U.S. patent application number 09/791043 was filed with the patent office on 2002-08-22 for dental material packaging.
Invention is credited to Dumais, Alain, Pieroni, Robert J., Pierson, Paul R..
Application Number | 20020112971 09/791043 |
Document ID | / |
Family ID | 25152496 |
Filed Date | 2002-08-22 |
United States Patent
Application |
20020112971 |
Kind Code |
A1 |
Pieroni, Robert J. ; et
al. |
August 22, 2002 |
DENTAL MATERIAL PACKAGING
Abstract
The invention provides a storage stable dental composition
comprising a volatile organic solvent and a polymerizable material
enclosed by a package,which includes a cover and a container made
of a polymer such as a copolymer of a cycloolefin and an open chain
olefin. In accordance with an embodiment of the invention is
provided a stored packaged dental product by the process including:
enclosing a dental composition in a package with at least a
substantial portion of an injection molded polymer such as a
thermoplastic copolymer of a cycloolefin and an open chain olefin,
and storing the dental composition in the package for at least 1
week.
Inventors: |
Pieroni, Robert J.;
(Rehoboth Beach, DE) ; Pierson, Paul R.; (Camden,
DE) ; Dumais, Alain; (Northvale, NJ) |
Correspondence
Address: |
DENTSPLY INTERNATIONAL INC.
570 West College Avenue
York
PA
17405-0872
US
|
Family ID: |
25152496 |
Appl. No.: |
09/791043 |
Filed: |
February 22, 2001 |
Current U.S.
Class: |
206/63.5 ;
433/163; 433/49 |
Current CPC
Class: |
A61C 5/66 20170201; A61C
2202/02 20130101; A61C 19/006 20130101 |
Class at
Publication: |
206/63.5 ;
433/49; 433/163 |
International
Class: |
A61B 019/02; A61C
001/14; A61C 003/04 |
Claims
What is claimed is:
1. A storing and dispensing package for a dental material
comprising in combination: an openable, closed container and a
support holder for said container; said container comprising an
interior chamber and a sealed end, said sealed end being sealed
with a cover; said container further comprising a shoulder
proximate to said sealed end; said holder comprising a base
portion, a puncture protrusion and a container receiving aperture,
such that in use, said cover may be punctured with said puncture
protrusion and then said container can be received in said
aperture, whereby physical engagement between said holder and said
shoulder supports said container within said aperture and by said
holder; said base portion being rounded and having support legs
thereon; wherein when said container is received within said
aperture, the center of gravity of said combination of said
container and said holder is located within said rounded portion of
said base portion.
2. A package as in claim 1, wherein said container is formed from a
thermoplastic polymeric material.
3. A package as in claim 2, wherein said thermoplastic polymeric
material is a copolymer of a cycloolefin and an olefin
4. A method of dispensing a dental material comprising the steps of
providing an openable, closed container and a support holder for
said container; said container comprising an interior chamber and a
sealed end, said sealed end being sealed with a cover; said
container further comprising a shoulder proximate to said sealed
end; said holder comprising a base portion, a puncture protrusion
and a container receiving aperture; and puncturing said cover by
physical contact with said puncture protrusion, placing said
container in said aperture, such that physical engagement between
said holder and said shoulder supports said container within said
aperture and by said holder; and wherein said base portion being
rounded and having support legs thereon; wherein when said
container is received within said aperture, the center of gravity
of said combination of said container and said holder is located
within said rounded portion of said base portion.
Description
[0001] The invention relates to packaged dental compositions and
methods of use thereof. The invention provides a storage stable
packaged dental composition having one or more volatile components
and methods of use thereof. In accordance with the invention there
is provided a storage stable packaged dental compositions having
one or more volatile components such a polar organic solvent and/or
low molecular weight monomer.
