Intertek announced that it is now offering comprehensive services for the development of orally inhaled and intranasal drug products (OINDPs) for both small molecules and biologics. This follows the company’s acquisition of Melbourn Scientific.
The services include formulation, analytical method development and validation, drug product physical characterization, chemistry, manufacturing and controls (CMC) support, stability studies and QC release testing. The company can also provide regulatory affairs consultancy, bioanalysis and extractables and leachables (E&Ls) studies for all types of inhalation medicine products.
There is an increasing demand for more user-friendly drug delivery products, such as OINDP, which can offer improved patient outcomes. The development of these products requires specialist capabilities and test facilities for techniques such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI), spray pattern/plume geometry and delivered dose assessment.
A key challenge in OINDP development is the control of E&Ls. With inhalation products that deliver the drug directly to the lungs, the rubber and plastic inhaler device components are in constant contact with the product formulation. Consequently, there is a potential for substances to leach from the device components into the drug product. Intertek can provide E&L studies supporting OINDP development.