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Pharmaceutical Processing News
News Release from: Reactarray (Anachem) | Subject: ReactArray Solo
Edited by the Processingtalk Editorial
Team on 25 May 2006
Polymorph screening to aid drug patent
protection
Any significant patent filing has to demonstrate that a company has made a reasonable effort to identify the polymorphs of a drug compound and has checked for polymorph interconversions
The essential task of producing and identifying the diversity of crystal forms or polymorphs of new drugs during development has traditionally been complex, tedious and time consuming This stage, however, is vital in ensuring optimal bioavailability of the therapeutic, shelf-life and process handling in manufacturing
This article was originally published on Processingtalk on 22 May 2006 at 8.00am (UK)
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ReactArray Solo: designed to give a great reaction
Parallel chemistry is widely employed to improve productivity and investigate compound synthesis parameters more exhaustively: ReactArray Solo simplifies set-up and control of reaction vessels
Fast analytical method generation for drug studies
Now, with the ReactArray workstation, formulation chemists can generate much more data, more quickly, by performing controlled drug degradation assays in parallel
Moreover, regulatory agencies worldwide require that, as part of any significant filing, a company demonstrates that 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.
Further reading
Fully automated equilibrium solubility testing
Exhaustive drug solubility screening early in the development process has become an important focus for pharmaceutical scientists: the unique new ReactArray ST workstation makes this easier
Broaden your chemistry process screening horizons
ReactArray Microvate rack enables investigation of a wider range of solvents, reagents and catalysts, by providing a larger number of small volume reactors
Fully automated equilibrium solubility testing
Solubility testing of pharmaceutical products, NCEs and intermediates has become increasingly important earlier and earlier in development
Now, new ReactArray Solo makes this vital process faster and more efficient.
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 tightly control a number of manually prepared studies in parallel, to simultaneously test many parameters and drive the production of different drug polymorphs.
Real time changes to experimental conditions can be easily made, maintaining control of the study as it progresses.
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 maximum exploration of form diversity through varying solvent and temperature changes during reactions.
Microvate contains forty eight mini reaction vessels accommodating study volumes 250micro-litres to 2ml.
Such small volumes help preserve starting materials that may only be available in minimal quantities and reduce 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 (-30C to 150C) to drive the formation of diverse polymorphic forms.
Setting up reaction tasks is logical and easy with ReactArray Solo 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.
ReactArray workstations have been developed through collaboration between Anachem and chemists within the pharmaceutical industry to provide a proven and robust concept that meets the demand for high throughput reaction screening and optimisation.
Today there are over 200 systems in use worldwide.
Anachem is a leading supplier of laboratory equipment and services, established for over thirty five years with key expertise in liquid handling, chromatography, automation and process optimization solutions.
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