[0002] One major problem with prior art injection molded packaging
of dental compositions having one or more volatile components is
the loss of a major portion of the volatile components from the
dental compositions during storage. When the stored dental
compositions with effectively reduced volatile components are used
the originally available results are not provided. Thus, for
example, dental adhesive and/or primer compositions stored in prior
art injection molded packaging loose much, if not all, of their
capacity for adhesion and/or priming. Other problems with prior art
injection molded packaging of dental compositions include weight
decrease of the polymeric material while enclosing the dental
composition due to diffusion of components of the polymeric
material from the polymeric material, and may cause contamination
of the dental composition by components of the polymeric material.
A weight increase of the polymeric material while enclosing the
dental composition may be due to infusion of water from ambient
humidity and/or solvent (or other components) from the polymeric
material. Thus a weight increase of the polymeric material may be
indicative of a loss of solvent from the dental composition and/or
water contamination of the dental composition. When the stored
dental compositions (with effectively contaminated and/or depleted
components) are used, the originally available results are not
provided. These problems of prior art injection molded packaging of
dental compositions are solved by the present invention.
BACKGROUND OF THE INVENTION
[0003] To ensure proper functioning of dental materials, they need
to be protected from undergoing changes during storage. These
changes of material may occur if external substances (e.g.
moisture) penetrate the dental materials, or if parts of the dental
materials (e.g. solvents) evaporate or otherwise diffuse off.
Therefore a suitable packaging is needed to prevent both intrusion
of moisture into the dental materials and evaporation of solvent or
other vital parts of the dental materials. Several ways of
packaging have been tried, mostly using laminate materials
consisting of different polymers. However, particularly for very
small containers of dental materials (e.g. single unit dosage
containers), laminate materials are not a viable solution as they
are too difficult to shape and process.
[0004] It is an object of the invention to provide a storage stable
dental composition such as one containing a volatile organic
solvent and a polymerizable material enclosed by a package,which
includes a cover and a container.
[0005] It is an object of the invention to provide a stored
packaged dental product by the process including: enclosing a
dental composition in a package with at least a substantial portion
of an injection molded polymer, and storing the dental composition
in the package for at least 1 week.
[0006] It is an object of the invention to provide a stored
packaged dental product by the process comprising: enclosing a
dental composition including a volatile organic solvent in a
package, at least a substantial portion of the package comprising a
polymer having a high chemical resistance and barrier capability
toward polar organic solvents and water. After storing the dental
composition in the package for at least two weeks at 37.degree. C.
at least 50 and more preferably 75 or even 90 percent of the
volatile organic solvent remains in the package.
[0007] As used herein open chain olefins are noncyclic olefins and
include linear open chain olefins, straight chain olefins, branched
chain olefins and branched open chain olefins. Open chain olefins
are not closed chain olefins or ring olefins. Linear open chain
olefins are most preferred open chain olefins for use in making
copolymer for use in accordance with the invention.
[0008] As used herein volatile component refers to a component (of
a dental composition) having vapor pressure more than that of water
at 20.degree. C.
[0009] As used herein volatile polar solvents refers to polar
solvents, such as water, ethanol and acetone, which are at least as
volatile as water at 20.degree. C.
[0010] As used herein volatile organic solvents refers to organic
solvents, such as ethanol and acetone, which are more volatile than
water at 20.degree. C.
[0011] As used herein moderately volatile organic solvent refers to
an organic solvent, such as ethanol, which is more volatile than
water, but not more volatile than ethanol i.e. vapor pressure more
than that of water at 20.degree. C., but less than or equal to 43
mm Hg at 20.degree. C.
[0012] As used herein very volatile organic solvent refers to an
organic solvent, such as acetone, which is more volatile than
ethanol i.e. vapor pressure more than 43 mm Hg at 20.degree. C.
[0013] As used herein high permeability barrier capability for
water (and high water barrier capability) refers to polymeric
material having a water vapor permeability below 0.07 g
(mm)(m.sup.-2)(d.sup.-1) measured by DIN 53122 at 23.degree. C. and
85 percent relative humidity.
[0014] As used herein high penetration barrier capability for
solvent of a polymeric material toward polar organic solvents
refers to less than 2 percent by weight loss of polar organic
solvents from a composition having at least 5 percent by weight of
polar organic solvent(s) while enclosed in the polymeric material
for at least two weeks at 37.degree. C.
