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Oral Formulations

Clinical expertise and innovative technologies to enhance your drug’s performance

With over 75 years of experience we have the formulation expertise to tailor your API for optimal solubility, bioavailability, and permeability. As the innovators of softgel technology, we are particularly proficient in a large range of oral dose forms, supported by broad clinical knowledge and a regulatory track record that can shorten your development time and ensure positive delivery. Our proprietary technologies such as Zydis® fast dissolve and controlled release can further enhance your product’s performance. With our team of over 1,000 scientists and our critical mass of global facilities, we can customize our services according to your requirements and support your project through its entire lifecycle – from development to supply.

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

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  • Innovative, proprietary technologies that enhance outcome and improve compliance
  • Expert scientists experienced in overcoming the challenges of potent and complex compounds
  • Rich variety of oral dosage forms, customized to your API needs
    • Tablets: immediate-release, sustained-release, delayed-release, film-coated, layered, orally disintegrating
    • Capsules: powder, granule fill
    • Powders: sachets, powder in a bottle
    • Pellets: can be incorporated into tablets or capsule filled
    • Liquids: solutions, suspensions, emulsions
    • Specialty liquids: microemulsions, self-emulsifying systems
  • More new chemical entities (NCEs) to market than the global competition
  • First-class facilities with global compliance
  • Personalized project management
  • Strategic regulatory planning and support

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We provide a full-range of formulated study supplies and services:

  • Preclinical (GLP toxicology)
  • Prototype formulation screening studies
  • “First in Man” studies
  • Phase I – Phase III clinical
  • Formulation/process optimization
  • Scale-up/technology transfer
  • Commercial manufacturing technical support

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Our state-of-the-art equipment includes:

  • Direct tablet compression
  • Fluid bed processing (granulation, drying, coating)
  • High-shear wet granulation
  • Dry granulation (roller compaction, slugging)
  • High-speed tablet compression
  • Unit dose lyophilization
  • Perforated pan tablet coating
  • Automated capsule filling (powder, granules, pellets)
  • Microencapsulation
  • Becomix semi-solids processing
  • Low-humidity/moisture requirements
  • High-potency compound handling
  • DEA controlled substances (schedule I – V)
  • Light-sensitive compound handling
  • Solvent handling capability
  • Pediatric dosages forms
  • Taste-masking

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

  • Somerset, New Jersey, U.S.A.
    • Research and development
    • Pilot line
    • Commercial line with controlled and potent drug capabilities
    • FDA audited
  • Swindon, U.K.
    • Research and development
    • Pilot line with controlled and potent drug capabilities
    • FDA and MCA audited
    • Controlled drug capabilities

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

  • Winchester, Kentucky
    • 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
      • Over 98% on-time, in-full delivery performance for the past 3 years 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
    • 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
  • San Diego, California