The task of producing and identifying the diversity of crystal forms or polymorphs of new drugs in development has normally been a complex, tedious and time consuming process.
The stage is vital in ensuring optimal bioavailability of the therapeutic, shelf life and process handling in manufacturing.
Moreover, regulatory agencies worldwide require that a company demonstrates it has made a reasonable effort to identify the polymorphs of a drug compound and has checked for polymorph interconversions.
Any polymorph forms not cited in the patent application may be copied by a rival company and manufactured in that form without infringing patent.
Thus, polymorph screening is a high priority for the pharmaceutical industry in protecting its intellectual property and the huge investments made in bringing a novel drug to market.
ReactArray Solo is a new parallel chemistry product that enables high throughput generation of more experimental data without consuming large quantities of materials.
It can control a number of manually prepared studies in parallel, to simultaneously test many parameters and drive the production of different drug polymorphs.
Control is maintained as the technology allows real time changes to be made to experimental conditions.
ReactArray Solo uses robust hardware that is already adopted and proven by pharmaceutical scientists worldwide. It is quick and easy to set up with intuitive interactive control software.
For polymorph screening ReactArray Solo employs the Microvate rack to permit exploration of form diversity through varying solvent and temperature changes during reactions.
Microvate contains forty-eight mini reaction vessels accommodating study volumes 250µl to 2ml.
Such small volumes help preserve starting materials that may only be available in minimal quantities and minimise costs of reagent consumption.
Arranged in twelve independent temperature zones the various solvents under test can then be subjected to an array of different temperature profiles (-30oC to 150oC) to drive the formation of diverse polymorphic forms.
Setting up reaction tasks is logical and easy with ReactArray Solo's Windows based software that provides intuitive control of reactions.
Methods can be run under live manual control or as pre-programmed automatic tasks. The temperature and stirring conditions of any vessel/zone can be changed and real time plots of these changes can be viewed at any time.
The unique e-mail prompt gives users freedom from the bench as ReactArray Solo performs its tasks and calls the operator back only when intervention is required.
Data can be reviewed in the archive browser and exported for further processing.
For more details of the ReactArray Solo, visit Anachem's website.