DK155572B - PROTECTIVE SEALING COMPOSITION IN FORMED CONDITION FOR SURGICAL DRAWINGS - Google Patents

Description

in DK 1555723

The present invention relates to a protective sealing composition in the form of a shaped gelled ring or plate for application around a surgical fluid drainage opening, comprising a mixture of a gelling water-absorbing particulate hydrocolloid rubber and a non-toxic liquid polyhydroxy alcohol.

Protective sealing compositions in the form of shaped rings or plates for placement around surgical fluid drainage openings are known. A known composition of such compositions comprises a gelled mixture of karaya gum and glycerine. See. for example. U.S. Pat.

10 3,302,647 and 3,954,105. As described in the first-mentioned patent, where the drainage opening is a stoma, the karaya-glycerine sealing composition can be used in the form of a shaped ring which is placed around the stoma between the ostomy gasket and the wearer's body. The purpose of the ring is to provide a protective seal, ie. it is desired to prevent 15 intestinal fluid or urine discharged from the stoma from seeping out around the ring so that all the depleted fluid is collected in the ostomy bag or pocket. The sealing ring also performs the function of protecting the skin area around the stoma from the irritating urine or irritating intestinal fluid, which, in the case of ileostomies, may contain gastric juices. As illustrated in the second of the above-mentioned patents, the karaya-glycerine composition can also be used in the form of a plate or a cover. Such covers may also be used around stoma openings or they may be as described in U.S. Pat.

3,954,105 is used around drainage openings in connection with a wound or surgical incision.

Sealing compositions of the type described preferably have an initial tackiness, usually referred to as "dry tack", hereinafter referred to as "dry tack", so as to provide an initial adhesive adhesion to the skin around the drain opening. It is especially important that the compositions provide a high degree of adhesiveness when in contact with aqueous fluid. This is usually referred to as "wet tack", hereinafter referred to as "wet tack". The hydrocolloid in the composition, such as karaya, absorbs water, causing the hydrocolloid to swell and increase its tackiness. However, there is a tendency for the composition to decompose upon continued exposure to the aqueous fluid, especially when the fluid is urine or an intestinal discharge containing gastric juices, thereby losing mechanical strength and eventually becoming ineffective for the desired protective sealing function. Below

; DK 155572 B

During use, such sealing rings or covers must be replaced frequently. It has been desired to increase the mechanical and / or adhesive durability of such rings or covers, but so far no satisfactory means have been provided to achieve this result.

Other types of protective sealant compositions are also known. For example, U.S. Patent No. 3,980,084 discloses an ostomy gasket of a polymeric material made by polymerizing an acrylate with a glycol. In order to make the material more water-absorbent, it is proposed to add an absorbent material which may be, inter alia, caraya rubber 10 or pyrogenic silica. The patent does not contain a proposal to add pyrogenic silica to ostomy gaskets formed by glycerine and karaya. On the contrary, it is mentioned that karaya-type gaskets tend to be too water-absorbing and it would be illogical to try to solve this problem by adding another water-absorbing material such as pyrogenic silica.

From Danish Patent Application No. 969/78, an adhesive for medical use is known, e.g. for attaching an ostomy bag. The adhesive comprises a gelled mixture of a plasticized polymethacrylate added with a chlorinated rubber and an inert particulate filler which may be silica (silica). From the context it appears that this is neither pyrogenic silica nor colloidal silicon dioxide gel, but rather a conventional inert filler, e.g. of the type known as silica flour, which is made from finely ground quartz sand.

The present invention is based, in part, on the observation that a new and surprising result is obtained by incorporating a small amount of colloidal silica in the form of pyrogenic silica or colloidal silica gel into protective seal compositions of the kind mentioned in the preamble.

Accordingly, the invention relates to a protective sealing composition in the form of a shaped gelled ring or plate for application around a surgical fluid drainage opening, comprising a mixture of a gelling water-absorbing particle hydrocolloid rubber and a non-toxic liquid polyhydroxyal carbon and is characterized by dispersing in the composition from 0.1 to 4.0% by weight of colloidal silica in the form of pyrogenic silica or colloidal silica gel.

In particular, the resistance of such compositions is increased in the form of

DK 155572B

3 formed rings or plates against degradation caused by intestinal fluids and / or urine markedly by incorporation of pyrogenic silica in an amount as low as 0.2%. At silica concentrations above 4%, the wet adhesive capacity of the composition is reduced to such an extent that the composition is ineffective. However, by limiting the amount of colloidal silica dispersed in the composition, the mechanical durability of the composition can be increased without appreciable reduction of its wet adhesiveness, and satisfactory dry adhesiveness can also be obtained.

