Bandaging material

FIELD: medicine.

SUBSTANCE: described bandaging material contains non-volatile silicone fluid mixed with colloidal silicon dioxide, volatile solvent and silicone elastomer. Material is improved composition applied for specific tissue area amenable to pathogenic infections and/or scarring.

EFFECT: has improved composition.

33 cl, 4 tbl, 7 ex

 

The present invention relates to compositions based on silicone, method of producing such compositions and use of such compositions in medicine. In particular, although not exclusively, the present invention proposed a dressing material based on silicone.

Skin damage caused by trauma or surgery, such as cuts, wounds and/or skin lesions that can cause scarring or scars, and not to the regeneration of the original tissue. Accordingly, such scars or scars undesirable because they can not only create serious cosmetic problems, but scar tissue is also usually lack the functionality of normal skin. For example, the sense of touch can be reduced or completely lost, and can form weak spots in those places where the scar tissue is connected with undamaged tissue. In order to reduce the formation of scars and improve the condition of existing scars have developed various therapies and treatments.

Accordingly, in attempting to reduce the formation of scars and prevent the growth of pathogens in the target tissue wound site were developed dressings for wounds, including films or hydrogels of aqueous plastics. A specific disadvantage of the dressing material in the form of a hydrogel is that it is not what may be well adapted to the changing topography of the surface of the body, and thus the material can have a different pressure on different parts of the body. Accordingly, such dressings in the form of a hydrogel may not completely cover the desired position in the tissue. In addition, since the water content in such dressings in the form of a hydrogel may change with changes in humidity, thus altering the efficiency and lifetime of dressing, then top dressing material is usually applied coating or surface layer. Moreover, since the bandage from the hydrogel can be heavy, awkward and difficult to hold in the correct position for proper maintenance usually requires professional attention of doctors or nurses.

Respectively, were developed alternative dressings for wounds, including silicone oils, also known as siloxanes.

Although silicone oil can exhibit good compatibility with human tissues and have desirable biological properties, such as allowing normal functioning of the skin due to the transmission from the skin of water vapor, gases and toxins, acting as a barrier to potential pathogens, usually by themselves silicone oil are in the form of free flowing liquids/oils and do not have the necessary Phi is practical consistency, which would ensure their suitability for use as a wound. Typically, the wound dressing material is desired, the consistency of thick cream or lubricant, so that the dressing material sufficiently strongly retained on the underlying target tissue, and to remove it from the target area would require a focused effort.

With the aim of increasing the viscosity of the silicone oils were developed dressings for wounds, comprising a mixture of silicone oil and up to about 3% wt. colloidal silicon dioxide (white carbon black). Although such mixtures can provide superior consistency compared to unmixed silicone oils, usually to improve the adhesion to the wound and prevent smudging bandages desirable more viscous mixture (i.e. resistant to smearing). However, the mixture comprising silicone oil and colloidal silicon dioxide, which have a high viscosity and provide improved adhesion and resistance to smearing", usually it is difficult to impose on the target tissue, without causing additional damage and/or pain.

In an attempt to overcome the trade-off between improved adhesion to the target tissue and causing additional damage and/or pain were proposed dressings on wounds, VK is chausie silicone oil, colloidal silicon dioxide and volatile diluent. Accordingly, the inclusion of biologically compatible volatile diluent may provide an opportunity for making bandages for wounds in the form suitable for smearing the cream, gel or oil that can be applied to the wound without causing further damage or discomfort. After the mixture is applied to the site of the wound, the evaporation of the volatile solvent from the composition usually results in a final composition having increased viscosity and exhibiting improved adhesion to the wound and a high resistance to creasing.

Although these songs and made some progress in respect of the problems of the dressing material for wounds on the basis of silicone oil having the desired consistency, a particular problem with such dressings for wounds associated with the time required for the composition, once applied to the desired area of the tissue acquired the necessary increased viscosity, adhesions and resistance to bleeding. Typically, the time needed for evaporation may be approximately 15 minutes or more before the composition will exhibit sufficient adhesion to the target tissue.

