Formulations for Inhalation
The delivery of therapeutics by the inhalation route is used to combat a variety of diseases, such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and other lung diseases characterised by obstruction of airflow and shortness of breath.
Evolution of drug delivery systems has resulted in a number of different device technologies essential to delivering the requisite levels of active ingredient into the lungs for maximum dose delivery and efficacy. Tepnel is experienced in the quality control testing for the batch release of formulations delivered by Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI), nebulizer solutions and suspensions and nasal sprays (aqueous, powder, and propellant driven).
MDI’s and DPI’s have unique differences with respect to formulation, container, closure, manufacturing, in-process and final controls, and stability.
Tepnel staff has specific experience in the area of Dry Powder Inhaler testing >300 batches of finished product per annum for release across the EU, US and other market approved geographies. With a specific emphasis on high quality cGMP compliant analytical services we look to incorporate lean manufacturing principles into our analytical processes which reduce turnaround time and increase speed to market.
Technologies available for inhalation testing:
Next generation impactors
Andersen cascade impactors
Multistage liquid impinger (MSLI)
HIAC Royco particulate matter analyzer
TSI digital flow meters
Copley Scientific Inhaler testing data analysis software (CITDAS)
Model TPK critical-flow controller
Mositure meters [TBC]
Humidity and temperature controlled testing cabinets
Sections in Batch Release Services
- ICH Stability Testing Services
- Batch Release Services
- Raw Material Testing Service
- Method Development and Validation