The present invention can be used for protective seal compositions made from gelled mixtures of a particulate hydrocolloid rubber and a liquid polyhydroxy alcohol which can be formed as shaped rings or plates and cured by gel formation. Based on the present use, the hydrocolloid gum is preferably karaya rubber, but other gelling hydrocolloid gums can be used as a partial or complete replacement for the karaya. Among such gel-forming hydrocolloid gums are ghatti, zedou, tragacanth, gelatin, dextran, pectin, xanthan and similar natural gums. Synthetic rubbers including sodium carboxymethyl cellulose and hydroxyethyl cellulose may be used. Such hydrocolloid rubbers are characterized by being polysaccharides, by being hydrophilic and water absorbent, and by being gelling in admixture with glycerine or other polyhydroxy alcohol.

For the purposes of the invention, the hydrocolloid rubbers are used in the form of fine particles (ie, as powders). For example. For example, karaya rubber is used in a ten to 25 extensible state of comminution to allow the powder to pass a sieve with a mesh width of 0.149 mm or less. The powdered rubbers are, as they are used, air dry, ie. dry by touch, but may contain some moisture, such as 10 to 18 weight percent moisture.

The major liquid component of the sealing composition is preferably a non-toxic liquid polyhydroxy alcohol. Based on current use, glycerine is the preferred alcohol, but other polyhydroxyal alcohols having similar properties can be used such as e.g. Propylene glycol, sorbitol, etc. The polyhydroxy alcohol is preferably not only non-toxic and non-irritating when applied to the skin, but also has a soothing or softening effect, as obtained with glycerine or similar softening polyhydroxy alcohol.

In preparing the sealing composition, a sufficient amount of polyhydroxy alcohol one is used to form an

DK 155572 B

flowing mixture which can be formed into the desired ring or plate shape and then cured by gel formation. The relative amounts of polyhydroxy alcohol and the hydrocolloid may be varied while continuing to obtain these general results. If too little alcohol is present, the mixture will become too stiff to flow in the mold, while the molded composition, if too much alcohol is present, will be too soft and insufficiently gelled. In accordance with current practice with regard to mixtures of karaya gum and glycerine, about equal parts by weight of the gum and alcohol give good results.

However, a formal mixture can be prepared using more or less of the glycerine or other polyhydroxy alcohol. Generally, the mixture may contain from 35 to 55% of the caraya or other hydrocolloid and from 35 to 55% of glycerine or other polyhydroxyal carbon. As a more specific example, mixtures 15 can be prepared using amounts ranging from 80 to 120 parts by weight of glycerine per 100 parts of karaya gum.

In accordance with the invention, colloidal silica in the form of pyrogenic silica or colloidal silica gel is dispersed in the sealing composition. Pyrogenic silica is preferred. The 20 pyrogenic silica is prepared by flame hydrolysis of silicon tetrachloride. It is available 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., USA. These products are colloidal silica with a very large surface area. A suitable specific product is e.g. "Cab-O-Sil®" with the type designation "Grade M-5".

In the broadest aspect of the invention, colloidal sieve 1 in -cium dioxide is incorporated into the composition in an amount of from 0.1 to 4.0% by weight.

(This and other percentages are based on the total weight of the composition including the silica and all other ingredients in the finished product.) Within the stated range, the gel composition's durability in contact with urine and / or intestinal fluids is significantly increased while the wet adhesiveness remains sufficient. . However, it is preferable not to use more than 1.5% silica (i.e., from 0.1 to 1.5%) so that the dry adhesive and the wet adhesive are more fully maintained.

In order to reduce the viscosity of the mixture and facilitate its formation, it has been found desirable to incorporate sodium carboxymethyl cellulose (CMC) into the mixture. There can be e.g. 2 to 15% CMC is used. IN

5

DK 155572 B

representative compositions are combined from 3 to 8 parts by weight of CMC with 40 to 50 parts of both karaya and glycerine and from 0.5 to 1.2 parts of pyrogenic silica. When CMC is omitted, the optimum amount of pyrogenic silica is somewhat lower, such as from 0.2 to 0.8% of the mixture.

The compositions may contain other minor ingredients such as preservatives or antibacterial agents. For example. For example, a preservative may be used as an all cooling parahydroxybenzoate or a mixture of such benzoates, the so-called parabens. For example. For example, a mixture of methyl, ethyl, propyl and butyl parabens can be used. When 10 parabens are used, such as in amounts of 0.1 to 0.5%, it may be desirable to first dissolve the parabens in propylene glycol or other glycerine co-solvent, in which the parabens are more soluble than in glycerine. There can be e.g. is used from 2 to 10 parts of propylene glycol per 100 parts of glycerine.

