CA1102697A

CA1102697A - Ostomy composition

Info

Publication number: CA1102697A
Application number: CA302,533A
Authority: CA
Inventors: James L. Chen; Rudolfo D. Cilento; John A. Hill; Anthony L. Lavia
Original assignee: ER Squibb and Sons LLC
Current assignee: ER Squibb and Sons LLC
Priority date: 1977-06-08
Filing date: 1978-05-03
Publication date: 1981-06-09
Also published as: NZ187189A; US4166051A; FR2393566A1; SE7806691L; DK152093C; ZA782595B; DK152093B; NO149966C; IT7849756A0; AU522619B2; GB1598968A; NO149966B; JPS6120308B2; DE2825196C2; DE2825196A1; NO781986L; NL184998B; IE46830B1; BE867939A; NL184998C

Abstract

ABSTRACT

A composition adapted for use around the stoma con-sisting of a homogeneous mixture of a pressure sensitive adhesive component, mineral oil, and hydrocolloid gums or cohesive strengthening agents or a mixture of hydrocolloid gums and cohesive strengthening agents. By controlling the amount of mineral oil the resulting composition can be easily shaped according to the particular need.

Description

Major abdominal surgery for a number of diseases involving different parts of the gastro-intestinal and urinary tract can result in the patient being leEt with an abdominal stoma. The three most common types of abdominal stoma are the colostomy, the ileostomy, and the ileal conduit. In the case of an ileostomy, ileal conduit, and many colostomy operations, the patient is unable to control the passage of bodily waste material and must rely upon an appliance attached to their body to collect this material.
These appliances can be attached directly to the body by means of an adhesive faceplate or mounting gasket or can be attached to an ostomy washer or skin barrier which is fitted around the stoma.
A mounting gasket including a sealing ring formed from a karaya-glycerol gel is described by Marsan in U. S.
Patent 3,302,647. Ostomy washers formed of other materials have been taught in the art. For example, Etes in U. S.
Patent 3,640,741 discloses a washer formed of a cross-linked alginate or carboxymethylcellulose gum, Pratt in U. S.
Patent 3,612,053 describes an ostomy sealing washer formed from an oil-extended block copolymer having a water activatable adhesive on one surface, Marsan in U. S. Patents 3,712,304 and 3,799,166 describes an ostomy seal made from starch and _ I _ 6~ S~16 gelatinized starch cross-linked with glyoxal, Marsan in U. S. Patent 3,878,847 describes a thin membrane that con-tacts the stoma, Marsan in U. S. Patent 3,908,658 describes an ostomy seal formed from a gel o~ mineral oil, stryene-isobutylene copolymer and an ethylene-vinyl acetate copolymer, and Kross in U. S. Pa-tents 3,877,~31 and 3,980,084 describes ostomy seals formed from polymeric materials.
Chen in U. S. Patent 3,339,5~6 describes a bandage having an adhesive layer consisting of a mixture of gelatin, pectin, sodium carboxymethylcellulose, and polyisobu-tylene and a water insoluble polyethylene film which is currently employed as a skin barrier by ostomates. Other commercially available skin barriers contain a cloth mesh layer or poly-ethylene web sandwiches between two adhesive layers. The adhesive layers comprise a conventional pressure sensitive adhesive and a hydrocolloid.
In employing any of these systems it is di~ficult for the ostomate to achieve a tight fluid proof seal betwccn the mounting gasket, washer, and/or skin barrier and the stoma. Leakage of the corrosive effluent from the s-toma will eventually cause disintegration of the mounting ~asket, washer, or skin barrier necessitating removal of the appli-ance. Also, this erosion can permit the corrosive effluent to contact the skin contiguous to the stoma causing serious irritation.
Ostomates having this problem employ various products to fill the area between the stoma and the gasket, washer, and/or skin barrier. Karaya powder is the most widely used product at this time. Various ointment or pas-te -type products 3~ have been suggested and used by ostomatcs to protcc~ thc~ arca ~Z697 SA16 of skin contiguous to the stoma including those taught by Steinhardt in U. S. Patent 3,029,1~7, Cyr et al. in U. S~ Patent 3,029,188, Chen in U. S. Patent ~906,951, and Pichierri in U. S. Patent 4,00~,263.
Another problem facing many ostomates involves the actual attachment o the appliance. In order to secure the appliance and achieve a tight fit around the stoma, it is desirable that the body surface be relatively flat and smooth.

