UK-based Oxford Instruments Molecular Biotool’s (OIMBL) technology is the first commercially-available platform to provide magnetic resonance imaging (MRI) capability that is compliant with United States Pharmacopeial (USP-4) guidelines.
With issues of manufacturing cost and patient compliance high on the pharmaceutical industry’s agenda, pressure is building on drugmakers to adopt smarter, cost efficient ways of producing effective and easy to use medications.
Trundle told in-PharmaTechnologist that although MRI has a significant role to play in improving drug delivery “[it] has so far been scarcely used by formulation chemists due to both the high instrument purchase and running costs.”
He explained that in contrast with existing systems in which superconducting magnets require constant cooling PharmaSense “uses a permanent magnet to provide the right resolution,” and can therefore be run at a much lower cost.
He added that “there are a number of USP 4 compatible systems without the capability to deliver MRI data sets. However, there is no direct competitive commercial ‘like for like’ instrumentation.”
Analysis under “real-world” conditions
PharmaSense’s combined MRI platform and USP-4 compatible dissolution flow cell system can detect the presence and movement of protons in water or lipids. The data, which can be output in a two or three dimensional format, provides analysis of the ingress of water into the support matrix of the tablet under examination.
The system simulates physiological conditions by varying ionic concentration, temperature and pH allowing drugmakers to determine the hydration, swelling, erosion and active pharmaceutical ingredient (API) release characteristics of products under assessment.
Trundle added that: “By combining MRI and a USP 4 compatible dissolution flow cell, [PharmaSense] could help pharmaceutical companies enhance tablet design, and so improve drug efficacy and patient compliance.”
OIMBL is already working with UK drugmaker AstraZeneca and, according to Trundle, “has [also] engaged with a number of pharmaceutical companies to assess the use of PharmaSense across the broadest range of tablet formulations. “
Trundle also said that the firm, which manufactures the platform at its factory in Oxfordshire, can provide all the necessary installation and operator training programmes for industrial clients who chose the system.
He added that OIMBL plant has “an applications facility to run customer samples and carry out instrument demonstrations.”