High intensity X-ray diffraction can provide an efficient, reliable and cost effective means of revealing polymorph composition which can be can be critical to product performance
The appearance of different crystal structures (also known as polymorphs) in a crystallising substance can be critical to its performance in use.
During manufacture, process control factors such as pressure and rate of cooling determine the composition of polymorphs that will occur.
The ability to look at the detailed crystal structures developing during the manufacturing process allows an understanding of how the presence or absence of a particular polymorph can alter the behaviour, appearance, texture and other characteristics of the finished product.
The properties which different polymorphs confer are often the key to improved or diminished product performance in terms of efficacy, safety and bio-availability.
These properties are particularly important in drug development.
Product function will change according to the composition of polymorphs within the formulation.
Frequently there will be a predominance of one kind with only a small proportion of others which makes detecting and characterising them particularly difficult.
High intensity X-ray diffraction is an essential tool and the facilities at Daresbury Laboratory, together with the expertise of the Darts team, provide an efficient, reliable and cost effective means of revealing polymorph composition.
The specialist facilities and service which Darts provides are practical for large and small companies, both of which have benefited from using the service for such investigations.
Pharmaceutical companies seeking to protect the discovery of a new drug only have adequate protection for their product if their patent covers all of the relevant polymorphic forms.
This is also required information in drug approval procedures.
In cases of patent infringement, Darts says it has been instrumental in providing critical evidence that the polymorphic composition of a drug was being copied.
Not only is this technology being applied to understanding drug formulation, it has also been applied to the more commonplace case of improving the taste and texture of chocolate.
The development of the desired polymorphic form of cocoa butter was shown to depend on a narrow set of process conditions.
Once understood, these could then be reproduced to ensure optimum product characteristics making both the manufacturer and its consumers happy.
The Darts service has proved to be essential to small biotechs, critical to big pharma and useful to many manufacturers operating solidification processes, says Darts.
