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

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 Clinical trials today

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 Introducing Cypak IPP - core benefits

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 IPP system components

IPP enables fast and secure data flow from individual medication dose to analysis database IPP enables end to end data flow Patient use / data generation Secure transmission to PC Secure transmission over Internet Secure data storage and retrieval Analysis of clean data

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 ) IPP validation and references “ 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

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

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 Design and manufacturing

Manufacturing process Paperboard cuttingCircuit printingAdhesive printing Electronics mountingBlister mountingThe IPP is ready!

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 Information setup

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 Patient use

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 Data retrieval

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 Remote information management

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 Application areas