Patent Application
20210008052
This invention relates to novel wound dressings and scar management products. Particularly, this invention relates to wound dressings which incorporate an active pharmaceutical ingredient (“API”), and scar management products also containing an API. In each case, the API is delivered to the wound or scar area to reduce and prevent dermal scarring.
It is well-known that fibroblast cells are a major contributor to scar formation. Reducing the activity of such cells has the potential to significantly reduce dermal scarring due to injury or surgery.
Bio Med Sciences, Inc. of Allentown, Pa., manufactures and markets the Silon-TSR® and Rylon® brands of wound dressings. Additionally, Bio Med Sciences, Inc. manufactures and markets the Silon® and Oleeva® brands of scar management products including patches and splinting materials.
Pirfenidone is a drug that is currently approved by the U.S. Food and Drug Administration (“FDA”) to treat pulmonary fibrosis, a disease wherein fibroblasts accumulate in lung tissue and differentiate into myofibroblasts that secrete collagen and other proteins. This same biophysiological mechanism is known to induce scar formation in dermal wounds. Others have described in the literature the use of 8% Pirfenidone gel applied topically to ameliorate localized scleroderma. More recently others have described the topical application of 8% Pirfenidone lotion to dermal scar sites to reduce hypertrophic scarring.
Silicone polymers are well-known to be functional in the topical or transdermal delivery of various APIs.
In an effort to improve the art, I have created both wound dressings and scar management products containing Pirfenidone to be delivered to the open wound or transdermally to the closed wound site to reduce and prevent dermal scarring.
In a preferred embodiment, the invention, as illustrated
The following examples are not intended to be limiting, as variations on these designs, configurations and processes would be obvious to those skilled in the art. Likewise, it is believed that other materials and APIs could be used to achieve the same concept of this invention. The following examples illustrate various preferred embodiments of the invention and preferred methods of manufacturing these preferred embodiments of the invention. In these examples, 3% by weight of Pirfenidone was mixed into the silicone formulation used to make the layer 15 of the dressing 11 comprising the wound/skin contacting side or surface of the dressing 11. However, a preferred range of 0.5% to 20% by weight of Pirfenidone may be used for the purpose of this invention by mixing 0.5% to 20% by weight of Pirfenidone into the silicone formulation used to make the layer 15 of the dressing 11, that is, the layer of the dressing comprising the wound/skin contacting side or surface of the dressing. Additionally, this invention could apply to numerous wound dressing and scar management methodologies.
Three percent by weight of Pirfenidone was mixed into the silicone formulation of the wound contacting side of Silon-TSR wound dressing, which is manufactured as described in Dillon U.S. Pat. No. 4,832,009, which is incorporated herein by reference.
Three percent by weight of Pirfenidone was mixed into the silicone formulation of the wound contacting side of Rylon-1 wound dressing.
Specifically, a carrier substrate is passed through a reservoir of uncured liquid silicone having 3% by weight Pirfenidone mixed therewith, and an adjustable blade “knife” is set to meter off excess liquid silicone mixed with Pirfenidone that is on the carrier substrate, thereby leaving a layer of liquid silicone, having 3% by weight Pirfenidone mixed therein, on the carrier substrate. An apertured mesh then is laid down onto and into contact with the layer of liquid silicone having 3% by weight Pirfenidone mixed therein, and the resultant material then is passed through a tunnel style oven to apply heat and effectuate crosslinking of the silicone to form a web of at least partially impregnated apertured mesh material on the carrier substrate. The web then is passed through a die cutting apparatus to punch-cut the final dressing shapes.
Three percent by weight of Pirfenidone was mixed into the silicone formulation of the skin contacting side of Oleeva Fabric scar management dressing, which is manufactured using the technology describe in Dillon U.S. Pat. No. 7,087,135, which is incorporated herein by reference.
Three percent by weight of Pirfenidone is mixed into the silicone formulation of the skin contacting surface of a thermoplastic splinting material, which is manufactured as described in Dillon U.S. Pat. No. 5,759,560, which is incorporated herein by reference.
Three percent by weight of Pirfenidone is mixed into the silicone formulation of the skin contacting side of Silon-TEX compression garment textile material, which is manufactured as described in Dillon U.S. Pat. No. 8,084,051, which is incorporated herein by reference.
In use, the inventive dressing is positioned in place by applying the wound/skin contacting surface of the inventive dressing over and into contact with an open wound or a closed wound site, and is maintained in place over and in contact with the open wound or the closed wound site for an effective amount of time, thereby reducing or preventing dermal scarring. When the inventive dressing is used in conjunction with an open wound, the dressing may be changed and replaced as needed or required with fresh dressings of the invention, to continue delivery of the treatment to the open wound to reduce or prevent dermal scarring. Likewise, when the inventive dressing is used in conjunction with a closed wound site, the dressing may be changed and replaced as needed or required with fresh dressings of the invention, to continue delivery of the treatment to the closed wound site to reduce or prevent dermal scarring.
| Number | Date | Country | |
|---|---|---|---|
| 62847115 | May 2019 | US |
