Injectables are mostly molecules that otherwise cannot be delivered into the bloodstream. These are molecules that are very sensitive to oxidation, so they are presently given in an emulsion where they suffer chemical and physical long-term instability, along with additional drawbacks. LDS loads active molecules onto the novel nano-domains, providing solutions to the disadvantages of the injectable emulsions such as thermodynamically stability, pain upon injection, solubilization, and high activity.
PK in Dogs: NEOPROL formulations (NP09) Demonstrating bio-equivalence to commercial product
Neoprol was established by Integra Holdings (the Hebrew University health-care investment company) in 2014. Based on Prof. Nissim Garti’s technology, the company developed an improved and novel patented intravenous propofol formulation for the induction and maintenance of anesthesia. NP-09, a 10mg/ml propofol nano-liquid formulation, was developed to have a bio-equivalence profile (similar PK and PD), while overcoming the hurdles of the commercially available products. This product was proven safe in pre-clinical studies in both small (rodents) and larger animals (dogs and monkeys), as well as succeeding in extensive toxicological studies. GMP manufacturing process were completed, including long-term stability studies (according to the ICH guidelines), with exceptional success. Regulatory packages were submitted to the European and FDA authorities and a Phase 2a clinical study is scheduled to start during Q1 of 2021.