Therefore, it may be necessary to capture the target site or to record the song on the target issue for lighting the m site during this period, to prevent separation of the composition from the target tissue until then, until it reaches the desired viscosity. Accordingly, this may lead to a reduction in efficacy and possible applications of the composition as a coating composition on some areas of the body especially on those areas that cannot be easily fixed, and those areas that are not readily available, can be difficult. In addition, the requirement to wait for quite a long period of time until the composition reaches the desired viscosity. once in the application, and the need to capture the target tissue may lead to a reduction in the tolerability of the patient and may require professional application and attention of the doctors or nurses.

Thus, the present invention is directed to the creation of improved compositions suitable for application to the target tissue, in particular to the target tissue is exposed to pathogenic infection and/or scarring, especially on the skin injury or wound.

According to the first aspect of the present invention proposed a composition comprising non-volatile silicone fluid mixed with the colloidal silicon dioxide, volatile diluent and a silicone elastomer. This composition is hereinafter referred to as the composers who Oia according to the present invention.

Accordingly, the composition according to the present invention is intended to solve the above technical problems associated with the application of the dressing material for wounds on the target tissue area. Unexpectedly, it was found that the introduction of silicone elastomer composition according to the present invention can not only produce a composition having essentially the same viscosity that is comparable composition not comprising silicone elastomer, but also can promote the evaporation of the volatile solvent from the composition according to the present invention. Accordingly, the composition according to the present invention after application to the target tissue can achieve the required high viscosity, adhesion properties and resistance to smearing by evaporation of the volatile diluent within a shorter period of time than essentially identical composition that does not contain silicone elastomer. Convenient that usually do not need to record the target tissue or fix the composition of the target tissue until the volatile solvent to evaporate to obtain a final composition having the desired viscosity, adhesive properties and resistance to smearing, so that it can be used as dressing materials wounds. Consequently, the efficiency and applicability of the compositions according to the present invention can be improved in comparison with a comparable composition not comprising silicone elastomer, since the composition according to the present invention can be applied to the target tissue area of all areas of the body that are not readily available or which cannot easily be fixed. In addition, the composition according to the present invention can be in the form capable of smearing the cream, gel or oil that can be applied to the target tissue without causing further damage or discomfort.

Conveniently, the composition according to the present invention can provide increased tolerance by the patient and can eliminate the need for a professional overlay and the supervision of doctors or nurses.

Essentially, the composition according to the present invention can be called "composition fast drying" compared to the identical, essentially, a composition that does not contain silicone elastomer. From the point of view of theory suggest that the silicone elastomer may promote the evaporation of the volatile solvent from the composition according to the present invention.

The term "silicone elastomer" means a silicone polymer, which is at room temperature oblad is no capacity for significant restoration of the shape and size after removal of the tensile forces, if you have not exceeded the limit of elasticity. Acceptable if the silicone elastomer is a thixotropic solid body, so that the viscosity of the silicone elastomer decreases over time, when it applied shear force.

Acceptable if the silicone elastomer has a mass-average molecular weight greater than or equal to 150,000, preferably greater than or equal to 200000, more preferably greater than or equal to 250000, even more preferably greater than or equal to 300000.

Preferably the silicone elastomer comprises a silicone polymer. More preferably, the silicone elastomer is a silicone cross-polymer (i.e. cross-linked silicone polymer). Even more preferably silicone elastomer includes cross-polymer dimetikona (dimethicone) (i.e. cross-linked polymer dimetikona). Silicone elastomer, especially dimethiconol cross-polymer, may be unsubstituted or substituted, for example substituted by a simple polyester type of polyethylene glycol (PEG). Most preferably, if the silicone elastomer, especially cross-polymer dimetikona is unsubstituted.

