Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/7016—Disaccharides, e.g. lactose, lactulose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/01—Hydrocarbons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/18—Iodine; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/56—Materials from animals other than mammals
  • A61K35/63—Arthropods
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions

Definitions

• the present invention relates to the sector of medical devices and in particular regards an improvement of a known composition for protect! ng and healing bedsores and vascular and diabetic ulcers.
• the disadvantages presented by the aforesaid known composition are basically due to the fact that the composition , albeit innovative and equally valid in solving the problem of knitting skin lesions up to and including Stage 4 (according to the system of classification of sores or lesions, in particular pressure ulcers or bedsores proposed by the National Pressure Ulcer Advisory Panel in 1991), is initially creamy but in a short time presents a reduction of its fluid-plasticity with subsequent hardening of the composition (approximately thirty days) no longer allowing the health operator to apply it in an optimal way on the same bedridden patient, with evident further disadvantages linked both to the need of having to acquire new cream in an extremely short time and, as a consequence , to the costs for a new supply, the amount of cream that cannot be used because the composition has hardened being obviously wasted.
• the fundamental problems that are to be overcome with the present composition are:
• Stage-4 sores including post-traumatic sores, postoperative sores, and excoriations and abrasions in general, creating a life-saving drug, valid also such as protective sun cream;
• Betadi ne-based formulation better known universally as "Knutson's preparation” (referred to in various Chinese and Japanese patents), made up of 20 parts of sugar, 5 parts of Betadine ointment and 2 parts of 10% Betadine, this composition , albeit indicated in the case of clinically evident surface and deep infections (from Stage 2 to Stage 4), in so far as it favours cleansing and removal of necrosis and exudate and promotes an effective tissue granulation , presents problems if applied to diabetic patients and to subjects with renal insufficiency or hyperthyroidi sm (on account of the presence of iodine in the Betadine, i.e., povidone- iodine) .
• the main purpose of the present invention is precisely to overcome the above disadvantages presented by said known compositions by providing an innovative improved composition to be used in the sector of medical devices for protect! ng and healing serious bedsores and vascular and diabetic ulcers of patients, including bedridden ones, or subjects with renal insufficiency or hyperthyroidism.
• a further purpose of the present invention is to obtain a new and inventive creamy composition that will present improved character! sites of fluid- plasticity, rendering the ointment equally plasto- fluid for a longer period of time, namely, at least twenty- four months.
• the present composition has been improved following upon uni nterrupted studies, research, and clinical tests conducted by the present applicant who has an experience of over thirty years operating in the geriatric field.
• the above purposes are achieved by providing an innovative composition for protect! ng and healing serious bedsores and vascular and diabetic ulcers as specified in the ensuing claims annexed to the present description .
• FIG. 1 shows a cobweb diagram, present! ng along the six radial axes the values in grams (which can also be read in percentages) of the weights of the elements constituting the optimal composition according to the i nvention ;
• FIG. 2 shows a table presenting in the first column the elements constituting the optimal composition according to the invention , entered in decreasing order of weight in grams appearing in the second column, as well as the corresponding percentages of the same elements present in the composition itself, appearing in the third column;
• FIGS. 3A-3H show the appearance of a first case regarding a diabetic lesion, from the first day of treatment with the present composition , dating back to May 8, 2013, up to complete healing on May 6, 2014;
• FIGS. 4A-4H show the appearance of a second case regarding an extremely serious pressure ulcer, from the first day of treatment with the present composition , dating back to July 30, 2013, up to complete healing on November 5, 2013;
• FIGS. 5A-5H show the appearance of a third case regarding a diabetic lesion, from the first day of treatment with the present composition , dating back to June 26, 2013, up to complete healing on December 13, 2013;
• FIGS. 6A-6H show the appearance of a fourth case regarding an extremely serious pressure ulcer, from the first day of treatment with the present composition , dating back to October 10, 2013, up to practically complete healing on April 4, 2014;
• Figures 7A-7H show the appearance of the particular consi stency of the present improved composition (dating back to October 3, 2013 in Figures 7B-7C-7E- 7F) compared with the known one ( Figures 7A-7C-7D- 7F) , the new composition preserving over time its own characteristics of fluid-plasticity, without there occurring for approximately two years either a subsequent hardening of the composition itself (the photographs of Figures 7D-7E-7F refer to the same specimens applied on a gauze after approximately thirty days from their corresponding appl i cation) , or any loss of the particular healing properties thereof.
• the above i ngredi ents and the correspond! ng weights for a composition of 100 g of product are the following:
• Betadine liquid 10% povidone-iodi ne
• olive oil containing squalene
• the improved composition is character! sed both in that it is made up of natural i ngredi ents and in that the ratios of weight composition constitute golden ratios; namely, the ratio of their values in weight remains constant and equal to the exact value of (1 + 5)/2, which is approximately equal to 1.6180.
• Said golden ratios may be verifying be computing the ratio between the total weight to the weight of the ingredient a), as likewise between the weight of the ingredient a) to the total weight of all the other ingredients b)+c)+d)+e)+f) .
• Powdered sugar, povi done-iodine (PVP-I) in the liquid state with 10% content of povi done-iodine, petroleum jelly, and liquid paraffin, also referred to as white mineral oil, have been already amply defined, also as regards their specific therapeuti c advantages, in the descri ption of the prior patent of which the present constitutes an improvement .
