Softgel Formulation

13a-ADVILpm-S-Catalent-009 v2

As the innovators of softgel technology , we offer the world’s best trained team to deliver the most comprehensive formulation services. We have over 75 years of experience solving complex challenges in formulation, solubility, bioavailability, and development.  When you consider softgel solutions early in the process, we can save you time and money by taking the required proactive steps to ensure the most successful outcome.

Supported by our strong track record in regulatory approvals, we can successfully deliver all formulation activities applicable to lipid-based formulations and liquid APIs, including:

  • Compatibility
  • Solubility
  • Dispersion and digestive studies
Catalent RP Scherer Softgel Benefits
  • Innovator’s expertise in solving complex development and formulation challenges for softgels
  • Expert ability to:  
    • Enhance bioavailability for better outcome
    • Improve poor water solubility
    • Improve API stability
    • Improve dose uniformity of potent compounds
  • 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
  • Specialized handling and manufacturing for cytoxic compounds
  • Proprietary softgel formats, such as Vegicaps® capsules, targeted to specific markets for enhancing compliance
  • Reliable and consistent quality of finished product in both clinic and commercial market
  • Maximized investment by utilizing Catalent throughout the entire lifecycle of your product
Catalent RP Scherer Softgel Services

We offer a variety of services that help you select the most stable and bioavailable API forms in order to optimize your dosage: 

  • 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 RP Scherer 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
Catalent RP Scherer Softgel Facilities

Our deep formulation expertise supported by a global infrastructure of cGMP, FDA, EMA and locally accredited softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.