Mainly, if the silicone elastomer comprises silicone cross-polymer, this silicone cross-polymer preferably includes a number of cross-linking (cross-linker), less than or equal to 10% mA is., more preferably less than or equal to 8 wt.%, even more preferably less than or equal to 5% wt.

Preferably the silicone cross-polymer includes a cross connection in a quantity greater than or equal to 1% wt., more preferably greater or equal to 2% wt.

Preferably the composition according to the present invention includes a silicone elastomer in amounts greater than or equal to 0.1% wt., preferably greater or equal to 0.2 wt.%, more preferably greater or equal to 0.25 wt.%, even more preferably greater or equal to 0.3 wt.%, most preferably greater or equal to 0.5% wt. Preferably the composition according to the present invention includes a silicone elastomer in amounts less than or equal to 10 wt.%, more preferably less than or equal to 5 wt.%, even more preferably less than or equal to 2% wt., even more preferably less than or equal to 1.5 wt.%, most preferably less than or equal to 1% wt. Especially preferred composition according to the present invention includes from 0.2 to 1 wt.%, in particular from 0.2 to 0.8 wt.%. silicone elastomer.

For convenience and ease of processing silicone elastomer may be blended with one or more silicone fluids of lower viscosity, such as non-volatile silicone fluid and/or volatile silicon is s liquid as described later, for example, such as a linear Dimethicone or cyclomethicone (cyclomethicone).

Accordingly, the use of a mixture of silicone elastomer and non-volatile silicone fluids allows you to more easily mix the elastomer with other components of the composition according to the present invention, namely with the colloidal silicon dioxide, non-volatile silicone fluid and a volatile diluent.

Preferably, if the silicone elastomer is mixed with one or more non-volatile silicone fluids of lower viscosity, in particular with non-volatile linear dimethicones.

Alternative silicone elastomer may be blended with one or more volatile silicone liquids, especially cyclomethicone, as hereinafter defined, in particular with decamethylpentasiloxane or Dodecamethylcyclohexasiloxane.

It should be understood that when used in compositions according to the present invention a mixture of silicone elastomer and silicone fluids of lower viscosity, this silicone fluid of lower viscosity may be identical volatile diluent or non-volatile silicone fluid in the composition according to the present invention. Alternative silicone fluid of lower viscosity of the mixture of silicone elastomer and silicone fluids of lower viscosity to moreoticus from volatile solvent and non-volatile silicone fluid in the composition according to the present invention.

Especially preferred mixture of silicone elastomer and silicone fluids of lower viscosity include a mixture of cross-polymer dimetikona, as defined here, and nonvolatile Dimethicone or non-volatile cyclomethicone or pentacosane. Especially preferred silicone cross-polymer include dimethiconol cross-polymer, as defined here, cicadellinae silicone fluid, for example silicone elastomer (rubber) a mixture of Dow Corning 9040 Silicone Elastomer Blend, supplied by Dow Corning Inc., Midland, Michigan, USA, and dimethiconol cross-polymer dimethiconol silicone fluid, for example silicone elastomer blend Dow Corning ® 9041 Silicone Elastomer Blend, also supplied by Dow Corning Inc.

Acceptable, if the mixture of silicone elastomer and silicone fluids of lower viscosity is also thixotropic. Acceptable, if the mixture of silicone elastomer and silicone fluids of lower viscosity has a high viscosity, measured at 25°C. the Viscosity of the mixture of silicone elastomer/silicone fluid of lower viscosity may be determined using a rotational viscometer, such as a viscometer Brookfield Synchro-lectric viscometer or rheometer type core/plate Wells-Brookfield Core/Plate viscometer supplied by Brookfield Engineering Laboratories, Stoughton, MA, USA, using test methods ASTM D-1084 (viscose is the EPR-type Cup/spindle) and ASTM D-4287 (for viscometer type cone/plate). Acceptable use of viscometers, designed for high viscosity (models HA and HB).