An ostomate whose abdomen is flabby or who has scar tissue as a result of surgery may need to contruct a platform type of dressing by piecing together a skin barrier. The con-struction of such a dressing is both time consuming and expenslve.

This invention is directed to a composition adapted for use by an ostomate. The composition is a homogeneous mixture of a pressure sensitive adhesive component, mineral oil, and hydrocolloid gums or cohesive strengthening agents or a mixture of hydrocolloid gums and cohesive strengthening agents.
The composition can be shaped so as to fill the area between the stoma and a mounting gasket, ostomy washer, and/or skin barrier. Also, the composition can be employed to build-up an area of the abdomen around the stoma so as to pro~
vide a relatively flat and smooth surface to which an appliance or skin barrier can be securely attached.

The compcnents of the composition of this invention are selected to obtain the desired balance of plasticity, cohesive strength, and tack. The composition differs from the rela-tively rigid ostomy washers and the amorphous ointments, pastes, or po~ders described above in that it has a putty~like con-sistency which ~ermits it to be easily shaped by hand and fitted around the stoma or used to build-up an area of the abdomen under a skin barrier. Since the composition is contacting the body around the stoma it must not contain ingredients which will irritate this already sensitive area of skin.
The composition should be tacky so as to aid in securing the appliance or skin barrier to the body but must not be so sticky that it can not be easily shaped by hand.
The composition must possess sufficient elasticity so that when in place on the abdomen it can follow changes in contour and shape caused by movement of the ostomate. The composition should resist disintegration caused by contact with effluent leaked from the stoma.
The composition of this invention can be viewed as being a homogeneous mixture of a plasticizing agent and a homogeneous premix including a pressure sensitive adhesive component and hydrocolloid gums or cohesive strengthening agents or a mixture hydrocolloid gums and cohesive strengthening agents.
The pressure sensitive adhesive component of the com-position provides dry adhesion or dry tack and holds the entire composition together. Various natural or synthetic viscous substances either possessing dry tack by themselves or developing such tack upon the addition of a plasticizer such as natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, polyisobutvlenes, etc., ~`

~ S~16 are suitable for this purpose. ~ow molecular weight poly-isobutylenes having a viscosity average molecular weight of from about 36,000 to about 58,000 (Flory) are pre~erred.
Such polyisobutylenes are commerciallv available under the trademark Vistane~ from Exxon Co. as grades LM-MS and LM-MH.
Optionally, in order to increase the elasticlty and flexibilit~
of the composition elastomeric polymers such as medium molecular weight polyisobutylenes having a viscosity average molecular weight of from about 1,150,000 to 1,600,~00 (Flory) or butyl rubber which is a copolymer of isobutylene with a minor amount of isoprene having a viscosity average molecular weight o~
from about 300,000 to about 450,000 (Flory) can be added.
Butyl rubber having a viscosity average molecular weight of about ~25,000 (commercially available as grade 077) is pre-ferred. The elastomer can be added in amounts o:E up to about 30% by weight of the pressure sensitive adhesive. The pressure sensitive adhesive and the optionally added elastomer together should be from about 40~ to about 60~ by weight of the premix.
Preferably, the low molecular weight polyisobutylene pressure sensitive adhesive and the higher molecular weight butyl rubber elastomer are employed in a ratio o~ from about 3 to 1 to about 5 to 1 on a weight basis, 4 to 1 being most preferred, and the combination is present at from about 45 to about 55~ by weight of the premix.
Chen in U.~. Patent 3,339,546 disclosed the in-corporation of various water soluble or swellable hydrocolloids in an adhesive com~osition. It was felt that these hydrocolloid materials would absorb moisture such as perspiration and pro-vide wet adhesion or we~ tack for the composition. It has been found that certain hydrocolloid gums while possessing .~

