Röchling and HS Design Developing a Ground-Breaking Drug Delivery System

Developing and manufacturing plastic products for the medical and pharmaceutical industry is the Röchling company’s core competency in the Medical division. The range stretches from precision plastic parts to high-quality packaging. Close communication between the divisions and across locations is needed so that the customer receives exactly what he is looking for.

This was exactly the same in the case of “Sympfiny.” In mid-2016, Röchling Medical in Rochester, NY/USA, received a request from HS Design, Gladstone, NJ/USA, a user-driven product development firm providing innovative design solutions in medical and pharmaceutical environments. HS Design was looking for a new partner with which to take part in a tender by a worldwide leading pharmaceutical company. Röchling Medical in Rochester immediately contacted its European sister companies, which had the desired expertise.

The pharmaceutical manufacturer’s idea: In future, children who will not swallow bitter medicine can receive it in the form of multiparticulate medications. This involves tiny pellets that are about the size of salt crystals. These micropellets are multilayered, whereby the outermost layer neutralizes the taste of the actual active ingredients, without affecting their impact.

Looking for a Development Partner
The challenge: How to package the multiparticulate medications and orally administer them easily, reliably and in exact dosages to children when at home? HS Design had a range of ideas and designs but needed a development partner, with whom the ideas could be further developed and converted into a functional industrial design. This partner had to be in a situation to create prototypes and pilot parts as well as to produce and market the system in large-scale production if successful.

The solution: The Sympfiny system comprises a container with a child resistant closure (CRC), in which the medication is kept. An oral syringe can then be connected precisely to the container, whereby two valves open automatically and are closed again when disconnected. This syringe removes the medication from the container and transfers a precise dose to the mouth. This easy handling allows the multiparticulate medication to be administered just as simply, exactly and safely as with liquid medications.

Optimal Functionalities
What sounds easy is hard work in development and implementation. The technical challenges started with the novel substance, with which there was little experience up to then. The optimal functionality for the syringe for administering the medication and, above all, the connection between the syringe and the container had to be honed to perfection. The project’s level of complexity is shown not least in the fact that more than 80 companies took part in the tender but in the end, only two companies and their proposals were selected for further development.

“The whole project is a combined teamwork between the three Röchling Medical divisions’ locations. Close communication and prox­imity between all those involved is required,” says Valérie Duval, Head of Global Sales at Röchling Medical. Before the start of the project, rules were defined, tasks were divided and responsibilities were determined, both within Röchling and in collaboration with development partner HS Design. Valérie Duval talks about a win-win situation, into which Röchling brings its knowledge and expertise in manufacturing and processing. The container is manufactured in Neuhaus am Rennweg, the oral syringe and closure are produced by injection molding and fully assembled in Brensbach, both plants located in Germany.

Within just eight months, Röchling succeeded in developing a system with a total of 12 parts and in making pre-series parts. “It was also an advantage for us that we could manufacture our tools by ourselves,” explains Duval, who has been familiar with the topic of plastic since childhood: In the 1960s, her grandfather, an apple farmer in Normandy, invested in a company that produced plastic plates for children, an extremely innovative business at the time. Duval has been employed in the plastics industry for 29 years and specializes in primary packaging and drug delivery systems for the pharmaceutical industry. The clinical tests with Sympfiny start next. There is one thing that the 52-year-old knows well from experience: “The pharmaceutical industry is all about playing the long game – you need to have patience and build trust.”