US 3249109 A
Description (OCR text may contain errors)
Ma 3, 1966 H. MAETH ETAL 3,249,109
TORI CAL DRESS ING Filed Nov. 1, 1963 HARRY MA ETH R. DAVID PENNINGS BY Vndrus 9f Star/ 52 A'f-ronwsvs INVENTORS United States Patent 3,249,109 TOPICAL DRESSING Harry Maeth, 101 Main, and Ralph David Pennings, 302 Main, both of Mosinee, Wis. Filed Nov. 1, 1963, Ser. No. 320,809 9 Claims. (Cl. 128-268) This invention relates to a pharmaceutical preparation and more particularly to a pharmaceutical preparation for topical application to mucous membranes.
It is often desired to apply a dressing to the mucous membranes of the body, such as the oral cavity. For example, it may be desired to apply a post-operative dressing following gum surgery, or to use a dressing for intraoral traumatic wounds. In the past, dressings to be used in the oral cavity were generally made of tinfoil and included a base plate material which required heat to adapt it to its position on the membrane. If the dessing included a medicament or therapeutic agent, leakage of the agent generally occurred and could not be controlled. This resulted in the incomplete application of the agent to the site of treatment and dispersion of the agent into the mouth and possible entry into the alimentary tract.
The present invention is directed to an adhesive dressing to be topically applied to the body and in particular to the mucous membranes, such as the oral cavity. More specifically, the dressing or pharmaceutical preparation includes a flexible adhesive base composed of hydrated gelatin and including a small amount of pectin. In addition, a medicament or therapeutic agent can be incorporated in the flexible base. The base material is applied to the membrane at the site of the treatment and will adhere to the moist membrane. To prevent loss of the medicament or therapeutic agent, a backing member is applied to the outer surface of the flexible base. The backing member may take the form of a generally inert fabric, such as glass fibers, muslin or the like.
The hydrated gelatin base, which serves as the vehicle for the medicament or therapeutic agent, is flexible and is very adhesive and will readily adhere to the surfaces of the oral cavity or other mucous membranes. The gelatin base will remain flexible for extended periods of time and will not crack or chip. Moreover, the base does not contain oils or essential oils which can be irritating or toxic to the patient.
The use of the fabric backing layer insures theproper dosage of the medicament or therapeutic agent and prevents the dispersion of the agent from the site of treatment, thereby preventing the dispersion of the agent into the mouth and possible entry into the alimentary tract.
The pharmaceutical preparation or dressing can be used as a post-operative dressing in gum surgery, as a dressing for intraoral traumatic wounds, for the management of soft tissue lesions in the mouth, and as an irradiation shield for the treatment of malignant conditions with X-ray. In addition, it can also be used for topical application to the skin for abrasions, burns, varicose ulcers, and the like.
Other objects and advantages will appear in the course of the following description.
The drawings illustrate the best mode presently contemplated of carrying out the invention.
In the drawings:
FIG. 1 is a perspective view of a dressing prepared in accordance with the invention;
I FIG. 2 is a modified form of the invention showing the dressing in the form of a roll; and
FIG. 3 is a second modified form of the invention showing the dress-ing in the form of a pre-cut strip.
3,249,109 Patented May 3 1966 FIG. 1 shows a dressing 1 to be used for topical applications and particularly to the mucous membranes of the body. The dressing has particular application to the mucous membranes of the oral cavity, but also includes other areas such as the vagina, rectum, etc.
The dressing 1 includes a flexible hydrated gelatin base 2 and a fabric backing member 3. The hydrated gelatin base 2 contains by weight, 10 to 40% gelatin, 5 to Water, 15 to 80% polyhydric alcohol and up to 15% pectin.
The preferred range of composition, in weight percent is as follows:
Percent Gelatin 1033 Water 50-85 Polyhydric alcohol 15-35 Pectin 1-4 The hydrated gelatin gives the base its consistency and bulk and serves as the vehicle for the incorporation of medicaments and therapeutic agents.
Pectin is a carbohydrate obtained from the dilute acid extract of the inner portion of the rind of citrus fruits or apple peel. Pectin consists chiefly of partially methoxylated polygalacturonic acids.
The pectin provides adhesive properties to the hydrated gelatin and enables the gelatin base to be readily applied to moist surfaces, such as the mucous membranes.
The polyhydric alcohol serves to prevent brittleness and retains the flexible characteristics of the material for extended periods. The polyhdric alcohol can be glycerin, polyoxyethylene, propylene glycol, sorbitol, ethylene glycol (when used externally), and the like.