~ SA16 the ability to absorb such moisture, in fact, are not suitable for use within the composition since upon swelling they turn into a soft gelatinous mass. This swelling and loss of con-sistency can cause the composition to erode and disintegrate.
Thus, if a hydrocolloid gum is included within the premix it should have a large capacity to absorb moisture, should provide wet adhesion, and should also hydrate and swell at a relatively slow rate so as not to cause disintegration of the composition. Guar gum, locust bean gum, and mixtures thereof have been found to be suitable with guar being pre-ferred and such gums can be present at up to about 40% by weight of the premix.
An additional gum substance having soothing or healing properties can be included within the premix. Pectin, gum karaya, and mixtures thereof have been found to be suitable with pectin being preferred and can be present at from 0% to about 25% by weight of the premix provided that the total amount of gums within the premix is no more than about 60%
by weight, preferably up to 55%.
A cohesive strengthening agent can be included within the premi~. Such agents while not providing any wet tack function similarly to the hydrocolloid in absorbing moisture and thus decreasing the tendency o~ the composition to erode and disintegrate. Also, when combined with hydrocolloid gums the cohesive strengthening agent will control the swelling of the gum and lessen the rate of disintegration. Of course, the cohesive strengthening agent employed in the premix must also result in a final composition having the desired con-sistency after addition of the plasticizing agent. Suitable cohesive strengthening agents are finely divided cellulose materials including purified wood cellulose such as that available commercially under the trademark Solka-Floc and microcrystalllne cellulose such as that available commercially under the name Avicel, finely divided substantially water in-soluble cross-linked dextran such as tha-t available commercially under the trademark Sephadex, finely divided substantially water insoluble cross-linked sodium carboxymethylcellulose such as that available commercially under the trademark Aqualon or that described in U. S. Patent 3,5~,364 and available commercially from The Buckeye Cellulose Corp., and a finely divided substantially water insoluble starch-acrylonitrile graft copolymer such as -that described in U. S. Patent 3,661,815 and commercially available from the Grain Processing Corp. These materials can be present at up to about 60% by weight of the premix, preferably 55~ ified wood cellulose lS the preferred cohesive strengthener.
If desired, the premix can include a mixture of one or more hydrocolloid gums and one or more cohesive strengthening agents. Such a mixture should be present at from about 40~ to about 60~ by weight of the premix, preferably 45% to 55%.
Small amounts, i.e. less than 5% by weight of the premixj of other ingredients can be also included. For example, an antioxidant such as butylated hydroxyanisole, a deodorant, or a perfume agent can be included.
The premix is prepared by forming a homogeneous dispersion of the pressure sensitive adhesive component and the elastorner with a heavy duty mixer, e.g. a kneader mixer or sigma blade mixer. The hydrocolloid gums, cohesive ~treng-thening agent, and any other optional-ingredients are added and mixing is continued until a homogeneous dough is ~ Trade Mark formed. Alternatively, the elastomer is first broken down by mixing for several minutes, a portion of tlle pressure sensitive adhesive and other in~redients are added and mixing con-tinued until a homogeneous mass is formed. The balance of the pressure sensitive adhesive is then added and the mlxing continued until a homogeneous dough is formed. This dough is a relatively tough cohesive mass.
In order to prepare a composition which can be easily shaped by hand a plasticizing agent is added to the premix.
1~ The plasticizing agent must be compatible with the ingredients in the premix and, in particuIar, must not impair the dry tack resulting from the pressure sensitive adhesive component of the premix. Mineral oil is the preferred plasticizer.
The mineral oil and the premix are present in the final composition in a ratio of ~rom about 1 to 10 to about 3.5 to 10 on a solids weight basis. If an insufficient amount of mineral oil is added the composition will be too touyh to shape by hand and if too much mineral oil is add~(~ thc composition becomes sticky and difficult to handle.
The final composition is prepared by grac1ually adding the mineral oil to the doughy premix while continuously mixing until a homogeneous product is obtained. This compo-sition can be packaged as bulk in jars or shaped and packaged in smaller amounts.
The following examples are illustrative of the inven-tion. Other suitable adhesive composition can be obtained by minor variations in the amounts of ingredients employed.

