MEDICAL PACKAGING CONTAINER

• US 20140370219A1
• Filed: 10/05/2012
• Published: 12/18/2014
• Est. Priority Date: 10/07/2011
• Status: Abandoned Application

• Current Assignee: Mitsubishi Gas Chemical Company Incorporated (Mitsubishi Electric Corporation)
• Original Assignee: Mitsubishi Gas Chemical Company Incorporated (Mitsubishi Electric Corporation)
• Inventors: Ogawa, Shun, Hirokane, Takeshi, Kashiba, Takashi, Arakawa, Shota, Usuda, Kenichiro
• Application Number:
  US14/349,806
• Publication Number:
  US 20140370219A1
• Time in Patent Office: Days
• US Class Current: 428/36.6
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: B32B 2250/03 3 layers
• CPC Class Codes: B32B 2250/24 All layers being polymeric
• CPC Class Codes: B32B 2307/306 Resistant to heat
• CPC Class Codes: B32B 2307/54 Yield strength; Tensile strength
• CPC Class Codes: B32B 2307/702 Amorphous
• CPC Class Codes: B32B 2307/7244 Oxygen barrier
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/325 comprising polycycloolefins
• CPC Class Codes: B32B 27/36 comprising polyesters
• CPC Class Codes: C08G 63/199 Acids or hydroxy compounds containing cycloaliphatic rings
• CPC Class Codes: C08G 63/83 Alkali metals, alkaline earth metals, beryllium, magnesium, copper, silver, gold, zinc, cadmium, mercury, manganese, or compounds thereof C08G63/823 takes precedence
• CPC Class Codes: C08G 63/866 Antimony or compounds thereof
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1379 Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit

Abstract

Provided are a medical packaging container having a polyester resin (A1) including diol units and dicarboxylic units, the diol units including at least one diol unit in an amount of 1 to 30 mol % selected from diol units having a bridged alicyclic skeleton derived from a compound represented by formula (1), formula (2), or formula (3), the dicarboxylic acid units including dicarboxylic acid units having a naphthalene skeleton in an amount of 70 mol % or more; and a manufacturing method of the polyester for the container.

Claims

1. A medical packaging container comprising a polyester resin (A1) comprising diol units and dicarboxylic units,

the diol units comprising at least one diol unit in an amount of 1 to 30 mol % selected from diol units having a bridged alicyclic skeleton derived from a compound represented by formula (1), formula (2), or formula (3),

the dicarboxylic acid units comprising dicarboxylic acid units having a naphthalene skeleton in an amount of 70 mol % or more.

2. The medical packaging container according to claim 1, wherein the diol units comprise at least one diol unit in an amount of 1 to 30 mol % selected from diol units having a bridged alicyclic skeleton derived from a compound represented by the formula (1) or the formula (2).

3. The medical packaging container according to claim 1, wherein the diol units comprise diol units having a bridged alicyclic skeleton derived from a compound represented by the formula (1) in an amount of 1 to 30 mol %.

4. The medical packaging container according to claim 1, wherein the dicarboxylic acid units having a naphthalene skeleton are derived from at least one dicarboxylic acid unit selected from the group consisting of 1,3-naphthalenedicarboxylic acid, 1,4-naphthalenedicarboxylic acid, 1,5-naphthalenedicarboxylic acid, 2,6-naphthalenedicarboxylic acid, and 2,7-naphthalenedicarboxylic acid.

5. The medical packaging container according to claim 1, wherein the dicarboxylic acid units comprise the dicarboxylic acid units having a naphthalene skeleton in an amount of 90 mol % or more.

6. The medical packaging container according to claim 1, wherein the diol units comprise diol units derived from ethylene glycol.

7. The medical packaging container according to claim 1, wherein the polyester resin (A1) has all of the following properties (i) to (iii):

(i) a glass transition temperature of 110°

C. or higher as measured with a differential scanning calorimeter;

(ii) a moisture permeability coefficient of 1 g·

mm/m²/day or less; and

(iii) an oxygen permeability coefficient of 10 cc·

mm/m²/day/atm or less.

8. The medical packaging container according to claim 7, wherein the polyester resin (A1) has the following property (iv):

(iv) an increase amount in nitrogen concentration of 5 ppm or less when a polyester resin film having a thickness of 100 μ

m is immersed in a 1 wt. % aqueous solution of albumin.

