Preformulation



Overview

Reliable evaluations to ensure your long-term success

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With development capability for both small and large biomolecules, we provide complete CMC services for oral, inhalation, and sterile products from preformulation through clinical supply, including scale-up and technology transfer to our commercial manufacturing facilities. Our rigorous physiocochemical characterization of APIs - a regulatory expectation - can help you avert situations that result from failure to detect polymorphic forms and poor salt selection. Supported by integrated project management, our balanced preformulation approach can ensure a consistent quality of product from discovery to clinic, and beyond.

Learn more about how we can help your preformulation goals in these areas:

Catalent Benefits
  • Scientific, regulatory, and product development expertise
  • Proprietary technologies to enhance product performance and extend your product's lifecycle
  • Critical mass of facilities and personnel to customize your project according to specific requirements
  • State-of-the-art equipment
  • Personalized project management from development to market
Catalent Services

We provide studies necessary to elucidate the drug substance candidate with optimal physicochemical properties.

  • Salt synthesis and salt form selection 
  • Polymorph screening 
  • Solid and solution state stability 
  • pH/temperature degradation rate profile 
  • pKa determination 
  • pH/solubility profile 
  • Adsorption/desorption 
  • Excipient compatibility studies 
  • Container/closure compatibility