Note: Descriptions are shown in the official language in which they were submitted.
~ i56790
Protective adhesive paste preparations for use with
ostomy applicances are known and widely used by ostomates.
Such preparatio~ are commonly formulated with karaya gum,
but other hydrocolloid gums can be used. The gum in powder
form is mixed with an alcohol or other organic solvent solution
of an adhesive film-forming resin. Preparations of this kind
are described in British patent 1,430,515, and have been sold
commercially in the United States and other countries for a
number of years.
When the person wearing the ostomy appliance (the
ostomate) has difficulty in maintaining a liquid-tight seal
between the ostomy applicance and the skin around the stoma an
adhesive paste may be of great value. The problem of luid
leakage is aggravated where the skin around the stoma is
irregular, or where folds of skin occur in this area. Under
such conditions, even though the ostomy device is used with a
molded sealing member such as a ring, blanket, or the like, a
complPte liquid-tight seal cannot be assured. To obtain a
more perfect seal the ostomate applies a coa,ing of an adhesive
in a ring around the stoma, permits the paste to dry, and then
apply the ostomy device. Additional paste may also be applied
to the skin-engaging side of the ring or blanke. before appli-
cation.
With ileostomies and colostomies the area around the
stoma is exposed to intestinal fluids, which in the case of
ileostomies may include gastric juices containing proteolytic
enzymes. With urostomies the area around the stoma is exposed
--2--
~,.
1 156790
to urine. Therefore, in the use of paste preparations, as described
above, one problem is that the applied paste is not sufficiently
resistant to intestinal fluids or urine. It has been desired to
increase the mechanical and adhesive endurance of such adhesive
pastes when applied around the stoma, but heretofore no means has
been provided for accomplishing this result.
One of the skin irritation problems associated with the
use of ostomy appliances is referred to as adhesive trauma, which
is the stripping of the skin through repeated application and
removal of the adhesively-attached ostomy appliance. Adhesive
trauma is aggravated by increases in the frequency with which the
ostomy device is removed and reapplied. By providing an adhesive
past preparation of greater endurance, it should be possible to
reduce the frequency of removal of the ostomy device, thereby
reducing skin irritation caused by the skin-stripping effect.
The present invention is based in part on the discovery
that a new and suprising result is obtained by the incorporation
of a small amount of colloidal solica (SiO2), preferably in the
form of a fumed silica, in protective adhesive pastes for use with
ostomy appliances, which are composed of mixtures of hydrocolloid
gum and solutions of film-forming resins. More specifically, the
resistance of such pastes to the action of intestinal fluids and/or
urine is markedly increased by incorporating from 2 to 6% by weight
of fumed silica or other high surface
I 156790
area silica material. The desired liquid-tight sealing engage-
ment of the ostomy device is more effectively maintained and
for longer periods of time. In addition, the stability of the
paste preparations and their shelf-life prior to application
are significantly improved.
Protective adhesive paste formulated in accordance with
present invention can be advantageously used in a variety of
ostomy applications. The paste can be used in conjunction with
every type and form of molded ostomy barriers (rings, blanXets,
etc.). Further, the paste can be applied in various ways, such
as on, under, or next to the other barrier material. In addition,
for certain applications, the paste may be used as the only
barrier material, being formed into a skin blanket, ring, or
other form of barrier by itself. Also, the ?aste will have an
application for use around other surgical fluid drainage openings
besides stomas, such as a wound or surgical incision.
The present invention is believed to be generally
applicable to the protective adhesive pastes for use with os~omy
appliances of the kind which are formulated essentially as ~ix-
tures of water-absorbing particulate hydrocolloid gum with an
organic solvent solution of an adhesive film-forming resin.
