Zydis® Fast Dissolve

Fast Dissolve tablets & granules, unique delivery of allergens and other large molecules - Catalent’s Best-in-Class Family of Fast Dissolve Technologies

05a-ZYDIS-S-Catalent 0282- v2

The Zydis® ODT 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 evaluations 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 or sublingual absorption
  • Improved compliance in many therapeutic markets
    • Excellent for children, elderly, pets, and those having trouble swallowing
    • Allows for the instant dosing without need of water
  • More efficient delivery
    • May 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 that includes:

  • 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 insoluable 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)
Best in Class Family of Fast-Dissolve Technologies

Zydis® Ultra

  • Further enhanced Fast-Dissolve formulations
  • Greater taste masking capabilities; increased doses
  • Functional coating for controlled / sustained release applications

Zydis® Nano

Nanoparticles have been shown to greatly increase both the rate and extent of drug dissolution thus improving bioavailability, allowing reduced dose, dose frequency and potentially improve patient safety.

Zydis® Nano is a nano particulate formulation using Zydis® technology to enable oral delivery of poorly soluble API’s in class leading orally disintegrating tablet. Utilizing established techniques, nano-particles of the API are formed by wet milling and used in suspension in the Zydis® process allowing for rapid dispersion of the nanoparticles in the finished dose form.

Zydis® Granules and Gels

A highly versatile and patient friendly, single unit granule formulation as a stick pack which is a highly accepted dose form sharing the convenience of conventional Zydis® Ultra and allowing for high drug load and broadest of taste-masking techniques.

The challenge:

  • High dose phosphate binding agent, large tablet size
    • Poor patient acceptance for existing chewable tablet formulation
    • High pill burden for dialysis patients
    • Too high drug load for ODT dosing platforms
    • Poor potassium control associated with negative outcomes

The Zydis® solution:

  • Zydis® granule formulation
    • High patient compliance and patient acceptance of novel dose form
    • With food dosing perfectly suited to granule solution
    • Improved compliance, potassium control and patient outcomes
  • Patient need & therapy “gap” enabled market access & reimbursement for novel dose form

The originator product was a large tablet that was difficult for patients who were already enduring a large pill burden. Documented compliance issues often lead to treatment failures in respect of poor potassium control and associated clinical problems.  Single dose packs of Zydis® granules sprinkled on food were a massive step forward in patient care which were readily accepted and resulted in improved clinical outcomes.

Zydis® Bio

The ability through class leading Zydis® ODT technology to deliver fast-dissolve formulations of large molecule proteins & peptides

The challenges of oral delivery of proteins & peptides well documented and are not limited to:

  • pH
  • Peptidase & proteolytic enzyme activity
  • Potential interaction with other constituents of GI fluids
  • High molecular weight

Zydis® Bio sub-lingual delivery overcomes these challenges:

  • Avoids harsh environment of GIT
  • Use of bio-adhesives / absorption enhancers
  • Pre-gastric delivery (e.g. buccal, sublingual, oesophageal)
  • pH relatively neutral (5.5 - 7.2 depending on salivary flow rate)

Benefits of Zydis® Bio for peptide & protein drugs

  • Potential for sublingual / buccal absorption
  • Solid, unit doses presented in protective pack
  • Low temperature processing minimizes manufacturing losses of labile drugs
  • Solution / suspension dosing achieves good content uniformity for low dose actives
  • Solid dosage form and low water activity aids long term stability
  • Liquid processing facilitates containment of potent drugs in production
Facilities

We have four fast dissolve dosage form facilities dedicated to Zydis® development and production.

  • Somerset, New Jersey
    • 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
  • Kakegawa, Japan
    • Research and development
    • Pilot line, manufacture for Phase I clinical trials
  • Schorndorf, Germany
    • Zydis® Granules
    • Research and development
    • Commercial Manufacture
    • FDA and MCA audited