44 (0)115 871 8888
Email: cmadden@molprofiles.co.uk

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