For OINDPs the rate and extent of drug absorption are usually assessed using in vivo pharmacokinetic (PK) studies in which drug plasma concentrations are characterized. In the OINDP space there is limited understanding of the relationship between in vitro dosing parameters (e.g. delivered dose content uniformity, aerodynamic particle size distribution (APSD) metrics etc.) and the actual fate of the aerosol dose in vivo. There is therefore a requirement to determine the regional deposition of an aerosolised dose and the determination of the systemic exposure of the dose in the lung.
Nanopharm has developed its own proprietary in silico regional deposition model and 3-compartmental PBPK model. The regional deposition model enables the determination of the distribution of the dose across the different lung generations. The PBPK model predicts the pharmacokinetic behavior of the drugs in lungs using the regional deposition modelling data and dissolution kinetics of the aerosol dose.
The use of modelling and simulation services has enabled the design of device and formulation systems to achieve comparability to the target product profile. In addition, these services have aided clients to select test and reference products for generic programs. The use of our modelling and simulation services are currently being utilised to determine the therapeutic concentration of an aerosol dose in the different generations of the airways.