Acceptable, if the kinematic viscosity of the mixture comprising 15% by volume of silicone elastomer and 85% by volume of a linear polydimethylsiloxane having a kinematic viscosity of 5 cSt (namely, fluid Dow Corning 200 5cSt, supplied by Dow Corning), at 25°With greater than or equal 220000 cSt, more preferably greater than or equal to 240000 cSt, most preferably greater than or equal to 250,000 in FTA when measuring the above-mentioned methods. Preferably, the kinematic viscosity of the mixture comprising 15% by volume of silicone elastomer and 85% by volume of a linear polydimethylsiloxane having a kinematic viscosity of 5 cSt (namely, fluid Dow Corning 200 5 cSt, supplied by Dow Corning), at 25°With less than or equal to 800,000 Centistokes, more preferably less than or equal to the 700,000 Centistokes, most preferably less than or equal to 600,000 Centistokes when measured above methods.

Acceptable if silicone elastomer itself is non-volatile.

Acceptable, if the mixture of silicone elastomer and silicone fluids of lower viscosity is non-volatile. In other words, the silicone elastomer by itself, and the mixture of silicone elastomer and silicone fluids of lower viscosity, respectively, do not show appreciable elasticity pair p and the ambient temperature. Preferably the content of volatile matter in silicone elastomer per se and the mixture of silicone elastomer and silicone fluids of lower viscosity, respectively, at 150°With less than or equal to 0.6 wt.%, more preferably less than or equal to 0.4 wt.%, most preferably less than or equal to 0.3% wt. calculated on the total weight of the silicone elastomer as such and the mixture of silicone elastomer and silicone fluids of lower viscosity, respectively.

Acceptable, when the silicone elastomer is in the form of a mixture of silicone elastomer and silicone fluids of lower viscosity silicone elastomer is present in a quantity less than or equal to 40% by volume, preferably less than or equal to 30% by volume, more preferably less than or equal to 20% by volume of the volume of the mixture. Acceptable, when the silicone elastomer is in the form of a mixture of silicone elastomer and silicone fluids of lower viscosity silicone elastomer is present in a quantity greater than or equal to 5% by volume, preferably greater than or equal to 10% by volume, more preferably greater than or equal to 15% by volume of the volume of the mixture. The rest of the above mixtures are usually essentially amounts to one or more of these silicone fluids of lower viscosity.

Professionals understood what about, in the case when the silicone elastomer is in the form of a mixture of silicone elastomer and silicone fluids of lower viscosity, it is necessary to use the appropriate amount of such a mixture, so that the total content of the silicone elastomer in the composition according to the present invention preferably fall within the preferred limits defined above. Acceptable, if such a quantity can be determined using conventional experiments, based on the known concentration of the mixture of silicone elastomer and silicone fluids of lower viscosity.

Preferably, when the silicone elastomer is in the form of a mixture comprising a silicone elastomer and silicone fluid of lower viscosity, as defined here, this mixture is present in amounts greater than or equal to 1% wt., more preferably greater or equal to 1.5 wt.%, most preferably greater or equal to 2% wt. calculated on the total weight of the composition.

Preferably, when the silicone elastomer is in the form of a mixture comprising a silicone elastomer and silicone fluid of lower viscosity, as defined here, this mixture is present in a quantity less than or equal to 10 wt.%, more preferably less than or equal to 7 wt.%, most preferably less than or equal to 5% wt. in RA the couple on the total weight of the composition. Particularly preferred composition comprises 3% by weight. a mixture of silicone elastomer and silicone fluids of lower viscosity, as defined here, based on the total weight of the composition.

The term "volatile solvent" authors indicate the diluent, which essentially evaporates at normal body temperature (i.e. up to 38°With inclusive) and atmospheric pressure.

Preferably volatile diluent essentially evaporates at room temperature (i.e. 25°C) and atmospheric pressure.

