WO2007090411A1 - Biodegradable barrier film - Google Patents

Biodegradable barrier film Download PDF

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Publication number
WO2007090411A1
WO2007090411A1 PCT/DK2007/050017 DK2007050017W WO2007090411A1 WO 2007090411 A1 WO2007090411 A1 WO 2007090411A1 DK 2007050017 W DK2007050017 W DK 2007050017W WO 2007090411 A1 WO2007090411 A1 WO 2007090411A1
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WO
WIPO (PCT)
Prior art keywords
film
biodegradable
filler material
bag
biodegradable material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/DK2007/050017
Other languages
French (fr)
Inventor
Soeren Kirkegaard Nielsen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coloplast AS
Original Assignee
Coloplast AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coloplast AS filed Critical Coloplast AS
Priority to EP07702531A priority Critical patent/EP1983948A1/en
Priority to AU2007214130A priority patent/AU2007214130A1/en
Priority to CA002636615A priority patent/CA2636615A1/en
Priority to US12/223,711 priority patent/US20090216207A1/en
Priority to JP2008552682A priority patent/JP2009525201A/en
Publication of WO2007090411A1 publication Critical patent/WO2007090411A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J5/00—Manufacture of articles or shaped materials containing macromolecular substances
    • C08J5/18—Manufacture of films or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F2005/4402—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices disposable
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2300/00—Characterised by the use of unspecified polymers
    • C08J2300/16—Biodegradable polymers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/25—Web or sheet containing structurally defined element or component and including a second component containing structurally defined particles
    • Y10T428/259—Silicic material

