What if we didn’t have to understand the chemistry of a substance to measure its solubility? Single Particle Analysis, SPA, is a revolutionary analytical method, which enables the determination of solubility of pharmaceutical substances at the beginning of the drug development process without relying on complicated chemical analyses.

Single Particle Analysis, SPA, is the world’s first method for accurately measuring solubility from very small amounts of a substance. It is both significantly more precise and significantly faster than current technologies used in drug development. While other current methods measure how much of the substance has been dissolved in the liquid, this method turns the process around: a computer programme analyses microscope images to see how much the solid dissolving particle has diminished.

“SPA is a unique method based on optical shape recognition, and therefore requires no complicated chemical analyses or understanding of the chemical structure of the substance,” states researcher Sami Svanbäck who developed the method in Professor Jouko Yliruusi’s research group at the University of Helsinki’s Faculty of Pharmacy. 

SPA uses machine vision and optical shape recognition to operate on particles that are invisible to the human eye.

“SPA focuses on the physical size. As a particle diminishes, we can determine how fast it dissolves. And best of all, SPA is appropriate for most substances, not just pharmaceuticals,” explains Svanbäck. 

The SPA method enables the determination of a drug’s solubility in the drug discovery process. It examines very small amounts of substance to help find the most viable candidate for further development. 

Time is money in drug discovery

Single particle analysis offers a completely new way to address the central challenges of drug discovery: expense and duration. SPA can significantly speed up an early-stage decision-making by providing crucial, and previously unattainable, information about substances in development, making SPA the missing link of drug discovery. SPA thus enables holistic drug development based on both pharmacology and physical chemistry.

Drug discovery is a slow and costly process. The expenses of discovering a new drug are approximately €1-2 billion, and it takes 13.5 years on average. At the early stages of drug discovery, there are thousands of molecules to be studied, but only small amounts of the substances available.

“At the moment, there is no method available that could precisely determine the solubility of substances from tiny amounts,” says Professor Jouko Yliruusi.  

Information about the solubility of the substance is a critical success factor for drug development. After potency, solubility is one of the most important properties of a drug. Solubility is crucial because a substance that does not dissolve will not enter the bloodstream and cannot be effective in the body. Currently, in the absence of measuring the solubility of small amounts, the early stages of drug discovery focus on the pharmacological and toxicological effects of the drug candidate.

What does SPA mean for the patient?

SPA is at the cutting edge of personalised medicine.

In the near future, all patients will receive the medication and dosage specifically tailored to them. For this reason, it must also be possible to predict and change the solubility and release of each drug in the body of the individual.  

“Here SPA could help by providing extensive solubility data quickly and precisely,” states Svanbäck.

Invention based on research

Single Particle Analysis, SPA, is a unique invention and method with no predecessors in the research of pharmaceutical analysis. Postdoctoral researcher Sami Svanbäck developed the innovation in his doctoral dissertation. The idea arose from scientific research.

“SPA is a multidisciplinary combination of pharmaceutical technology, physical chemistry, optics, fluidics, machine vision, engineering and software design,” states Svanbäck.

The idea originally arose from theoretical musing and the hypothesis that the solubility of a substance could be determined by means of machine vision, from individual particles. This led to the development of the method and the instrument.

The SPA team is ready to go

After successful proof of concept studies with some of the largest pharmaceutical companies in the world, Yliruusi’s team is ready to launch its start-up company in January 2018. The patent application is currently in the international stage. The SPA team will be at the Slush event 30 November – 1 December 2017 – come meet the team! 

 

    Sami Svanbäck