Drug delivery platform
Drug delivery platform
Nanologica’s patented technology platform, enables the use of mesoporous silica for tailor-made drug delivery systems for enhanced bioavailability and controlled release.
Nanologica’s drug delivery technology is based on micrometer-sized spherical silica particles with thousands of nanometer-sized pores. The nanoporous particles have been designed to enable the delivery of drugs directly to the lung and the particle size is precisely controlled (1 – 5μm) to facilitate maximum lung deposition.
The particles are made from amorphous silica that is biosoluble, which means that they dissolve in pulmonary fluid and are eliminated from the body as silicic acid via the kidneys.
Pharmaceutical products for inhalation are created by encapsulating drug substances inside the pores of the particles. The pharmaceutical product can then be easily aerosolized into a dry powder for inhalation without additional excipients, with a fine-particle fraction (proportion of particles of optimal inhalable size) in the range of 70–80 percent, which is a doubling compared to conventional dry powder inhalation products. This means that a larger portion of the dose of drugs has the potential to reach the lung in comparison to conventional products. The flow properties of NAP™ are also not changed by being loaded with drug substance – the drug product remains free-flowing and can be easily dispensed to a dry powder inhaler.
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.
Nanoporous particles (NPPs) for inhalation
- Nanoporous spherical particles
- 1 to 5 µm
- Narrow particle size distribution
- Tuneable particle and pore size
- High loading up to 50%
- Free-flowing powder
Picture: When the API was loaded in Nanologica’s nanoporous particles (named NLAB Spiro™ in the graph), the bioavailability increased significantly compared to the commercial formulation of the API. SLF is simulated lung fluid, PBS is phosphate-buffered saline.
The aerodynamic properties of the particles are perfectly tailored for inhalation. Impactor measurements of Mass Median Aerodynamic Diameter (MMAD) for NAP™ (below refered to NLAB Silica) loaded with three different active ingredients show excellent flow properties
NAP™ has the potential of solving problems in pharmaceutical formulations by improving solubility, enhancing bioavailability and protecting APIs from degradation.
Graph: Reformulation of the HIV drug Atazanavir (ATV) using NPPs (above refered to NLAB Si-ATV) for improved bioavailability in vivo.
If you would like to know more about Nanologica’s drug delivery technology, please contact Gary Pitcairn, CSO email@example.com or e-mail firstname.lastname@example.org.
For more information:
Nanologica’s Technology Platform for Drug Delivery
Potential benefits of NAP™
• Enhancing dissolution kinetics of poorly soluble compounds
• Controlling release kinetics
• Improving bioavailability
• Stabilizing amorphous form
• Improving handling of APIs
• Applicable for a broad range of API, potentially including inhaled biologics
• Spherical particles
• 1 to 5 µm
• Tuneable particle and pore size
• High loading up to 50%
• Free-flowing powder suitable for inhalation