Demand is driving the need for high-volume, high-speed tablet presses and this calls for improved manufacturing efficiency. Such presses subject materials to a higher strain rate, which creates challenges with tablet strength, weight uniformity and scale-up from lab to commercial manufacturing. Understanding the strain rate sensitivity of the API and excipients plays a critical role in tablet robustness, especially in the formulation of controlled-release dosage forms.
Hypromellose (hydroxymethyl cellulose) is the leading matrix-forming polymer in controlled-release tablets. It is often and typically used at levels between 20 and 30 percent, and therefore can significantly impact the formulation’s physical characteristics.
Ashland’s Benecel™ xrf hpmc, with lower nitrosamine levels, can improve formulation stability by minimizing the potential for interaction between API and excipients that results in N-nitrosodimethylamine (NDMA), a nitrosamine impurity. Recent drug recalls have been caused due to higher nitrosamine levels in the dosage form resulting from such interactions.
Register to learn about the optimization of controlled-release formulations for high-speed, high-throughput manufacturing, with specific focus on improving efficiency and API stability.
Kapish Karan, MS, Global OSD R&D Leader, Pharmaceuticals, Ashland
At Ashland, Global OSD R&D Leader Kapish Karan is focused on pharmaceutical oral solid dosage, leading long-term innovation and providing support for strategic customers. He has more than eight years of experience in film-coating applications, design of immediate- and modified-release coating products, unit operations associated with the preparation of oral solid dosage forms and oral drug delivery. His recent expertise has expanded into continuous processing as it relates to the manufacture of oral solid dosage forms.
Kapish is a member of the American Association of Pharmaceutical Scientists. He has published and presented on granulation, coating technology and taste masking at various technical conferences.
Who Should Attend?
Pharmaceutical professionals in these roles:
- Research and Development
- New Product Development
- Principal Scientists
- Business Development
- Process Engineer
- Project Management/Pilot Plant
- Pharma Manufacturing
What You Will Learn
Attendees will learn:
- Strategies to produce robust controlled-release tablets for the most challenging high-throughput commercial tableting conditions
- The impact of strain rate sensitivity on compression, tablet strength and weight uniformity
- Strategies to improve API and formulation stability by reducing the potential for nitrosamine formation
Ashland’s pharma business is well known for acetylenics, cellulosics, and film coatings, and their polymers have a rich and diverse history supporting active pharmaceutical ingredient delivery. Deploying resources to build on their existing high impact and high value technologies, they are widening their portfolio of cellulose-based polymers (HPMC, HPC, CMC, HEC, EC), growing their excipient portfolio for injectables/biologics, including the possibility for customization, and they’re focusing on film coatings that live up to customer needs.
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