By combining the ingredients to produce the light-flow casting composition, the parabenes can first be dissolved in the small amount of propylene glycol and then the propylene glycol solution of the paraben is mixed with the greater amount of glycerine. The pyrogenic silica can then be dispersed in the combined polyhydroxy alcohols by mixing until a uniform dispersion is obtained. The hydrocolloid rubber powder is then added and the mixing is continued until the composition is uniformly mixed. The composition is then formed before gelation, which can take place within 5 to 10 minutes. For molding, the composition can be poured into annular or sheet molds and, under slight pressure, molded to the desired shape such as using a movable mold or press plate as the upper molding. During the molding process, the composition will quickly bind to a gel state. When desired, the gelation can be promoted by heating the composition either in the mold or after molding. The composition can e.g. is subjected to microwave heating in the mold, or the shaped rings or plates may be passed through an infrared heat tunnel. The heating temperature is not very critical as gelling will take place and become complete at room temperature. By heating the shaped plates or rings to a temperature of approx. However, at 71 to 82 ° C, quenching and gelling will be completed in a shorter time. During the bonding, there is usually no loss of polyhydroxyal alcohol, and the composition should therefore not be heated to a temperature above the same boiling point of polyhydroxy alcohol.

The practice of the present invention in preferred embodiments

DK 155572B

6 forms and the results obtained are further illustrated in the following examples.

Example 1 In a presently preferred embodiment, a protective sealing composition according to the invention is prepared using the following formula.

Formula A

Ingredients_% by weight (1) 2% pyrogenic SiO2 ^ in glycerine mixture ^ 50.0 (2) Karaya gum powder 45.0 (3) Sodium carboxymethylcellulose (CMC) ^ 5.0 100.0 15 O-Sil® M-5 "(b) Passes screen with mesh width of 0.105 mm; 10 - 18 G Humidity (c) "CMC 7HOX8F" (Hercules, Incorporated, Wilmington, Delaware) (d) Glycerin blend: 94.795% glycerine, 4.839% propylene glycol, 0.161% methyl paraben, 0.028% propylparaben and 0.177% butyl paraben.

In the mixture of the above ingredients, the glycerine mixture is mixed with the pyrogenic silica uniformly dispersed therein with the karaya gum powder and sodium carboxymethyl cellulose until a uniform gelling mixture is obtained. This mixture is poured before gelation into molds to form rings or plates and cured in molds to produce the ring or plate product. The curing can be achieved by leaving the composition in the molds overnight at ambient temperature. Alternatively, the curing can be accelerated by heat exertion from infrared lamps or by microwave radiation. Microwave heating is preferred.

To improve the dry adhesive, a small amount of appropriate pressure-sensitive adhesive is deposited at the bottom of the molds before being filled with the mixture. The adhesive may e.g. be the medical pressure sensitive 35 vinyl acrylic adhesive with the designation "H49" from U.S. Adhesives, Chicago,

Illinois, USA.

7

DK 155572 B

Eksempei_2.

In another embodiment, a protective sealing composition according to the invention is prepared using the following formula.

5

Formula B

Ingredients_ Weight Percent (1) Propylene Glycol (USP) 2.25 (2) Methyl paraben 0.075 (3) Propylparaben 0.013 (4) Butyl paraben 0.082 (5) Glycerin (USP, 99%) 46.58 (6) Pyrogenic SiO2 0.50 (7) Karaya gum powder 50.50 15 100.00

In the mixture of the above ingredients, the ingredients (2) to (4), the parabens, are dissolved in ingredient (1), the propylene glycol. This solution is added to ingredient (5), the glycerine, and mixed to uniformity. Ingredient (6), the pyrogenic silica, is then dispersed in the liquid solution of the foregoing ingredients and the dispersion mixed until uniform. The karaya powder, ingredient (7) is then added with continued mixing until a uniform gelling mixture is obtained. This mixture is poured before gel formation in molds to form rings or plates and cured in molds to produce the ring or plate product. Curing can be achieved by leaving the composition in the molds overnight at ambient temperature. The cure can be alternatively accelerated by the influence of heat from infrared lamps filtered by microwave radiation.

In the above example, the pyrogenic silica "Cab-O

Sil® M-5 ". The karaya rubber is in the form of a powder which can pass a sieve with a mesh width of 0.105 mm and can contain from 10 to 18% moisture.

