WO2017146603A1

WO2017146603A1 - Pharmaceutical composition for the treatment of burns, use, and method of treatment

Info

Publication number: WO2017146603A1
Application number: PCT/RO2016/000009
Authority: WO
Inventors: Nicolae ARCASIU
Original assignee: Arcasiu Nicolae
Priority date: 2016-02-24
Filing date: 2016-02-24
Publication date: 2017-08-31

Abstract

The present invention relates to a pharmaceutical composition for the treatment of burns in humans and animals comprising, by weight, 3% tetracycline hydrochloride, 1000 I.U./g bacitracin, 10% liquid paraffin, 10% lanolin, and the remainder to 100% pure petrolatum, and to uses of the pharmaceutical composition in methods of treatment of burns.

Description

PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF

BURNS, USE, AND METHOD OF TREATMENT

[0001] The present invention relates to a pharmaceutical composition for the treatment of burns in humans and animals, as well as to uses of the pharmaceutical composition in methods of treatment of burns.

[0002] Burns are injuries of the skin or other tissues caused by thermic, chemical or mixed agents. Depending on the severity of trauma, burns are classified as: first degree burns, affecting only the superficial layer of skin, the epidermis; second degree burns, which affect also the layer under the epidermis, hypodermis; third degree burns, affecting all layers of the skin; and fourth degree burns, comprising injuries in deeper tissues, such as muscles, tendons or bones.

[0003] first Degree and second degree burns of small area are usually treated without specialized medical intervention, by cooling the affected area, usually by applying cold water, then removing foreign bodies. Wounds caused by burns are prone to infections, leading to prolongation of the healing time. This treatment has the disadvantage that often the dressing applied sticks to the wound, causing wound damage when it is removed and slowing wound healing.

[0004] Larger second degree burns and those of third or fourth degree are treated by wrapping the patient or the affected area of the patient with sterile sheets and transporting the patient to the hospital, where the following are applied: fluid infusions to prevent dehydration, surgical cleaning of areas affected by burn. Covering the wound with a dressing makes that dressing to adhere to the affected area, causing wound damage, so that its removal is difficult and painful, associated with rupture of newly formed tissues, which delays healing, and a vicious scar remains on that area requiring new surgery in order to be removed.

[0005] The present invention provides a pharmaceutical composition comprising bacitracin and tetracycline for the treatment of burns in humans and animals, uses of such pharmaceutical compositions in the treatment of burns of all degrees, and methods of treatment of burns by using such pharmaceutical composition.

[0006] The pharmaceutical composition of the invention comprises, by weight, 3% tetracycline hydrochloride, 1000 I.U./g bacitracin, 10% liquid paraffin, 10% lanoline, and the remaining up to 100% pure petrolatum. This pharmaceutical composition prevents the risk of infection of the wound due to the action of the combination of antibiotics, and fat excipients used (petrolatum, lanolin, paraffin) cause the prevention of loss of fluid through the wound, thus avoiding dehydration, cerebral edema, shock and other adverse effects.

[0007] Another aspect of this invention relates to the use of the composition according to the invention for the treatment of burns, especially severe burns, of second, third or fourth degree. The composition according to the invention is used by topical application, for 3-4 times daily for 8 consecutive days, by covering with a sufficient layer of the composition, preferably of 3-4 mm thickness. The bigger is the severity of the burn, the thicker should be the layer of the composition applied. Thus, it is preferred to apply the composition according to the invention in a layer of a thickness more than 2 mm, preferably more than 3 mm. For the areas with burns of higher degrees (third or fourth degree) or with extended surfaces, applying a layer of the pharmaceutical composition with a thickness greater than 4 mm is advantageous. Depending on the severity and location of the burn, the wound may be left thus covered with the layer pharmaceutical composition only, or, for more severe and/or more extended burns, after applying the layer of pharmaceutical composition the wound may be covered with a sterile plastic of suitable thickness and consistency. Such a sterile plastic of suitable thickness and consistency may be, for example, in the form of a foil, a plastic sheet, a reamer, or of a covering prefabricated in a suitable shape to cover one hand, or the entire upper limb, or a foot or the whole lower limb. Adjustments can be made by using adhesive tape. Covering the wound on which the composition according to the invention was applied by using such a sterile plastic has the advantage that dehydration is effectively prevented by avoiding fluid loss from the affected area, without the coating material adherring to the wound; at the same time the pharmaceutical composition is efficiently maintained to the affected area, thus preventing its transfer from the plague to other media (such as litter, hospital bed, health staff clothes). Thus, it is advantageous that as soon as burns are found, to be coated with the composition of the invention and then with the above mentioned sterile plastic so that these will be able to produce their advantageous effects immediately, even before the patient reaches a hospital.

