Zydis^® Fast Dissolve

The no. 1 orally disintegrating tablet in the world

Zydis^®, our proprietary fast-dissolve formulation, is a unique, freeze-dried oral solid dosage form that disperses instantly in the mouth - no water required. With more than 20 products launched in 50 countries, it continues to be the world’s best-in-class, orally disintegrating tablet (ODT) technology. Our Zydis^® fast dissolve team is the best trained in the world, offering feasibility testing as well as support across the entire lifecycle of your product. Whether you are considering an ODT to enhance pharmacokinetics through pre-gastric absorption, looking for a way to improve patient compliance, or seeking a marketing advantage for a valued brand, Zydis^® fast dissolve can help enhance the value of your investment and accelerate your product’s potential.

Catalent Benefits

• Better pregastric absorption for certain drug compounds
  • Disperses instantly in the mouth, allowing for buccal absorption
• Improved compliance for various therapeutic markets
  • Excellent for children, the elderly, pets, and those having trouble swallowing
• More efficient delivery
  • Allows for faster onset of action and reduction of metabolites
• Ideal for certain indications
  • Excellent for treating pain and other conditions where rapid dosing and absorption are required, including allergies and travel-related illness
• Improved patient compliance
  • Faster absorption lends the possibility of reduced and less frequent dosage
• Enhanced marketing appeal 
  • Fast-dissolve perceived by consumers as easier to swallow and faster-acting
• Protection from counterfeiting
  • Tamper evident

Valuable Product Differentiation

• High level of customer preference
• Multiple colors and shapes
• Embossing with corporate logos and product codes
• Unique packaging, including child-resistant options
• Taste masking and flavors formulated for specific markets, including pediatrics and veterinary medicine

How It Is made

Utilizing a unique lyophilization (freeze-drying) process to manufacture finished dosage units. Zydis^® is produced via a four-stage process:

• Stage 1 - Mixing 
  • The bulk API is formulated into a liquid solution or suspension.
• Stage 2 - Filling and freezing
  • The liquid is precisely filled into pre-formed blisters and passed through a specially designed cryogenic freezing process to control the ultimate size of the ice crystals. 
• Stage 3 - Lyophilization
  • The frozen units are then transferred to large-scale freeze dryers for the lyophilization process. 
• Stage 4 - Sealing
  • The blisters containing the dried Zydis^® units are then sealed via a heat-seal process to protect the product from varying environmental conditions and ensure long-term stability.

How It Works 

Catalent Services

Through expert analysis and interpretation of data, our Zydis^® fast dissolve technology team will fully characterize your API and associated Zydis^® formulations throughout the development process to provide a robust data package in support of regulatory filings. 

• Feasibility programs
  • Tailored to meet the known product requirements such as API unit dose
  • Consideration of the relevant API characteristics identified during the technical evaluation of preformulation data 
  • A range of prototype Zydis^® formulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine the compatibility of a candidate API with the Zydis^® technology 
  • Short-term (4 week) accelerated physical stability studies typically undertaken before recommendations for a full development program are made
• Full in-house analytical and regulatory services 
  • Full characterization of your API and associated Zydis^® formulations via expert analysis and interpretation of data throughout the development process to provide a robust data package in support of regulatory filings
• Smart full-lifecycle management from molecule to market - with Lean efficiency standards 
• Expert handling and maximization of potent and controlled drugs
• Bench, pilot, and full-scale cGMP manufacturing in the U.S. and Europe

Catalent Capabilities

We employ the most advanced equipment for our Zydis^® fast dissolve preformulations and formulations. The resulting data is used to direct the selection of Zydis® formulators 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 in humidity
• Characterization of hydrates and olymorphs
• X-ray powder diffraction (XRPD)
  • Characterizes solid-state phrase behavior
• Characterization of moisture sorption properties and physical 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 dedicated to Zydis® unit production.

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