6~7 ~Ex~mp;le\l This exam~le is directed to preparing a composition consisting of mineral oil and a premix.
Percent by weight Premix ingredients oE the premix Polyisobutylene of a viscosity average molecular weight (Flory~
of 36,~00 to 45,000 *~Vistanex LM-MS of Exxon) 40 Butyl rubber of a viscosity average molecular weight (Flory) of 425,000 (Exxon grade 077) 10 Guar gum of high grade extra fine powder *(Jaguar A-40-F
of Stein ~all Co.) 30 Finely divided purified wood cellulose *(Solka-Floc BW-100 of Brown Co.) 20 1.6 kg. of butyl rubber is broken down by mixing in a kneader mixer for two to five minutes. 3.2 kg. of the low molecular weight polyisobutylene is added and mixed with the butyl rubber for two to five minutes. 4.8 kg. of guar gum and 3.2 kg. of the finely divided purified wood cellulose are com-bined in a powder mixer and the resulting powder is added to the polyisobutylene-butyl rubber mixture. Mixing of the ingredients is continued until a homogeneous mass is formed with the polyisobutylene and butyl rubber completely inter-dispersed (about 10 to 20 minutes). The remaining 3.2 kg. of the low molecular weight polyisobutylene is added and mixing is continued until a homogeneous dough is formed (about 10 to 20 minutes~.
The resulting 16 kg. of premix is combined with 4 kg.
of mineral oil. The mineral oil is added gradually over the course of about 15 to 20 minutes with continuous stirring until a homogeneous mass is formed.

*Trade Mark i7~ ' 9~ SA16 Exarnples 2 to 33 Following the procedure of example 1 but employing the following ingredients other compositions within the scope of the invention are obtained.

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A composition adapted for medicinal use and having a consistency which permits it to be shaped by hand comprising a homogeneous mixture of mineral oil and a premix in a ratio of from about 1 to 10 to about 3.5 to 10 on a solids weight basis;
wherein said premix comprises a homogeneous mixture of from about 40% to about 60% by weight of a pressure sensitive adhesive component and either up to about 60% by weight of hydrocolloid gums, or up to about 60% by weight of cohesive strengthening agents, or from about 40% to about 60% by weight of a mixture of hydro-colloid gums and cohesive strengthening agents; wherein said up to 60%
by weight hydrocolloid gums are up to about 40% by weight of guar gum, locust bean gum, or mixtures thereof and from 0% to about 25%
by weight of pectin, gum karaya, or mixtures thereof; and wherein said cohesive strengthening agent is finely divided cellulose, finely divided substantially water insoluble cross-linked dextran, finely divided substantially water insoluble sodium carboxymethylcellulose, or finely divided substantially water insoluble starch-acrylonitrile graft copolymer.

2. The composition of claim 1 wherein said pressure sensitive adhesive component comprises low molecular weight polyisobutylene and an elastomer, said elastomer being present at from 0% to about 30% by weight of said low molecular weight polyisobutylene.

3. The composition of claim 2 wherein said pressure sensitive adhesive component is a mixture of polyisobutylene having a viscosity average molecular weight of from about 36,000 to 58,000 on the Flory scale and butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory sclae, said polyisobutylene and said butyl rubber being combined in a ratio of from about 3 to 1 to about 5 to 1 on a weight basis.

4. The composition of claim 3 wherein said up to 60%
by weight hydrocolloid gums are up to about 40% by weight guar gum and from 0% to about 25% pectin by weight and said cohesive strengthening agent is purified wood cellulose.

5. The composition of claim 4 wherein said premix comprises from about 45% to about 55% by weight of a mixture of said low molecular weight polyisobutylene and said butyl rubber combined in a ratio of about 4 to 1 on a weight basis and either up to about 55% by weight of hydrocolloid gums, or up to about 55% by weight of purified wood cellulose, or from about 45% to about 55% by weight of a mixture of hydrocolloid gums and purified wood cellulose; wherein said up to 55% by weight of gums are up to about 40% by weight of guar gum and from 0% to about 25% by weight of pectin.

6. The composition of claim 5 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of finely divided purified wood cellulose.

7. The composition of claim 6 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

8. The composition of claim 5 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of pectin.

9. The composition of claim 8 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

10. The composition of claim 5 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, and about 50% by weight of finely divided purified wood cellulose.

11. The composition of claim 10 wherein said mineral oil and said premix are combined in a ratio of from about 3.5 to 10 on a solids weight basis.

12. The method of protecting the area of skin between the stoma and an attached appliance, face plate, or skin barrier comprising shaping the composition of claim 1 by hand and placing the shaped mass around the stoma.

13. The method of providing a smooth abdominal sur-face around the stoma for attachment of a skin barrier or appliance comprising shaping the composition of claim 1 by hand and applying said composition over any rough areas in the abdominal surface.