Acceptable, if volatile diluent exhibits a significant vapor pressure at ambient temperature. Preferably the volatile solvent has a heat of vaporization at 25°With greater than or equal to 50 kJ kg-1more preferably greater than or equal to 75 kJ kg-1even more preferably greater than or equal to 100 kJ kg-1most preferably greater than or equal to 125 kJ kg-1. Preferably the volatile solvent has a heat of vaporization at 25°With less than or equal to 275 kJ kg-1more preferably less than or equal to 250 kJ kg-1even more preferably less than or equal to 225 kJ kg-1most preferably less than or equal to 200 kJ kg-1.

Acceptable if the volatile solvent has a low viscosity, measured at 25°s Wascott the volatile diluent may be measured using a glass capillary viscometer type Ubbelohde (Ubbelohde), supplied by Fisher Scientific Co., Pittsburgh, PA, USA, using test method ASTM D-445, IP71.

Preferably the volatile solvent has a kinematic viscosity of greater than or equal to 0.5 mm2with-1more preferably greater than or equal to 2 mm2with-1especially greater than or equal to 3 mm2with-1when measured in accordance with the above method. Preferably the volatile solvent has a kinematic viscosity of less than or equal to 10 mm2with-1more preferably less than or equal to 9 mm2with-1, especially less than or equal to 8 mm2with-1at 25°when measured in accordance with the above method.

Preferably the volatile solvent is a volatile silicone fluid medium (such as liquid), because they are usually compatible with non-volatile silicone fluid. Acceptable, if volatile silicone fluid comprises a silicone polymer, especially a silicone polymer cyclomethicone. Preferred volatile silicone fluids selected from the following: polydimethylsiloxane, such as cyclohexasiloxane, Cyclopentasiloxane, Dodecamethylcyclohexasiloxane, decamethylcyclopentasiloxane, octamethylcyclotetrasiloxane; polymethylsiloxane, such as hexamethyldisiloxane; or polymethylsiloxane, for example octamethyl roxan.

Highly preferred volatile silicone fluids include polydimethylsiloxane, in particular Cyclopentasiloxane and cyclohexasiloxane, especially Dodecamethylcyclohexasiloxane and decamethylcyclopentasiloxane.

Examples of suitable volatile silicone fluid is Dow Corning 244, which includes cyclomethicone octamethylcyclotetrasiloxane, Dow Corning 245, which includes cyclomethicone decamethylcyclopentasiloxane Dow Corning 246, which includes cyclomethicone Dodecamethylcyclohexasiloxane, and Dow Corning 345, which includes cyclomethicone decamethylcyclopentasiloxane.

Preferably, the mass-average molecular mass of a volatile diluent is greater than or equal to 150, more preferably greater than or equal to 250, most preferably greater than or equal to 300. Preferably, the mass-average molecular mass of a volatile diluent is less than or equal to 1000, more preferably less than or equal to 800, even more preferably less than or equal to 600, most preferably less than or equal to 500.

To change the speed of the escape, if so desired, you can also use a mixture of volatile silicone fluids. Volatile diluent may be added to the mixture of non-volatile silicone fluids, colloidal silicon dioxide and silicone elastomer in any proportion required is th to reduce the viscosity of the composition according to the present invention, with the aim of obtaining pliable oil or light grease. At very high dilution, for example, if 1 mass part of a mixture of non-volatile silicone fluids, colloidal silicon dioxide and silicone elastomer added to 1000 mass parts of the volatile diluent, the product can be applied in the form of a movable fluid using the appropriate device for the application (applicator), such as ball applicator or even in the form of spray from an aerosol can. At the other extreme version only 1 parts by weight of a volatile diluent may be added to 99 parts by weight of a mixture of non-volatile silicone, colloidal silicon dioxide and silicone elastomer with the aim of obtaining a viscous composition, which contributes to its application.

