Classifications

• • 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
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
  • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• • 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
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
  • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
  • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer

Definitions

• the present invention relates to a system for the percutaneous release of active principles, and in particular to a shaped support to be worn, preferably in the form of a bra, buttock support or eye-mask, which adheres to the skin and is able to incorporate, in a vehicle, cosmetic or pharmacological active principles.
• Cosmetic products in particular those with a toning or anti-cellulitis action are currently applied onto the skin by means of more or less prolonged massaging. It is known that some cosmetic effects may be better obtained when the necessary active substances are applied in a regular and dosed manner; in particular, mention may be made of substances which are able to act with toning effects which prevent and help treat stretch-marks, prevent ageing of the skin, stimulate the skin's tissues, together with a soothing, softening, decongestant , refreshing action providing protection against aggressive chemical, physical and biological agents which are harmful.
• Application performed with a conventional massage may have the following drawbacks: adequate quantities for the effect required, but excessive side effects and/or irritation due to the high concentration; quantities without negative effects which are effective and applied repeatedly at short time intervals, but with considerable inconvenience for the user; quantities without negative effects, which are applied with the usual methods, but which have little or no effect; quantities with limited negative effects, but applied with incorrect procedures.
• the systems for the percutaneous release of pharmacological active principles currently in use are generally in the form of patches, the application of which is not always liked or aesthetically acceptable.
• the pharmaceutical and cosmetic formulations for application to the skin are emulsions of various types and complexity and are not compatible with the adhesive ⁇ used.
• a dermo-compatible adhesive which contains one or more cosmetic or pharmacological active substances.
• This adhesive is able to release in a controlled manner the active substance percutaneously.
• the percutaneous release system may be advantageously incorporated in a shaped support so that it can be worn and carried for a long time.
• the application time or presence of the product is in any case determined by the specific use.
• the present invention relates to a shaped support comprising a part adhering to the skin, characterized in that said adhering part comprises an adhesive incorporating, in a vehicle, one or more cosmetic, dermatological or pharmacological active substances.
• the present invention also relates to a method for the manufacture of said support.
• Figure 1 illustrates a way of embodiment a shaped support according to the invention in the form of a bra
• FIGS 2 and 3 illustrate various embodiments of the bra according to Figure 1;
• Figure 4 illustrates another method of manufacturing the shaped support in the form of a support for the buttocks and the upper part of the thighs
• Figure 5 illustrates yet another method of manufacturing the shaped support in the form of an eye- mask.
• a first problem solved by the present invention is the compatibility between the adhesive and the vehicle containing the active substance.
• the vehicle to be inserted into the adhesive is an emulsion, which has the following composition:
• the emulsifying system may be formed with one or more emulsifiers which are normally available in commerce.
• emulsifiers which are normally available in commerce.
• the quantity of water indicated above must not be exceeded otherwise the emulsion, although stable, will contain an excessive amount of water for production requirements.
• Anionic or non-ionic emulsifiers may be used.
• the percentage content of the water varies from about 0 to 55% by weight.
• Preferred examples of emulsifiers are the combinations: ceteareth-3 + sodium lauryl sulphate; glyceryl behenate
• emulsions such as water/oil/water, oil/water/oil, water/silicone/ water, silicone/water/ silicone, water/silicone, silicone/water.
• the mixture of active substances is composed depending on the effects required in the product.
• the other substances present in the product are inserted on the basis of criteria used in accepted industrial practice, such as adjuvants for the stability, preservation, colouring and perfuming of the finished product.
• the production of the emulsions complies with normal industrial practice which envisages the preparation of the different phases at the correct temperature and the subsequent mixing thereof in order to obtain the emulsion, the order of phase addition depending on the type of emulsion required.
• the active substance may be introduced into the adhesive also in forms other than an emulsion.
• a first example consists in the solidified anhydrous lipid mixtures, as illustrated in Table 2.
• formulations devised are based on the exclusive use of fatty substances mixed in proportions such as to obtain an anhydrous lipid mass with paste-like consistency able to return to the liquid state with a slight raising of the temperature.
• Formulations containing vegetable oil and cocoa butter in various proportions were prepared.
• the active substances present which are selected depending on the required effect, must be compatible with the oily vehicle; water-soluble substances cannot be used.
