Image source: Agilent
Agilent Technologies Inc. has recently announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation and software to enable customers to meet 21 CFR Part 11 and other regulations through its application, the new NanoDis System delivers a dedicated workflow that is automatable and auditable.
Designed in collaboration with Dr Emre Türeli from nanoparticle manufacturer MyBiotech GmbH, the NanoDis System enables R&D formulation chemists to deliver new formulations into manufacturing faster, and also allows manufacturing teams to deliver consistent batches of QC passed new drug products ready for commercial sale—all in an automated and compliant manner.
Lifesaving drugs are increasingly being developed using nanoparticles for targeted drug delivery. These new dosage forms offer the promise of advancing patient care and treatment outcomes—particularly for oncology and cardiology patients—by reducing side-effects and improving drug solubility and bioavailability. However, nanoparticles can be incredibly difficult to work with from a dissolution testing perspective. This testing is a critical regulatory requirement for the development, manufacturing, and QC of medical drug dosage forms.
The Agilent NanoDis System was selected as a finalist for the CPhI Pharma Awards for excellence in Pharma: Analysis, Testing, and Quality Control. The awards celebrate the thinkers and creators at the forefront of driving the pharmaceutical industry forward through innovation, technology and strategies.
