From stability challenge to commercial launch, Xcelerate expedites packaging process for medicines sensitive to moisture, oxygen and volatile compounds
Auburn, AL, November 4, 2019 – Aptar CSP Technologies, a leader in material science and active packaging solutions that ensure product protection, extend shelf life, and improve user experiences and part of AptarGroup, Inc., announces the launch of a complete solution service offering focusing on de-risking development and insuring speed-to-market. Xcelerate was recently awarded the 2019 All-Star Innovator by Pharma Manufacturing Magazine.
Xcelerate combines Aptar CSP Technologies’ unique material science and active packaging solution and associated services with FreeThink Technologies’ leadership in accelerated predictive modeling in shelf-life determination. Utilizing FreeThink’s ASAPprime® technology, an optimized active packaging solution product is modeled and tested without the need for expensive, time-consuming line trials. The result is a “right the first time” approach that virtually eliminates repetitive design processes and reformulations caused by stability test failures.
Aptar CSP Technologies offers a portfolio of services (research and development, clinical and stability studies, commercial planning and production, etc.) built around its proprietary 3-Phase Activ-Polymer™ technology platform, which is delivered in a variety of configurations:
- Activ-Blister™ solutions control the internal atmosphere of individual blister cavities. Applied via CSP Technologies’ patented heat-staking process without the use of adhesives, the technology accommodates any tablet and capsule size.
- For bottled medicines, Activ-Seal™ closures incorporate moisture and gas scavenging technology press-fit into an induction-sealed, tamper-evident screw cap.
- The Activ-Vial™ portfolio consists of one-piece, flip-top desiccated vials and desiccated bottles across a range of sizes.
- Activ-Film™ was developed to enhance transdermal drug delivery systems (TDDS), which provide controlled delivery of active substances through the skin.
Xcelerate reduces the entire active packaging design, testing and implementation process. The comprehensive, hands-on approach also includes capabilities to produce clinical trial and stability samples, regulatory support, consulting and testing during commercial implementation.
Aptar CSP Technologies launched Xcelerate in response to the increased complexity of matching moisture- and oxygen-sensitive medicines to ideal packaging solutions. As drug companies produce more potent APIs, larger molecules and modified release profiles, there is increased risk for stability issues associated with moisture, oxygen and volatile reactives. Innovative dosage forms such as chewable and disintegrating tablets also face significant shelf life challenges with respect to humidity sensitivity. These products may also face the added challenge of global distribution demands in Climate Zones 3/4b (hot/humid).
Xcelerate’s customized process determines a drug product’s moisture and oxygen sensitivity using highly accelerated stability studies open to specified environmental conditions such as temperature, relative humidity and oxygen level, then uses modeling to create theoretical package designs. Once the optimal packaging sorbent levels are determined, laboratory, clinical and stability study sample supplies can be prepared for confirmation or actual use.
“Our complete solution of material science driven active packaging solutions, and the newly launched Xcelerate Development Services offer improved stability, extended shelf-life and expedited time-to-market for sensitive medicines,” 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 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
Aptar CSP Technologies is a global material science company providing innovative, highly-engineered advanced packaging 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 [email protected] or visit www.csptechnologies.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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