New solution to old challenges: Packaging-based solutions for oral solid dose stability challenges associated with moisture, oxygen and volatile compounds
Auburn, AL– Aptar CSP Technologies– a leader in active packaging solutions that ensure product protection, enhance brand recognition and improve use experiences – is presenting its Activ-Blister™ Solutions for the protection of moisture and oxygen-sensitive tablets and capsules, alongside FreeThink Technologies and itsASAPprime® technology for accelerated shelf-life determination. The combination is a “right the first time” approach to stability challenges and blister package design that virtually eliminates protracted testing and costly reformulations. The webinar, titled Rethinking Oral Solid Dose Packaging, will be conducted on March 28 at 11:00 a.m. EST.
Activ-Blister™ solutions control the internal atmosphere of individual blister cavities, allowing for improved product performance and enhanced shelf-life. Using proprietary three phase polymer technology, engineered materials can absorb customized amounts of water vapor, oxygen, and/or volatile compounds, and can be produced in shapes and sizes to accommodate any tablet and capsule size. This innovative technology can be applied via heat-staking, without the use of adhesives, and added to existing packaging lines.
Working together with FreeThink Technologies, a leader in accelerated shelf-life determination, and utilizing their ASAPprime® technology, a drug product’s moisture and oxygen sensitivity is determined using highly accelerated stability studies open to specified environmental conditions – such as temperature, relative humidity and oxygen level. With this analysis, modeling creates a theoretical blister design with Activ-Blister™ solutions to achieve desired shelf life.
Once the optimized blister and sorbent are determined, laboratory, clinical and stability study packaged product can be manufactured. This total process from Aptar CSP Technologies is called Xcelerate and provides expedited end-to-end expertise for packaging of sensitive oral solid doses, from R&D to commercial launch.
The combination of Activ-Blister™ solutions and ASAPprime® technology is in response to the increased complexity of matching moisture- and oxygen-sensitive oral dose products to ideal packaging solutions, as well as to the ever-growing demand to expedite time to market. Tablets and capsules are today’s most popular drug delivery forms, and stability issues are only 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 4a/4b (hot/humid) are also increasing.
“Activ-Blister™ solutions and the Xcelerate complete packaging service offer improved stability, extend shelf-life and expedite time to market for sensitive oral solid dose products,” said Craig Voellmicke, Vice President, Business Development, Aptar CSP Technologies. “Together, they provide a valuable combination of effective drug protection and ease of adoption.”
About Aptar CSP Technologies
Aptar CSP Technologies is a global material science company providing innovative, highly engineered advanced packing solutions to protect sensitive products. CSP is a responsive, flexible partner committed to offering customers a single, reliable source for custom product design, development, and manufacturing. CSP has a proven track record of pioneering technological solutions that ensure product protection and enhance its customers’ brand equity. Its product categories include vials, bottles, films, blisters, molded components, and specialized packaging solutions. For more information, call (334) 887-8300, email cspinfo@csptechnologies.com or visit www.csptechnologies.com.
Aptar CSP Technologies is part of AptarGroup, Inc. Aptar is a leading global supplier of a broad range of innovative dispensing, sealing and active packaging solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets. Aptar uses insights, design, engineering and science to create innovative packaging technologies that build brand value for its customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 14,000 dedicated employees in 18 different countries. For more information, visit www.aptar.com.
About FreeThink Technologies, Inc.
FreeThink Technologies, Inc., is a contract research organization with specialization in the field of stability. The company develops stability indicating methods, determines shelf-life in highly accelerated studies using the science and commercial software it developed (ASAPprime®), and provides packaging and formulation solutions to stability issues. The company also develops new technologies in different fields. FreeThink is headquartered in Branford, Connecticut. For more information, visit www.freethinktech.com.
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