U.S. FDA Approves Aptar’s Proprietary Activ-Film Technology for use with Rechargeable Implantable Neurostimulator

  • Aptar CSP Technologies

Sophisticated implantable medical device for urinary and bowel dysfunction leverages Aptar’s groundbreaking 3-Phase Activ-Polymer technology to control moisture and extend use life.

Aptar CSP Technologies, a leader in active material science solutions (part of AptarGroup, Inc.), announced that its proprietary Activ-Film technology was approved by the U.S. Food and Drug Administration (FDA) for use within a recently launched Rechargeable Implantable Neurostimulator (INS) that treats urinary and bowel dysfunction. The Activ-Film material is integrated into the medical device to control humidity, improve the accuracy of readings, and extend use life.

Aptar CSP’s Activ-Film material leverages the company’s patented 3-Phase Activ-Polymer platform technology to manage the device’s internal atmosphere, adsorbing moisture that could otherwise accumulate and affect the implant’s stability and performance. Controlling the humidity within the device protects the battery and enables it to have little to no degradation during its use life.

“This is another example of our consistent commitment to helping customers bring advanced solutions to patients and improve user experiences and outcomes,” said Badre Hammond, Vice President Commercial Operations, Aptar CSP Technologies. “We are dedicated to continued material science innovation that facilitates the development and commercialization of next generation implantable medical devices.”

Activ-Film material is a configuration of Aptar CSP’s 3-Phase Activ-Polymer technology. In addition to protecting a range of implantable medical devices, the highly-engineered technology is utilized in various formats for a broad array of applications, including oral solid dose drugs, drug delivery systems and probiotics. The material science technology can be customized to deliver integrated active solutions that absorb moisture, scavenge oxygen, odor, or VOCs, emit aromas, or reduce pathogens.

See also

Aptar CSP Technologies’ Activ-Blister™ Solutions Now Available for Manufacturing in the EMEA Region

Aptar CSP Technologies, part of AptarGroup, Inc. and a leader in active material science solutions to ensure product protection, extend shelf life and improve patient experience, announces a new manufacturing site able to produce its Activ-Blister™ Solutions for oral slide dose drugs in Europe. The move is part of a key strategic effort to expand production of Activ-Blister™ technology globally.

Aptar CSP presents 'rethinking oral solid dose packaging' webinar

Aptar CSP Technologies – a leader in active packaging solutions that ensure product protection, enhance brand recognition and improve use experiences, and part of AptarGroup Inc – is presenting its Activ-Blister Solutions for the protection of moisture and oxygen-sensitive tablets and capsules, alongside FreeThink Technologies and its ASAPprime 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.

CSP Technologies' focus for enhancing the shelf life for transdermal and oral solid dose drugs

Despite being two very different drug delivery platforms, oral solid doses and transdermal patches can face similar packaging headspace challenges that impact shelf life; besides moisture and oxygen ingress, exposure to certain conditions can lead to the formation of volatile organic compounds (VOCs) and other gases that, in turn, may interact with drug products and capsules, adversely impacting their stability.

  • Bianka Cramblit
  • Product Info
  • English
  • Created 21 May 2021
  • Modified 21 May 2021
  • Hits 473