OPTIMIZED ORAL DOSE PRODUCT PERFORMANCE
With our modified release capabilities, Catalent offers a complete range of formulation development and manufacturing services for modified release oral dose forms. As an innovator of coated multi-particulate dosage forms and a world leader in the production of coated beads and tablets, we bring decades of experience and a network of FDA-compliant facilities to ensure your modified release development and manufacturing success at every level. With extensive experience working with potent and complex compounds, we aim to develop modified release formulations and processes that are scalable, economical, and easy to manufacture, with the end goal of shortening your time to reach the market. We have the expertise to take on your project at any stage of your product’s lifecycle. For products in the earliest phases, we help you to proactively recognize the potential benefits and advantages of developing a modified release dose form, some of which include increased product value, enhanced patient compliance, and maximization of your investment.
Our modified release formulation and analytical development and manufacturing services for oral dose forms include:
- Soft and hardshell Capsules
- Powders, Pellets, Beads, and Granules
Customers are drawn to our modified release expertise and capabilities across the entire product lifecycle because of our:
- Unsurpassed expertise and quality
- Added expertise working with potent APIs, nonchlorinated solvents, and DEA-controlled substances
- Understanding of product optimization and lifecycle management
- Manufacturing experience and track record, particularly around fluid bed technology
Catalent is highly experienced in producing controlled-release technologies for the following:
- Matrix tablets
- Osmotic tablets
- Bi-layer tablets
- Traditional tablets
- Mini Tablets
- High-potency pellets
- Drug-layered spheres
- Taste-mask particles
- Beads for modified release
- Tablets in capsules
Our facilities have a strong track records for both quality and regulatory compliance, including:
- Exceptional reputation for service and compliance
- Notable standards of compliance and customer satisfaction
- Industry leading on-time delivery performance
- Track record for successful general and pre-approval inspections (PAI) by multiple international regulatory authorities
Sites with modified release experience:
- Winchester, Kentucky, U.S.A.
- Schorndorf, Germany
- Somerset, New Jersey, U.S.A.
- St. Petersburg. Florida, U.S.A.