Inhalation and nasal product development

Inhalation of drugs can be an effective way of achieving therapeutic concentrations locally in the lungs or nasal passages while limiting systemic exposure. However developing such drug products for inhalation requires specialised formulation and characterisation expertise in order to ensure effective and quality product development. Our dedicated team for development of inhalation formulations supports the following dosage forms for new chemical entities (NCEs) and generics:

  • Pressurised metered dose inhalers (pMDI)
  • Dry powder inhalers (DPI)
  • Nebuliser solutions and suspensions
  • Nasal solutions and suspensions
  • Nasal aerosols and powders
Our inhalation formulation development services include:
  • Preformulation
  • Formulation development
  • Device selection and evaluation
  • Aerosol characterisation
  • Reverse engineering
  • Product characterisation
  • Batches for GLP and cGMP studies
  • In vitro bioequivalence
  • Process development, scale-up and tech transfer
  • Stability testing
  • cGMP manufacture of clinical trial material 
Particle engineering technologies Chemical tests Physical tests Aerosol tests Inhalation manufacturing Product characterisation
Jet milling ID & assay Fill weight & leakage rate Emitted dose & dose content uniformity Pressure filling suspension & solution MDIs Priming/repriming & Cyr test for MDIs
Powder blending Moisture content Pressure Delivered dose by breathing simulation DPI formulations Spray pattern & plume geometry
Spray drying Impurities & degradation products Shot weight & total actuations Geometric particle size distribution by laser diffraction Cold filling suspension& solution MDIs Impact of flow rate or orientation
Laser particle sizing evaluation Excipient assays & release (HFA propellants, ethanol, oleic, acid, lactose) Microscopic evaluation & solid state characterisation Aerodynamic particle size distribution by cascade impactor Aqueous suspension & solution Device cleaning studies & simulated patient testing

 

Helping our customers breathe easy.

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