Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-05-23
2002-05-21
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S445000, C424S443000, C424S078060, C424S400000, C424S725000, C514S185000, C514S887000, C514S947000, C514S974000, C514S828000
Reexamination Certificate
active
06391323
ABSTRACT:
The present invention concerns a composition for the treatment of burns, sunburns, abrasions, ulcers and cutaneous irritation. More specifically, the invention relates to a preparation for topical administration having analgesic, antiseptic and skin healing promoting activity. The preparation is particularly suitable for the treatment of burns, scalds and sunburns, and is useful in general in the treatment of any alteration of the dermal tissue that may require the reactivation of the epithelisation processes.
As it is known, the exposure to an excessive heat of any kind causes on the human epidermis, and often also on the underlying tissues, situations of pathological alteration and lesions the seriousness of which varies according to the duration and the intensity of the exposure, and to the sensitivity of the single individual. Real burns or scalds may be caused, for instance, by the contact with hot matter or articles, such as flames, hot liquids or burning bodies, or also by an excessive exposure to radiation sources, including the sun. According to the current clinical classification, a burn may be of first, second or third degree, depending upon the gravity of the lesion. The first-degree burns are limited to the superficial layers of the epidermis and are characterised by local erythema (redness) and light edema (swelling); the second-degree burns involve a damage extended to the dermis, more marked edema and formation of blisters containing serous exudate, and the third-degree burns are accompanied by a true destruction of the structural elements of the skin, with formation of blisters, sores and the presence, in the most serious cases, of charred zones. In the most critical cases the involvement is extended to general phenomena, such as shock, acute intoxication and anaemia.
Reactions quite similar to the ones described above may be produced by the contact with aggressive chemical agents, such as concentrated acids or alkalis, or by electrical discharges. Likely, albeit less serious, reactions may also originate from the contact of the skin with animal secretions or stinging plants, such as jellyfish stings or insect bites. Irritation, redness, itching and, sometimes, blister formation may also be caused by an intense rubbing of the skin, while a stronger rubbing may give rise to abrasions and grazes. Lastly, another quite common group of pathologies affecting the superficial tissues are ulcerous-dystrophic alterations, such as torpid sores, decubitus or bed-sore, varicose or stasis ulcers and rhagades.
In all of the cases presented above, in agreement with the various levels of severity, recourse is made to the topical administration of remedies that should exert a range of different actions, including an analgesic action, a stimulating action on the reparative processes of the skin tissues, i.e. an action promoting healing of the lesions, an anti-inflammatory action and, moreover, an antiseptic action, in order to prevent the occurrence of secondary infections on the affected zones. Actually, the injured tissues are particularly prone to the development of infections, which obviously hinder a rapid and complete healing of the skin.
A product for topical application known to be particularly useful for the treatment of burns, scalds and sunburns, as well as for the treatment of other affections of the superficial tissues such as the disorders and injuries mentioned above, is the ointment sold in Italy under the trademark Foille® (Synthelabo). The latter contains four different active ingredients, i.e., benzocaine, benzyl alcohol, 8-hydroxy-quinoline and colloidal sulphur. The first two ingredients have anaesthetic properties, the third one is an antiseptic and the fourth one enhances the formation of stratum corneum (horny layer).
In the use of the above and of other possible remedies against burns, a timely application is extremely important. It may be anticipated that the therapy will be the more effective the shorter is the time elapsed between the event that caused the lesions and the application of the remedy on the said lesions. Suitable products may be in the form of ointments or salves, creams, emulsions, gels, foams, sprays or medicated dressings or bandages, which must be directly applied on the affected zone and must be kept into contact with the lesion, if necessary by soaking the dressing from the exterior with further product, until the reparative process is seen to stably proceed.
In such situations it would be desirable that the recovery time be as short as possible, not only because this reduces the pain or discomfort caused to the patient, but also because the longer the lesion remains exposed to the environment the higher is the risk of secondary infections. As pointed out in the foregoing, the latter obviously slow down or negatively affect the recovery process. In view of that, it is extremely important that a preparation for the treatment of skin lesions such as burns and the like be highly active in promoting the regeneration of the injured tissues, thus enhancing the healing process.
A product which is known to possess the above properties, and which may be used to formulate a medicament suitable for the treatment of burns and of other lesions of the skin is chlorophyll (see Merck Index, 11
th
ed., 1989, Merck & Co. Inc., monograph No. 2155).
As it is known, chlorophyll is the green pigment of plants, contained in various proportions and types also in algae. The said pigment plays a primary role in the vegetal metabolic activity known as photosynthesis. The chlorophyll molecule, in its variants a, b, c and d,is characterised by an active nucleus known as porphyrin (a cyclic tetrapyrrolic structure wherein the four pyrrole rings are joined through four methene bridges, i.e.=C−) at the centre of which is bound a magnesium atom. Commercial chlorophyll is normally an intensely dark-green aqueous, alcoholic or oil solution, substantially containing chlorophyll a and chlorophyll b, i.e. the two variants that are found (in the approximate ratio of 3:1) in higher plants and in green algae. The most common uses of chlorophyll are in the production of soaps, oils, cosmetics and perfumes, as well as in the food industry, for the production of liquors and confectionery.
“The porphyrin structure of chlorophyll is the same found in heme, i.e. the prosthetic group of hemoglobin, wherein at the center of the molecule an atom of iron is present instead of the magnesium atom. It is, very likely, this similitude to the complex responsible for the cellular respiration that accounts for the interesting physiological properties of chlorophyll and, in particular, for its activity as promoter of the cutaneous restoration processes. It is to be noted, in addition, that one of the two carboxy groups pending from the porphyrin structure is esterified, in chlorophyll, with an unsaturated alcohol known as phytol. The latter is a constituent of vitamin E, the therapeutic properties of which are well-known.”
An alkaline hydrolysis of chlorophyll in mild conditions causes the opening of the cyclopentanone ring present in the molecule and the replacement of both ester groups present (one of which is esterified with phytol) with alkaline metal ions. The corresponding derivatives, known as chlorophyllins, have been proposed as well for the treatment of ulcerative lesions and burns, especially in the presence of concomitant infection. Examples of such indication are found in the U.S. Pat. Nos. 2,120,667 and 2,729,7586.
With reference to the use of chlorophyll in preparations for the treatment of burns and sunburns, the U.S. Pat. No. 3,949,071 proposes the application to the injured skin area of a buffer solution having a pH value of 8-10 containing a base, preferably consisting of an alkaline metal carbonate; one or more surface-active agents; a mixture of unsaturated fatty acids; a volatile agent such as diethyl ether, the evaporation of which is supposed to cause some relief to the burnt skin and, as the proper active ingredients, eugenol, i.e. an essential oil
Dudash Diana
Ostrup Clinton
Smith , Gambrell & Russell, LLP
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