Active ingredient wound care and scar management products, process of manufacture and useful articles thereof

Abstract

To provide a scar management product effective for reducing and / or preventing dermal scarring, and to provide a process of manufacture thereof.SOLUTION: Provided is a scar management product for reducing and / or preventing dermal scarring at a closed wound site, the scar management product comprises a skin-contacting layer having a skin-contacting surface, the skin-contacting layer having a first side and a second side, the first side of the skin-contacting layer comprising: the skin-contacting layer including the skin-contacting surface of the skin-contacting layer; and pirfenidone incorporated into the skin-contacting layer, and the skin-contacting layer being a cured silicone material having pirfenidone mixed therein.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to novel wound dressings and scar management products. In particular, the present invention relates to wound dressings containing an active pharmaceutical ingredient ("API"), and scar management products also containing an API. In each case, the API is delivered to the wound or scarred area to reduce and prevent dermal scarring. [Background technology]

[0002] It is well known that fibroblasts are a major contributor to scar formation, and inhibiting the activity of these cells could significantly reduce dermal scarring caused by injury or surgery.

[0003] Bio Med Sciences, Inc., of Allentown, Pennsylvania, manufactures and sells Silon-TSR® and Rylon® brand wound dressings. Additionally, Bio Med Sciences manufactures and sells Silon® and Oleeva® brand scar management products, including patches and splints.

[0004] Pirfenidone is currently approved by the U.S. Food and Drug Administration (FDA) to treat pulmonary fibrosis, a disease in which fibroblasts accumulate in lung tissue and differentiate into myofibroblasts, which secrete collagen and other proteins. This same biophysiological mechanism is known to induce scar formation in dermal wounds. Topical application of 8% pirfenidone gel has also been documented to improve localized scleroderma. More recently, topical application of 8% pirfenidone lotion to dermal scar sites has been reported to reduce hypertrophic scarring.

[0005] Silicone polymers are well known for their ability to deliver a variety of APIs topically or transdermally. Summary of the Invention

[0006] To improve upon this technology, the inventors have created both wound dressings and scar management products containing pirfenidone to be delivered to open wounds or delivered transdermally to closed wound sites to reduce and prevent dermal scarring. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 shows a partial schematic cross-sectional view of a preferred wound dressing or preferred scar management dressing constructed in accordance with the present invention, in which the numeral 15 refers to the layer of the dressing having the wound or skin-contacting side or surface of the dressing, and the numeral 13 generally refers to the remainder of the dressing shown in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0008] In a preferred embodiment, the present invention comprises a dressing 11, which may be a wound dressing for use on an open wound or a scar management dressing for use on a closed wound site to reduce and / or prevent scarring in the skin, as shown in Figure 1. In the preferred embodiment of the present invention shown in Figure 1, dressing 11 has layer 15 which comprises the wound or skin contacting side or surface of dressing 11, and an API (preferably pirfenidone) is incorporated into layer 15 for delivery to the wound or scarred area to reduce and / or prevent scarring in the dermis.

[0009] The following examples are not intended to be limiting, as variations in their design, configuration, and process will be apparent to those skilled in the art. Similarly, it is contemplated that other materials and APIs can be used to achieve the same concepts of the present invention. The following examples illustrate various preferred embodiments of the present invention and preferred methods for manufacturing these preferred embodiments of the present invention. In these examples, 3% by weight of pirfenidone was incorporated into the silicone formulation used to make layer 15 of dressing 11, including the wound / skin-contacting side or surface of dressing 11. However, a preferred range of 0.5% to 20% by weight of pirfenidone can be used for purposes of the present invention by incorporating 0.5% to 20% by weight of pirfenidone into the silicone formulation used to make layer 15 of dressing 11, i.e., the layer of the dressing that includes the wound / skin-contacting side or surface of the dressing. Furthermore, the present invention is applicable to numerous wound dressings and scar management methodologies.

[0010] Example 1: 3% by weight of pirfenidone was mixed into the silicone formulation on the wound contact side of a Silon-TSR wound dressing prepared as described in U.S. Patent No. 4,832,009 to Dillon, which is incorporated herein by reference.

[0011] Example 2: 3% by weight of pirfenidone was mixed into the silicone formulation on the wound contact side of the Rylon-1 wound dressing.

[0012] Specifically, a carrier substrate is passed through a reservoir of uncured liquid silicone mixed with 3 wt% pirfenidone, and an adjustable blade "knife" is set to meter out excess liquid silicone mixed with pirfenidone on the carrier substrate, leaving a layer of liquid silicone mixed with 3 wt% pirfenidone on the carrier substrate.Then, an apertured mesh is placed in contact with the layer of liquid silicone mixed with 3 wt% pirfenidone, and the resulting material is then passed through a tunnel oven to apply heat to cause crosslinking of the silicone, forming a web of at least partially impregnated apertured mesh material on the carrier substrate.Then, this web is passed through a die-cutting device to punch out the final dressing shape.

[0013] Example 3: 3% by weight of pirfenidone was mixed into the silicone formulation on the skin-contacting side of the Oleeva Fabric scar management dressing, manufactured using the technology described in U.S. Patent No. 7,087,135 to Dillon, which is incorporated herein by reference.