[0015] As used herein very high penetration barrier capability for
solvent of a polymeric material toward polar organic solvents
refers to less than 0.5 percent by weight loss of polar organic
solvents from a composition having at least 5 percent by weight of
polar organic solvent(s) while enclosed in the polymeric material
for at least two weeks at 37.degree. C.
[0016] As used herein high penetration barrier capability for water
of a polymeric material toward water and humidity refers to a less
than 3 percent by weight increase of a composition due to infusion
of water through the polymeric material while the composition is
enclosed in the polymeric material for at least two weeks at
37.degree. C.
[0017] As used herein very high penetration barrier capability for
water of a polymeric material toward water and humidity refers to a
less than 1 percent by weight increase of a composition due to
infusion of water through the polymeric material while the
composition is enclosed in the polymeric material for at least two
weeks at 37.degree. C.
[0018] As used herein high chemical resistance of polymeric
material refers to polymeric material having both a less than 3
percent by weight increase of the polymeric material, and a less
than 0.5 percent by weight decrease of the polymeric material while
the polymeric material is immersed in water and /or solvent for at
least two weeks at 37.degree. C. A weight decrease of the polymeric
material while enclosing a dental composition (and/or immersed in
water and/or solvent) may be due to diffusion of components of the
polymeric material from the polymeric material, and may cause
contamination of the dental composition by components of the
polymeric material. A weight increase of the polymeric material
while enclosing a dental composition and/or immersed in water
and/or solvent may be due to infusion of water and/or solvent into
the polymeric material, and may indicate that the polymeric
material allows loss (or gain) of solvent from the dental
composition and/or water contamination of a dental composition.
[0019] As used herein low molecular weight monomer refers to an
acrylic monomer, such as methyl methacrylate having a gram
molecular weight less than 150.
[0020] As used herein single unit dosage refers to volumes of a
dental composition between 0.01 and 1 ml.
SUMMARY OF THE DRAWINGS
[0021] FIG. 1 is a perspective view of a covered container in
accordance with the invention.
[0022] FIG. 2 is a side elevational view of the container of FIG. 1
showing an internal chamber in phantom lines.
[0023] FIG. 3 is a top plan view of the container shown in FIG.
1.
[0024] FIG. 4 is a perspective view of a folder or stand for use
with the container of FIG. 1.
[0025] FIG. 5 is a top plan view of the holder shown in FIG. 4.
[0026] FIG. 6 is a side, cross-sectional view taken along line 6-6
of FIG. 5.
[0027] FIG. 7 is a side elevational view of the holder of FIG.
4.
[0028] FIG. 8 is a front elevational view of the holder of FIG.
4.
SUMMARY OF THE INVENTION
[0029] The invention provides a storage stable dental composition
comprising for example a volatile organic solvent and/or a
polymerizable material enclosed by a package, which includes a
cover and a container made of a polymer such as a copolymer of a
cycloolefin and an olefin. Preferably a thermoplastic polymeric
packaging made of a copolymer of a cycloolefin and an open chain
olefin is used. This packaging material combines ease of processing
by injection-molding with properties giving protection of the
dental materials by high barrier capability and chemical resistance
to water and polar organic solvents, such as acetone. Furthermore,
containers made from this packaging material may be sealed by
thermal welding with a laminate plastic foil. The invention
provides a stored packaged dental product by the process
comprising: enclosing a dental composition in a package, at least a
substantial portion of the package comprising thermoplastic polymer
having a high barrier capability and chemical resistance to water
and polar organic solvents. Preferably the thermoplastic polymer
has high penetration barrier capability for solvent toward polar
organic solvents and a high water barrier capability. After storing
the dental composition in the package for at least two weeks at
37.degree. C. at least 50, preferably 75 and most preferably 90
percent of the volatile organic solvent remains in the package.
[0030] The invention to provide a stored packaged dental product by
the process including: enclosing a dental composition in a package
with at least a substantial portion of an injection molded polymer,
such as a thermoplastic copolymer of a cycloolefin and an open
chain olefin, and storing the dental composition in the package for
at least 1 week.
