Nanexa AB - What is Pharmashell®

What is

WHAT IS PharmaShell®?

PharmaShell® is a unique drug delivery system enabling a high drug load and low injection volume, with excellent in-situ stability, and controlled burst release and depot length.

How

HOW DOES PharmaShell® WORK?

PharmaShell® covers drug microparticles at the atomic level in a highly protective, extremely thin film coating (approximately 30 nm) of slow-dissolving nontoxic inorganic oxides.

The formulation is a suspension containing coated drug particles with a controlled solubility of the coating. As the coating dissolves, the drug is released in a pre-defined manner over time.

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.

The controlled release is steered by modulating the coating thickness, the composition of the coating and process parameters. We are currently primarily using nontoxic aluminum oxide and zinc oxides in the ALD coating.

Biologics

DOES PharmaShell® WORK WITH BIOLOGICS?

PEPTIDES

In preclinical tests, peptides have proven applicable for PharmaShell® formulation.

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.

PROTEINS

In preclinical tests protein have proven applicable for PharmaShell® formulation.

In a lysozyme protein model, enzyme activity was unaffected and there was a sustained in vitro release of coated protein.

ALD

WHAT IS ALD (ATOMIC LAYER DEPOSITION)?

For professionals in advanced materials manufacturing Atomic Layer Deposition has long been prized as a precise, conformal and customizable coating that protects and extends the life of many of the world’s most advanced products. So, what if ALD could bring the same advantages to pharmaceutical formulation?

ALD pharma pioneers

Nanexa has strong roots in industrial innovation through its origins at the Ångström Laboratory at Uppsala University, where it developed Atomic Layer Deposition nanotechnology and semiconductor technology.

Until 2022, Nanexa had a small-scale Atomic Layer Deposition manufacturing, fill and finish facility in Uppsala where it produced ALD coatings. The facility is GMP-certified by the Swedish Medical Products Agency for production of clinical trial material.

Nanexa is, together with its partner Applied Materials Inc, global leaders in ALD, scaling up its manufacturing capabilities in a new aseptic, two-line manufacturing plant for PharmaShell, which can handle production to up to kg batches, with filling and finishing onsite as well.

The completed pilot plant is the first GMP pharmaceutical manufacturing plant in the world with full Atomic Layer Deposition capabilities.