When a drug is going to be developed, not only does an active substance have to be developed - it must also be an effective drug preparation, so that the substance can be properly absorbed by the body. RISE is collaborating with the pharmaceutical company Umecrine Cognition, which is developing an effective new drug, which can help patients who have hitherto received inadequate treatment.
The pharmaceutical company Umecrine Cognition develops drugs for neurological disorders of the central nervous system, such as the disease hepatic encephalopathy. It is a serious neurological and psychiatric condition associated with liver disease, which in the worst case can lead to death. There is currently no approved treatment for these neurological disorders.
May be come a completely new medicine
RISE, together with Umecrine Cognition, has developed a drug preparation, i.e. the composition and manufacturing of a drug, that can be given to patients.
"In short, it can be said that RISE is working with two levels of problem: firstly, it tries to develop some form of drug preparation, which allows the drug to be absorbed by the blood
when the tablet or capsule is taken", says Nicolaas Schipper, researcher at RISE.
The second part of the job is to ensure that those capsules actually exist, manufacture them and ensure that all quality requirements are met.
"You cannot do this just in a laboratory, the product must be tested on patients. Here we do the analyses that are needed, and make sure that we produce the right drug in the right concentration", says Nicolaas Schipper.
Many challenges in testing new drugs
The drug in question has not been tested by any pharmaceutical company other than Umecrine Cognition, which two years ago tested it on patients for the first time.
"It is a big challenge, and a big job, to manufacture drugs for patients. It requires infrastructure, quality systems, facilities, trained staff and so on. It is a challenge that we solve at RISE", says Nicolaas Schipper.
"The collaboration with RISE has provided the flexibility often required by a smaller company and at the same time access to advanced equipment and high levels of competence", says Magnus Doverskog, CEO of Umecrine Cognition, who argues that drug preparation is an underestimated part of drug development, which often ultimately leads to delays and high costs.
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Problem solving through lipids
But there are more challenges than that – the substances you work with in pharmaceutical products are, in many cases, sparingly soluble. This problem has been solved by developing a dosage form with significantly better solubility, thanks to the addition of lipids which have been shown to produce better results than other types of formulations previously tested.
"The lipids give us amazing opportunities to dissolve sparingly soluble substances. At the same time they are taken care of by our physiological digestive system for the absorption of fats", says Nicolaas Schipper.