• a second example consists in oily substances, as illustrated in Table 3.
• the formulations realized are based on the mixing of the active ingredients with an oily vehicle, the oil used may consist of a single oil or of a mixture of oils in variable proportions. All types of oils (vegetable, animal, mineral, synthetic, silicone) may be used and formulations were prepared with a vegetable oil, a mineral oil, a synthetic oil and a silicone oil and with mixtures of vegetable oil + mineral oil, vegetable oil + silicone oil, synthetic oil and silicone oil.
• the active substances present must be compatible with the oily vehicle; water-soluble substances may not be used.
• a third example are solutions, as illustrated in the Table 4.
• the formulations thus composed are based on the use of a solvent which incorporates the active substances.
• General solvents used in cosmetics may be used, for example: water, demineralized and/or purified water, distilled water, glycerol, ethylene glycol, propylene glycol, methyl alcohol, isopropyl alcohol and solvents for adhesive bases.
• Oil substances may also be used as a solvent in accordance with the formulation indicated for the oily substances.
• the active substances are directly dispersed in the compatible solvent which is then used in the production of the active release system.
• a fourth example are microcapsules, as illustrated in Table 5.
• the formulations thus composed incorporate the microcapsules directly in the adhesive mass where - this being a typical characteristic of microcapsules - they gradually break up releasing the active principle contained in them.
• microcapsules are composed essentially of an active base "nucleus" and by a coating based on fatty acids. In the cosmetic field, these microcapsules are useful in relation to their constitution since the fatty acids have a useful action on the skin.
• the schematic composition of the microcapsules is as follows: ingredient
• the grain size ranges between 200 and 800 microns and may be in a dry form or already dispersed in an aqueous solution.
• microcapsules are used in the product, a further improvement in temporal release of active substances associated with their breakage and dissolving mechanism is obtained.
• Another advantage associated with the use of microcapsules is a reduction in the use of preservatives and a reduction in the possible drawbacks resulting from interaction between active substances and adhesive mass.
• microcapsules with a non-hardened gelatinous membrane a hardened gelatinous membrane, a membrane based on urea-formaldehyde resin, a membrane based on fatty acids and a membrane based on natural waxes.
• the suitable adhesive system must be of the non- irritating type, dermo-compatible and in any case formulated for the specific use.
• the adhesive system is chosen from the group consisting of: acrylic adhesive in solvent, acrylic adhesive in an aqueous solution, and silicone and polyurethane adhesives.
• the present invention also provides a method for the manufacture of the shaped support described above.
• the method envisages the preparation of a master namely a mixture comprising the adhesive mass and the active principles in their various formulations, as described above.
• a first rolling head with a roller doctor blade containing suitable collecting shoulders, deposits a master consisting of an adhesive containing the active principles onto a roller supporting the liner arranged in a horizontal position so as to form a moist adhesive mass; once treated in a first oven, arranged on the liner, said moist adhesive mass is introduced into a drying oven from which it emerges in the form of a dry mass; upon leaving said oven, a calendering head joins together with pressure the liner spread with the dry mass and the supporting film.
• Drying takes place in an oven with at least five chambers for forced circulation of hot air, at temperatures, inside the respective chambers, of 40, 80,
• a support is obtained in which the adhesive contains, dispersed in the mass, the active substance.
• the support thus obtained is then suitably shaped depending on the intended use.
• a first rolling head with a roller doctor blade containing suitable collecting shoulders, deposits a moist adhesive mass onto a roller supporting the liner arranged in a horizontal position so as to form a moist adhesive mass; once treated in a first oven and arranged on the liner, said moist adhesive mass is made to pass under a second rolling head with a Mayer bar; said head deposits on said adhesive mass a colloidal solution containing one or more active principles, the resultant stratified mass is introduced into a drying oven from which it emerges in the form of a dry mass; upon leaving said oven, a calendering head joins together with pressure the liner spread with the dry mass and the supporting film.
• Drying is performed as described above.
• the liner support roller is arranged in a horizontal position for at least one metre.
• the shaped support is in the form of a complete bra, understood as being a cup covering the breast entirely.
• bras Articles of clothing known as bras are today still made of a fabric which is reinforced with rigid structures and supported with shoulder straps and fixed with hooks or other closing systems.
• These garments may have, among other things, the following drawbacks: overall rigidity; metal, plastic or other rigid and/or semi-rigid material inserts for ensuring the support and shape; hooks or fastening systems; supporting systems such as shoulder straps which are not always aesthetically pleasing; points where there is rubbing or friction on the skin; manufacture involving manual processing operations; fixed standard sizes with the need for numerous variations in order to satisfy different requirements; - discomfort resulting from the rigid parts present in the article of clothing; problems of use in particular physiological and/or pathological conditions; costs.
