Drug delivery platform

A known problem and a real risk in clinical development programs is that patients generate different inhalation flows (inhalation rates) when using dry powder inhalers. This means that variability in how much drug is delivered to the lung with today’s available technology is large.

Experiments conducted by Nanologica in which budesonide (an inhaled corticosteroid) was loaded into NAP™ have shown that the drug delivery from a commercially available capsule-based dry powder inhaler is independent of the flow rate used to generate the aerosol cloud. The trials show that the company’s nanoporous particles provide a consistent drug delivery across a range of clinically relevant inhalation flows, which is hugely significant. Simply put, this means that Nanologica’s delivery technology is less dependent on the patient’s ability to take a deep breath to get the drug into the lung.

Creating drugs for inhalation using nanoporous particles addresses several of the challenges that the pharmaceutical industry in this area faces today. Examples of challenges are amorphous and/or insoluble drug substances, as well as the delivery of biological molecules to the lung, something that today’s available technology cannot handle. With the help of Nanologica’s delivery technology, these challenges should be able to be addressed.

In order to provide a chemically stable pharmaceutical product, the drug substance in dry powder formulations is normally in a so-called crystalline form, i.e. definite molecular structure. For some pharmaceutical substances, the solubility of the crystalline form is very low, which can make it difficult to reach a sufficient concentration of the drug substance in the body to obtain a therapeutic effect. The alternative is to use the drug substance in amorphous form (disordered molecular structure). However, this creates significant challenges in terms of chemical and physical stability and handling of the drug substance, as the amorphous form is less stable and more difficult to handle. When drug substances are loaded into Nanologica’s nanoporous particles, the substance is encapsulated inside the pores of the particle and retained in an amorphous form. This increases the solubility of the substance, while protecting it inside the particle.

Nanologica believes that NAP™ has the potential to protect also biological molecules, which can solve the problems of degradation that exist for almost all large molecules. The research in the field of inhaled biological drugs is at an early stage but is something that the company intends to continue.