Perfect match of active agent, formulation and applicator
So far there are very few approved nasal applications for brain-enhancing substances. Despite obvious advantages – easy administration for children instead of parenterals, in emergencies for asthma or epilepsy patients or poor venous access in the case of older patients – nasal application has enjoyed little support thus far. The development of such nasal applications often swings back and forth between optimism and disappointment. M et P has been engaged in the effects of medicine administrated over nasal application for many years. This also includes consideration of the optimum application aids. As CSO Dr. Claudia Mattern comments: “Nasal application is the direct way of absorbing brain-enhancing substances. It is the focus of our research.”
The development and successful use of brain-enhancing nasal dosage forms however only works when the three factors active agent, formulation and applicator are optimally matched. Newly developed delivery systems and brain research findings make nasal application an increasingly interesting alternative.
Drugs like “Tescum/Tescum Junior” are one example of a new nasal application development of testosterone for men. Like all nasal applications, in its existing formulation “Tescum/Tescum Junior” needs a container to ensure perfect administration. Multi-dose containers for multiple administration do not satisfy these demands. Although most multi-dose containers now operate without preservatives, contamination of the application tip was not taken into account for these containers. At the same time, depending on the formulation, exact dosing is not always guaranteed for multi-dose containers. M et P began development of a suitable solution for this challenging process and chose Harro Höfliger as a competent system builder for filling and sealing their devices.
Nasal application is the direct way of absorbing brain-enhancing substances. It is the focus of our research. With Harro Höfliger we have a competent partner for filling and sealing our devices.
Dr. Claudia Mattern
CSO M et P Pharma AG
From lab to prototype system
The nasal device for ‘Tescum/Tescum Junior’ is a unit dose container, whose pin is easily twisted off for application. The product contains no preservatives and features long-term stability. Dosing accuracy is +/– 5 percent. In cooperation with Harro Höfliger, M et P conducted a large-scale trial series. Based on the results, a pilot system was developed at Harro Höfliger for M et P. The individual processes for filling the unit dose device were finally optimized in the system at the M e P laboratory. Today the prototype system is used in the lab to produce material for clinical studies and commercial samples. At the same time experience from this system is used in the planning and development of the first production line.
The controlled filling process and reliable sealing of the twopart device with ultrasound fulfills the highest technical standards. Harro Höfliger’s liquid filler successfully fills the thixotropic oil formulation with a viscosity of 3,000 to 10,000 mPa · sec for exact doses. The material composition also posed a challenge for the applicator. A low-density polyethylene enriched with titanium dioxide (TiO2) as additive was selected.
The prototype system went into operation in 2012. Today the patented line fills and seals around 5,000 applicators daily. An additional commercial scale production system by Harro Höfliger went into operation at the end of 2016.