GB2165450A - Skin-patch for use in the topical administration of ointment - Google Patents

Abstract

A skin-patch for use in the topical administration of ointment and, in particular, to a skin-patch for use in the continuous administration of controlled quantities of nitroglycerin ointment comprises a backing member, and at least around the periphery of the backing member on one face thereof an adhesive layer adapted for releasably adhering to the skin. Also, there is associated with the backing member inwardly of the peripheral adhesive layer a graduated scale to facilitate dispensing of an ointment dosage by measurement with reference to the scale, and a peripheral band of release sheet covers the skin adhesive. <IMAGE>

Description

SPECIFICATION Skin-patch for use in the topical administration of ointment The present invention relates to a skin-patch for use in the topical administration of ointment and, in particular, to a skin-patch for use in the continuous administration of controlled quantities of nitroglycerin ointment to the skin or mucosa of a patient, to a process for producing the same, and to its use.

Topical application of nitroglycerin to the skin for the treatment of both Raynaud's disease and angina pectoris is well known. Several investigators have described substantial improvement in the acrosclerosis associated with Raynaud's disease resulting from nitroglycerin.

The treatment of angina pectoris with nitroglycerin or rapid acting nitrites has been described by Davis et al in the American Journal of the Medical Sciences, Vol. 230, No. 3, September, 1955. In that article, the authors suggested that nitroglycerin ointment, because of the slowed absorption through the skin, might result in the superior vasodilating effect of the nitroglycerin being prolonged in relation to coronary circulation. They reported that the results obtained were dramatic and convincing enough such that they have instituted nitroglycerin ointment treatment on a regular basis.

It is an object of the present invention to provide an adhesive skin-patch for use in the continuous administration of a predetermined quantity of an active material such as nitroglycerin, through the skin, over a period of time.

Another object of the present invention is to provide an adhesive skin-patch by which a quantity of active material such as nitroglycerin formulated as say an ointment can be dispensed for treatment in an easily determined and controlled manner.

According to the present invention, there is provided a skin-patch for use in the continuous administration of a controlled quantity of an ointment comprising an active material such as nitroglycerin to the skin or mucosa of a patient under treatment, which patch comprises: a) a backing member, b) around the periphery of the backing member on one face thereof a releasable adhesive layer adapted for contacting with the skin, c) associated with the backing member inwardly of the peripheral adhesive layer a graduated scale to facilitate dispensing of an ointment dosage by measurement with reference to the scale, and d) a releasable layer covering said adhesive layer.

As will be seen from the description herein, in particular from the description with reference to the drawings, the patch of the invention may comprise any arrangement of the above-defined features which can be adhered to the skin of a patient.

Accordingly, the term "patch" is to be construed in its broadest sense as including plasters, dressings, medicinal bandages or the like which include the features which of themselves define the skin-patch of the invention.

Preferably the skin-patch according to the invention is one in which a separate layer (an internal backing layer) attached to the backing sheet within the peripheral adhesive layer carries said graduated scale. Also, it is preferred that an adhesive layer should cover the said one face of the backing member and the separate (internal backing) layer should thereby be attached to the one face of the backing member. In that manner there is effectively left exposed (or exposable) said peripheral adhesive layer.

More preferably, the skin-patch is one for the continuous administration of controlled quantities of nitroglycerin ointment to the skin or mucosa and thus is one in which the graduated scale can permit accurate dispensing of a nitroglycerin ointment dosage by measurement with reference to the scale.

Furthermore, in the skin-patch of the invention the backing member, for example, by virtue of being carried on the separate internal backing layer, preferably has associated therewith two linear markings spaced from each other by a width equal to or at leasfessentially equal to the width of a ribbon of ointment dispensed from a tube, at least one of said markings and preferably both comprising a graduated scale. In addition, where two such scales are provided the graduations of one scale are preferably different from the graduations of the other scale. However, while the provision of two such scales is preferred, nevertheless any suitable single scale or other suitable calibration may be employed as desired, for example, as described specifically below with reference to the accompanying drawings.

Preferably also in the skin-patch according to the invention, the backing member is provided by a substrate having one surface thereof coated with a pressure-sensitive hypoallergenic adhesive and the remaining layers are provided by a liner having a release agent coating on one surface, the liner and substrate being adhered together via their thuscoated faces, and the liner being separable or separated into two portions, one of which provides the separate internal backing layer carrying the graduated scale and the other of which provides the release sheet layer. In addition, the skin-patch may be presented as a roll comprising a plurality of such patches each linked to another by a tear line to permit separation of a single patch from any remaining patches in the roll.

