Zydis^® Fast Dissolve

Faster, more reliable delivery with the no. 1 orally disintegrating tablet  

Zydis^®, our proprietary fast-dissolve technology, 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, Zydis^® fast dissolve continues to be the world’s best-in-class, orally disintegrating tablet (ODT) technology. 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^® technology can help enhance the value of your investment and accelerate your product’s potential.

Catalent Benefits

• Better pre-gastric 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^® units are 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 Capabilities

• Development teams in the U.S. and Europe
• Bench, pilot, and full-scale cGMP manufacturing in the US and Europe
• Fully validated and globally approved regulatory manufacturing sites with exemplary records
• Expert management of potent and controlled drugs
• Operational excellence and efficiency via Lean Six Sigma principles 
• Full in-house analytical and regulatory services for product development and launch

Facilities

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