Enabling Taste-Masking & Delivery With New Technologies

More than 35% of the general population has serious issues swallowing medicines. Nearly one-quarter of people in long-term care facilities and 45% of elderly institutionalized patients suffer from some form of dysphagia. But age is not the only factor. More than one-third of adolescents ages 11-20 report issues with swallowing tablets.

With the need in the US and Europe to provide pediatric alternatives for new drugs, developers are examining ways to provide a simple alternative for taste-masking and delivery—ones that reduce the complexity of formulation, successfully mask odor and taste, are friendly to use and provide the correct dose every time. Current common approaches such as additives, matrix entrapment, physical barriers and release modulation can create issues through complexity. Capsugel has developed new technologies designed to optimize taste-masking and delivery.

What you'll learn:

• The new technologies designed to optimize taste-masking and delivery
• The science behind specific multiparticulate formulation technologies
• Case studies on the development and use of specific multiparticulate formulation technologies

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Enabling Oral Delivery of Sensitive Molecules

Enteric capsule drug delivery technology (ECDDT) was developed to provide oral delivery with full enteric protection and rapid release in the GI tract without the use of coatings. ECDDT’s intrinsically enteric properties are attained by incorporating pharmaceutically approved enteric polymers in the capsule shell using conventional capsule manufacturing processes. By eliminating the need for enteric coating, ECDDT can enable the oral delivery of sensitive molecules, such as nucleotides and peptides, biological products such as vaccines, and live biotherapeutic products (LBPs), which can degrade at the high temperatures or can be sensitive to aqueous coating solution associated with coating processes.

Speaker:

• Hassan Benameur, Ph.D.

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Capsule Filling: Manufacturing Efficiency and the added value of Technical Service

As challenging new formulations are developed, how prepared is your team to optimize performance in encapsulation? This webinar will provide insight into improving productivity in the filling of capsules for pharmaceutical products. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. Field examples will illustrate best encapsulation practices.

Key Learning Objectives:

• Understand the different capsule filling technologies and dosing options
• Recognize the importance of formulation from the start of the project
• Examine the role of excipients and their relation to filling technology
• Proper capsule selection

Speakers:

• Patrick Sienaert, Quality Assurance Manager
• Tom Walraevens, Technical Service Head

Mitigating Risk and Speeding Development with Advanced Capsule Technology

During the past 20 years, disruptive innovations have changed the drug discovery process and enabled many new drug targets and development of effective drugs against complex diseases representing unmet medical needs in the areas of cancer, autoimmune diseases and viral infections. Since 2010, capsules have been used for 21 products for such indications that have gone through accelerated, fast track, orphan and priority review processes. Capsules increasingly deliver strategic value in drug development by enabling rapid advancement of products built on QbD principles and supported by PAT.

This webinar will highlight the use of capsules to support current needs in drug development, including their utility in risk mitigation by facilitating robust process and product scale-up using traditional and advanced manufacturing approaches. Case studies will cover use of two-piece capsules in a broad range of applications, including bioavailability enhancement, modified release, pediatric solutions, and fixed dose combinations.

Speakers:

• Matt Richardson, Ph.D. — Manager of Pharmaceutical Business Development, Capsugel
• Sven Stegemann, Ph.D. — Director for Pharmaceutical Business Development, Capsugel
• Gerard Scarlato, Ph.D. — Manager of Business Development, Capsugel

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Innovative, PAT-Integrated Bioprocess Environment

Ongoing work at Bend Research is focused on developing and implementing a process-development methodology that applies state-of-the-art automated sampling technology and on-line and at-line cell-state monitoring technologies—novel and existing—to bioreactor processes. This methodology couples these tools with applied mathematics, data-integration techniques, and an understanding of bioreactor and biologic processes. Ultimately, this methodology offers an improved way to tune and manage cell and protein production processes by optimizing bioreactor processes using real-time data-integration technologies. 

The goal of the work at Bend Research is to develop a solutions-based client offering focused on optimizing product quality while streamlining R&D, pilot-scale, and commercial process definition. As well, we are using modeling technologies with a focus on optimizing or maintaining product quality across manufacturing sites and scales. The focus of internal and external research programs has largely been driven by existing and anticipated industry interests and challenges.

Speakers:

• Jeffrey Breit, Ph.D., Director, Bend Research
• Brandon Downey, Technical Group Lead, Bend Research

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