From the above it will be seen that, in accomplishing the above-mentioned objects, one aspect of the invention is the provision of a skin-patch that includes an external moisture-impervious backing and a smaller internal backing having graduations thereon. Furthermore, the graduations may be of different types or kinds provided they are suitable to afford a doctor and/or a patient with a convenient and accurate means of measuring out a controlled quantity of an ointment containing a known amount of an active material such as nitroglycerin to be applied to the skin-patch.In addition, the surface area of the internal backing layer of the skin-patch is chosen so that a therapeutically useful amount of an active material, e.g. a drug, can be delivered trans dermallyto a patient after it has been measured onto the internal backing layer, and the patch then applied to the skin of the patient. The internal backing layer is surrounded by an adhesive layer applied to the backing member, and which is covered with a detachable or releasable layer that can be removed to expose the adhesive layer for convenient attachment of the patch to the skin.

The patch may also include a removal tab to simplify later stripping of the patch from the skin, and such a tab may be provided by an area at an edge of the backing member which is not adhesive coated.

As will be appreciated from the decription herein, the skin-patch of the invention may be used in the administration of controlled quantities of any active material presented as an ointment or the like and suitable for topical application in a percutaneous or transdermal treatment. However, in particular, and preferably in accordance with the present invention the skin-patch is adapted for use in presenting nitroglycerin ointment in the topical treatment of Raynaud's disease and angina pectoris. Normally, a 2% nitroglycerin ointment is used in such treatment.

To use the skin-patch for such (or any other) treatment, it is necessary to perform an initial calibration both as to the dosage requirement of the individual patient in terms of the active material to be administered and in relation to the quantity of ointment to be applied to the skin-patch. In the former respect, conventional techniques are available to determine a patient's dosage requirements, and in the latter respect all that is required is a calibration of active material dosage vs. the graduations on the skin-patch graduated scale.

Thereafter, the patient can be instructed to apply a given amount of ointment to the skin-patch with reference to the graduated scale, and by doing so is assured of receiving the previously-calibrated dosage.

Thus, for example, to use the skin-patch for treatment of Raynaud's disease or angina pectoris the necessary predetermined amount of nitroglycerin ointment can conveniently be extruded from a tube onto the graduated area on the internal backing layer, with the dosage of nitroglycerin ointment being controlled by extruding say a predetermined length of ointment as measured against the graduated scale. Furthermore, where there are two spaced scales as in the abovementioned preferred embodiment, the extruded ribbon of ointment can be controlled not only as to length with reference to a graduated scale, but also as to width with reference to the spaced scales, thus ensuring a good measure of control over dosage.

After the necessary amount of nitroglycerin ointment has been applied to the internal backing layer, the releasable layer surrounding the internal backing layer is removed to expose the adhesive layer. The patch is then applied to the skin of the patient and pressed down firmly to ensure that it is attached to the skin via the said adhesive layer, and thereby ensuring that the measured dosage is administered to the patient as desired. Thereafter, at the end of the treatment the patch can be removed by grasping the patch itself or any skin removal tab provided at the edge ofthe patch and separating the patch from the patient's skin.

When used in the above-described manner the skin-patch of the invention can provide continuing in situ administration of active material over a period of time. Thus, in the case of administration of nitroglycerin the skin-patch can provide several hours of continuous protection against episodes of pain or discomfort in a patient. It is, of course, in that context in which the term "continuous" is used in the present specification and claims.

The skin-patch of the invention may be prepared by any suitable process which leads to the defined structure. Preferably, however, the patch is prepared by coating a suitable substrate such as a vinyl film with a hypoallergenic medical grade adhesive and then laminating the coated vinyl or other substrate to a reiease-coated liner, e.g. a paper liner.

Accordingly, the invention also provides a processforthe production of a skin-patch such as a patch as defined above, which process comprises coating one surface of a plastics film substrate with a hypoallergenic medical grade adhesive, providing a liner such as a paper liner bearing a release agent coating on one surface, laminating the substrate at its adhesive-coated face with the paper liner at its release agent-coated face, cutting the laminate if necessary to a desired width and/or length, and differentially cutting the laminate e.g. with a die, through the liner and if necessary the substrate, so as to provide a single skin-patch or a plurality of patches linked by a tear line such as a line of perforations, each such patch comprising a backing memberformedfrom a portion ofthefilm substrate, a separate internal backing layer supported on the backing member formed from one portion of the liner and a releasable layer surrounding the internal backing layer formed from another portion of the liner.