Definitions

  • the present invention relates to a film suitable for use as an ostomy bag.
  • the used ostomy bag could be w.c. disposable instead of having to go with the day refuse, with odour problems as a consequence.
  • the bag is biodegradable.
  • EP0703762 describes a so-called bag-in-bag solution.
  • the outer bag is similar to a conventional ostomy bag with charcoal filter. This outer bag provides the barrier towards odour.
  • the inner bag which is the flushable one, is biodegradable and or/water soluble. The two bags are separated before the inner bag is flushed out in the w.c.
  • GB2083762 describes a film made of PVOH coated with PVDC, vinyl chloride-vinylidene chloride-copolymer, atactic polypropylene, nitrocellulose, waxes, greases, silicones, or pressure-sensitive adhesives.
  • the principle in a multi-layer laminate is that a biodegradable and or water-soluble layer gives the main part of the mechanical strength, and a mechanical weak layer gives the main part of the barrier properties.
  • the present invention discloses the construction of a biodegradable film that has barrier towards faeces odour and with no cracking sounds.
  • a central aspect of the present invention relates to a film of biodegradable material comprising on at least one surface a substantially exfoliated silicate filler material.
  • example 4 illustrates that a biodegradable material (with no crackling) still has no crackling after coating.
  • the film also is heat-sealed and is transparent.
  • Laminates of polymers cannot both be sufficiently impermeable for odour and at the same time be biodegradable; and Glass and metal can only be vapour-deposited on polymers that do not contain softeners, as the softener evaporates during the vacuum process.
  • Biodegradable polymers without softeners are to stiff and crackling to be useable as ostomy bags.
  • a substantially exfoliated silicate filler material e.g. Nanolok®, which is applied with water, which evaporates under mild conditions, the softener can be maintained in the film.
  • the biodegradable material is degraded 90% (of weight) after six months. It is, however, preferred that the biodegradable material is degraded 100% after six months, allowing for 10% of the weight of the film to be non-degradable material (e.g. the coating of substantially exfoliated silicate filler material).
  • the biodegradable material is selected among biodegradable polyesters in general. Particularly preferred is the biodegradable material selected from the group consisting of PVOH (polyvinyl alcohol), Starch, PLA (polylatic acid), PHB (polyhydroxybutyrate), and Polycaprolactone.
  • Such films are Ecoflex (an aliphatic-aromatic copolyester based on the monomers 1 ,4-butanediol, adipic acid and terephthalic acid), Mater-Bi (a blend of starch and Ecoflex), and PVOH.
  • Ecoflex an aliphatic-aromatic copolyester based on the monomers 1 ,4-butanediol, adipic acid and terephthalic acid
  • Mater-Bi a blend of starch and Ecoflex
  • PVOH a blend of starch and Ecoflex
  • the biodegradable film can be softened eg. with glycerol which is 100% biodegradable.
  • a "film” is understood as a thin, planar sheet with a thickness of about 10-100 micrometer.
  • the dimensions (height x with) is in the range of 126x200mm.
  • exfoliated means the complete separation of individual layers of the original particle, so that polymer completely surrounds each particle, desirably so much polymer is present between each platelet, that the platelets are randomly spaced. No X-ray line appears because of the random spacing of exfoliated platelets.
  • exfoliated is used to describe a surface treated nano-clay, which possesses a sufficiently enlarged gallery spacing to permit the nano-clay to fully disperse (exfoliate) in a plastic matrix.
  • the exfoliated silica filler material is coated on the surface of the biodegradable material.
  • substantially exfoliated silicate filler material is exfoliated silicate nano-flake material. In another embodiment the substantially exfoliated silicate filler material is exfoliated silicate flake filler material.
  • the coating may consist of nanoclay or any other mineral material having the ability to be intercalated, exfoliated, and dispersed in a liquid suspension.
  • the suspension may also contain a polymer adding cohesion to the coating after the liquid is evaporated.
  • the clay particles In order for the coating to function as a gas barrier the clay particles must have one dimension in the nanometer range, preferably they are bigger in dimensions being parallel to the substrate.
  • An preferred nanoclay is nanoclay from the smectite family.
  • the exfoliated silica filler material is (vermiculite e.g. the microlite®) as described in WO05044938 and WO05063871.
  • Nanolok is an aqueous suspension of silica nano-flakes and polymers (see httpj// ⁇ wwJ . nmatcQm/t ⁇ ch,packaglngs.Jitmj). After Nanolok has been coated onto the substrate (the biodegradable film) the water evaporates, resulting in a layer of nano-flakes and polymers. This layer is very impermeable (O 2 -permeability ⁇ 0,01 CC X mil/100in 2 x day X atm), a factor ten (closer) than PVDC. Due to this, the Nanolok layer can be made very thin, 1 -2 ⁇ m, as thin that it constitutes less than 10% of the complete film, which together can be seen as biodegradable.
  • This solution is advantageous, as you don't need to separate bags before flushing the inner bag, and keep the (somewhat soiled) outer bag.
  • One aspect of the invention relates to the use of a film of biodegradable material coated with a substantially exfoliated silicate filler material for the manufacture of an ostomy bag.
  • Another aspect of the invention relates to a method for manufacturing an ostomy bag comprising the steps of:
  • the film can also be used in other contexts, where biodegradability/solubility shall be combined with a high barrier, for instance for urine bags, but also in completely other connections where a product is to be sealed, for instance for packaging of foodstuffs or where a controlled release is desired, i.e. the packaging degrades/dissolves whereby the content is released.
  • the preferred size of the bag is (with x height) 126x200mm.
  • Oxygen transmission rate is in units of cc/m 2 day atm @ 23 9 C, 0% RH.
  • Thickness in microns The oxygen transmission rate for films A and B were reduced significantly from 200-600 down to 2-2.5 cc/m2 day atm @ 23 9 C, 0% RH. The oxygen transmission rate was also significantly reduced for film C.
  • using a meyer rod was not perfect for a film with such high flexbility, and it is speculated that the coating obtained was not even. Even lower OTR's (higher reduction) is anticipated with even coating on this type of film.
  • scatol (3-Methylindol) is applied to a beaker and the test-film set on top.
  • the beaker is placed within a larger beaker with a screw-lid.
  • the test-persons unscrews the lid and samples the scatol small on a scale from 1 (no smell) to 5 (intense smell).

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Medicinal Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials Engineering (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Materials For Medical Uses (AREA)
  • Biological Depolymerization Polymers (AREA)
  • Coating Of Shaped Articles Made Of Macromolecular Substances (AREA)
  • Laminated Bodies (AREA)

Abstract

The present invention discloses the construction of a biodegradable film that has barrier towards faeces odour and with no cracking sounds. This is obtained through using a substantially exfoliated silicate filler material, which is applied with water (evaporating under mild conditions) such that the softener of the biodegradable material can be maintained in the film.