DETAILED DESCRIPTION OF THE INVENTION
[0031] The invention is now described in reference to FIGS. 1
through 8. With more particular reference to FIGS. 1 through 5 is
seen storage stable dental composition packaging system 10 having a
package 12 and a volatile dental composition 14. The volatile
dental composition 14 is enclosed by package 12. Package 12
includes container 16 and cover 18. Container 16 is made of polymer
such as a copolymer of a cycloolefin and an olefin. Dental
composition 14 comprises for example a volatile organic solvent and
a polymerizable material. The storage stable dental composition
packaging system is stored for weeks, months or even years without
significant loss of volatile organic solvent from dental
composition 14 in closed package 12. In use container 16 is placed
in holder 20 and uncovered for use by pealing or puncturing cover
18 from container 16. The user dispenses dental material by dipping
a dental applicator (not shown) into uncovered container 16, for
example while container 16 is supported in a holder 20.
[0032] As will be further discussed below, container 16 has an
interior chamber 17 which, as shown in FIG. 2, holds dental
composition 14. Chamber 17 has an open top 17a which is closed by
cover 18. Cover 18 may be a laminate foil which is bonded to
container 16, or cover 18 may be formed from the same material as
container 16, or other suitable plastic material and affixed to
open end 17a of container 16. In use, in order to obtain access to
chamber 17 and hence to dental composition 14, it is merely
necessary to remove cover 18, or more preferably, puncture cover 18
with a suitable device.
[0033] Exemplary thermoplastic polymeric cycloolefin- olefin-
copolymer useful for storage stable packaging of dental composition
in accordance with the invention are disclosed in EP 407,870; EP
156,464 and EP 283,164. Thus each discloses copolymers of
cycloolefin and olefin useful for making containers and covers for
use in accordance with the invention. The disclosures of EP
407,870; EP 156,464 and EP 283,164 are each hereby incorporated
herein by reference each in its entirety.
[0034] Copolymer of cycloolefin and open chain olefin useful for
storage stable packaging of dental composition in accordance with
the invention have the following properties: thermoplasticity,
suitable for injection-molding, high moisture-barrier capability,
high barrier capability towards organic solvents, high chemical
resistance, high rigidity, and suitability for sealing with
laminate foil via thermal welding or ultrasonic welding. Preferred
copolymers of cycloolefin and open chain olefin for use in
accordance with a preferred embodiment of the invention are
copolymers of norbornene and ethylene for example the
norbornene-ethylene-copolymer sold by Ticona GmbH as Topas 6013.
Topas 6013 norbornene-ethylene-copolymer has the following
properties: thermoplasticity, can be processed on conventional
injection molding machines; high moisture vapour barrier:
permeability of 0.035 (g)(mm/m.sup.2 )(24 hours) at 23.degree. C.,
85% relative humidity, high barrier capability towards polar
organic solvents such as acetone, high resistance towards water,
strong acids and bases, and polar organic solvents such as
methanol, ethanol and acetone, high rigidity: yield stress of 66
MPa, tensile modulus of 3200 MPa and suitable for sealing with
laminate foil via thermal welding.
[0035] In accordance with a preferred embodiment of the invention
is provided a storage stable dental composition comprising a
volatile organic solvent and a polymerizable material enclosed by a
package, which includes a cover and a container comprising a
copolymer of a cycloolefin and an olefin. Preferably the package
has an open end 17A sealed closed by a cover 18. Preferably the
packaged dental composition is stored at about 23.degree. C. for at
least one year and at least about 50, more preferably about 70 and
most preferably about 80 percent of the volatile organic solvent
remains in the package. Preferably the storage stable packaged
dental composition is stored at about 23.degree. C. for at least
two years and at least about 50, more preferably 75 and most
preferably about 90 percent of the volatile organic solvent remains
in the package. Preferably the storage stable packaged dental
composition is stored at about 23.degree. C. for at least two years
and at least about 50, more preferably about 75 and most preferably
about 95 percent of the volatile organic solvent remains in the
package. Preferably the volatile organic solvent of the storage
stable packaged dental composition comprises acetone. Preferably
the storage stable packaged dental composition is at least 20
percent by weight acetone both before and after storage at about
23.degree. C. for two years and at least 95 percent of the volatile
organic solvent remains in the package after the storage.