Preferably, in such a process each one portion of the liner is printed with a graduated scale suitable to permit measurement of an ointment dosage, and preferably before differential cutting is effected.

Also, the other portion of the liner may be printed with marking by way of lettering, design and/or ornament to indicate that it is distinct from the one portion of the liner and intended to be releasable from the substrate.

In addition, the invention includes a method for the preparation of a skin-patch for use in the continuous administration of a controlled quantity of an ointment comprising an active material such as nitroglycerin to the skin or mucosa of a patient under treatment, which method comprises applying to a skin-patch as defined above a quantity of ointment controlled by reference to a measure on the graduated scale of the patch, before attaching the thus-prepared patch at a suitable location to the skin of the patient, as well as a skin-patch beating a measured dosage of an active material when prepared by such a method.

Furthermore, the invention includes a pack for use in the topical administration of an active material wherein an ointment comprising the active material is used locally in the treatment, which pack comprises one or more skin-patches as defined above in which the graduated scale permits measurement of ointment dosage in the chosen administration regimen, together with one or more means such as a tube containing and for dispensing the ointment, optionally together with directions for administering controlled quantities of ointment to the skin or mucosa from the skin-patch by applying a ribbon of ointment to the patch using the graduated scale for measurement of ointment, and thereafter attaching the patch to the skin via the releasable adhesive layer on the backing member.

Also, the invention includes use of a skin-patch as defined above or a pack as defined above for the presentation of an active material for use in the treatment of patients susceptible of treatment by said active material, by applying to the patch a quantity of an ointment comprising the active material controlled with reference to the graduated scale associated with the backing member, e.g.

carried on the separate internal backing layer.

The invention will now be described by way of example with reference to the accompanying drawings in which: Figure 1 is a front view of one embodiment of a skin-patch according to the present invention showing one type of calibration on the separate internal backing layer and one arrangement of releasable layer; Figure 2 is a rear view of the patch of Figure 1; Figure 3 is a perspective view of the patch of Figure 1 with the releasable layer removed and with the adhesive layer exposed; Figure 4 is a front view of another embodiment of a skin-patch according to the present invention showing another type of calibration on the separate internal backing layer and another arrangement of releasable layer;; Figure 5 is a perspective view of the patch of Figure 4 with the releasable layer removed and with the adhesive layer exposed, and also with ointment applied to the separate internal backing layer; and Figure 6 is a front view of a further embodiment of a a skin-patch according to the present invention.

Referring to the drawings, Figures 1 and 2 show front and rear views of one embodiment of a skinpatch 10 according to the invention. The patch 10 comprises an overall backing member 14, a separate internal backing layer 12 secured or adhered to one face of the backing member 14 and a releasable layer 11 secured or adhered to the same face of the backing member 14 about the perimeter of the internal backing layer 12. The internal backing layer 12 and releasable layer 11 may conveniently be secured to the backing member 14 by first applying a releasable adhesive to the entirety of one surface of the backing member 14 and then applying the internal backing layer 12 and the releasable layer 11 to the adhesive surface. That portion of the adhesive surface 15 applied to the backing member 14 which is exposed when the releasable layer 11 is removed is shown in Figure 3.

The backing member 14 is a conventional polymeric plastics film such as a vinyl film commonly used in plasters, bandages or other dressings. In addition, the adhesive layer 15 should be composed of a hypoallergenic material such as an acrylic adhesive commonly used in adhesivecoated plasters, bandages or other dressings.

Furthermore, the releasable layer 11 may be composed of paper material having a conventional silicone-containing release agent on the surface thereof in contact with the adhesive layer 15. Also, the releasable layer 11 may have a cut 20 to permit easier removal of the releasable layer from the adhesive layer 15 by bending and peeling away from the cut 20.

The internal backing layer 12 may be composed of the same paper material as the releasable layer 11, although it should be kept in mind that the paper material should allow only minimal absorbency of the nitroglycerin or other ointment. Indicia 13 are printed on the exposed surface of the internal backing layer 12 and one form of the indicia presented as a graduated scale suitable for measuring an amount of nitroglycerin ointment to be applied to the internal backing layer 12 is shown in Figures 1 and 3.