• the present invention in its first preferred embodiment, relates to a product which is able to eliminate or reduce the abovementioned drawbacks.
• the shaped support is a bra which comprises a shaped surface treated with a suitable adhesive, does not cause irritation, is dermo-compatible and in any case designed for the specific use, being able to adhere to the skin.
• the support is able to perform efficiently the function of a bra. It perfectly matches the surface and preferably does not have inside it rigid parts or hooks which may be troublesome or create discomfort.
• the bonding substance incorporates active substances which are able to perform a cosmetic, dermatological or medical action.
• the support is able to cover the breast entirely, replacing fully the usual garments.
• Figure 1 shows a possible embodiment of a breast covering cup according to the present invention.
• the cup is formed by a suitably shaped punch.
• the dimensions A, A' and B are determined by the person skilled in the art depending on the final design.
• the top part is made of fabric or other suitable pliable material.
• the bottom part which extends over an area identical to the top part, consists of the adhesive system for the percutaneous release of the active substances.
• the adhesive support arranged along the shaped edge of the punched form also allows connection with the edges which, once they are made to adhere, form the bra cup.
• Figures 2 and 3 are examples of different embodiments of the breast covering cup according to the present invention.
• the particular manufacturing method results in a product which has the advantage that it can be removed from the skin where it has been applied without any type of inconvenience or negative reaction.
• the combination of adhesives used may be chosen from among those proposed so that, unlike other existing systems, the product can be kept on the application area even in a water or salty water environment.
• the product helps limit the associated problems both favouring the functions and performing protective activities.
• the product Owing to the original combination of components, ingredients and the production process, the product is considerably cheaper than a bra of the traditional type.
• the customary procedure for the manufacture of a similar article of clothing requires several stages with operations performed by an operator.
• the product offers the advantage of a completely automatic cycle, not requiring manual finishing operations.
• the bra as a result of its constructional properties, may be without rigid or reinforcing parts, shoulder straps or hooks or other elements indispensable for wearing purposes.
• the shaped support is in the form of a buttock support, understood as being a specific support forming part of intimate clothing able to perform a modelling function supporting the buttocks.
• a second preferred embodiment of the present invention relates to a product which is able to eliminate or reduce the abovementioned drawbacks.
• the shaped support comprises an adhesive as described above, able to cause said support to the adhere to the skin.
• the product is able to perform effectively the supporting and modelling function. It perfectly matches the surface and does not have inside it rigid parts or hooks which may be troublesome or create discomfort.
• the adhesive substance may incorporate the active substances able to perform a complete cosmetic, dermatological or medical action, in particular an anti-cellulitis, toning action preventing stretch marks.
• the product may applied in order to perform a medical action for the treatment of aesthetic and circulatory problems as well as torn and aching muscles, with both a curative and a preventive action, and in particular may be applied during sports activities, containing substances which favour the action of the muscle under stress.
• the product is able to cover entirely the part to be treated and may be conveniently positioned underneath usual clothing.
• Figure 4 shows an example of embodiment of the shaped support for buttocks and thighs according to the present invention.
• the adhesive support is arranged so as to ensure adhesion of the shaped support to the skin in the relevant area of the body.
• shaped support may be easily devised by the person skilled in the art.
• the particular manufacturing method results in a product which has the advantage that it can be removed from the skin where it is applied without discomfort or negative reactions of any kind.
• the combination of adhesives used may be chosen from those proposed so that, unlike other existing systems, the product can be kept on the application area even in a water and salty water environment.
• the product owing to the original combination of components, ingredients and the production process, may be manufactured by means of a completely automatic cycle, without the need for any finishing operations.
• the shaped support is in the form of a mask for the area surrounding the eyes.
• Some of the problems which may arise are as follows: - products which are difficult to apply with possible problems affecting the eyes; low level of effectiveness compared to the dose applied; exclusively physical systems which require prior heat treatment and cannot be transported over long distances; physical systems which must be applied using ties, elastics or other fixing systems with the possibility of points where there is rubbing and friction with the skin or complications as a result of interference with the hair; fixed standard sizes and storage problems; difficulties of use in unprotected environments, such as transportation means, all the environments outside one's home, communal environments, etc.; problems of use in particular physiological and/or pathological conditions; costs.