Description

Biodegradable Barrier Film
Field of the invention
The present invention relates to a film suitable for use as an ostomy bag.
Background In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also, in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
When replacing the ostomy bag, it would be advantageous for an ostomy-operated patient if the used ostomy bag could be w.c. disposable instead of having to go with the day refuse, with odour problems as a consequence. However, to make such flushing of the used bag environmentally friendly it is required that the bag is biodegradable.
EP0703762 describes a so-called bag-in-bag solution. Here, the outer bag is similar to a conventional ostomy bag with charcoal filter. This outer bag provides the barrier towards odour. The inner bag, which is the flushable one, is biodegradable and or/water soluble. The two bags are separated before the inner bag is flushed out in the w.c.
GB2083762 describes a film made of PVOH coated with PVDC, vinyl chloride-vinylidene chloride-copolymer, atactic polypropylene, nitrocellulose, waxes, greases, silicones, or pressure-sensitive adhesives. The principle in a multi-layer laminate is that a biodegradable and or water-soluble layer gives the main part of the mechanical strength, and a mechanical weak layer gives the main part of the barrier properties.
In the course of time several experiments have been made to prepare flushable ostomy bags, but the preparation of a foil that is both biodegradable and at the same time has the sufficient barrier towards faeces odour has not succeeded until date. Summary of the invention
The present invention discloses the construction of a biodegradable film that has barrier towards faeces odour and with no cracking sounds.
Detailed Disclosure A central aspect of the present invention relates to a film of biodegradable material comprising on at least one surface a substantially exfoliated silicate filler material.
This film meets the following requirements:
1 ) It is biodegradable, i.e. 90 percentage of the weight of the film is degraded after six months (as determined by ISO 14852); 2) It is impervious to water and faeces odour for at least for 10 hours; examples 2 and 3 illustrates a marked reduction in oxygen permeability and smell penetration when a biodegradable film is coated with a substantially exfoliated silicate filler material.
3) It is at least, or less, stiff and crackling than a standard ostomy bag; example 4 illustrates that a biodegradable material (with no crackling) still has no crackling after coating.
In preferred embodiments, the film also is heat-sealed and is transparent.
Hereby a dilemma in the art is solved: Laminates of polymers cannot both be sufficiently impermeable for odour and at the same time be biodegradable; and Glass and metal can only be vapour-deposited on polymers that do not contain softeners, as the softener evaporates during the vacuum process. Biodegradable polymers without softeners are to stiff and crackling to be useable as ostomy bags. By using a substantially exfoliated silicate filler material, e.g. Nanolok®, which is applied with water, which evaporates under mild conditions, the softener can be maintained in the film.
In one aspect of the invention the biodegradable material is degraded 90% (of weight) after six months. It is, however, preferred that the biodegradable material is degraded 100% after six months, allowing for 10% of the weight of the film to be non-degradable material (e.g. the coating of substantially exfoliated silicate filler material). In a preferred embodiment, the biodegradable material is selected among biodegradable polyesters in general. Particularly preferred is the biodegradable material selected from the group consisting of PVOH (polyvinyl alcohol), Starch, PLA (polylatic acid), PHB (polyhydroxybutyrate), and Polycaprolactone. Examples of such films are Ecoflex (an aliphatic-aromatic copolyester based on the monomers 1 ,4-butanediol, adipic acid and terephthalic acid), Mater-Bi (a blend of starch and Ecoflex), and PVOH.
The biodegradable film can be softened eg. with glycerol which is 100% biodegradable.
In the present invention, a "film" is understood as a thin, planar sheet with a thickness of about 10-100 micrometer. Typically, for use as an ostomy bag, the dimensions (height x with) is in the range of 126x200mm.
By exfoliated means the complete separation of individual layers of the original particle, so that polymer completely surrounds each particle, desirably so much polymer is present between each platelet, that the platelets are randomly spaced. No X-ray line appears because of the random spacing of exfoliated platelets. Often exfoliated is used to describe a surface treated nano-clay, which possesses a sufficiently enlarged gallery spacing to permit the nano-clay to fully disperse (exfoliate) in a plastic matrix.
Various methods exist to apply the substantially exfoliated silicate filler material to the biodegradable material. In one embodiment, the exfoliated silica filler material is coated on the surface of the biodegradable material.
In one embodiment the substantially exfoliated silicate filler material is exfoliated silicate nano-flake material. In another embodiment the substantially exfoliated silicate filler material is exfoliated silicate flake filler material.