It is also contemplated that the base 2 will include a pharmacologically active material such as a medicament or a therapeutic agent. More specifically, the pharmacologically active material may include enzymes such as hyaluronidase; vasoconstrictors such as epinephrine; bactericides; bacteristatics; antacids; anesthetics; corticosteroids; antibiotics; hemostats; fluorides such as sodium fluoride, stannous fluoride, calcium fluoride; astringents, hormones; vitamins; tissue growth promoters such as Peruvian balsam; deodorants such as charcoal, and chlorophyll, and the like. The pharmacologically active material is used in an amount up to 10% by weight of the composition with the particular amount depending on the activity of the material.
The backing member 3 is formed of an inert, non toxic fibrous material such as glass fiber, muslin and the like. The use of glass fiber cloth has proven particularly satisfactory as a reinforcement and as a dam to reduce the spreading of the pharmacologically active material bility and a marked resistance to steam, corrosive fumes and most acids. In addition, the glass fiber will not absorb water and can be readily sterilized and re-sterilized and withstands repeated folding and creasing.
The fabric backing member 3 serves as a barrier and assures that the proper dosage of the medicament or therapeutic agent is supplied to the site to be treated. The backing member 3 prevents the agent from being dispersed into the mouth and prevents the entry of the agent into the alimentary tract.
To prepare the dressing of the invention, the gelatin and a portion of the Water and glycerin are mixed at an elevated temperature of about C. to form a gelatin component. ing portion of the water and glycerin to form a pectin component which is then added to the heated gelatin component. In some cases it may be desirable to add a The pectin is then mixed with the remainsmall amount, in the range of 1 to 2% of the total composition weight, of alcohol, such as ethyl alcohol, to the pectin component. The alcohol provides a rapid hydration of the pectin and can be omitted, but, if omitted, increases the time required for preparation.
After adding the pectin component to the gelatin component, the medicament or therapeutic agent is added as a solution or suspension, depending upon the particular agent used. The entire composition is then agitated to thoroughly mix the components and is subsequently poured into the desired mold and cooled. The backing member 3 is then overlayed onto the base material.
Example 1 As a specific example of the preparation, 30 grams of gelatin, 30 cc. of distilled water and 30 cc. of glycerin were mixed together and heated to a temperature of 90 C. to melt the gelatin. After the gelatin was melted, the pectin component consisting of 5 cc. of ethyl alcohol, 40 cc. of distilled water, cc. of glycerin and 5 grams of pectin was added to the liquid gelatin component and mixed therewith.
After adding the pectin component, 8 grams of Benzocaine and 40 cc. of alcohol, and 0.5 gram of Triburon (triclobisonium chloride) in 10 cc. of distilled water were added to the composition. After mixing in the Benzocaine and Triburon, the composition was poured into a mold and cooled. A glass fiber backing sheet was then overlayed over the composition and pressed firmly therein.
The resulting dressing was flexible and very adhesive and could readily be applied to mucous membranes.
Example 2 Three grams of pectin, 10 cc. of ethyl alcohol, 80 cc. of distilled water and 40 cc. of glycerin were mixed together. Forty grams of gelatin were added to this mixture and the entire composition heated to a temperature of 90 to 100 C. to melt the gelatin. Subsequently, 0.25
gram of Triburon in 17 cc. of glycerin and 20 cc. of distilled water were added to the gelatin-pectin composition. The resulting composition was then poured onto a suitable mold and cooled.
FIG. 2 shows a modified form of the invention in which the dressing is in strip form. In this embodiment the dressing includes a hydrated gelatin base 4 similar in composition to gelatin base 2 of the first embodiment. A fabric backing member 5 is applied to one surface of the base 4 and the backing member 5 is similar in structure and function to the backing member 3 of the first embodiment. In addition, a protective strip of material, such as waxed paper or other material, is applied to the outer surface of the barrier and serves to prevent the strip from sticking to itself when it is wound in spiral form.
The strip shown in FIG. 2 can be unwound as desired and cut to any length, depending on the nature of the site to be treated.
FIG. 3 shows a second modified form of the invention in which the dressing is in the form of a pre-cut strip. In this embodiment, the hydrated gelatin base 7, similar to base 2 of the first embodiment, is applied to an adhesive backing member 8. In this embodiment, a protective strip of material is applied to the adhesive surface of the strip 8 and can be removed immediately prior to application of the strip to the body surface.
