Preformulation



Oral Preformulation

Proprietary technologies and expert testing to enhance your drug’s performance

With state-of-the-art facilities and a team of over 1,000 highly trained scientists, we are ready to customize your formulations according to specific requirements, utilizing our site-to-site connectivity to enable a seamless continuum of service from development to supply. 

Backed by a range of expert testing and release capabilities, our preformulation services team provides expert support from preclinical stages of drug development through regulatory filing for oral drug products. With over 75 years of experience developing world-class formulations for innovators around the globe, Catalent has the scientific, regulatory, and product development expertise to support a vast range of projects – from oral to inhalation to sterile. Our proprietary technologies, such as Zydis® fast dissolve, controlled release, and softgel capsules, are best considered early in the process to enhance the outcome of treatments and extend the lifecycle of your product. Supported by our state-of-the art facilities and a strong track record in regulatory approvals, we can successfully deliver all preformulation activities applicable to oral dosage forms, including lipid-based formulations and liquid APIs, such as:

  • Compatibility
  • Solubility
  • Dispersion and digestive studies

Learn more about how the following can impact your project at the preformulation stage:

Catalent Benefits
  • Industry leaders in solving complex development, preformulation, and formulation challenges
  • Potential for enhanced bioavailability to provide better treatments for your patients
  • API and excipient physical testing
    • Determine the drug candidate with optimal physicochemical properties
    • Help avert situations that can result from failure to characterize 
    • Assist in selecting the best polymorph and salt form for your API
  • Improved dose uniformity of your potent compounds
  • Specialized handling and manufacturing for cytotoxic compounds (for selected dosage forms)
  • Reliable and consistent quality of finished product in both clinic and commercial market
Catalent Services

Our variety of services can help you optimize dosages with the most stable and bioavailable API forms.

  • API and excipient physical testing for physicochemical properties
    • Salt synthesis and salt form selection
    • Polymorphic screening and selection
    • Solid and solution state stability
    • pH, temperature degradation rate profile
    • pKa, pH-distribution coefficient
    • pH solubility
  • Intrinsic dissolution
  • Excipient compatibility
  • Micromeritics: flowability, density (true, bulk, tap), porosity, surface area
  • Dynamic vapor sorption-desorption (hygroscopicity) profile
  • Biopolymer analysis by GPC
Catalent Capabilities

Our first-class facilities, equipment assets, and expertise allow us to handle your most demanding preformulation challenges.

  • X-ray powder diffraction (vT, vRH)
  • Thermal analysis: DSC, TGA, TMA
  • VTI Dynamic Vapor sorption/desorption
  • 500 mHz NMR
  • LC-MS
  • Optical microscope with image analysis (light, polarized, hot-stage)
  • Intrinsic dissolution
  • GPC with triple detection array (TDA)
  • Particle-size determination by laser light diffraction and light obscuration
  • BET surface area determination
  • FTIR
Facilities

We have 2 fast dissolve dosage form facilities plants dedicated to Zydis® fast dissolve production.

  • US: Somerset, New Jersey
    • Research and development
    • Pilot line
    • Commercial line with controlled and potent drug capabilities
    • FDA audited
  • Europe: Swindon, UK
    • Research and development
    • Pilot line with controlled and potent drug capabilities 
    • FDA and MCA audited
    • Controlled drug capabilities

Our three oral solids facilities have strong track records for both quality and regulatory compliance. 

  • Winchester, Kentucky, U.S.A.
    • Capabilities
      • Category I - III and solvent-based processing
      • Extrusion and spheronization
      • Commercial high-shear granulation
      • Blending
      • Tablet compression
      • Hardshell-capsule filling
      • Pan-coating
      • Fluid bed
    • Compliance
      • Often noted by customers as one of Catalent’s top sites for quality and service
      • Over 98% on-time, in-full delivery performance for the past 3 years
      • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities
  • Schorndorf, Germany
    • Capabilities
      • Category I - IV and solvent-based processing
      • Commercial high-shear granulation
      • Blending
      • Dry granulation
      • Extrusion and spheronization
      • Tablet compression
      • Hardshell-capsule filling
      • Pan-coating 
    • Compliance
      • Passed three FDA pre-approval inspections (PAI) and numerous inspections by national and international regulatory authorities
  • Somerset, New Jersey, U.S.A.
    • Capabilities
      • Preformulation
      • Non-sterile oral dosage form development
      • Analytical support for oral dosage form development
      • Small-scale commercial manufacturing for non-sterile oral dosage forms
      • Hardshell-capsule filling
    • Compliance
      • Passed numerous pre-approval inspections by both U.S. and international regulatory authorities