• Olive oil is a very important element for the human skin and for the skin of the majority of animal species.
• the lipidic composition of olive oil is very similar to that of skin sebum.
• triglycerides which have a composition similar to skin sebum, it contains compounds in the non- saponifi eatable fraction that are polyphenol substances such as oleouropein and hydroxytyrosol , which perform an essential action against free radicals principally responsible for ageing of the skin and consequently loss of elasticity and tonicity of the skin.
• olive oil contains squalene (according to the variety and the extraction process, in olive oil there may be found from two hundred to twelve thousand milligrams of squalene per kilogram) , in which various vitamins essential for body functions are contained, such as vitamin A (which counters the excess of dryness of mucosae), vitamin E (a valid ally against ageing of the skin), and vitamin D (fundamental in favouring assumption and absorption of calcium).
• vitamin A which counters the excess of dryness of mucosae
• vitamin E a valid ally against ageing of the skin
• vitamin D fundamental in favouring assumption and absorption of calcium
• squalene is one of the most important constituents of sebum, an oily substance that keeps the outermost layer of the epidermis hydrated, slowing down evaporation of water.
• Sebum moreover protects the skin from the harmful effects of various nature to which the skin is usually subjected (detergents , chemical products, micro-organisms, solar radiation , etc.).
• Some research attributes to squalene also a protective action against skin cancer, thanks to its capacity to combat the free radicals and absorb harmful solar radiation .
• Squalene is a very important substance in the physiology of animals and plants in so far as it has a density lower than water and is a biochemical precursor of steroids and triterpenes , this being the reason why it is generally used also as adjuvant in vaccines.
• squalene In addition to exerting an immunostimulant action, squalene also boasts a precious emollient and nutritive activity, which contributes to prevention of wrinkles and dryness of the skin, thus constituting a valid anti -ageing agent. Once applied, it is absorbed rapidly without leaving the skin greasy. Hence, perhaps it was not by any chance that the anti -wrinkle cream used by Cleopatra (69-30 B.C.) had a base of olive oil (rich in squalene) , milk, incense, and juniper berries. Squalane, which is obtained by hydrogenation of squalene, represents the saturated form of this substance . Elimination of the double bonds decreases the susceptibility to oxidation and increases the preservabi 1 ity of the product.
• squalene is produced starting from acetyl -CoA derived from the metabol i sm of the various nutrients (carbohydrates , proteins, and in particular fats) and is rapidly converted into cholesterol .
• nutrients carbohydrates , proteins, and in particular fats
• squalene is particularly abundant in the sebum.
• honey its antibacterial action has been known for some time, which is due to its high sugar concentration and acid pH, altogether equivalent to that of the honey solutions, thanks to the action of the glucosidase enzyme contained therein.
• Said enzyme which is inactive in pure honey, in solution is activated , thus convert! ng glucose into gluconic acid and hydrogen peroxide.
• the preparation according to the present composition cannot go rancid owing the presence of the above components , above all olive oil, petroleum jelly, and white mineral oil, which all have anti- rancidity function.
• each component is likewise improved as regards the effects already known of the individual components of the system, even though innovative is addition of the mixture of the three oily components constituted by the substances d)+e)+f). Thanks to the synergistic effect thereof, the improved composition that is obtained constitutes a single medical device having valid disinfectant, anti -inflammatory , antimicrobial , lenitive, and analgesic effects in combi nation with the properties necessary for obtaining an effective healing, as appears from the cases presented merely by way of non- limiting example in the annexed Figures 3A to 6H, which highlight more clearly the effects of the ointment obtained from said composition applied repeatedly over time in order to cause regression from Stage 4 to Stage 1 of the ulcers and lesions of various types and finally bring them to complete healing.
• Each element constituting the pharmaceutical composition for protecting and healing bedsores and vascular and diabetic ulcers namely, powdered sugar, petroleum jelly or petrolatum, Betadine or liquid 10% povi done-iodine, olive oil containing squalene, white mineral oil or liquid paraffin, and orange-blossom honey in oily consi stency, can individually also be introduced in weight percentages oscillating by 10% with respect to the amounts given previously .
• the improved composition of the present invention can be applied every day on the sores to be dressed, as a single remedy, even in the case of extremely serious Stage-4 lesions (as i 11 ustrated in the figures of the four cases provided by way of example, namely, from Figure 3A to Figure 6H) , in order to reduce first the seriousness of the lesion to Stage 1 and then arrive at partial healing and finally complete healing of the lesion itself.
• the improved composition forming the subject of the present invention enables healing of external lesions and sores, of any type and extent, via acceleration and reinforcement of the healing process, without any further application of a local antibiotic treatment .
• the composition enables definitive healing of the sores with an elastic and adequately humidified final appearance of the surfaces of the lesions themselves during healing, as well as even with arrest of exudate. Owing to its characteristics, the improved composition hence does not involve formation of fissures or cracking of the scab, and likewise prevents onset of bacterial complications (infections) of the lesions.
• the advantages of the present improved composition are innumerable precisely because it is designed to be applied like an ointment, even though it is a life- saving drug for the treatment and healing of any type of sore, from bedsores, to vascular, diabetic, posttraumatic, postoperative sores and ulcers, as well as obviously simple excoriations and abrasions in general .

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• 2015
  • 2015-06-19 EP EP15753169.0A patent/EP3160454A1/de not_active Withdrawn
  • 2015-06-19 WO PCT/IB2015/054624 patent/WO2015198196A1/en active Application Filing

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