The dressing of the invention is used for topical application, and particularly to the moist mucous membranes. For example, the dressing can be used as a post-operative dressing following surgery, as a dressing for traumatic wounds, 'as a dressing for soft tissue lesions and it also may be employed as an irradiation shield for the treatment of malignant conditions with X-ray. In this lattercase, a radiation barrier, such as powdered lead or barium sulphate, can be incorporated in the flexible base 2 in an amount of about 10 to 30% by weight of the base. The lead or barium sulphate is radiopaque material and serves as an irradiation shield to protect structures such as teeth and soft tissues from the radiation. This type of barrier is considerably more flexible and pliable than sheet lead for intraoral use, and being a lightweight material, is exceedingly more comfortable to the patient.
The dressing of the invention is flexible and will tightly adhere to moist membrane surfaces. If the dressing is to be applied to the external body tissues, it may be necessary to moisten the tissue before application.
It is contemplated that pharmacologically active materials can be incorporated in the hydrated gelatin base and the backing member serves to concentrate the activity of the material at the site of treatment and prevents the pharmacologically active material from dispersing outwardly into the mouth or other regions of the body.
Various modes of carrying out the invention are contemplated as being within the scope of the following claims particularly pointing out and distinctly claiming the subject matter which is regarded as the invention.
1. A pressure sensitive dressing for topical application, comprising a solid, flexible hydrated gelatin base capable of maintaining its shape and containing a suflicient amount of pectin to provide initial adhesiveness for application to moist tissue and containing a sufiicient amount of a polyhydric alcohol to maintain flexibility for extended periods, and a generally inert non-toxic fibrous backing member disposed on one surface of said base and serving to prevent the outward dispersion of materials from the base.
2. A dressing for topical applications, comprising a solid, flexible, adhesive, film-like, hydrated gelatin base consisting essentially by weight of 10 to 40% gelatin, 5 to 85% water, 15 to of a polyhydric alcohol, and up to 15% pectin, and a fibrous backing member applied to one surface of the base, said backing member reinforcing the base and serving to prevent the outward dispersion of materials from the base.
3. The structure of claim 2, in which the hydrated gelatin base contains up to 10% by weight of a pharmacologically active material, said backing member serving to concentr-ate the pharmacologically active material at the site of treatment and preventing the outward dispersion of said material.
4. The structure of claim 2, in which the polyhydric alcohol is selected from the group consisting of glycerin, polyoxyethylene, propylene glycol, ethylene glycol, and sorbitol.
5. The structure of claim 3, in which the backing member is composed of glass fiber fabric.
6. A pressure sensitive dressing for topical applications, comprising a nonflow-able flexible, adhesive, hydrated gelatin sheet consisting essentially by weight of 10 to 33% gelatin, 50 to water, 1 to 4% pectin, 15 to 35% glycerin, and up to 10% of a pharmacologically active material, and a fabric backing member applied to one surface of the hydrated gelatin sheet, said backing member serving to concentrate the pharmacologically active material at the site of treatment and preventing the outward dispersion of said material.
7. The structure of claim 6 in which the hydrated gel-atin sheet also includes from 1 to 2% by weight of alcohol.
8. A dressing for topical applications, comprising a flexible, adhesive, hydrated gelatin base consisting essentially by weight of 10 to 40% gelatin, 5 to 85% Water, 15 to 80% of a polyhydric alcohol, up to 15% pectin and from 10 to 30% by weight of a material selected from the group consisting of lead and barium sulfate, and a fibrous backing member applied to one surface of the base, said backing member reinforcing the base and serving to prevent the outward dispersion of the material from the base, said material serving as a radiation shield to protect portions of the body from radiation.
9. A pressure sensitive article, comprising a flexible, adhesive, hydrated gelatin base containing up to 30% by weight of a radiopaque material, and a fabric backing member applied to one surface of the hydrated gelatin base, said backing member serving to concentrate the radiopaque material at the site of treatment and prevent the outward dispersion of said materiaL-said mtaerial serving as a radiation shield to protect portions of the article from radiation.
References Cited by the Examiner UNITED STATES PATENTS 307,537 11/1884 'Foulks 167 84 335,799 2/ 1886 Baby. 2,115,237 4/1938 Scholl 128268 X 6 Donaldson 1'28156 Shrontz 128-268 Reese.
Hirsch 106-125 Steinhardt 32--2 X FOREIGN PATENTS Germany.
OTHER REFERENCES Macleods Physiology in Modern Medicine, Bard, 8th edition, 1938.
ROBERT E. MORGAN, Primary Examiner.
15 RICHARD A. GAUDET, Examiner.
C. F. ROSENBAUM, Assistant Examiner.