Preferably the storage stable packaged dental composition is at
least 20 percent by weight acetone both before and after storage at
about 23.degree. C. for one year and at least 90 percent of the
acetone remains in the package after the storage. Preferably the
storage stable packaged dental composition is at least 40 percent
by weight acetone both before and after storage at about 23.degree.
C. for two years and at least 95 percent of the volatile organic
solvent remains in the package after the storage. Preferably the
storage stable packaged dental composition is at least 40 percent
by weight acetone both before and after storage at about 23.degree.
C. for one year and at least 90 percent of the acetone remains in
the package after the storage. Preferably the storage stable
packaged dental composition is at least 50 percent by weight
acetone both before and after storage at about 23.degree. C. for
two years and at least 95 percent of the volatile organic solvent
remains in the package after the storage. Preferably the storage
stable packaged dental composition is at least 50 percent by weight
acetone both before and after storage at about 23.degree. C. for
one year and at least 90 percent of the acetone remains in the
package after the storage.
[0036] In accordance with a preferred embodiment of the invention
is provided a storage stable packaged dental composition wherein
the dental composition comprising a solvent and a polymerizable
material is enclosed by a container comprising a polymer such as a
copolymer of a cycloolefin and an olefin, the dental composition,
the packaged dental composition is at least 10 percent by weight
solvent both before and after storage at about 43.degree. C. for
one week, and at least 99 percent of the solvent remains in the
package after storage. Preferably at least 99.5 percent of the
solvent remains in the package after storage. More preferably at
least 99.8 percent of the solvent remains in the package after
storage. Most preferably the solvent is a volatile organic solvent
and at least 99.9 percent of the solvent remains in the package
after storage.
[0037] In accordance with a preferred embodiment of the invention
is provided a method of storing polymerizable material, comprising:
providing a dental composition and a package, the package
substantially enclosing the dental composition, the dental
composition comprising a polar organic solvent at least a portion
of the package comprising a thermoplastic polymer comprising a
copolymer of a cycloolefin and an olefin and having a high
penetration barrier capability for water and solvent and high
chemical resistance, whereby when the dental composition is stored
at about 23.degree. C. in the package for at least two years and at
least 90 percent of the polar organic solvent remains in the
package. Preferably the dental composition, initially comprises at
least 10 percent by weight of the solvent before storage at about
43.degree. C. for one week and at least 99 percent of the solvent
remains in the package after the storage. More preferably the
dental composition, initially comprises at least 15 percent by
weight of solvent before storage at about 43.degree. C. for one
week and at least 99.8 percent of the solvent remains in the
package after storage.
[0038] In accordance with a preferred embodiment of the invention
is provided a packed dental product, comprising: a package
substantially enclosing a dental composition comprising a solvent.
The package comprising a container and a cover. At least a portion
of the container comprises a thermoplastic copolymer of a
cycloolefin and an olefin and having a high permeability barrier
capability for water and high chemical resistance. The cover
comprises a metal foil. When the dental composition is stored at
about 23.degree. C. in the package for at least two years and at
least 99 percent of the dental composition remains in the
package.
[0039] The cover 18 may comprise a polymeric film, such as
polyethylene or polypropylene laminated to the metal foil.
Preferably the cover comprises a molded member, sheet, film or
coating of thermoplastic polymer comprising a copolymer of a
cycloolefin and an olefin and having a high permeability barrier
capability for water and high chemical resistance. Preferably the
container is injection molded. Preferably the package has a longest
dimension less than 4 cm. Preferably the container has a longest
dimension less than 2 cm. Preferably the cover comprises a
thermoplastic polymer comprising a copolymer of a cycloolefin and
an open chain olefin and having a high permeability barrier
capability for water and high chemical resistance towards both
water and the solvent. Preferably the copolymer has a permeability
to water of less than 0.07 (g) (mm/m.sup.2)(24 hours) at 23.degree.