Example 3

A composition is prepared as described in Example 2 except that the kara gum powder is replaced on a weight basis with algin powder. The algin is provided by Kelco Company, Clark, New Jersey.

DK 155572 B

8

Example 4

Using the mixing procedure described in Example 2, a protective sealing composition is prepared according to the following formula.

Formula C

Ingredients_ Weight Percent (1) Propylene Glycol (USP) 2.88 (2) Methyl paraben 0.098 (3) Propylparaben 0.017 10 (4) Butyl paraben 0.105 (5) Glycerin (USP, 99%) 56.4 (6) Pyrogenic SiO2 0.5 (7) Xanthan Rubber 40.0 100.00 15 In the foregoing formula, xanthan gum is a food grade product supplied by Kelco Company, Clark, New Jersey.

Example 5 A protective sealant composition is prepared using the mixing and molding procedure described in Example 2 on the following composition.

Formula D

Ingredients_ Weight Percent (1) Propylene Glycol (USP) 2.37 (2) Methyl paraben 0.079 (3) Propylparaben 0.014 (4) Butyl paraben 0.087 (5) Glycerin (USP, 99%) 46.45 (5A) Sorbitol (USP, 70%) 5.0 (6) Pyrogenic SiO2 1.5 (7) Zedoux powder 44.5 100.00

By mixing the foregoing ingredients, the ingredients (5) and (5A), glycerin and sorbitol, as described for glycerin, ingredient (5), are combined in the process of Example 1.

35

DK 155572B

9

Example 6

A protective sealant composition is prepared in accordance with the mixing procedure of Example 2 using the formula below.

5

Formula E

Ingredients_ Weight Percent (1) Propylene Glycol (USP) 3.05 (2) Methylparaben 0.10 (3) Propylparaben 0.02 (4) Butyl Paraben 0.11 (5) Glycerin (USP, 99%) 59.72 (6) Pyrogenic SiO2 2.0 (7) Sodium carboxymethyl cellulose 35.0 15.00

The sodium carboxymethyl cellulose is CMC 'VnOXF'1. Oe shaped rings or plates are preferably cured by microwave heating.

Example 7 A protective sealant composition was prepared according to the following formula.

Formula F

Ingredients_ Weight Percent 25 (1) Propylene Glycol (USP) 2.71 (2) Methylparaben 0.09 (3) Propylparaben 0.020 (4) Butyl Paraben 0.1 (5) Glycerin (USP, 99%) 53.08 30 (6) Deionized Water 3.0 (7) Pyrogenic SiO2 1.0 (8) Sodium Carboxymethyl Cellulose 15.0 (9) Karaya Rubber Powder 25.0 100.00

In the mixing of the above ingredients, the same mixing procedure as described in Example 2 with regard to the ingredients (1) to (5) is used. Ingredient (6), the deionized water, is added

DK 155572 B

then, and the mixture is continued to produce a uniform mixture. Ingredient (7), the pyrogenic silica, is then dispersed in the liquid solution to form a uniform dispersion. Ingredient (8), sodium carboxymethyl cellulose, is then added with continued mixing, and ingredient (9), karaya, is finally added and mixing is continued until a uniform gel-forming composition is obtained. The molding and gelling process is the same as described in Example 2.

Example 8

Durability and adhesive tests were conducted using the basic formula given below and amounts of pyrogenic silica from 0 to 2.5% ("Cab-O-Sil® M-5").

15 Basic formula

Ingredients_ Weight Percent (1) Propylene Glycol (USP) 0.735 (2) Methyl paraben 0.098 (3) Propylparaben 0.029 (4) Butyl paraben 0.049 (5) Glycerin (USP, 99%) 49.04 (6) Pyrogenic Si 5 (7) Karaya Rubber Powder 50.0 25 For the durability tests, the simulated intestinal fluid was prepared as described in USP XIX "Intestinal Fluid, Simulated, TS," page 765 (1974). The simulated urine was prepared as described in Remington's Pharmaceutical Sciences, "Urine", pages 598-9, Ed. 15 (1975). The dry adhesive and wet adhesive tests were performed by a modification of ASTM method 02979-71 using a 0.5 cm diameter test body.