[0008] In another aspect of the present invention, the pharmaceutical composition of the invention is used in a preferred method of treatment of burns, especially more severe burns of second, third or fourth degree, or of large extent, wherein after application for 8 consecutive days of the pharmaceutical composition of the invention as described above, a second pharmaceutical composition it is then applied daily until healing, 1 to 3 times a day, which comprises, in percents by weight: 15% liquid paraffin, 15% solid paraffin and 70% petrolatum. These promote cicatrization.

[0009] Using the bacitracin and tetracycline hydrochloride composition according to the invention for the treatment of burns in a patient has the following advantages: decrease of the pain, decrease of the risk of infection to the wound due to antibiotics from the composition; blisters are not formed, and those formed withdraw so the skin recovers without scarring. At the same time, applying a sufficiently thick layer of composition, optionally covered by the sterile plastic, causes body fluids to remain in the body so that the brain is adequately irrigated, and the usual effects of dehydration are avoided: cerebral edema, shock, coma, and death of the patient. There will be no longer necessary to clean the area or to apply bandages that need to be changed 2-3 times daily by elaborated and painful operations. Healing occurs in a natural way; crusts, bedsores are eliminated concurrently with the formation of new skin, without the need of removing them mechanically and thus scars are not formed. Transplantation surgery (skin autograft) or plastic surgery for removing scars are no longer needed, which makes the use of the pharmaceutical composition according to the invention for the treatment of burns to be much easier to tolerate by the patient, less painful, to have a shorter duration, and a much reduced cost.

[0010] By equipping the specialized intervention teams, ambulances, fire engines, hospitals, aircraft carriers, etc. with kits containing sufficient amounts of the composition of the invention and sterile plastic, respectively, as described above, for example in the form of a film, a sheet, or a sleeve made for a hand or the whole upper limb, or for a foot or the entire lower limb, victims of burns would benefit of much higher chances of survival and healing than at present, because they could thus benefit from the earliest moment possible of the beneficial effects of the use of the pharmaceutical composition of the invention as described above.

All the items required are contained in the kit.

Claims

1. Pharmaceutical composition for the treatment of burns in humans and animals which comprises, by weight, 3% tetracycline hydrochloride, 1000 I.U./g bacitracin, 10% liquid paraffin, 10% lanoline, and the remaining up to 100% pure petrolatum.

2. Pharmaceutical composition according to claim 1 for use in the treatment of burns, wherein the composition is administered topically to areas of a patient affected by burns in a layer covering the whole affected area, 3-4 times a day for 8 consecutive days.

3. Pharmaceutical composition for use according to claim 2, wherein the pharmaceutical composition according to claim 1 is applied in a layer of sufficient thickness so that to remain visible on the surface of the affected area, preferably a layer with a thickness greater than 2 mm, more preferably a thickness greater than 3 mm, and, for third or fourth degree burns, preferably a thickness greater than 4 mm.

4. Pharmaceutical composition comprising, by weight, about 70% petrolatum, 15% solid paraffin, and 15% liquid paraffin for use in the treatment of burns in humans or animals subsequent to the use as claimed in claim 2, by topical application to the areas affected by burns, for 1 to 3 times a day until healing.

5. Method of treatment of a human or animal subject suffering from burns, comprising the steps:

1 ) topical application of the composition according to claim 1 so as to cover the affected area, in a layer of sufficient thickness so that to remain visible on the surface of the affected area, preferably a layer with a thickness greater than 2 mm, and more preferably greater than 3 mm, and, for third or fourth degree burns, preferably with a thickness greater than 4 mm for 8 consecutive days, 3-4 times a day, followed by

2) topical application in a layer so as to cover the affected area, for 1 to 3 times per day until healing, of a composition comprising, by weight, about 70% petrolatum, 15% solid paraffin, and 15% liquid paraffin.