Based on present usage, the hydrocolloid gum is preferablv
karaya gum, but other hydrocolloid gums can be used as a partial
or complete substitute for karaya. The class of water-a~sorbing
hydrocolloid gums is well known and such gums ha~e comparable
properties. For example, useable hydroco~loid gums include:
--4--
I 1516790
plant exudate gums like zedou, ghatti, arabic, and tragacanth;
plant extract ~ums like pectin plant seed gums like guar and
locust bean; and seaweed extract gums like carrageenan. Other
gums, such as cellulose and cellulose derivative gums may also
be used, such as carboxymethyl cellulose and hydroxyethyl
cellulose. Such hydrocolloid gums are characterized by being
polysaccharides, and by being hydrophilic and water-absorbing.
For the purpose of the present invention, the hydro-
colloi~ gums are used in a fine particulate form, that is, as
powders. For example, the gum may be employed in a suf~iciently
fine state of subdivision so that it will pass a 100 mesh or
finer screen. The powdered gums as used are air-dry, that is,
dry to the touch, but may contain some moisture. For example,
karaya gum powder may contain from 10 to 18% by weight moisture.
The adhesive film-forming resin should be non-toxic and
applicable to the skin. Such resins are those which can be used
as medical adhesives. The resin should be soluble in alcohol
or other organic solvent which can be used in the formulation.
The resin must be film-forming, that is, on evaporation of the
solvent, a resin film will be formed. For example, particularly
desirable resins include the monoester resins sold by GAF
Corporation, Chemical Division, New York, N. Y. as the "Gantrez
ESn*resins. In terms of chemical structure, these resins are
al~yl monoesters ofpoly (methyl vinyl ether~maleic acids). The
alkyl groups may be ethyl, isopropyl, or butyl. These resins are
soluble in the lower primary alcohols, and are supplied in alcohol
solution, so they are readily adapted for use in preparations of
the present invention. A preferred Gantrez resin is sold under
* Trade Mark
!B
l 156790
:
the code designation "ES-335-I~. It is the isopropyl monoester
and is supplied as 50~ solution in isopropanol. Other of the
Gantrez*resins, such as "ES-225" are supplied as solutions in
ethanol. (ES-225 is the ethyl monoester.) For the purpose of
the present invention, both isopropanol and ethanol are especially
desirable solvents. Other film-forming resins may be used instead
of or in addition to the above-described monoester resins. For
example, polyvinyl pyrrolidone has similar properties. One suit-
able commercial product is the "K-30~ polyvinyl pyrrolidone
product of GAF, which has a molecular weight of about 40,000.
(GAF Corp., Chemical Division, New York, N. Y.)
The organic solvent for dissolving the resin is preferably
ethanol, isopropanol, or mixtures thereof. However, other organic
solvents in which the resin is soluble can be employed, providing
the solvent is non-toxic and applicable to the skin. Where the
resin is supplied as an ethanol or isopropanol solution it is
convenient to use an additional amount of the same alcohol to
complete the solvent system.
In general, the ingredients are combined in the required
proportions to produce a paste, which s relatively stiff and
yet readily spreadable. For example, from 40 to 70 parts by
weight of the resin can be used per 100 parts of the karaya or
other hydrocolloid gum, and sufficient alcohol or other organic
solvent will be used to form a paste of the desired_~onsistency.
2S As indicated, the resin will be dissolved in the solvent, and
the hydrocolloid particles dispersed in the resin solution. For
example, from 150 to 175 parts by weight of isopropanol may be
used per 100 parts of resin.
* TradP Mark
,~
l 15679~
In accordance with the present invention a colloidal
silica material is incorporated in the paste preparation to
provide increased resista~ce to urine and/or intestinal f~uids.
Fumed silica is preferred, although precipitated silica can also
be used. Fumed silica is produced by flame hydrolysis of silicon
tetrachloride. It can be obtained from various manufacturers,
including the Cab-O-Sil* products of Cabot Corporation, Boston,
Massachusetts, and the Aerosil*products of Degussa, Inc., New
York, N. Y. These products are collidal silicon dioxide of very
high surface areas. They are supplied as dry white powders. For
example, one suitable specific product is the Grade M-5 of Cab-
O-Sil. Colliodal silica formed by precipitation from aqueous
solutions are also available commercially. These products have
the general formula sio2. x H2O. One suitabie product is Quso
G-30*of Pniladelphia Quartz, Valley Forge, Pennsylvania.