[0014] Example 4: Three percent by weight of pirfenidone was mixed into a silicone formulation on the skin-contacting surface of a thermoplastic splint material prepared as described in US Pat. No. 5,759,560 to Dillon, which is incorporated herein by reference.

[0015] Example 5: 3% by weight of pirfenidone was mixed into a silicone formulation on the skin-contacting side of Silon-TEX compression garment fabric material, manufactured as described in U.S. Patent No. 8,084,051 to Dillon, which is incorporated herein by reference.

[0016] In use, the dressing of the present invention is placed in place by placing the wound / skin contacting surface of the dressing over an open or closed wound site and maintained in place over the open or closed wound site for an effective period of time, thereby reducing or preventing dermal scarring. When the dressing of the present invention is used in conjunction with an open wound, the dressing can be changed as needed and replaced with a new dressing of the present invention to continue treatment of the open wound and reduce or prevent skin scarring. Similarly, when the dressing of the present invention is used in conjunction with a closed wound site, the dressing can be changed as needed and replaced with a new dressing of the present invention to continue treatment of the closed wound site and reduce or prevent skin scarring.

Claims

1. 1. A scar management product for reducing and / or preventing dermal scarring, comprising: a skin-contacting layer having a skin-contacting side; and an anti-fibrotic active pharmaceutical ingredient incorporated into said skin contact layer that reduces fibroblast activity.

2. 23. The scar management product of claim 22, A scar management product, wherein the skin contact layer comprises 0.5% to 20% by weight of pirfenidone.

3. 23. The scar management product of claim 22, A scar management product, wherein the skin contact layer comprises 3% by weight of pirfenidone.

4. 23. The scar management product of claim 22, A scar management product, wherein the skin contact layer comprises a silicone formulation.

5. 5. The scar management product of claim 4, A scar management product, wherein the silicone formulation comprises 0.5 to 20% by weight of pirfenidone.

6. 5. The scar management product of claim 4, A scar management product, wherein the silicone formulation comprises 3% by weight of pirfenidone.

7. 7. A scar management product according to any one of claims 4 to 6, A scar management product wherein the silicone formulation is a silicone.

8. 7. A scar management product according to any one of claims 4 to 6, A scar management product, wherein the silicone formulation is a polyorganosiloxane.

9. 7. A scar management product according to any one of claims 4 to 6, A scar management product wherein the silicone formulation is polydimethylsiloxane.

10. 10. The scar management product of claim 1, and further comprising a remainder of the scar management product disposed on said skin-contacting layer; The scar management product, wherein the remaining portion comprises a fabric, a foam, a nonwoven film, a mesh, a thermoplastic material, or a material other than a fabric.

11. 1. A method of manufacturing a scar management product, comprising: mixing pirfenidone with a silicone formulation to form a mixture, wherein the silicone formulation comprises polyorganosiloxane, silicone, silicone gel, silicone elastomer, or polydimethylsiloxane; applying the mixture to a carrier to form a layer of the mixture thereon; and curing the layer of mixture.

12. 12. The method of claim 11, The method further comprising the step of applying expanded polytetrafluoroethylene to the layer of the mixture before curing.

13. 13. The method of claim 12, the silicone formulation is a silicone; the layer of the blend and the expanded polytetrafluoroethylene form an interpenetrating polymer network of silicone and polytetrafluoroethylene, the interpenetrating polymer network having a first surface and a second surface, the first surface forming the skin-contacting side of the skin-contacting layer; The method further comprising laminating a thermoplastic splint material to a second surface of the interpenetrating polymer network.

14. 12. The method of claim 11, The method further comprising the step of applying a mesh layer having openings to the layer of mixture before curing.

15. 12. The method of claim 11, Before hardening, applying a microporous polymer sheet membrane to the layer of the mixture and allowing or causing the layer of the mixture to impregnate the microporous polymer sheet membrane; applying a backing material to the distal surface of the impregnated microporous polymer sheet material, wherein the backing material contacts the mixture that has passed through the microporous polymer sheet membrane.

16. 16. The method of claim 15, The method, wherein the backing material comprises a fabric, a foam, a nonwoven film, or a material other than a fabric.

17. 12. The method of claim 11, The method further comprises applying a laminate of a microporous polymer sheet membrane and a backing material to the layer of mixture prior to curing, allowing or causing the layer of mixture to impregnate the microporous polymer sheet membrane.

18. 18. The method of claim 17, The method, wherein the backing material comprises a fabric, a foam, a nonwoven film, or a material other than a fabric.

19. 1. A method of manufacturing a scar management product, comprising: mixing pirfenidone into a silicone formulation to form a mixture thereof; applying the mixture to a fabric to form a fabric coated with the mixture; and converting the fabric to which the mixture has been applied into a scar management product.

20. 20. The method of claim 19, The method, wherein the scar management product is a garment.

21. 1. A method for reducing dermal scarring, comprising: Providing a scar management product according to any one of claims 1 to 11, 22 or 23; placing the skin-contacting surface of the skin-contacting layer of the scar management product over and in contact with the closed wound site; and maintaining the scar management product in contact with and over the closed wound site for a period of time effective to reduce and / or prevent dermal scarring.

22. 10. The scar management product of claim 1, A scar management product, wherein the anti-fibrotic active pharmaceutical ingredient is pirfenidone.

23. 11. The scar management product of claim 10, A scar management product, wherein the remainder of the scar management product comprises a backing layer.

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