|When changing dosage form from glass to plastic, container-content interaction is the main concern. These Non-Interactive (NI) materials minimize both leachables and sorption, offering a glass-like performance when it comes to preserve the intended potency of drugs.||
Certain applications with highly diluted active ingredients, such as large volume parenterals, are prime candidates.
Why inert films?
When changing dosage form from glass containers like vials and ampoules to a plastic premixed bag, the chief concern is interaction.
This is an unavoidable challenge, and understanding the interaction mechanism between contents and packaging, including the manufacturing process, is critical to drug stability.
To tackle this challenge, we selected and developed materials which prevent sorption and leachables.
Polyolefin oligomers, residual solvents, various additives, adhesives, and active ingredients volatilized from ink may elute from packaging materials.
These leachables cause drug contents to become unstable and break down through various chemical reactions.
Where conventional bags cannot prevent leachables from migrating into solution over time, the NI layer acts as the ultimate defense.
Our NI material prevents sorption of active ingredients to the contact surface, and maintains glass-like stability for liquid contents
Performance data shows that our MediTect™ bags maintain the potency of active ingredients of drug solutions over time in step with glass vial controls.