Cubi-Tech Extrusion Limited, a Cubic Pharmaceuticals Ltd company, puts an end to some of the problems inherent in pharmaceuticals production.
Process efficiency and continuous manufacturing are certainly hot topics in the pharmaceutical industry right now, and with good reason.
Global population growth and the escalating nature of current health crises are driving the corresponding demand for new technology capable of producing medicines faster, while yet maintaining full quality and compliance.
SiSTME, a single-step thermo mechanical engineering process for pharmaceutical manufacturing invented by the University of Greenwich in conjunction with Cubic Pharmaceuticals Ltd, is the solution the industry has been crying out for.
A continuous manufacturing system that can handle the most challenging active pharmaceutical ingredients, for example those with poor water solubility or weak physical properties, SiSTME uses solid-state extrusion granulation to produce tablets and capsules that dissolve up to 20 times faster than those produced traditionally.
Dr Mo Maniruzzaman, co-inventor of SiSTME and a field expert in pharmaceutical formulations and technology, described the manufacturing platform – the result of superlative collaboration between academia and industry – as a “first in class” approach to solving a number of pervasive production problems that pharmaceutical industry is currently facing.
“The global pharmaceutical market is going through a period of dramatic change in which emerging markets, easier to manufacture medicines and novel manufacturing platforms will increase sector growth,” he said.
“The global medicine market was worth $1tn in 2014 and that is expected to be double in the next two or three years. That presents very positive opportunities for pharmaceutical industries in the UK, which had £24bn in exports that year.
“However, there are issues to be addressed to achieve the level of output required.”
For starters, more than 40% of candidates currently in the drug discovery pipeline suffer from either poor solubility or poor absorption into the human body.
“So, we need a product that has very good water solubility,” Dr Mo Maniruzzaman said. “And even if a drug does have some type of solubility advantage, we then need to ensure it does not suffer from poor flow or poor stability.
“Luckily SiSTME ticks both boxes by not only improving the solubility, but making the resultant products more process friendly, in other words with good flow properties.”
SiSTME produces salts in a solid-state through an acid-base reaction and as such, it supports the largely weakly acidic or basic proclivity of the drugs in the discovery pipeline.
And because water is not used to facilitate a reaction, nor any solvent added during the reactive mixing in the continuous twin-screw extruder barrel, the perennial problem of recrystallisation and resultant regulatory concerns are avoided.
“The number of new products coming on the market is forcing manufacturers to embrace new processes that reduce both time and waste,” he said.
“In order to action that, we need alternative technologies that can make medicine available quickly, efficiently and at reduced cost, but without compromising its quality.
“SiSTME is one of the very few technologies that can actually meet all those challenges.”
Saumil Bhatt is chief executive of Cubic Pharmaceuticals Ltd, which currently has three patents approved in the UK, including SiSTME, the latter being granted both in the UK and USA.
Together they cover the pharmaceutical manufacturing process from beginning to end – from prototype development through production and regulatory approval to subsequent scale-up.
The single-step production process brings with it a wealth of benefits, not least the fact it ends the ‘segmented’ approach that can allow deviations in formula and human error to creep in.
Mr Bhatt said: “At the Good Manufacturing and Distribution Practice Symposium held (online) at the beginning of December, the MHRA really pressed home the case for continuous manufacturing processes.
“One reason, as far as the regulator is concerned, is the otherwise inability of some companies to produce demonstrably genuine data during R&D and/or manufacturing.
“With SiSTME, milling, extrusion, and pressing to form dosage forms such as tablets all happen in one process, guided by the data inputted into a computer, so there are no recipe deviations, no human mistakes and nothing but a true record of all that took place.
“Integrity, transparency and consistency, that is what you get – quality by design!”
SiSTME is available for potential partnership to address challenges likes solubility, poor physical properties, and manufacturing.
Further information on SiSTME and the complementary services can be found on
https://cubi-tech.co.uk/patents/#SiSTME or
www.cubicpharmacy.co.uk
