New API production process ‘could transform pharma’
pharmafile | September 6, 2011 | News story | Manufacturing and Production |Â Â pharma manufacturing news, pharma productionÂ
UK researchers have started work on a new project to examine a new production method that they claim could “significantly impact the pharmaceutical sector”.
The team from the University of Bradford’s Centre for Pharmaceutical Engineering Science have created a co-crystallisation method based on twin screw extrusion, a process which is well established in the plastics industry but has yet to be applied extensively to commercial-scale pharmaceutical production.
The researchers say co-crystallisation provides an alternative to traditional methods of creating targeted soluble drug compounds and has “enormous potential to assist industry in creating new drugs with increased stability, faster and more efficiently”.
Co-crystallisation involves combing the solid form of an active pharmaceutical ingredient with other materials, such as vitamins or sugars, to make a new form with improved properties. Using this approach APIs can be generated with a longer shelf life, improved solubility and increased bioavailability.
The approach makes use of a wide range of intermolecular forces to create APIs with a uniform crystal structure, unlike conventional techniques such as salt formation which rely on ionisation of the API and can only generate a limited number of molecular forms.
The team plan to couple co-crystallisation techniques with twin screw extrusion, which makes use of high temperatures and shearing forces to convert the raw materials into co-crystals. In experiments, co-crystal purity of model drugs such as ibuprofen was shown to be close to 100%.
“The technique we’ve been using lends itself well to industrial scale manufacturing as it’s scalable, continuous and solvent free,” said Anant Paradkar, professor of pharmaceutical engineering science at Bradford University.
“Not only will we understand how the process works – which will enable the creation of new co-crystals – we’ll also be assessing how these might be delivered to patients.”
The three-year project is funded by the UK’s Engineering and Physical Sciences Research Council.
Phil Taylor
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