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The Medinoxx cup-blister system impresses with its tested pharmaceutical quality and safety.
MoreChecks by the Central Laboratory of German Pharmacists e.V
Stability of solid finished products after simultaneous sealing
The stability of three representative dosage forms with simultaneous blistering in a Medi cup was investigated. For this purpose ASS 100 mg HEXAL® tablets were sealed together with L-Thyroxin-Na ratiopharm® 100 µg tablets as well as Aciclovir ratiopharm® 200 mg. The chemical-physical stability was demonstrated over a period of 31 days.
Stability of liquids in the Medinoxx sealed-cup system
Industrially manufactured liquid drugs containing the active ingredients melperone, pipamperone and novaminsulphone 500 mg Lichtenstein® drops were individually blistered. The physicochemical stability was confrmed for a total period of 31 days by determining the content and the pH value.
Microbiological stability of liquids in the Medinoxx sealed-cup system
In addition to the above-mentioned verifcation of the stability of liquids, the microbiological stability including lactulose was investigated. The results obtained demonstrate the microbiological stability of all investigated liquid preparations for a period of 31 days.
Extractables Study
In addition to the stability studies already mentioned, it was investigated whether substances were extracted from the Medinoxx sealed-cup system under extreme conditions. On the basis of the results obtained, it cannot be assumed that substances from the cup and foil material accumulate in the blistered drug when ethanolic solutions (20%), for example, are filled.
Certifed production
of the Medinoxx sealed-cup system
All components of our sealed-cup system are manufactured in Germany and Austria using state-of-the-art production methods. Medinoxx’s manufacturing plants exclusively produce according to the DIN EN ISO 15378 standard for primary packaging developed from the ISO 9001 and GMP QM systems and the guideline of the German Federal Pharmacists’ Chamber “Testing and Storage of Primary Packaging”.