Ascendia Pharmaceutical Solutions and NETZSCH recently had the opportunity to reconnect and reminisce on the benefits of their collaborations over the years. Read on to learn more about how these two companies have worked together to change the pharmaceutical industry through novel dose-form optimization technologies using homogenization and agitator bead milling.
NETZSCH is a German technology company innovating in the grinding and dispersing industry for over 150 years, supplying equipment and machinery to provide their customers with technical solutions for a variety of applications. NETZSCH is most known in the pharmaceutical sector for the DeltaVita agitator bead mill which processes suspensions to increase the bioavailability and reduce food effect of poorly soluble drugs.
NETZSCH has worked with Ascendia for many years, providing Ascendia with equipment used in their proprietary NanoSol platform, a technology platform for increasing the bioavailability and solubility of poorly soluble drugs.
NETZSCH’s Regional Business Field Sales Manager, Dan Galvin, says “Ascendia’s expertise in complex formulation development, is simply elegant using all GRAS materials (Generally Regarded As Safe) to exceed client expectations. NETZSCH and Ascendia are client-pleasers!”
Agitator bead milling is a process that increases the bioavailability and solubility of drugs by drastically reducing their particle size. While the initial drug substance may be ten to one hundred microns in size, it can be reduced down into the low micron or nano range through the agitator bead milling process using grinding beads.
These drastically reduced APIs are beneficial in the fact that it allows for the use of less active material and less surfactant, therefore reducing toxicity concerns. Additionally, milling can allow for more targeted delivery of the drug to the patient and reduction or elimination of food effects.
The DeltaVita can mill under aseptic conditions with full clean-in-place and steam-in-place proprietary technology. The DeltaVita is the leader for milling poorly soluble drugs for parenteral administration.
As a specialty CDMO, Ascendia is known for many things, including their novel lipid nanotechnology solutions to poorly soluble drug compounds. The NETZSCH DeltaVita is utilized to develop the nanosuspensions for the NanoSol® technology platform produced by Ascendia.
Challenging compounds, usually displaying low solubility, are nano-sized using the DeltaVita, and combined with an excipient or surfactant to further support and stabilize them. These stabilized, nano-sized formulations can then be further processed into a variety of dosage forms using the NanoSol® technology. With the nano-sizing of the drug, drug loading can be increased, and the release of the drug can even be modified to develop long-acting injectables, oral formulations, or topical applications.
Ascendia’s NanoSol® technology, brought about through continued collaboration between the two companies, can be used for the early screening of drug compounds for the development of nano-suspensions, all the way through the scale-up process, up to manufacturing under GMP conditions.
Ascendia sees many drug compounds coming through their doors in need of dosage form optimization and process scale-up along with their wide array of technologies makes the impossible possible. The NETZSCH DeltaVita combined with the NanoSol® technology and the knowledge from Ascendia can breathe new life into previously shelved drug products. They can take a drug compound that got benched 30 or 40 years ago and, by bringing it into the new technology platforms available, provide a mode to effectively deliver that drug to patients.
Not only does Ascendia have state-of-the-art milling equipment produced by NETZSCH, but they also have the knowledge and expertise of their team of excellent scientists. This combination makes Ascendia the perfect partner for developing new compounds into drugs suitable for human use, allowing for a much faster and cost-effective development process.
Ascendia’s CEO, Jim Huang, says “NETZSCH's process and system design for aseptic milling is the clear global standard for repeatable and safe production of suspensions, which is a big addition to Ascendia’s wet milling production capability for sterile suspensions and nanosuspensions.”
Additionally, drugs that are already on the market in one dose form can also be transformed into new, novel, improved dose formulations. Oral medications that may have initially needed to be taken daily can be reformulated using NanoSol® technology into an injectable that is only needed once a month, or even once every three months. These technologies allow Ascendia to push the boundaries of what’s been done before and provide benefits not only to the drug developers but to the patient as well.
Developers who need a new dosage form for their compound, no matter what stage they are in the drug development pipeline, are encouraged to reach out to Ascendia to start a new project in as little as two weeks and learn more about how they can utilize their technologies and expertise to develop optimal dose formulations that maximize the efficacy of the drug product and safety to the patient.
Additionally, drug developers who are still screening their potential drug compounds are encouraged to reach out to Ascendia to create the optimal drug formulation and dose form from the start.