GP Solutions (UK) Ltd have been approached by Schwarz Biosciences GmbH, Germany, to supply Dose Guard™, our child resistant senior friendly label solution for pharmaceutical blister packs and wallets.
Although their clinical trial study is to be carried out in Europe, part of the study will go to the USA where by law, all clinical trial packaging materials have to be in a child resistant format. This is in compliance with the Federal Register 16CFR Part 1700, to which Dose Guard™ is tested and approved as 99% senior effective, 96% child effective.
The drug/tablets will be enclosed in a blister pack, which will then be placed into a patient wallet card, which is printed with dosage instructions. This wallet card is sealed using a pressure sensitive adhesive.
The Dose Guard™ secondary layer is accurately positioned on the reverse of the wallet card by hand, using printed tick marks. By utilising the “peel & push” mechanism of the label, the patient can access each tablet step by step in a controlled and safe manner by first peeling off the tab of the label at the perforations, then pushing the tablet through the foil and wallet card. This process is repeated for each tablet until the medication/treatment program is completed.
Clinical Studies are undertaken for each & every new drug discovery to determine the performance and efficacy of the compound.
The average duration of a clinical trial is seven years and the testing, evaluation process begins at Phase I, where the numbers are limited. Based upon the results / test data, the number of patients (included in the trial) increases and new countries are introduced.
Clinical trials represent the R&D pipeline of all major pharmaceutical companies, as such the performance and specification of all packaging & Premium Label Solutions material is highly critical, and timelines are extremely important.