Zydis® Fast Dissolve

Early API evaluation & characterization by the innovators of the leading fast-dissolve

As the innovator of Zydis®  fast dissolve, the number 1 disintegrating oral tablet in the world, we offer the best trained team in the world to deliver the most comprehensive formulation services available in any CMO. Leveraging our deep experience in fast-dissolve formulation, our proven expertise has launched over 20 Zydis®  technology-based products in over 50 countries. Drug candidates proposed for Zydis® formulation vary in their stage of development; from new chemical entities (NCE) in early clinical development to marketed products, we have supported Zydis® fast dissolve applications across a broad range of both OTC and Rx drugs – from human antipsychotics to canine NSAIDs.

Catalent Benefits 
  • Enhance therapeutic outcome 
    • Potential pre-gastric absorption for certain drug compounds
    • More efficient delivery - faster onset of action (actual and perceived); potential reduction of dose and metabolites
    • Improved compliance for children, the elderly, pets, and more
  • Innovator’s expertise and customized feasibility testing for Zydis® fast dissolve application 
  • Highly trained scientists experienced in working with potent and controlled compounds
  • Smarter lifecycle management – from preformulation to bench, pilot, and full-scale cGMP manufacturing in the U.S. and Europe  
  • Operational excellence and efficiency via Lean Six Sigma principles 
  • Globally integrated state-of-the-art facilities
How It Works
  • Preformulation/formulation for Zydis® fast dissolve development preliminaries
    • Starts with a review of existing preformulation data
    • Specific focus given to information relevant to Zydis® fast dissolve formulation and manufacturing processes
    • Zydis®  technology questionnaire explores data of specific interest, e.g., drug form, solubility, and stability
    • Following review, an initial technical evaluation of the proposed drug candidate’s suitability provided, highlighting relevant gaps in the preformulation data 
    • Appropriate preformulation work package proposed - either stand-alone through our preformulation services team or as part of a Zydis® fast dissolve feasibility program
  • Zydis® fast dissolve feasibility program
    • Tailored to meet the known product requirements such as API unit dose
    • Considers the relevant API characteristics identified during the technical evaluation of preformulation data
    • A range of prototype Zydis® fast dissolve formulations prepared under different processing conditions (bench-scale) 
    • Analytical techniques applied as appropriate to determine the compatibility of a candidate API with Zydis® technology
    • Short-term (4 week) accelerated physical stability studies typically undertaken before recommendations for a full development program are made.
  • Further Zydis® product development
    • Formulation optimization, process development and scale-up; clinical manufacture, analytical development and registration stability studies
    • Expert analysis and interpretation of data throughout our development programs fully characterize the API and associated Zydis® formulations and providing a robust data package in support of regulatory filings
Catalent Capabilities

We employ the most advanced equipment for our Zydis® fast-dissolve preformulation and formulation development programs. The resulting data is used to direct the selection of Zydis® formulations and manufacturing process conditions.

  • Optical microscopy
    • Characterizes the API crystal form and identifies any changes during formulation and processing
  • Freeze-drying microscopy
    • Identifies critical formulation parameters such as collapse temperature, eutectic/glass transition temperature
  • Particle size analysis (laser diffraction)
    • Determines particle size ranges relevant to Zydis® suspension stability (for insoluble API)
  • Dynamic Vapor Sorption
    • Characterizes moisture sorption properties and physical stability of lyophilized formulation to humidity
    • Characterizes hydrates, polymorphs and amorphous content
  • Thermal methods (DSC, TGA)
    • Identifies glass-transition, melting and crystallization temperatures
    • Characterizes hydrates and polymorphs
  • X-ray powder diffraction (XRPD)
    • Characterizes solid-state phase behavior
  • Analytical chemistry (HPLC, UV, NIR, FTIR)
    • Chemical analysis of API in support of preformulation studies (e.g., solubility determinations, compatibility testing)
Facilities

We have two 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