C. and 85% relative humidity. More preferably the copolymer has a
permeability to water of less than 0.05 (g)(mm/m.sup.2)(24 hours)
at 23.degree. C. and 85% relative humidity.
[0040] In accordance with a preferred embodiment of the invention
is provided a stored packaged dental product by the process
comprising: enclosing a dental composition in a package, at least a
substantial portion of the package comprising thermoplastic polymer
having a high resistance toward polar organic solvents and a high
water barrier capability, and storing the dental composition in the
package for at least two weeks at 37.degree. C. and after the two
weeks at least 90 percent of the volatile organic solvent remains
in the package. Preferably the package includes a molded portion
and a laminated portion. Preferably the package is made by sealing
a molded portion to a laminated portion. Preferably the
thermoplastic polymer of the molded portion is injection molded and
has an average thickness from about 0.4 mm to about 6 mm. More
preferably the injection molded thermoplastic polymer has an
average thickness from about 0.6 mm to about 4 mm. Most preferably
the injection molded thermoplastic polymer has an average thickness
from about 0.8 mm to about 3 mm. Preferably the thermoplastic
polymer is a copolymer of a cycloolefin and an open chain olefin.
The open chain olefin is preferably a straight open chain olefin or
a branched open chain olefin. The open chain olefin of the
copolymer used to mold at least a portion of the package,
preferably has a gram molecular weight which is less than half of
the gram molecular weight of the cycloolefin of the copolymer.
Preferably the package has a cover over a readily opened end, and
the cover comprises a polymeric film, such as polyethylene or
polypropylene laminated to the metal foil such as aluminum
foil.
[0041] In accordance with a preferred embodiment of the invention
is provided a dental method of use, of a thermoplastic polymer,
having a high permeability barrier capability for water, high
chemical resistance, as at least a substantial portion of a package
enclosing a dental composition comprising at least 3 percent by
weight of volatile organic solvent, whereby the dental composition
is stored in the package at about 23.degree. C. for at least two
years and after the two years at least 90 percent of the volatile
organic solvent remains in the package. Preferably the dental
composition comprises at least 5 percent by weight of volatile
organic solvent. More preferably the dental composition comprising
at least 10 percent by weight of volatile organic solvent.
[0042] Cover 18 may be peeled or otherwise removed if it is a foil
or other flexible closure for open end 17a of container 16. As
discussed above, cover 18 may also be formed from a plastic,
relatively hard material, such as the same material forming
container 16. Cover 18 may be punctured by any means, such as any
handy or available dental instrument (not shown).
[0043] According to one embodiment of the invention, container 16
is placed in a holder 20 for use. Holder 20 may be fitted with a
protrusion 21, which has a sharp end 22 which is useful for
puncturing cover 18. Holder 20 is also provided with an aperture 30
wherein container 16 may be placed. Preferably, container 16 at
open end 17a has a shoulder 31 which will physically engage holder
20 when container 16 is placed in aperture 30. Holder 20 is
provided with a base portion 40 which may be formed from a rounded
portion 41 integrally formed with the remaining portions of holder
20.
[0044] Holder 20 may also be provided with support legs 42 to
support holder 20 upon a flat surface (not shown). Preferably,
rounded portion 41 of holder 20 provides a center of mass somewhere
contiguously within rounded portion 41, even when a full container
16 is placed within aperture 30. In this way, particularly with the
use of support legs 42, container 16 will be held in a
substantially upright position similar to that shown in FIG. 2,
wherein container 16 is placed in aperture 30 and shoulders 31 of
container 16 physically engage holder 20.
[0045] Various alterations and modifications of the invention will
be apparent to those of ordinary skill in the art without departing
from the scope and spirit of this invention. Accordingly, it should
be understood that the invention is not limited to the illustrative
embodiments set forth herein.
* * * * *