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Preformulation Testing

An in-depth knowledge of the strengths and weaknesses of your API is fundamental to the long-term success of your product. Solid State Chemistry and preformulation studies paint a clearer picture of what drug candidate you should chose early on, optimization opportunities, or any obstacles that will need to be overcome moving forward. At Pii, our advanced analysis techniques, solid state chemistry and preformulation testing services can often result in manufacturing efficiency, reduced costs and improved timelines.

The Solid State Chemistry group, through our UK division Pharmaterials, provides exceptional service seamlessly in line with Pii’s dosage form development and GMP manufacturing capabilities.

Using state-of-the-art technologies, we are able to rapidly capture all relevant information with minimal drug substance per experiment. This means that we can support all of your screening needs, no matter what stage of the drug development process you are in. Pii’s Solid State Screening and preformulation testing services include:

  • Moisture content
  • FTIR
  • Microscopy
  • Forced Degradation studies
  • Identification of degradation products
  • Excipient characterization
  • Drug/Excipient Compatibility Studies
  • Crystal Morphology
  • pKa determination
  • Thermal Analysis by DSCX-Ray diffraction
  • Raman Mapping
  • Sorption/Desorption Studies

Through Pii’s extensive toolbox we can:

  • Determine the compound’s physical and chemical characteristics of client compounds
  • Identify the best form of drug substance and excipients to use in dosage form development
  • Generate data that are a prerequisite to dosage form development
  • Produce preclinical prototype development formulations for animal efficacy and toxicity testing

Our goal is not to just measure, but to understand.

Selecting the right compound to move forward is a critical step to a successful drug development campaign. Pii helps clients develop assess their drug candidates solid state and physicochemical characteristics. A deep understanding of each provides a better decision on the best candidate to take into the clinic as well as secure intellectual property protection.

The Pii Difference

Pii has the expertise and knowledge it takes to ensure a successful formulation development path, leading you to a more robust drug development campaign. We have maximized our analytical toolbox to help our clients avoid future pitfalls or to trouble shoot existing formulation problems to get you back on track.

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