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Pharmaceutical Packaging
The pharmaceutical package is an essential part of the pharmaceutical product offering. There are a variety of demands on the typical pharma package. Requirments may include physical and chemical product protection, product visibility, tamper resistance, and patient compliance enhancement, all with a minimum of regulatory and environmental concerns. TOPAS® cyclic olefin copolymer (COC) from TOPAS Advanced Polymers enables designers to meet these challenges in blister packaging for pharmaceuticals and other medical packaging applications.
The special combination of TOPAS properties includes high moisture barrier,high stiffness and strength, dimensional stability, and ready thermoformability. TOPAS COC is resistant to aqueous and polar organic media resulting in excellent chemical resistance to many drugs and reagents. TOPAS is also very biocompatible. Sterilization of products made from TOPAS may be accomplished by all conventional means: gamma, ethylene oxide (ETO) and steam. TOPAS is available in several grades with heat deflection temperatures ranging from 75ºC (167°F) to 170°C (338°F). Most TOPAS COC grades comply with applicable FDA and USP Class VI regulations and have achieved FDA status in the blister packaging of pharmaceuticals.
In rigid and flexible packaging, TOPAS is used as either a discrete layer or as a component in a blend with other polyolefins. TOPAS is used in the core layer of push-through packaging (PTP) in both co-extruded and laminated structures. Outer layers may consist of polypropylene, polyethylene, PETG or SBC (for a halogen-free approach); other polymers such as PVC, may also be employed. TOPAS has a wide processing window and can be thermoformed on standard blister lines. TOPAS COC draws well in thermoforming thus maximizing blister wall uniformity and barrier performance even in cavities deeper than one inch. Tests on commercial thermoforming equipment have shown up to a 20% faster cycle time than PVdC coated PVC films. The lower specific gravity of TOPAS (typically 1.02) results in significantly greater film yield per pound versus vinyl-based films. In rigid packaging, TOPAS can be processed easily on conventional injection molding equipment and typically does not require predrying.
High heat grades of TOPAS, when combined with PE, create films that allow terminal steam sterilization of prefilled blisters (liquids, other drugs). Such films are easily thermoformed and die-cut without sharp edges. In blends with other polyolefins, TOPAS dramatically increases stiffness thus allowing downgauging of films. These blends enable TOPAS COC-based film, with a combination of high moisture barrier, clarity and thermoformability, to be used as a barrier material for sterile products, such as single-dose liquid medications and other drugs, solutions and veterinary pills. TOPAS grade 8007F-04 has nearly ten times the moisture barrier of PVC and is used in thermoformable, pharmaceutical blister packaging film. TOPAS also provides excellent barrier to alcohols and is chemically resistant to most polar compounds. TOPAS is useful for many wrapping applications beyond protection of moisture-sensitive drugs. Scrub packs, electrodes and other devices may be stored in this manner for extended periods of time.
Property Profile:
- High clarity
- Easy formability
- Excellent moisture and chemical barrier
- High stiffness
- Good compatibility with PE
- Broad worldwide approvals for food contact and pharmaceutical applications
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