Referring now to Figures 4 and 5, those show another embodiment of the skin-patch of the invention in which the features which are the same as the features of the embodiment shown in Figures 1 to 3, are identified by the same numerical designations. In the embodiment shown in Figures 4 and 5, a cut 21 in the releasable layer 11 is located through a corner of the layer to facilitate removal of the releasable layer 11 from the adhesive layer 15. Also, the indicia comprise two spaced parallel lines 16 and 17 with graduations in inches on one scale line 16 and in centimeters on the other scale line 17. The width of the space between the lines 16 and 17 is generally the width of an ointment tube opening and the ribbon of ointment produced thereby, so that the thus-presented linear arrangement permits of accurate measurement of ointment dosage with minimum variability.A ribbon of say nitroglycerin ointment 18 as applied between the two parallel lines 16 and 17 is shown in Figure 5.

Finally, referring to Figure 6, that shows a further embodiment of the skin-patch of the invention in which the releasable layer 11 surrounding the internal backing layer 12 is narrower than the releasable layers shown in Figures 1 and 4 such that the backing member 14 extends beyond the perimeter of the releasable layer 11. The adhesive layer applied to the backing member 14 does not extend beyond the perimeter of the releasable layer 11, thus providing a continuous tab 23 about the perimeter of the backing member 14 which may be gripped easily to strip the patch from the skin. Also, the cut 22 in the releasable layer 11 is located intermediate opposite ends of the patch.

Production of skin-patches in accordance with the present invention and as described above may be carried out by coating vinyl film or the like with a hypoallergenic medical grade adhesive and then laminating the coated vinyl to a release-coated paper liner. The vinyl/adhesive/release-coated liner laminate may then be wound into rolls, cutto width and rewound into narrower rolls of the desired width. Those rolls are then appropriately printed and die cut.

Differential die cutting is performed so that a band of releasable paper liner can be peeled away from the backing member 14 as layer 11, to expose a band of adhesive 15 whereby the patch can be secured to the patient, whilst leaving a portion of the liner forming the internal backing layer 12 on the member 14. Also, differential die cuts 20, 21 and 22 are made to facilitate the removal of the releasable layer 11 from backing member 14. The patches may be die cut so that they are produced in individual units; or perforations may be cut or other lines of weakening formed between individual patches so that a roll of patches can be produced from which a patch can be torn away along the perforations or the like, as it is needed.

As will be appreciated by those skilled in the art the invention is not limited to the above specific description and modifications and variations of the invention may be made without departing from the essence and scope thereof. Thus, for example, layers 11 and 12 may carry additional indicia or designs or decoration either by way of instruction or to differentiate the two layers. Also, the backing member 14 may be cut orotherwiseformed so that the layer 11 at its outside edges extends beyond the edges of the member 14.

Claims (24)

1. A skin-patch for use in the continuous administration of a controlled quantity of an ointment comprising an active material such as nitroglycerin to the skin or mucosa of a patient under treatment, which patch comprises: a) a backing member, b) around the periphery of the backing member on one face thereof a releasable adhesive layer adapted for contacting with the skin, c) associated with the backing member inwardly of the peripheral adhesive layer a graduated scale to facilitate dispensing of an ointment dosage by measurement with reference to the scale, and d) a releasable layer covering said adhesive layer.

2. A skin-patch according to claim 1, wherein a separate layer attached to the backing sheet within the peripheral adhesive layer carries said graduated scale.

3. A skin-patch according to claim 2, wherein an adhesive layer covers the one face of the backing member and said separate layer is thereby attached to the one face of the backing member.

4. A skin-patch according to any one of the preceding claims for the continuous administration of controlled quantities of nitroglycerin ointment to the skin or mucosa in which the graduated scale permits measurement of a nitroglycerin ointment dosage.

5. A skin-patch according to any one of the preceding claims, wherein the backing member has associated therewith two linear markings spaced from each other by a width at least essentially equal to the width of a ribbon of ointment dispensed from a tube, at least one of said markings comprising a graduated scale.

6. A skin-patch according to claim 5, wherein each linear marking comprises a graduated scale and the graduations of one scale are different from the graduations of the other scale.

7. A skin-patch according to any one of the preceding claims, wherein the backing member is provided by a substrate having one surface thereof coated with a pressure-sensitive hypoallergenic adhesive and the remaining layers are provided by a liner having a release agent coating on one surface, the liner and substrate being adhered together via theirthus-coated faces, and the liner being separable or separated into two portions, one of which provides the separate layer carrying the graduated scale and the other of which provides the releasable layer.

