Zydis® ODT Technology
MEET CONSUMER DEMAND FOR FAST RELIEF
Zydis® fast-dissolve formulation is a unique orally dissolving tablet (ODT) that disperses almost instantly in the mouth – no water required. Dissolving in little as 3 seconds and up to 10x faster than other ODT products, Zydis® technology continues to be the global best-in-class ODT technology for over-the-counter drugs.
This convenient, fast and palatable dosage form is an excellent choice for consumers with Dysphasia (difficulties to swallow), pediatric and geriatric patients. It is an ideal platform for active ingredients treating pain, allergies, travel-related illness and other indications where rapid dosing and absorption is required.
With over 80 years as a leading innovator in the global OTC industry and more than 30 Zydis® ODT products launched in 60 countries, we have strong track record and expertise in helping clients expand their portfolio into new dosage forms that are convenient to use. Whether you are trying to enhance pharmacokinetics through pre-gastric absorption, to increase consumer compliance, to look for new formulations for better claims, or to seek a marketing advantage for a valued brand, we can be your innovation partner to increase the value of your investment and find new opportunities to grow your brand.
ZYDIS® ODT CONSUMER BENEFITS
- Easy to take: Orally dissolves in as little as 3 seconds, leaving a good mouth feel; gives consumers the flexibility to take without water at any time or place
- Taste & flavor: Taste masking and wide range of flavors formulated for specific markets, including pediatrics and veterinary medicine
- Better pregastric absorption for certain drug compounds
- Unique Packaging: Including child-resistant options
- Various applications
- Pediatric and geriatric application
- Fast Onset
- Ease of use
- Wide range of therapeutic areas
- Allergy (Anti histamine, immunotherapy)
- Anti-emetic (Travel sickness)
- Gastro (Diarrhea, Constipation)
- Anti-psychotic (Parkinson’s disease, schizophrenia)
- Anxiolytic (Anti-depressants)
HOW IT WORKS
- Zydis® Ultra is our next generation ODT formulations with increased drug loading and greater taste masking capabilities compared to our conventional Zydis® It is ideal for consumer health (OTC) drugs with bitter or strong tasting APISame dissolution profile
- Greater taste masking capabilities
- Increased doses > 400mg
- Functional coating for controlled / sustained release applications
- High speed manufacturing
- On-line printing for flexible solutions
- Wider range of application
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
- Full in-house analytical and regulatory services
- 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
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
- Freeze-drying microscopy
- Particle size analysis (laser diffraction)
- Dynamic Vapor Sorption
- Characterization of hydrates and polymorphs
- X-ray powder diffraction (XRPD)
- Characterization of moisture sorption properties and physical analytical chemistry (HPLC, UV, NIR, FTIR)
Catalent’s world class ODT center of excellence is based in Swindon, U.K, dedicated to Zydis® research, development and unit production with capabilities in controlled and potent drug. The facility remains in highest compliance and subject to annual review with FDA/cGMP, Canadian HPB, British MHRA, European Community.