Expanded capabilities from the world leader in orally disintegrating tablets
Lyopan® proprietary fast-dissolve technology is advancement in orally disintegrating tablets (ODT’s), to deliver better treatments for a wider dose range of active ingredients in a fast-dissolve tablet. Lyopan fast-dissolve tablet technology enhances capabilities for higher API dose loading, controlled release formulation options, and increased taste masking options. The manufacturing process also requires less water than current ODT technologies, reducing energy consumption.
Lyopan fast-dissolve tablets complement Catalent’s currently marketed Zydis® proprietary fast-dissolve formulation, 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 continues to be the world’s best-in-class, orally disintegrating tablet (ODT) technology. Lyopan builds upon this experience by expanding orally dissolving tablet formulation options and dose ranges.
Our Lyopan and 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, Lyopan and Zydis fast dissolve can help enhance the value of your investment and accelerate your product’s potential.
Lyopan Advancements
- Higher API Dose Loading
- Ability to handle > 200 mg active API dose in tablet
- Increased Tastes Masking Capabilities
- Coated API allows for increased taste masking ability
- Controlled Release formulation options
- Coated API to modify API release, including enteric and controlled release options
- Potential for improved manufacturing efficiency and cycle times
- Requires less water in processing than Zydis, saving energy and time
Lyopan and Zydis Better Treatments
- Improved efficacy and safety with better pregastric absorption for certain drug compounds
- Bucal absorption allows for faster onset of action and reduction of metabolites
- More efficient delivery
- Disperses instantly in the mouth (<3 seconds) without the need for water
- Improved compliance for various therapeutic, OTC, and animal health markets
- Faster absorption lends the possibility of reduced and less frequent dosage
- High patient preference
- For patients having difficulty swallowing tablets, disperses instantly in the mouth (<3 seconds) without water
- Enhanced convenience and marketing appeal
- Fast-dissolve perceived by consumers as easier to swallow and faster-acting, without the need for water
- Protection from counterfeiting
- Ideal for certain indications
- Excellent for treating conditions where rapid dosing and absorption are required or tablet swallowing is difficult, including pediatric, geriatric, pain, CNS, allergies, travel-related illness, and animal health
Lyopan and Zydis 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 mixing, filling, and lyophilization (freeze-drying) process to manufacture finished dosage units. Lyopan is produced via a four-stage process:
- Stage 1 - Mixing
- An aqueous mixture of tablet components is produced, separately from API
- The bulk API is coated to achieve desired formulation properties separately from other tablet components
- Stage 2 - Filling and freezing
- The bulk API powder and aqueous mixture are 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.
Catalent Services
Through expert analysis and interpretation of data, our Lyopan and Zydis fast dissolve technology team will fully characterize your API and associated Lyopan and 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 Lyopan and Zydis formulations prepared under different processing conditions (bench-scale); analytical techniques applied as appropriate to determine the compatibility of a candidate API with the Lyopan and Zydis technologies
- 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 Lyopan and Zydis formulations via expert analysis and interpretation of data throughout the development process to provide a robust data package in support of regulatory filings
- 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
Facilities
We have two fast dissolve dosage form facilities dedicated to Lyopan and Zydis unit production.
- U.S.: Somerset, New Jersey - Zydis
- Research and development
- Pilot line
- Commercial line with controlled and potent drug capabilities
- FDA Audited
- Europe: Swindon, U.K. - Zydis and Lyopan
- Research and development
- Pilot line with controlled and potent drug capabilities
- FDA and MCA audited
- Controlled drug capabilities
CLOSE
