A team of researchers at Purdue University have developed a novel system combining mathematical models with inkjet printing technology to generate patient tailored medication doses. This technique could result in a great leap forward in personalized medicine by reducing drug toxicity and improving efficacy. The study has been published in the Journal of Pharmaceutical Sciences.
Although novel drugs are subjected to rigorous clinical testing in order to work out optimal doses that are both effective and safe, every patient is different; this means that the determined recommended dose is often inappropriate for many. If the dose is too high the patient may experience unpleasant side-effects from drug toxicity; too low and it may not be effective. Tailoring medication to suit the patient is therefore desirable, but this can be difficult to achieve and is often guess work.
“Pharmaceutical companies make one or two or three dosage levels, so people try breaking tablets in half and other methods to get the right dosage,” said lead author Gintaras Reklaitis in a news-release.
In a bid to tackle this problem, the scientists developed a two-step system that identifies and then produces the optimal dose of a drug for a particular patient. The first stage involves taking blood samples from patients after a small amount of a particular drug has been given. The data obtained from this is then combined with trial data to establish the appropriate dose via mathematical modeling.
Next, the drug is dissolved or melted with polymers and is then deposited onto tablets or films in precise quantities using “drop-on-demand” inkjet printing technology. Although melting is a little more tricky, it is advantageous because it improves drug solubility and allows greater control of drug properties.
“If we say the patient needs 23 milligrams every 8 hours, there is no 23-milligram tablet on the market,” said Arun Giridhar who has been leading a team of researchers that are collaborating on the project. “I can make a 23-milligram dose, but to make something that small and that precise is challenging to do with powders. It is much easier to dissolve or melt the drug formulation. Both are viable technologies.”
A prototype device has been built and the team is now hoping to move toward commercialization. Clinical studies will also need to be carried out to ensure that the system is effective.
“We envision that in its final form the printing will be done in an automated fashion. The pharmacist could key in the dose, the machine prints 20 tablets, and off you go,” said Reklaitis.