Inhaled Drug Delivery - Formulation Development

Pharmaterials provides a contract, fee for service, offering for the formulation of dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs). Our specialization covers both small molecules (such as inhaled corticosteroids, beta agonists etc) and macromolecules (such as antibodies, vaccines etc). Our business also expands to the formulation of intranasal products.  We can provide formulation by traditional approaches or by development of design space and quality by design packages.

Whatever your respiratory drug delivery needs we are happy to provide:

• early stage pre-formulation support
• candidate drug selection support
• design and engineering of particles suitable for inhalation
• material characterization and sourcing
• drug-excipient compatibility testing
• formulation development of inhalation and intranasal drug products
• development and optimization of manufacturing processes e.g. particle size reduction process
• selection of an inhaler device.
• in vitro testing of prototype formulations
• stability testing of drug and formulations
• development of cleaning verification processes
• cGMP manufacturing in our facility for DPi and pMDI

We can offer both conventional and bespoke technologies such as:

• Air-jet milling (micronisation)
• Spray drying
• Freeze drying
• Controlled crystallization
• Inhalation powder blending
• Microfluidisation
• Pressure and cold propellant filling technology
• Vibratory sieving of carrier particles 
• Geometric particle size distribution
• Aerodynamic particle size distribution
• Impurities testing
• Emitted dose testing
• Surface morphology determination
• Powder blend homogeneity
• Solubility of drug in the propellant such as HFA 134a and 227ea
• Solid state form changes induced by drug exposure to propellant
• Primary, secondary and tertiary structures of macromolecules
• Stability testing
• cGMP manufacture for DPI and pMDI

Equipment

• Sturtevant Qualification Micronizer
• Lab Plant spray-drying equipment
• Freeze-drying equipment
• Turbula® mixer
• Vibratory sieves
• Pamasol lab plant propellant filling and crimping equipment
• Precision GMP powder filling
• GEA Pharmaconnect TRV high shear powder blender
• Microfluidiser
• NGI
• DPI and pMDI total trap sampling apparatus
• TSI Aerodynamic particle sizer
• Malvern mastersizer
• Thermal analysis equipment (DSC MC-DSC, ITC, TGA, DVS)
• X-Ray powder diffraction
• SEM and TEM
• Specific surface area analyser (B.E.T)
• Surface energy analysis (IGC)
• Spectroscopy (i.e. IR, Raman, UV/VIS, FLD, CD)
• Chromatography (HPLC-UV/FLD, SEC-UV/FLD)

Please contact us for full details of this service.