The durability test apparatus comprises a tank for the simulated intestinal fluid or urine and a number of tripod sample holders which may be placed in the tank in contact with the solution. The sample holder has a 35 platform upstairs with a recess for receiving a sample. The central portion of the recess is cut to provide an opening through the platform. Placed in the test position, the test pieces bridge the openings. U-shaped weights are then placed over the samples. These weights

DK 155572B

11 is in the form of steel hooks with an approximate weight of 7.4 grams. In use, the hooks are placed over the samples so that when the hooks break through the samples they will fall freely through the openings in the platforms. Nylon threads are attached to the upper transverse arm portions of the inverted non-shaped hooks and the wires are attached to the operating arms of micro switches, the length of the wires being selected such that the micro switch will be activated when the sample is broken and a timer for it. the sample in question will be stopped. At the start of the test, after the samples are placed in the tank and the wires are attached to the micro switch 10 arms, the simulated urine or intestinal fluid is added to the tanks at a level above the samples position and the timer for each sample is started. The time elapsed for the breakthrough of each sample is thereby automatically recorded.

The durability samples were cut sections of rings 15 formed from the formulas with varying content of pyrogenic silica. Each sample weighed about 1.0 g and was of elongated shape. The central parts of the specimens in contact with the loaded hooks had dimensions of approx. 3.8 mm x approx. 7.6 mm. The measured time to breakthrough was corrected by multiplying the measured time 20 by 1.0 g of the sample divided by the actual weight of the sample. For the adhesive tests, cut pieces of the rings were placed on test discs with a central opening through which the adhesive sampler extended. Dry adhesiveness was determined with the surface of the sample in a dry state, and wet adhesiveness was determined after the sample had been in contact with water. The force needed to separate the sample body from the sample was measured in grams and recorded as grams per gram. centimeter of sample body media, which was 0.5 cm. On each sample, repeated tests were performed and the values were calculated as the average of five identical samples.

The results obtained by the durability and adhesive tests are 30 steps 11 below in Table A.

35 12

DK 155572B

Table A

% Pyrogenic Durability Durability Adhesive Durability

Si And in simulated urine simulated inte- (g / 0.5 cm) 5 _stinal fluid dry wet

None 2.0 hours 1.5 hours 216 324 0.25% over 24 hours 16.0 hours 342 406 0.5% 18.75 hours over 24 hours 338 428 1.0% over 24 hours over 24 hours 246 312 10 1.75% over 24 hours over 24 hours 164 270 2.5% over 24 hours over 24 hours 100 270

Example 9

Further durability and adhesive testing were performed using the basic formula set forth in Example 1 and the method therein. The silicon dioxide content varied from 0.2 to 4.0%. The total amount of pyrogenic silica and glycerine blend was kept at 50% by weight, the amount of glycerine blend being reduced accordingly as the amount of pyrogenic silica increased. The shelf-life times were measured based on hours per gram of sample and the samples were prepared with a diameter of 0.25 cm. The results obtained are summarized below in Table B.

Table B 25% Pyrogenic Shelf life (hours / g) Adhesive capacity

SiOg simulated simulated in- (g / 0.25 cm, dia) _urine_testinal fluid_ dry wet_ 0.2 98.7 87.1 322 594 30 0.5 61.0 64.7 390 558 1.0 93 68 320 586 2.0 148, 7 114.7 38 552 3.0 128.8 103.2 4 370 4.0 132 71.5 0 334

Example 10 In any formulation where the shaped ring or plate has insufficient dry adhesive, on that side of the ring 35

Claims (7)

A protective sealing composition in the form of a shaped gelled ring or plate for application around a surgical fluid drainage opening, comprising a mixture of a gelling water-absorbing particulate hydrocolloid rubber and a non-toxic liquid polyhydroxy alcohol, wherein the composition is dispersed from 0.1 to 4.0% by weight of colloidal silica in the form of pyrogenic silica or colloidal silica gel. 2. A composition according to claim 1, characterized in that the silica is pyrogenic silica. 3. A composition according to claim 1 or 2, characterized in that the silica is present in an amount of 0.1 to 1.5% by weight. A composition according to any one of the preceding claims, 20 THE CHARACTERISTICS OF THE HYDRAULIC COLUMN GUM IS KARAYA GUM POWDER. A composition according to any one of the preceding claims, characterized in that the alcohol is glycerine or a mixture of glycerine and propylene glycol. A composition according to any one of the preceding claims, 25, characterized in that it also contains from 2 to 15% by weight of sodium carboxymethyl cellulose. 7. A composition according to claim 1, characterized in that it is essentially composed of a mixture of karaya gum powder and glycerine, dispersing from 0.1 to 1.5% by weight pyrogenic silica 30 together with 3 to 8% by weight sodium carboxymethyl cellulose. 35