EP3160454A1 - Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers - Google Patents

Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers

Info

Publication number
EP3160454A1
EP3160454A1 EP15753169.0A EP15753169A EP3160454A1 EP 3160454 A1 EP3160454 A1 EP 3160454A1 EP 15753169 A EP15753169 A EP 15753169A EP 3160454 A1 EP3160454 A1 EP 3160454A1
Authority
EP
European Patent Office
Prior art keywords
composition
ulcers
healing
povidone
oil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP15753169.0A
Other languages
German (de)
French (fr)
Inventor
Simone TENERELLI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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Filing date
Publication date
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Publication of EP3160454A1 publication Critical patent/EP3160454A1/en
Withdrawn legal-status Critical Current

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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 .

Abstract

The present invention describes an improved complete therapy for protecting and healing lesions or serious bedsores and vascular and diabetic ulcers, starting from the composition of a medical device basically constituted by a mixture of the following component elements: powdered sugar, liquid 10% povidone-iodine; petroleum jelly, also referred to as Vaseline, soft paraffin, or petrolatum, together with the addition in equal percentages of olive oil, white mineral oil, also referred to as liquid paraffin, and orange- blossom honey, the latter with oily consistency. The composition comprises said component elements in percentages that set in appropriate proportions with one another give rise to golden ratios. The present composition solves innumerable problems that have not been solved by known similar compositions, constituting a valid life-saving drug maintaining unaltered its own characteristics over a time range of at least two years, likewise guaranteeing complete healing of extremely serious lesions at Stage 4 in a maximum time range of six months.

Description

IMPROVED PHARMACEUTICAL COMPOSITION FOR THE PROTECTION
AND HEALING OF PRESSURE ULCERS, DIABETIC ULCERS AND VASCULAR ULCERS
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 known composition , of which the present patent constitutes an improvement, is the patent application No. BA2013A000047 , filed on June 7, 2013 in the name of the present applicant and inventor, to which the reader is referred for the corresponding description and claims.
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:
- bestowing an optimal degree of fluid-plasticity on the creamy composition , guarantee! ng mai ntenance of said creamy properties for at least a period of two years from opening of the container in order to guarantee complete use thereof without any waste and special disposal of the residual unused composition ;
- 7 ncreasi ng and optimising the effectiveness of the composition in the case of serious lesions, namely,
Stage-3 and Stage-4 lesions;
- halving and, where possible, in any case minimising, the times of healing of Stage-3 and Stage-4 lesions;
- totally solving the problems linked to the treatment of all skin sores and ulcers up to and including
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;
- improving the applicability of the composition on skin lesions;
- overcoming the disadvantages linked to possible allergic reaction to the excipients that were used in the past, such as sugar paste (made up of 30 g of sugar, 60 g of lanolin, and 2 g tincture of benzoin), which was indicated in non-complicated wounds with bacteriostati c and eutrophysi ng properties ;
- overcoming the disadvantages of the sugar- and 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! sties 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 .
The above purposes and consequent advantages, as well as the characteristics of the composition according to the present invention will emerge more clearly from the ensuing detailed description , with reference to the attached drawings, wherein:
- Figure 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 ;
- Figure 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;
- Figures 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;
- Figures 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;
- Figures 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;
- Figures 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.
As i 11 ustrated in Figures 1 to 7F described above and attached hereto, there now follows a description of a complete therapy for protecting and healing serious lesions or bedsores and vascular and diabetic ulcers, starting from the composition of a medical device basically constituted by a mixture of the following six component elements: powdered sugar, petroleum jelly, liquid 10% povi done-iodine, olive oil, white mineral oil, and orange-blossom honey oil.
As may also be appreciated from said figures, the technical problem of obtaining a fluid-plasticity of the creamy medicament is solved by providing a composition compri si ng said set of six active compounds for a weight of one hundred grams, as appears in the cobweb diagram of Figure 1, as well as in the table of Figure 2. The above i ngredi ents and the correspond! ng weights for a composition of 100 g of product are the following:
a) (powdered) sugar: 61.81 g;
b) petroleum jelly (petrolatum) : 22.67 g;
c) Betadine (liquid 10% povidone-iodi ne) : 9.52 g; d) olive oil (containing squalene) : 2.00 g;
e) white mineral oil (liquid paraffin) : 2.00 g; f) orange-blossom honey (oil): 2.00 g;
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) .
Said individual components of the composition are all readily available on the market at an extremely low cost. 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 .
Particularly important in the present composition are the natural properties of olive oil and honey, which have been known for thousands of years.
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. In addition to 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. On the other hand, 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). In the human body, 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. 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.
In the human organism 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 . At the level of the sebaceous glands, instead, there is a lack of the enzymes necessary for performing said conversion , and it is for this reason that squalene is particularly abundant in the sebum.
As regards 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.
Hence, 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.
There may likewise be noted the total absence of added chemical substances and/or colorants .
The modal i ties of production of the present improved composition follow the present procedure :
- mixing of povidone-iodi ne with powdered sugar; - addition of petroleum jelly to said mixture;
- further addition and final mixing of said three oils (olive oil, white mineral oil, and orange- blossom honey oil).
During preparation , clots may form, which dissolve with a further mechanical amalgamation . The improved composition thus obtained acquires a dark- brown colour due to oxidation of povi done-iodine (Figures 7B-7C-7E-7F) , different from the original one, which was red, provided for compari son (Figures 7A-7C-7D-7F) so that it is possible to appreciate the differences objectively.
The properties of each component are 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 .
As in the prior known patent, 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 .
On the basis of the clinical data gathered by the inventor of the present improved composition in his thirty-year experience in the treatment of lesions and sores, it has been found that 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 , as may be clearly understood, 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 .
The advantages may be summari sed briefly in the following list:
- healing of the sore in a short time, with cicatrisation times of approximately five months in the case of Stage-4 ulcers;
- natural protection of the exposed tendons in Stage-3 and Stage-4 ulcers;
- creamy composition that does not form encrustations on the wounds;
- elimination of the necrotic escar without the need for surgical debridement;
- absence of allergenic substances;
- rapid di sappearance of pain, with evident di sappearance of suffering of the patient;
- absence of pain during removal of the gauze that adheres to the ointment, in so far as the ointment, by not adhering in an encrusting way not even to the gauze, does not traumati se or likewise damage the granulation tissue;
- creation of a proper humid micro-environment generated by the improved composition in contact with the wound;
- minimised costs of the composition as compared to the medi caments mentioned and known, the Tatter moreover having a very high cost;
- ease of production of the composition on an industrial scale;
- ease of use;
- di sappearance of any bad odours emanating from the wound;
- optimal absorption of the excess exudate;
- possibility of long conservation of the composition , without it losing its curative properties for at least two years from opening of the correspond! ng container;
- total resol ution of the problems linked to treatment of all skin ulcers up to and including Stage 4, including post-traumatic sores, postoperative sores and excoriations and abrasions in general ;
- optimisation of the applicability of the composition on skin lesions; and
- obtaining of a life-saving drug, valid also as excellent protective sun cream.
It is also evident that the weights in grams and the percentages indicated for obtaining the composition may undergo numerous modifications , adaptations , i ntegrations , and variations , including replacement of elements of the composition with other functional ly equivalent ones, without thereby departing from the sphere of protection of the ensuing claims.

