Inhalation Product Development

MedPharm has expertise in developing dry powder (DPI), suspension and solution formulations (MDI/pMDI), and products for delivery to the nasal cavity and the lungs. In addition to the tests of formulation, such as IVRT, and permeation, and penetration, MedPharm can test devices for API delivery in order to assess suitability and tailor a formulation to a device.

Pulmonary Drug Delivery

To date, MedPharm has helped to bring to market 3 inhalation products for delivery to the lungs, and has evaluated numerous pulmonary delivery devices. The experts at MedPharm offer a number of services to aid development:

  • Pre-formulation studies for dry powder, solution and suspensions, including powder processing, milling, freeze and spray drying
  • SWOT analysis of Nebulisers, DPI and MDI (both pressurised and non-pressurised) devices and formulation optimisation for these systems
  • In vitro formulation characterisation using IVRT along with Franz Cell based permeation and penetration studies with excised tissue. Additionally, pulmonary formulations are assessed for spray plume/particle size and distribution through NGI. Whilst NGI is considered a gold standard test, MedPharm has also developed laser diffraction tests to provide a quick screen for particle size and distribution. This allows for selection and optimisation of formulations for delivery to the airways.

MedPharm can develop engineered particles for delivery to the lung and has significant expertise in:

  • Protein and peptide formulation stabilisation
  • Pressurised HFA formulations
  • Assessing interaction of APIs with lactose and other carriers
  • Development of powders for inhalation and other routes of administration
  • Altering powder morphology and density
  • Encapsulation

Nasal Drug Delivery

MedPharm has expertise in developing dry powder, solution and suspension formulations for nasal delivery and has evaluated nasal delivery devices. Nasal delivery presents extra challenges as the approved excipients for use in these formulations is limited. MedPharm offers an array of IVRT, permeation and penetration services, along with specialist nasal formulation tests including:

  • In vitro epithelial cell culture models for drug absorption and toxicity studies
  • Mucocilliary clearance / frog palate models
  • In vitro deposition studies NGI/Nasal cast and laser diffraction studies for particle sizing and distribution
  • As with pulmonary delivery devices, MedPharm can carry out evaluation of delivery devices