Designing a deformulation workflow
When I was young, I liked to take things apart to see how they worked. From my dad’s scientific calculators through to my own Scalextric cars and model steam trains, my curiosity always got the better of me as I grappled screwdrivers, pliers and sometimes claw hammers in order to try and find out what was inside. Putting each item back together was never easy though, and often left me with a significant number of ‘spare parts’. Perhaps this experience is why I ended up following a career as a scientist rather than as an engineer!
Of course, most kids grow out of the desire to see what is inside every product or gadget. However, many of us at Malvern never really did! Indeed, helping our customers take things apart now forms part our business. This may involve designing products which help get inside a customer’s process in order to understand what is happening and aid process control. We work with end products as well, providing techniques that can probe a final formulation in order to understand how the composition and physical properties of the constituent materials affect product performance.
One area where Malvern’s toolbox of methods for pulling stuff apart is applied is in pharmaceutical product deformulation. Techniques such as Morphologically Directed Raman Spectroscopy (MDRS) are being used to understand the component-specific physical properties of the various Active Pharmaceutical Ingredients (APIs) and excipients within a formulation. This, in turn, can help with modeling or controlling the API bioavailability. By providing this knowledge early in the development of a new or generic product, MDRS can help companies get to market faster.
We have run a series of webinars showcasing how MDRS can be used alongside other material characterization techniques as part of pharmaceutical product bioavailability or bioequivalence testing.
You can watch recordings of the three part series by registering via the links below:
Part 1: focusing on nasal sprays
Part 2 – Dry powder inhaler development
Part 3 – Oral solid dose product development
Meanwhile, I await a Malvern Instruments method for providing a detailed assessment of the design and operation of my classic Sinclair pocket calculator from the 1970s. It worked perfectly, until I applied my own deformulation tools to understanding how!
Read more on deformulation:
Viva la “sameness” – generic drugs and ensuring equivalence
“To BE or not to BE” – Bio-equivalence strategies for topical formulations
A time for control: generic dry powder inhaler development
Fun in the sun or stifling the sniffles? – Generic Nasal Spray Design