The field of medication is changing. New ways of manufacturing techniques in the pharmaceutical industry, such as printing, are constantly researched and developed, and eventually these techniques will allow hospitals, pharmacies and doctors to print drugs on demand and mix different medications into one easy-to-administer dose. Mass production lines and continuous manufacturing processes will adopt some of these new technologies as well, bringing more challenges to effective quality control.

Inkjet or 3D-printed pharmaceuticals deliver a vast variety of benefits to both the patients and service providers of the medical industry. First and foremost, printing brings medication closer to the patient, as drugs are available faster and can be produced based on demand. This is extremely beneficial especially for patients with a need for personalized dosing. As all of us have different types of metabolism and even the same illnesses affect people differently, some can need variable dosing or to adjust the dosing based on their diagnostic response. Printable drugs and their modular and mobile manufacturing capabilities bring great benefits for these kinds of personalized therapies.

The development of inkjet printed drugs, where the medication is infiltrated into paper-like substances, has brought an ever-increasing amount of reliable ways for fabricating orodispersible drugs (or, in other words, drugs that dissolve in your mouth). Orodispersible films bring more variety of medicational options for different kinds of patients who for example have problems with swallowing tablets.

So far, the biggest problem in printed drugs has been the lack of proper quality control and assessment tools. As pharmaceuticals are extremely regulated and people’s actual lives depend on them, not just any techniques are fit for assessing safety and correct dosing. On top of being accurate and safe, quality control needs to be accessible, cost-effective, mostly automated and preferably IoT-connectable.

This is where spectrometry steps in.

Even though the first printed drug did not get its FDA approval in the United States until 2015, printed pharmaceuticals have been researched world-wide for many years. Niklas Sandler is a professor in Åbo Akademi University in Finland and has been researching printable pharmaceuticals for years. Sandler’s first research project on printable medicines started already in 2010. He is one of the pioneers in this particular area, as his team was the first to start systematic research on drug-printing in Finland. Material sensors have been used for quite some time in Åbo Akademi University, especially in the chemistry and paper converting departments as well as in the unit of functional materials. Åbo Akademi University has also done many projects in collaboration with VTT Technical Research Centre of Finland, from where Spectral Engines has originated from.

Material sensors are widely used in the research of pharmaceuticals all around the world, as they make the research of different materials as well as deeper understanding on different products much easier. Material sensors with NIR-technology have brought an option for traditional quality control methods, such as visual inspection and colorimetry, a technique used to determine the concentration of colored compounds in a solution.

“The NIR-technology used in Spectral Engines’ sensors is a simpler and faster way to approach quality control than most traditional methods”, professor Sandler emphasizes. “Printing technologies enable personalized manufacturing of medicines, but they also grow the demand for accessible quality controlling tools. The so-called point-of-care manufacturing and printing the correct medication onsite make it tremendously easier to care for patients. It would be optimal to find technologies for quality control and content measuring that are compact, easy to use and easy to integrate into printers and portable quality control devices. Spectral Engines has succeeded in this way better than anyone else.”

Maximal safety through improved possibilities for quality control

Spectral Engines’ handheld NIR spectrometer has been studied in Åbo Akademi University’s research for predicting drug content in inkjet printed orodispersible formulations.¹  The research done at Åbo Akademi aimed at proving that using a modern handheld NIR device in-line is a functional and reliable way of predicting drug content. It also succeeded in doing so, as it was proven that including spectral sensors in the production processes, drug manufacturers can offer maximal safety through improved possibilities for quality control.

Modern, compact and IoT-compatible NIR-devices, such as the Spectral Engines’ NIRONE Device, can collect vast amounts of data and analyze it in just a matter of seconds. Spectral Engines’ NIRONE Scanner Platform is a combination of the NIRONE Device, softwares, algorithms and interfaces, which have been developed specially to make data collecting and analyzing user-friendly, and data processing fast and easy.

“It is crucial to have these kinds of quick solutions if we are to print drugs in hospital environments and doctor’s offices in the future. Efficient patient care relies on fast decision making and tools that can help with this - the most important thing is to find technologies and softwares that help with process automation and make decision-making easier and faster. Each and every drug has to be scrutinized thoroughly. Efficient material sensing solutions help on following the guidelines of Good Manufacturing Practices. Sensors make way for new, better policies and customs when following these guidelines. It is extremely important to find technologies, softwares and solutions that work seamlessly together with the users and help with automating the decision-making. Spectral Engines’ solutions incorporate all of these features”, professor Sandler says.

Increased performance and more flexibility in manufacturing

“There already is almost an endless amount of printing technologies and they evolve all the time. I believe that Spectral Engines’ sensors and technologies can be integrated easily into almost all of them. I’ve found them truly versatile and extremely nifty”, Sandler emphasizes.

Some challenges still remain with printable pharmaceuticals. Inkjet printing has proven to be an excellent technique for printing medication, but 3D-printing is not yet accurate enough. There is an ever-expanding number of different printers, but they are not yet flexible enough for changing the manufactured drugs on the fly. Most of the equipment only print one medicine at a time.

“We still need more flexibility and diversity with the printers. It seems that the evolvement of printers or the chosen technique, be it 3D-printing or inkjet printing, will not be a problem for Spectral Engines’ sensors, as it seems that they can be integrated into almost anything. Even though 3D-printing constructs the drugs layer by layer and is completely different from inkjet printing, NIR technology can be easily used for quality control in both printing techniques. It is only a matter of time, not technical performance, when this will happen on a wider scale”.

“On top of the academic world, many commercial agents have also been extremely interested in these technologies. A lot of new concepts are being developed all the time. It is evident that spectral sensors and technologies can be easily integrated into large mass production lines and processes as well as to smaller printers in hospital environments. As all sorts of sensor technologies are already widely used in pharmaceutical manufacturing, these kinds of smaller, faster and easier solutions that Spectral Engines offers only increase the performance of production lines even further. In fact, we’re looking to start a commercial business in the nearby future and are thinking of using Spectral Engines’ solutions there as well”, professor Sandler concludes.

If you are interested in learning more on the benefits of material sensing in pharmaceutical industrial processes, download our presentation.

1.Hossein Vakili*, Henrika Wickström, Diti Desai, Maren Preis, Niklas Sandler: Application of a handheld NIR spectrometer in prediction of drug content in inkjet printed orodispersible formulations containing prednisolone and levothyroxine. International Journal of Pharmaceutics 524 (2017) 414–423