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Intelligent Pharmaceutical Packaging

Intelligent Pharmaceutical Packaging. Electronic Data Capturing system to improve data quality and cut time in clinical trial s with unparalleled cost efficiency . Clinical trials today. Primarily “paper and pen” based solutions Time consuming process

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Intelligent Pharmaceutical Packaging

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  1. Intelligent Pharmaceutical Packaging Electronic Data Capturing system to improve data quality and cut time in clinical trials with unparalleled cost efficiency

  2. Clinical trials today • Primarily “paper and pen” based solutions • Time consuming process • No objective time stamp on medicine intake • No objective time stamp on patient diary • No ability to link patient diary / experience to medicine intake • No reminder to improve compliance • Time consuming process to assure accuracy and audit trail

  3. Introducing Cypak IPP - core benefits • Automation of overall process • Doctor/patient interaction • Reconciliation / drug accountability • Patient compliance • Records medication usage with time stamp • Improves patient compliance through reminders • Electronic diary • Records and link patient experience, with time stamp, to actual medication • Data management • Increase overall data quality • Makes all data traceable

  4. IPP system components • The IPP • Secondary packaging adopted to the individual blister • Records individual medication dose with time-stamp • Electronic patient diary with time-stamp • Buzzer can be used for reminding • IPP Scanner • Transfers data between packaging and PC • Package on scanner connects automatically to host system or Internet site • IPP Software • Communicate with standard tools and third party solutions using ActiveX

  5. IPP enables end to end data flow Patient use / data generation Securetransmissionto PC Securetransmissionover Internet Secure datastorage andretrieval Analysis of clean data IPP enables fast and secure data flow from individual medication dose to analysis database

  6. IPP validation and references • Development of the IPP has been carefully documented, including functional specification and validation of functionality • Formal “part 11” compliance validation requires understanding of the complete system the IPP is part of and is to be preformed by validation expert, selected by end customer • Reliability testing has been preformed by two CRO´s ( CDC, Certus) showing that data captured from IPP is correct • Commercial use with patients is currently being performed by University of Lund in Sweden ( 1200 IPP packages ) “ The results strongly indicate that there are no differences between what is registered in the Cypak’s cardboard computer and a traditional paper diary ” Charlotte Werner, CDC

  7. Using IPP • Design and manufacturing • Information set-up • Patient use • Data retrieval • Remote information management

  8. Design and manufacturing • Allows standard blister packaging for tablets, ampoules, syringes, sachets etc. • Electronics and printable sensors do not affect the blister • Supports state-of-art packaging manufacturing process • Low cost for customization of packaging and graphic design • Foldable packaging design allows multiple form factors

  9. Manufacturing process Paperboard cutting Circuit printing Adhesive printing Electronics mounting Blister mounting The IPP is ready!

  10. Information setup • Packaging programmed with customer specific data, plus current date and time via IPP scanner • Unique identity can link packaging to database record • Packaging can be linked to specific Internet site • Programmable sound signal reminders for medication intake and patient diary

  11. Patient use • Lightweight and pocketsize • Intuitive and easy use - minimal patient education • All necessary information and instructions can be printed on package • Each medication dose pushed from cavity on blister is recorded • Printed “buttons” are used to answer questions for electronic patient diary • Sound signal reminder

  12. Data retrieval • Placed on the IPP scanner, connected to a PC, information is quick and automatically transferred • Information can be viewed on screen, printed or exported in several file formats • ActiveX component allows seamless integration to any third-party tools and programs

  13. Remote information management • Web-based data management for rational data exchange over the Internet • Preprogrammed URL allows packaging to connect automatically to specific Internet site • Encryption and digital signing performed by IPP itself • All encryption keys are stored in the packaging, eliminating eavesdropping and modification of data • Highest level of security - AES 128 bits encryption

  14. Application areas • Clinical trials • Secure and rational data capturing in clinical trials • OTC, RX • Enhanced packaging and service for existing drugs where compliance is a major issue • Healthcare • Compliance aid for patients, doctors and attendants • Secure packaging • Secure data storage, tamper detection, temperature monitoring etc. • Medical data collection devices • Core components can be integrated in most devices to store, collect and exchange data

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