What is
PharmaShell® enables the controlled release of APIs into the bloodstream – increasing compliance, reducing costs and ultimately enabling smarter care regimens.
How
By customizing both the thickness and composition of this coating we can control the speed at which the API is released into the bloodstream over days, weeks or months.
Biologics
In a lysozyme protein model enzyme activity was unaffected and there was a sustained in vitro release of coated protein.
In an in vivo mouse study a water soluble peptide was coated with PharmaShell® with a high drug load (>70% API). Whilst there was rapid clearance of the uncoated API, the initial release of the coated peptide showed a small initial burst release, Cmax/Css about 10×, then controlled release continuing for the full duration of the study: 8 days.
ALD
Nanexa are pioneers in using ALD coatings on Active Pharmaceutical Ingredients (APIs), filing their first patent for an ALD-encased API in 2013. Once seen as impossible, today Nanexa is leading the first clinical study in an ALD-encased pharmaceutical, and the first pharmaceutical manufacturing plant with ALD capabilities is in development.
Today Nanexa has a small-scale Atomic Layer Deposition manufacturing and fill and finish facility in Uppsala where it produces ALD coatings and fills vials. The facility is GMP-ccertified to produce clinical trial material by the Swedish Medical Products Agency.
Plus, it is is partnering with Applied Materials Inc, global leaders in ADL, to scale up its manufacturing capabilities with a new aseptic, two-line manufacturing plant for PharmaShell which will increase production to up to 3 kg batches, fill and finish is onsite too. The completed pilot plant will be the first GMP pharmaceutical manufacturing plant in the world with full Atomic Layer Deposition capabilities.
Today Nanexa has a small-scale Atomic Layer Deposition manufacturing and fill and finish facility in Uppsala where it produces ALD coatings and fills vials. The facility is GMP-ccertified to produce clinical trial material by the Swedish Medical Products Agency.
Plus, it is is partnering with Applied Materials Inc, global leaders in ADL, to scale up its manufacturing capabilities with a new aseptic, two-line manufacturing plant for PharmaShell which will increase production to up to 3 kg batches, fill and finish is onsite too. The completed pilot plant will be the first GMP pharmaceutical manufacturing plant in the world with full Atomic Layer Deposition capabilities.