8. A skin-patch according to any one of the preceding claims when presented as a roll comprising a plurality of such patches each linked to another by a tear line to permit separation of a single patch from any remaining patches in the roll.

9. A skin-patch as hereinbefore described with reference to and as illustrated in the accompanying drawings.

10. A process for the production of a skin-patch such as a patch according to any one of the preceding claims, which process comprises coating one surface of a plastics film substrate with a hypoallergenic medical grade adhesive, providing a liner such as a paper liner bearing a release agent coating on one surface, laminating the substrate at its adhesive-coated face with the paper liner at its release agent-coated face, cutting the laminate if necessary to a desired width and/or length, and differentially cutting the laminate through the liner and if necessarythe substrate, so as to provide a single skin-patch or a plurality of patches linked by a tear line, each such patch comprising a backing member formed from a portion of the film substrate, a separate internal backing layer supported on the backing member formed from one portion of the liner and a releasable layer surrounding the separate internal backing layer formed from another portion of the liner.

11. A process according to claim 10, wherein each one portion of the paper liner is printed with a graduated scale suitable for measurement of an ointment dosage before differential cutting is effected.

12. A process according to claim 10 and substantially as hereinbefore described.

13. A skin-patch when produced by a process according to any one of claims 10 to 12.

14. A method for the preparation of a skin-patch for use in the continuous administration of a controlled quantity of ointment comprising an active material such as nitroglycerin to the skin or mucosa of a patient under treatment, which method comprises applying to a skin-patch according to any one of claims 1 to 9 or claim 13 a quantity of ointment controlled by reference to a measure on the graduated scale of the patch, before attaching the thus-prepared patch at a suitable location to the skin of the patient.

15. A method according to claim 14, wherein the skin-patch is prepared for use in the topical treatment of Raynaud's disease in which nitroglycerin ointment is used locally in the treatment, a quantity of nitroglycerin ointment adapted for such treatment controlled by reference to said measure being applied to the patch before it is attached to the skin of the patient.

16. A method according to claim 14, wherein the skin-patch is prepared for use in the topical treatment of angina pectoris in which nitroglycerin ointment is used for systemic effect in the treatment, a quantity of nitroglycerin ointment adapted for said treatment controlled by reference to said measure being applied to the patch before it is attached to the skin of the patient.

17. A method according to claim 14 and substantially as hereinbefore described with reference to the accompanying drawings.

18. A skin-patch bearing a measured dosage of an active material when prepared by a method according to any one of claims 14to 17.

19. A pack for use in the topical administration of an active material wherein an ointment comprising the active material is used locally in the treatment, which pack comprises one or more skin-patches according to any one of claims 1 to 9 or claim 13 in which the graduated scale permits measurement of ointment dosage in the chosen administration regimen, together with one or more means such as a tube containing and for dispensing the ointment, optionally together with directions for administering controlled quantities of ointment to the skin or mucosa from the skin-patch by applying a ribbon of ointment to the patch using the graduated scale for measurement of ointment, and thereafter attaching the patch to the skin via the releasable adhesive layer on the backing member.

20. A pack according to claim 19 for use in the topical treatment of Raynaud's disease wherein nitroglycerin ointment is used locally in the treatment, which pack comprises one or more said skin-patches in which the graduate scale permits measurement of nitroglycerin ointment dosage in the treatment of said disease, together with one or more means such as a tube containing and for dispensing nitroglycerin ointment.

21. A pack according to claim 19 for use in the topical treatment of angina pectoris wherein nitroglycerin ointment is used for systemic effect in the treatment, which pack comprises one or more said skin-patches in which the graduated scale permits measurement of nitroglycerin ointment dosage in the treatment of said disease, together with one or more means containing and for dispensing nitroglycerin ointment.

22. Use of a skin-patch according to any one of claims 1 to 9 or claim 13 or a pack according to any one of claims 19 to 21 for the presentation of an active material for use in the treatment of patients susceptible of treatment by said active material, by applying to the patch a quantity of an ointment comprising the active material controlled with reference to the graduated scale on the patch.

23. Use of a skin-patch according to claim 22, wherein the active material is nitroglycerin to be presented for use in the treatment of Raynaud's disease or angina pectoris.

24. Use of a skin-patch according to claim 22 and substantially as hereinbefore described.