The coating may consist of nanoclay or any other mineral material having the ability to be intercalated, exfoliated, and dispersed in a liquid suspension. The suspension may also contain a polymer adding cohesion to the coating after the liquid is evaporated. In order for the coating to function as a gas barrier the clay particles must have one dimension in the nanometer range, preferably they are bigger in dimensions being parallel to the substrate. An preferred nanoclay is nanoclay from the smectite family.
In a preferred embodiment the exfoliated silica filler material is (vermiculite e.g. the microlite®) as described in WO05044938 and WO05063871. Nanolok is an aqueous suspension of silica nano-flakes and polymers (see httpj//^wwJ.nmatcQm/tøch,packaglngs.Jitmj). After Nanolok has been coated onto the substrate (the biodegradable film) the water evaporates, resulting in a layer of nano-flakes and polymers. This layer is very impermeable (O2-permeability <0,01 CC X mil/100in2 x day X atm), a factor ten (closer) than PVDC. Due to this, the Nanolok layer can be made very thin, 1 -2μm, as thin that it constitutes less than 10% of the complete film, which together can be seen as biodegradable.
This solution is advantageous, as you don't need to separate bags before flushing the inner bag, and keep the (somewhat soiled) outer bag.
One aspect of the invention relates to the use of a film of biodegradable material coated with a substantially exfoliated silicate filler material for the manufacture of an ostomy bag.
Another aspect of the invention relates to a method for manufacturing an ostomy bag comprising the steps of:
(a) providing a film of biodegradable material
(b) coat the film of (a) with a substantially exfoliated silicate filler material.
The film can also be used in other contexts, where biodegradability/solubility shall be combined with a high barrier, for instance for urine bags, but also in completely other connections where a product is to be sealed, for instance for packaging of foodstuffs or where a controlled release is desired, i.e. the packaging degrades/dissolves whereby the content is released.
Examples
Example 1
Flush test with two narrow Toilet's (tube dim. 073-80mm): 3L/6L Gustav Berg toilet, and 4L/6L Ifό cera toilet.
To obtain good flushability, it is important to have a flexible film. The maximum stiffness that allowed full flushability was the Materbi 50my biofilm. If this stiffness is exceeded, the ability to fold up around the contents is decreased, thereby decreasing flow through the toilet tube.
The preferred size of the bag is (with x height) 126x200mm.
Conclusion: The flush pouch with these dimensions can be flushed without complications with only one flush x 4L. (flush with only 3L will in some cases need two flushings).
Example 2: OTR test
The following films were evaluated on a Mocon 2/20 Ox Tran oxygen analyzer at 0% relative humidity and 239C. The films were then coated with Nanolok PT 3575 using a #12 meyer rod and air dried. The films were tested under the same conditions and the results are listed below:
Substrate Thickness6 Coating OTRa
A - blend of starch, PLA & glycerol 90 None 247 238
B - pure PLA 26 None 655 695
C - Biodegradable polyester 35 None 1721 1640
A - blend of starch, PLA & glycerol 90 Nanolok PT 3575 modified 2.6 2.3
B - pure PLA 26 Nanolok PT 3575 2.0 1 .8
C - Biodegradable polyester 35 Nanolok PT 3575 modified 5.0 13.7 a) Oxygen transmission rate (OTR) is in units of cc/m2 day atm @ 239C, 0% RH. b) Thickness in microns. The oxygen transmission rate for films A and B were reduced significantly from 200-600 down to 2-2.5 cc/m2 day atm @ 239C, 0% RH. The oxygen transmission rate was also significantly reduced for film C. However, using a meyer rod was not perfect for a film with such high flexbility, and it is speculated that the coating obtained was not even. Even lower OTR's (higher reduction) is anticipated with even coating on this type of film.
Example 3: Scatol test
A few drops of scatol (3-Methylindol) is applied to a beaker and the test-film set on top. The beaker is placed within a larger beaker with a screw-lid. The test-persons unscrews the lid and samples the scatol small on a scale from 1 (no smell) to 5 (intense smell). The results are presented below:
Time from closure of scatol beaker
Test-film 1/2 1 1/2 21/2 31/2 41/2 51/2 61/2 24
Mater-Bi 1 1 2 3 2 4 3 5
Mater-Bi 1 1 1 3 2 4 4 5
Mater-Bi 1 1 1 4 2 5 4 5
Mater-Bi 1 1 1 3 2 3 2 5
Average 1 1 1 ,3 3,3 2 4 3,3 5
Mater-Bi + coating 1 1 1 1 1 1 2 3
Mater-Bi + coating 1 1 1 1 1 2 2 2
Mater-Bi + coating 1 1 1 1 1 1 ,5 2 1
Mater-Bi + coating 1 1 1 1 1 ,5 3 2 2
Average 1 1 1 1 1 ,1 1 ,9 2 2
PVDC 1 1 1 1 1 1 2 2
PVDC 1 1 1 1 1 1 2 1
PVDC 1 1 1 1 1 1 1 1
Average 1 1 1 1 1 1 1 ,7 1 ,3
The smell penetrates the Mater-Bi film after 3V∑ hours. Penetrations is when the subjective smell is > 1. When coated, the smell is contained for up to 61/2 hours before smell penetration. The variability in penetration indicates that the coating is not uniform - yet. Example 4: Crackling test
A panel of 4 persons were asked to evaluate the level of crackling. However, they could not determine any difference between the samples of Mater-Bi with coating (Nanolok), Mater-Bi without coating and two standard ostomy bags presently on the market.
It is concluded that the coating does not cause crackling.

