Stock material or miscellaneous articles – Hollow or container type article – Nonself-supporting tubular film or bag
Patent
1995-11-20
1998-04-21
Nold, Charles
Stock material or miscellaneous articles
Hollow or container type article
Nonself-supporting tubular film or bag
428 354, 428 367, 4284758, 4284761, 428483, 428515, 53425, 53449, 53451, B32B 2728
Patent
active
057415668
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to novel autoclavable multilayer films of polymeric materials, packages and flexible containers made thereof as well as a process for the production of such articles and the use of the films. The articles made from the novel multilayer films are especially suitable to contain oxygen sensitive medical or nutritional fluids for parenteral or enteral administration, because they retain both their transparency and oxygen barrier properties after autoclavation.
BACKGROUND OF THE INVENTION
It has been a considerable technical problem for manufacturers of materials for medical containers or packages to provide an autoclavable material compatible with infusion fluids often containing fat emulsions, to be administrated parenterally. It is especially desirable to retain flexibility and transparency of the material after the autoclavation while simultaneously meeting the demand of having an oxygen and water barrier for the protection of sensitive contents during storage.
Another problem to be solved is to find a polymer material which fulfills these criteria and still is environmental friendly and without any hazards for the manufacturers.
In many medical materials polymer materials such as those prepared from halogenated hydrocarbons like PVC or PVDC have traditionally been used, since they often have low permeability for water and gases and have advantageous mechanical properties. Medical plastic bags made from PVC are, however, undesirable because medical fluids may dissolve softeners from the PVC, making them incompatible with many requirements in pharmaceutical applications. Such migration effects can be especially problematic when storing fat emulsions which tend dissolve hydrophobic components from the polymers. PVC and other polymers from halogenated hydrocarbons are also unsuitable for other technical reasons, like their tendency to corrode and to wear the manufacturing equipment, and because of their environmental hazards. To overcome these drawbacks manufacturers have tried to assemble substitute packaging materials in the form layered structures, where the properties of each of the layers are intended to support the others to achieve air and water impermeability, suitable mechanical properties and a possibility to sterilize the package material and its contents by steam or by irradiation.
Steam-sterilizable multilayer materials are disclosed in numerous publications. A typical simple multilayer film fulfilling this technical requirement consists of three layers: polyolefin/polyamide/polyolefin. The polyolefin layer acts as a water barrier and the polyamide can be both moisture resistant and act as a substantial oxygen barrier. However, this type of film is not sufficiently effective as a moisture barrier. More efficient films are developed in the patent specifications EP 0216 639 and U.S. Pat. No. 4,407,897.
The European patent application EP 0457 648 discloses a more sophisticated type of film with different polymer barrier layers having complementary properties. In applications with extremely rigorous requirements, like storage of materials for parenteral administration in medicine, not even these films are satisfying in terms of oxygen barrier shaping qualities.
EP 0236 099 discloses a sterilizable seven layer film with oxygen barrier characteristics having the structure A/B/C/D/C/B/A, where A is an outer layer, B is an adhesive layer, C is an intermediate layer, and D is barrier core layer. The barrier core layer, D, is preferably made from ethylene vinyl alcohol polymer and is surrounded by two moisture absorbing nylon containing moisture absorbing layers C. The outer layers A, preferably consist of a copolymer of a polyolefin, such as a polyethylene with an unsaturated carboxylic acid or acid anhydride. The moisture absorbing nylon layers, C, will however, include nylon 6, which makes the film unsuitable for medical applications due to the risk of an eventual caprolactam release which is regarded as a hazardous contribution to parenterally adminis
REFERENCES:
patent: 4407897 (1983-10-01), Farrell et al.
patent: 4581874 (1986-04-01), Rechsteiner et al.
patent: 4755419 (1988-07-01), Shah
patent: 5004647 (1991-04-01), Shah
patent: 5045369 (1991-09-01), Kobayashi et al.
patent: 5053281 (1991-10-01), Sakashita et al.
Farrell et al., Multilayer polymeric structures contain drying agent to maintain effectiveness of a moisture sensitive oxygen barrier layer, Abstract 003798772 of U.S. Patent No. 4,407,897.
Laminate with gas barrier properties useful for food packaging--comprises polyamide layer contg. structural units obtd. from M-xylene diamine, isophthalic acid and aliphatic discarboxylic acid; Polyoledin Polyethylene Polyvinyl Alcohol, Abstract 008648439/7 of JP 3087254.
Hogstrom Peter
Lindhe Curt
Lundmark Stefan
Maasola Hannu
Nold Charles
Pharmacia & Upjohn Aktiebolag
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