• a third embodiment of the present invention relates to providing a product which is able to eliminate or reduce the abovementioned drawbacks.
• the mask for the area surrounding the eyes comprises a shaped surface which is treated with an adhesive, as described above for the two previous embodiments, able to cause said surface to adhere to the skin.
• the product Owing to the specific shape and the fact that it adheres to the body's surface, the product is able to perform effectively the function of supporting active substances which are able to have a soothing and refreshing effect on the skin and/or in any case are able to exert a cosmetic, dermatological or medical action, and also perform an aesthetic function of both a masking and decorative nature .
• the product is able to cover the relevant area surrounding the eyes without affecting the eye-ball and therefore without causing any irritation.
• Figure 5 shows a possible embodiment of the mask according to the present invention.
• the manufacturing method and the components are similar to those described above for the breast support cup.
• the particular manufacturing method results in a product which has the advantage that it can be removed from the skin where it is applied without discomfort or negative reactions of any kind.
• the particular combination of adhesives used unlike other existing systems, allows the product to be kept on the application area even in a water and salty water environment. Owing to the original combination of components, ingredients and the production process, the product has a very low cost and has the advantage of a completely automatic cycle, not requiring any manual finishing operations.
• the active principles may be chosen from among those with a cosmetic or pharmacological action or the various actions may be combined.
• the firming effect for the breast may be obtained by means of use of active substances which may be used individually or as a mixture in variable proportions.
• active substances are substances extracted from medicinal plants (in the various forms available), such as alchemilla, capsella bursa pastoris, centella asiatica, echinacea, equisetum, fenugreek, ginseng, horse chestnut, liquorice, hop, sage; common mallow mucilage, calendula, algae; essential oils of camphor and mint; the following principles: glycyrrhetic acid, N-acetyl glucosamine, collagen, extract of Breckland thyme and lupine, hyaluronic acid, vitamins, in particular vitamin A, vitamin E, hydroxy prolisilene C, derivatives with hydroxyproline.
• examples of active substances which may be used include the substances favouring milk production: aniseed, caraway, fennel, vervain, Acacia cathecu, Asparagus racemosus,
• examples of active substances which may be used are artichoke, boldo, fumitory, rosemary, orthosiphon and the pharmaco- logically active chemical substances. It may be desirable to obtain a protective effect in the case of use of contraceptives in order to reduce the side effects.
• Example 1 The following examples further illustrate the invention: Example 1
• a shaped support in the form of a bra was made .
• the product thus made was subjected to practical tests in order to assess the degree of improvement which can be obtained. Twelve female volunteers were selected and asked to try the product and express an opinion on certain characteristics. It is obviously not possible to carry out a blank control test, but only a comparative subjective test.
• a shaped support in the form of a bra containing an active substance with a firming action was made.
• the product thus made was subjected to practical tests in order to evaluate the possibility for use. Eight female volunteers were selected and asked to test the product and express an opinion as to certain characteristics. No dummy test was carried out, but only a subjective test.
• a shaped support in the form of a mask surrounding the eyes was made .
• the product thus made was subjected to practical tests in order to evaluate the degree of acceptability obtainable. Eight volunteers of both sexes were selected and asked to test the product and express an opinion as to certain characteristics. It is obviously not possible to carry out a blank control test, but only a subjective test, making a comparison with conventional methods such as cold masks and creams.
• the subject-matter of the present invention also includes a method for cosmetic treatment of the breast, for example a toning treatment, which uses a shaped support in the form of a bra as described above; a method for the treatment of cellulitis, which uses a buttock and thigh support as described above, and a method for treating the area around the eyes, for example with an anti- wrinkle or decongestant effect, which uses a mask as described above.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Dermatology (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Cosmetics (AREA)
• Medicinal Preparation (AREA)

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Citations (4)

• 1997
  • 1997-02-05 IT ITMI970218 patent/IT1290255B1/it active IP Right Grant
• 1998
  • 1998-02-02 AU AU66189/98A patent/AU6618998A/en not_active Abandoned
  • 1998-02-02 WO PCT/EP1998/000539 patent/WO1998034652A1/en active Application Filing

Patent Citations (4)

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