In general, from 2 to 6~ by weight of the f~med silica
or other colloidal silica should be incorporated in the paste
product. Since the silica has a thickening action on the pre-
paration, the maximum useable amount is limited if the desired
paste-like consistency of,the product is to be maintained.
Fortunately, for the purpose of the present invention, the
desired improvement in endurance properties appears to be
optimized in the range of about 3 to 5% by weight, an~ in this
- range the paste character of the preparation can be maintained.
It will be understood, however, that where necessary the amount
of solvent can be increased, or the resin or hydrocolloid solids
decreased to maintain the paste form of the product.
* Trade Mark
--7--
.~, . . .
t 1~679û
In combining the ingredients to produce the paste, the
order of addition is not highly critical. However, it is advan-
tageous to first form the solvent solution of the resin, then
add the silica, and finally the hydrocolloid. Where other
minor ingredients are to be incorporated, these can first be
dissolved in a portion of the alcohol, and the silica can be
dispersed therein before combining with the alcohol solution
of the resin. Whatever the order of addition of the other
ingredients, it is desirable to add the hydrocolloid last.
Other minor ingredients which may be included zre
solvents or co-solvents such as glycerine or propylene glycol,
and preservatives or anti-bacterial agents, such as methyl-
or butyl paraben (para-hydroxy benzoate). A small amount of
water may also be added, but this is not usually necessary
and provides no advantage unless insredients are to be
incorporated which are water-soluble but not alcohol-soluble.
In general, the combined minor ingredients will constitu~e
less than 10% by weight of the complete formulation. For
example, the resin, the alcohol solvent, ana the hydrocolloid
may comprise 80% or more of the formulation, with the amount
of colloidal silica being less than 6%.
The practice of the present invention in a preferred
embodiment and the results obtained thereby are further
illustrated by the following examples.
1 156790
EXA~LE I
A protective adhesive paste for use with ostomy
a~pliances is prepared according to the following formula~
ormula
Ingredient No. Wt. %
(1) Isopropanol 12.8
(2) Glycerine (VSP 99%) 7.0
(3) ~lethylparaben 0.14
(4) Butylparaben 0~06
(5) Fumed silica 4.0
(6) Isopropanol solution
of film-formins
resin (50%) 40.0
(7) Gum karaya powder 36.0
100.00
In compounding the above ingredients, ingredients
1 to 4 may be first mixed, the methyl and bu.ylparaben
dissolving in the part of the isopropanol em?loyed for this
purpose. Ingredient ~, the fumed silica, is then mixed into
the solution of ingredients 1 to 4, and thoroughly dispersed
therein. Next, ingredient 6, the isopropanol solution of
the resin is added. Since the resin is a ;0~ solids solution
in isopropanol, the ~otal of isopropanol in the formula is
approximately 32.8% (12.8~ + 20.0%). As a final step, ingre-
dient 7, the gum karaya powder, is mixed into the solution ofingredients 1 to 6. The mixing is continued until a smooth,
homogeneous paste is obtained.
.
1 156790
In the foregoing example, the fumed silica is Cab-O-Sil
M-5 (Cabot Corporation, Boston, Massachusetts). The resin solution
is Gantrez ES-351-I (GAF Corporation, Chemical Division, New York,
N.Y.). The gum karaya is in the form of a powder passing a 140
mesh screen, and may contain from 10 to 18% moisture.
EXAMPLE II
The karaya paste of Example I was compared for endurance
properties with a commercial karaya paste product manufactured by
Hollister Incorporated, Chicago, Illinois. The commercial product
was composed primarily of gum karaya in admixture with an iso-
propanol solution of the same film-forming resin identified in
Example I (Gantrez ES 351-I). Both preparations were compared as
freshly prepared, and after seven weeks of room temperature
storage. For the test, the simulated intestinal fluid was prepared
as described in U S.P. XIX "Intestinal Fluid, Simulated, TS, 1I pg.