Claims

1) A pharmaceutical composition for protecting and healing bedsores and vascular and diabetic ulcers, comprising:
a) sugar;
b) petroleum jelly or petrolatum; and
c) povidone- iodine,
characterized in that said povidone-iodi ne is liquid 10% povidone-iodi ne and in that it further compri ses : d) olive oil;
e) white mineral oil or liquid paraffin; and
f) povidone- iodine,
wherein said sugar is powdered sugar and said six natural ingredients are mixed together; said composition thus formulated constituting a valid life- saving drug for healing bedsores and vascular and diabetic ulcers.
2) The pharmaceutical composition according to the preceding claim, characterized in that said six natural ingredi ents are mixed in the following amounts, with the corresponding weights in grams, for a total of one hundred grams of composition:
a) powdered sugar: 55-68 g; b) petroleum jelly or petrolatum: 20-25 g; c) liquid 10% povidone-iodi ne : 8.5-10.5 g; d) olive oil: 1.7-2.3 g; e) white mineral oil or liquid paraffin: 1.7-2.3 g; f) orange-blossom honey oil: 1.7-2.3 g.
3) The pharmaceutical composition according to the preceding claim, characterized in that said six natural i ngredi ents are mixed in the following amounts, with the correspond! ng weights in grams, for a total of one hundred grams of composition :
a) powdered sugar: 61.81 g; b) petroleum jelly or petrolatum: 22.67 g; c) liquid 10% povi done-iodine: 9.52 g; d) olive oil: 2.00 g; e) white mineral oil or liquid paraffin: 2.00 g; f) orange-blossom honey oil: 2.00 g.
4) The pharmaceutical composition according to
Claim 1, characterized in that at least one element that constitutes it may be present in the mixture with a weight composition ratio equivalent to the golden ratio; namely, at least one component of the mixture has a weight that is the middle proportional between the entire weight of the mixture and the weight of the remaining elements.
5) An industrial method for the producing a pharmaceutical composition according to any one of the preceding claims, characterized in that it basically envisages the following procedural steps:
- a first step of mixing of povidone-iodi ne with powdered sugar;
- a second step of further mixing of said first mixture with the addition of petroleum jelly;
- a third step of mixing with the addition of the three oils, namely, olive oil, white mineral oil, and orange-blossom honey oil, until the right fluid-plasticity of the composition itself is obtained.
EP15753169.0A 2014-06-26 2015-06-19 Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers Withdrawn EP3160454A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBA20140041 2014-06-26
PCT/IB2015/054624 WO2015198196A1 (en) 2014-06-26 2015-06-19 Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers

Publications (1)

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EP3160454A1 true EP3160454A1 (en) 2017-05-03

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Country Status (2)

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WO (1) WO2015198196A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITUB20161210A1 (en) * 2016-02-10 2017-08-10 Dioni Lorena ASSOCIATION OF SUGAR AND VASELINE AND ITS USE IN WOUNDS
WO2017151835A1 (en) 2016-03-03 2017-09-08 Access Business Group International Llc Composition for inhibiting moisture loss from skin comprising a humectant and honey

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU536885B2 (en) * 1979-04-18 1984-05-31 R. A. Knutson Wound and burn dressing
JP2001122790A (en) * 1999-10-22 2001-05-08 Mikasa Seiyaku Co Ltd Stable pharmaceutical preparation for treating bedsore, skin ulcer and wound
JP4559111B2 (en) * 2004-04-23 2010-10-06 興和株式会社 Composition for repairing damaged skin
ES2415362T3 (en) * 2005-04-08 2013-07-25 Mie University External agent to treat wounds
JP2007277135A (en) * 2006-04-05 2007-10-25 Mie Univ External preparation for wound treatment

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO2015198196A1 *

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WO2015198196A1 (en) 2015-12-30

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