Claims

Claims
1. Film of biodegradable material comprising on one surface a substantially exfoliated silicate filler material.
2. Film according to claim 1 , wherein the biodegradable material is degraded 90% (of weight) after six months.
3. Film according to any of the previous claims, wherein the biodegradable material is selected from the group consisting of PVOH (polyvinyl alcohol), Starch, PLA (polylatic acid), PHB (polyhydroxybutyrate), and Polycaprolactone.
4. Film according to any of the previous claims, wherein the film has a thickness of 10 to 100 micrometer.
5. Film according to any of the previous claims, wherein the substantially exfoliated silicate filler material is coated on the surface of the biodegradable material.
6. Use of a film of biodegradable material coated with a substantially exfoliated silicate filler material for the manufacture of an ostomy bag.
7. Method for manufacturing an ostomy bag comprising the steps of:
(a) providing a film of biodegradable material
(b) coat the film of (a) with a substantially exfoliated silicate filler material.
8. Ostomy bag comprising a film according to any of claims 1 to 5.
9. Urine bag comprising a film according to any of claims 1 to 5.
PCT/DK2007/050017 2006-02-10 2007-02-09 Biodegradable barrier film Ceased WO2007090411A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP07702531A EP1983948A1 (en) 2006-02-10 2007-02-09 Biodegradable barrier film
AU2007214130A AU2007214130A1 (en) 2006-02-10 2007-02-09 Biodegradable barrier film
CA002636615A CA2636615A1 (en) 2006-02-10 2007-02-09 Biodegradable barrier film
US12/223,711 US20090216207A1 (en) 2006-02-10 2007-02-09 Biodegradable Barrier Film
JP2008552682A JP2009525201A (en) 2006-02-10 2007-02-09 Biodegradable barrier membrane

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200600195 2006-02-10
DKPA200600195 2006-02-10

Publications (1)

Publication Number Publication Date
WO2007090411A1 true WO2007090411A1 (en) 2007-08-16

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PCT/DK2007/050017 Ceased WO2007090411A1 (en) 2006-02-10 2007-02-09 Biodegradable barrier film

Country Status (7)

Country Link
US (1) US20090216207A1 (en)
EP (1) EP1983948A1 (en)
JP (1) JP2009525201A (en)
CN (1) CN101384233A (en)
AU (1) AU2007214130A1 (en)
CA (1) CA2636615A1 (en)
WO (1) WO2007090411A1 (en)

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JP2009525201A (en) 2009-07-09
EP1983948A1 (en) 2008-10-29

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