Rethinking Oral Solid Dose Packaging
Sponsored by: Aptar CSP Technologies
- Oral Solid Dosage
- Blister Packaging
Date: 28 March
Days to go: 5
Time: 3PM London/11AM New York
Improving stability, shelf-life and time to market with Activ-Blister™ technology
Tablets and capsules are today's most popular drug delivery forms. However, in their development, there can be stability issues associated with moisture, oxygen and reactive impurities. These challenges are likely to increase with the development of more potent API's, larger molecules and modified release profiles. Innovative and evolving dosage forms, such as chewable and disintegrating tablets, also face heightened stability challenges and problems of shelf life. Adding to all of this, global distribution demands in zone 3/4b (hot/humid) are also increasing.
As traditional packaging options can be ineffective and/or inefficient, there is a need for new and specialised active packaging solutions to address these growing stability issues. Additionally, repetitive package design processes and drug reformulations, from stability failures, are costly and can delay product launches; improved package design tools and processes are also needed.
This Webinar will first look at the sources of moisture and oxygen in oral solid dose blister packaging and the common approaches to mitigate. Then, an active desiccant and scavenger management technology (Activ-Blister™ Solutions), that will meet these challenges and help expedite time-to-market, will be introduced and illustrated. To best design a blister package for specific applications, an accelerated shelf-life determination process (ASAPprime® technology from FreeThink Technology) will also be presented. This process includes examination of the drug products stability over a broad range of environmental conditions to develop a predictive model for shelf life. With this data, theoretical blister designs using Activ-Blister™ Solutions are created to deliver the desired shelf life.
Production of laboratory, clinical and stability study samples and regulatory and implementation support are also available, and are all part of Xcelerate services from Aptar CSP Technologies. Activ-Blister™ Solutions and the ASAPprime® Technologies are a good choice for oral solid doses in development seeking improved stability, shelf-life and time to market. These same products and services are also well suited for marketed product seeking new packaging options and/or extended shelf life.
Director, Corporate Business Integration, Aptar Pharma
Badre Hammond’s background is in Biochemistry and drug development with 15 years’ experience in pharmaceutical product development, packaging, and drug delivery systems.
Mr. Hammond has broad experience in managing development of novel drug product programs from formulation development, pre-clinical, CMC, to market launch.
He’s currently responsible for corporate business integration post M&As. His current focus is in commercial best practices, strategy, licensing, and business development.
Vice President, Business Development, Aptar CSP
Mr. Voellmicke is the VP of Business Development at Aptar CSP, a leader in the design, development and production of packaging that actively protect products.
Craig has 20 years of experience in the medical device and pharma packaging industries, including work at Becton Dickinson and Terumo.
He now also serves on the advisory board of the Active & Intelligent Packaging Industry Association (AIPIA), and is a member of the Healthcare Packaging Compliance Council (HCPC), representing Aptar CSP.
Maria J. Krisch,
Ph.D., Senior Scientist, FreeThink Technologies, Inc.
Maria Krisch is a Senior Scientist at FreeThink Technologies, Inc. where she is responsible for leading company projects focused on chemical and physical stability. Dr. Krisch received her B.A. in chemistry from Swarthmore College and her Ph.D. in physical chemistry with a focus on molecular dynamics from the University of Chicago (as an NSF Graduate Research Fellow).
She conducted post-doctoral research in physical chemistry at the University of California, Irvine, studying the surface structure and reactivity of liquids.
Dr. Krisch served on the faculty and led a research group at Trinity College in Hartford, CT for eight years before joining FreeThink Technologies, Inc. in 2017. She is a co-author on over 20 publications.
Key Learning Objectives
- To understand the sources of moisture/oxygen/VOC's in Oral Solid Dose blister packaging and the difference between active and barrier technology
- To understand the capabilities and benefits Activ-Blister™ Solutions technology
- Use of predictive modeling to optimize oral drug development and blister packaging design
- Review regulatory strategy to support successful submissions
- Formulation Scientist
- Formulation Development
- Formulation Engineer
- Formulations and Analytics
- Pharmaceutical Sciences
- Formulation and Process Design
- Pharmaceutical Development
- Formulation and Chemistry
- Principal Scientist
- Packaging Engineer
- Regulatory Affairs
- Package Design and Development
- Packaging Operations
- Packaging Technology