9. The medical packaging container according to claim 1, wherein the polyester resin (A1) has the following property (v):

(v) a melt flow rate in accordance with JIS K 7210 of 1 to 40 g/10 minutes under conditions of 260°

C. and 2.16 kgf.

10. The medical packaging container according to claim 1, wherein the polyester resin (A1) has a manganese atom content of 40 to 200 ppm and an antimony atom content of 50 to 200 ppm, with a ratio (M/P) of the total content (M) (ppm) of manganese atoms and antimony atoms to the phosphorus atom content (P) (ppm) of 1.5 to 4.0.

11. The medical packaging container according to claim 10, wherein the polyester resin (A1) is obtained by a manufacturing method comprising the steps of:

producing an oligomer by transesterification of a dicarboxylic acid diester component comprising naphthalenedicarboxylic acid diester and a diol component comprising at least one selected from the compounds represented by the formula (1), the formula (2), and the formula (3) in the presence of a manganese compound; and

polycondensing the oligomer in the presence of an antimony compound; and

wherein, in the manufacturing method, a phosphorus compound is used as a thermal stabilizer.

12. The medical packaging container according to claim 11, wherein the diol component further comprises ethylene glycol.

13. The medical packaging container according to claim 1, comprising a multi-layer structure having at least three layers, and

an innermost layer and an outermost layer in the multi-layer structure comprising the polyester resin (A1).

14. The medical packaging container according to claim 13, wherein at least one layer of the intermediate layers in the multi-layer structure comprises a polyolefin resin (B).

21. The medical packaging container according to claim 1, wherein the medical packaging container is an ampoule, a vial, or a prefilled syringe.

15. A medical packaging container comprising a multi-layer structure having at least three layers, an innermost layer and an outermost layer in the multi-layer structure each comprising an amorphous polyester resin (A), and at least one layer of intermediate layers in the multi-layer structure comprising a polyolefin resin (B).

16. The medical packaging container according to claim 15, wherein the amorphous polyester resin (A) is a polyester resin (A2) comprising:

diol units comprising at least one diol unit in an amount of 1 to 30 mol % selected from diol units having an cyclic acetal skeleton derived from a compound represented by formula (4) or formula (5), and

dicarboxylic acid units comprise dicarboxylic acid units having a naphthalene skeleton in an amount of 70 mol % or more;

17. The medical packaging container according to claim 16, wherein the dicarboxylic acid units having a naphthalene skeleton are derived from at least one dicarboxylic acid selected from the group consisting of 1,3-naphthalenedicarboxylic acid, 1,4-naphthalenedicarboxylic acid, 1,5-naphthalenedicarboxylic acid, 2,6-naphthalenedicarboxylic acid, and 2,7-naphthalenedicarboxylic acid.

18. The medical packaging container according to claim 16, wherein the dicarboxylic acid units comprise dicarboxylic acid units having a naphthalene skeleton in an amount of 90 mol % or more.

19. The medical packaging container according to claim 16, wherein the diol units comprises a diol unit derived from ethylene glycol.

20. The medical packaging container according to claim 15, wherein the polyolefin resin (B) is at least one selected from cycloolefin polymer, cycloolefin copolymer, and polypropylene.

22. A manufacturing method of a polyester resin, comprising the steps of:

producing an oligomer by transesterification of a dicarboxylic acid diester component comprising naphthalenedicarboxylic acid diester and at least one selected from the compounds represented by formula (1), formula (2), and formula (3), and a diol component comprising ethylene glycol in the presence of a manganese compound; and

polycondensing the oligomer in the presence of an antimony compound;

wherein a phosphorus compound is used as a thermal stabilizer, and

wherein the polyester resin has a manganese atom content of 40 to 200 ppm and an antimony atom content of 50 to 200 ppm, with a ratio (M/P) of the total content (M) (ppm) of manganese atoms and antimony atoms to the phosphorus atom content (P) (ppm) of 1.5 to 4.0.

23. The manufacturing method of the polyester resin according to claim 22, wherein the manganese atoms are derived from manganese acetate, the antimony atoms are derived from antimony trioxide, and phosphorus atoms are derived from phosphoric acid.

24. The manufacturing method of the polyester resin according to claim 22, wherein the ratio of ethylene glycol to the total of the compounds represented by the formula (1), the formula (2), and the formula (3) in the diol components is 70 to 99 mol %/30 to 1 mol %.

25. The manufacturing method of the polyester resin according to claim 22, wherein the naphthalenedicarboxylic acid diester is dimethyl 2,6-naphthalenedicarboxylate.