765 (1974). The simulated urine was prepared as described in
Remington's Pharmaceutical Sciences, "Urine", pg. 598- 9, Ed
15 (1975).
In preparing the samples, ribbons of the paste were
extruded from tubes having 5/16 inch orifices onto silicon release
paper. The test pasted ribbons had lengths of approximately 1
inch, and were standardized to a uniform weight of 3 grams. After
air-drying at room temperature for 20 to 24 hours, the paste
ribbons had solidified to a rigid condition, which permitted them
to be handled and placed in the test apparatus.
--10--
1 156790
The test apparatus includes a tank for containing the
simulated intestinal fluid or urine, and a plurality of tripod
testing fixtures, which may be placed in the tank in contact
with the solution. ,he testing fi~:ture has a platform at the
top with a sample-receiving recess. The center portion of the
recess is cut-out to provide an opening through the platform.
When placed in test position, the solidi ied paste ribbons
bridge the openings. U-shaped weights are then placed over the
ribbons, these weigh,s in the form of steel hooks weighing
approximately 7.4 grams. In use, the hooks are placed over
the samples so that when the hooks break through the samples
they would fall freely through the openings in the platforms.
l~ylon strinss are at_ached to the upper cross-arm portions of
the inverted U-sha?ed hooks and the strings are attached to the
operating levers o' micro switches, the lengths o' strings being
selected so tha~ when the sample is broken, the micro switch will
be activated, and a ~iming clock for the particular sample will
be stopped. In stz-ting the test, after the samples have been
placed in the tank and the strinss attached to the micro switch
levers, the simula.ed urine or intestinal fluid is added to the
tanks to a level above the position of the samples, an~ the
timing clocks for each sample are started. The elapsed time for
breakthrough of each sample is thereby automatically recorded.
The results of the test are summarized below in Table A.
Table A
Time (Hours to Break-Thru)
Test Solution Commercial E~ample I
Fresh 7 w~s Fresh 7 wks
Urine 0.26 1.95 168+ 168+
Intestinal Fluid 0.20 -.50 168+ 168+
1 156'~90
In Table A the designation "168+" indicates that the
test with the Example I preparation, both as freshly prepared
and after seven weeks of aging, were discontinued after an
elapsed time of 168 hours. Since no brea~throughs had occurred
by that time, further testing was discontinued. Each of the
re~orted values in Table A represent three samples, the average
times being shown.
The results with respect to the commercial preparation
i~dicate that the preoaration was some~hat more resistant to
the simulated urine and the simulzted intestinal fluid after
it had aged fo- seven weeks. However, the aaing involves
some se?aration of the prepar~tion so that it wzs no longer
homogeneous. Such separation is undesirable. 8y way o'
comparison, the ~xam~le I preparation was stable and homogeneous
after seven weeks of storage.
EXAMPLE III
As an al~ernate to the preferred formulati~n o Example I,
a protective adhesive paste can be prepared according to the
following formula.
Formula
Ingredient No. Wt.
(1) Isopropa~ol 22.8
(2) Glycerine (USP 99%) 17.0
(3) Methylparaben 0.14
(4) Butylparaben 0.06
(5) Fumed silica 4.0
. (6) Polyvinyl pyrrolidone* 20.0
(7) Gum karaya powder 36.0
100. oo
*K-30, G~ 1d~
1 1~6~9~
The ingredients for the above formula may be compounded
in the same manner as described with respect to the corresponding
ingredients of Example I.
OT~ER EXP~LES
With reference to the formulas of E~amples I and III,
other hydrocolloid gums in powder form may be substituted for
the gum karaya. The substitution may be on an equal weight
basis, or more or le,s of the substitute gum may be used. On
this basis, useable hydrocolloid gums include ghatti, arabic,
tragacanth, pectin, suar, locust bean, carrageenan, zedou,
sodium carboxymethyl cellulose, and similar gums.
In other variations of the formulas of Examples I and III,
ethanol may be substituted on an equal weigh. basis for the
isopropanol, and Gantrez ES-225 may be used therewith.
-13-
