The development of orally inhaled and nasal drug products (OINDP) involves a rigorous approach to formulation development, testing, stability and CMC support which are necessary to determine product efficacy, quality, safety and performance.
At Medicilon, we provide our clients with expert formulation development of varieties of inhalation drugs including DPI, aerosol inhalation and nasal spray. We fully corporate regulations and guidelines from FDA and other institutions all over the world to manage all aspects of stability study requirements such as ICH and accelerated stability studies at every stage of a product’s development.
Our specialist capabilities in development and analysis of inhalation drugs includes:
- Aerodynamic Particle Size Distribution, APSD
- Fine Particle Dose, FPD
- Delivered-Dose Uniformity, DDU
- Delivery Rate
- Total Delivered
In order to enable all tests, we are equipped with state-of art equipment such as Copley NGI, Copley BRS2100, SYMPATEC HELOS&INHALER, etc.
Other Drug Formulaton Services that Medicilon can Provide: