PII

Whatever your respiratory drug delivery needs Pii has the expertise and experience to
support you.

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Inhalation

Pii provides formulation and manufacturing services for dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs) and intransal products. Our specialization covers both small molecules (such as inhaled corticosteroids, beta agonists etc) and macromolecules (such as antibodies, vaccines etc).

To support your drug development, we offer a range of services to help you reach clinical trials and ultimately product launch in the quickest and most cost effective way. Whatever your respiratory drug delivery needs Pii has the expertise and experience to support you. Our inhaled drug delivery services include:

  • Early stage pre-formulation support
  • Candidate drug selection support
  • Inhalation particle design and engineering
  • Material characterization and sourcing
  • Drug-excipient compatibility testing
  • Formulation development of inhalation and intranasal drug products
  • Manufacturing process development and optimization, e.g., particle size reduction process.
  • Inhaler device selection
  • in vitro testing of prototype formulations
  • Stability testing of drug and formulations
  • Cleaning verification development
  • cGMP manufacturing for DPIs and pDMIs

We offer both conventional and customized technologies, such as

  • Air-jet milling (micronization)
  • Spray drying
  • Freeze drying
  • Inhalation powder blending
  • Microfluidization
  • Pressure and cold propellant filling technoloy
  • Vibratory sieving of carrier particles
  • Geometric particle size distribution
  • Aerodynamic particle size distribution
  • Impurities testing
  • Emitted dose testing
  • Surface morpholoy determination
  • Powder blend homogeneity
  • Solubility of drug in propellant, such as HFA 134a and 227ea
  • Solid state form changes induced by drug exposure to propellant
  • Primay, secondary and tertiary structures of macromolecules

Equipment

  • Sturtevant Qualification Micronizer
  • Lab Plant spray-drying equipment
  • Freeze-drying equipment
  • Turbula┬« mixer
  • Vibratory sieves
  • Pamasol lab plant propellant filling and crimping equipment
  • 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)

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