Pii has broad knowledge and technical experience in dosage form development and GMP manufacturing. Pii is able to provide clients with a wide range of options to develop small molecules into quality pharmaceutical products. The key to our success is being able to provide a flexible approach for the client whether it is a step by step approach to development work or simply the transfer of a product into development at late stage.

 

Over the years Pii has worked with over 400 NCEs having a range of physico-chemical characteristics.

Pii’s highly trained scientific team has extensive experience working with a variety of drug substances, with a range of physiochemical characteristics, including:

  • poorly aqueous soluble drugs
  • highly potent and cytotoxic drugs

 

Pii’s development capabilities include modified and extended release formulations. For poorly soluble compounds, Pii offers a variety of bioavailability enhancement technologies, including solid dispersion development and lipid-or micro/nano-based emulsions.

Dosage Forms

  • Conventional tablets
  • Conventional capsules
  • Controlled/delayed release tablets
    and Capsules
  • Hard gelatin/ HPMC liquid filled capsules
  • Soft Gels
  • Hot Melt Extrusion
  • Spray Drying
  • Ointments/Creams/gels
  • Suspensions/Syrups/Solutions
  • Suppositories/Pessaries
  • Sterile Injectable products
  • Freeze dried products
  • Coated Beads, Tablet and Capsules

 

Pre-Formulation Services

Preformulation protocols are designed to meet each client’s requirements.

  • Prototype development formulations
  • Problem solving of existing processes
    and formulations
  • Process Development
  • Lab scale to pilot scale manufacture
  • Registration Batch manufacture
  • Validation batch manufacture
  • Packaging into Bottle or blister packs
  • Analytical Methods Development and Validation
  • Dissolution Testing
  • Inhalation product development
  • Stability studies under ICH conditions at all stages of development
  • Extrusion and Spheronization
  • High Shear and Fluid Bed Processing
  • Bead and tablet coating
  • Over encapsulation
  • Back filling of capsules
  • Tablet in Tablet technology
  • Preclinical supplies preparation
  • Phase I – IV clinical trial supplies
  • cGMP clinical manufacture for
    Phase I – IV clinical trials supplies