Valid if the volatile diluent is present in amounts greater than or equal to 1%, more preferably greater or equal to 5%, even more preferably greater than or equal to 10%, even more preferably greater or equal to 15%, even more preferably greater or equal to 20%, most preferably greater or equal to 25% by weight calculated on the total weight of the composition according to the present invention. Valid, if the diluent is present in amounts less than or equal to 99.9%, preferably less than or equal to 80%, more preferably less than or equal the m 70%, even more preferably less than or equal to 60%, most preferably less than or equal to 50% by weight calculated on the total weight of the composition according to the present invention.

It should be understood that if the silicone elastomer is in the form of a mixture of silicone elastomer and a volatile silicone fluid, the total amount of volatile solvent in the composition according to the present invention (i.e. volatile silicone fluid in a mixture of silicone elastomer and a volatile silicone fluid plus volatile diluent as such) preferably falls within the above preferred ranges.

Valid if the volatile diluent may comprise the remainder of the composition according to the present invention.

The term "non-volatile silicone fluid (liquid)" the authors call the silicone liquid which essentially does not evaporate from the composition according to the present invention at normal body temperature (i.e. up to 38°With inclusive) and atmospheric pressure. Preferred non-volatile silicone fluid essentially does not evaporate from the composition at room temperature (i.e. up to 25°With inclusive) and at atmospheric pressure.

Accordingly, non-volatile silicone fluid itself has no appreciable vapor at ambient temperature the Reda. Preferably a content of volatile substances in itself non-volatile silicone fluid at 150°With less than or equal to 0.8 wt.%, more preferably less than or equal to 0.6 wt.%, even more preferably less than or equal to 0.4 wt.%, most preferably less than or equal to 0.3% wt. calculated on the total weight of non-volatile silicone fluid as such.

Valid if the component representing the non-volatile silicone fluid, forms the basis of the composition according to the present invention and provides the chemical properties of the barrier between the damaged target tissue and the environment. Valid if the non-volatile silicone fluid is a silicone polymer.

Preferred non-volatile silicone fluid is a non-volatile silicone oil. Preferred non-volatile silicone fluid has a kinematic viscosity at 25°, greater than or equal to 500 cSt, more preferably greater than or equal to 5000 cSt, most preferably greater than or equal to 10000 cSt, measured in accordance with ASTM D-445, IP71 using a glass capillary viscometer as described here. Preferably, the silicone fluid has a kinematic viscosity at 25°C, less than or equal to 200,000 cSt, more preferably less than or equal to 100000 cSt, most preferably less Jeravna 50000 cSt. Accordingly, viscosity up to 100,000 cSt can be measured according to ASTM D-445, IP71 using a glass capillary viscometer, and the viscosity of greater than 100,000 Centistokes can be measured using rotational viscometers and test methods ASTM D-1084 and ASTM D-4287.

Highly preferred are non-volatile silicone fluid having a kinematic viscosity at 25°With approximately 30,000 cSt, measured in accordance with ASTM D-445, IP71 using a glass capillary viscometer.

Preferred non-volatile silicone fluid comprises a silicone polymer, in particular a linear silicone polymer, especially a linear dimethiconol polymer. Acceptable, if a linear silicone polymer is essentially not include any cross-linking. Highly preferred non-volatile silicone fluids include polydimethylsiloxane polymer, especially a linear polydimethylsiloxane polymer.

Preferably, the mass-average molecular weight non-volatile silicone fluid is greater than or equal to 1500, more preferably greater than or equal to 2500, most preferably greater than or equal to 5000. Preferably, the mass-average molecular weight non-volatile silicone fluid is less than or equal to 100000, more preferably less than or equal to 50000, more preferably less than or equal to 25000, E. the e is more preferably less than or equal to 20000.

Advantageous if the composition according to the present invention a silicone elastomer, and if used, a mixture of silicone elastomer and silicone fluids of lower viscosity, has a higher viscosity than the non-volatile silicone fluid, which, in turn, has a higher viscosity than the volatile diluent.

It is clear that by increasing the viscosity of the non-volatile silicone fluid in the composition according to the invention can be obtained a composition having an increased service life and resistance to removal from the target tissue, especially after evaporation of the volatile solvent from the composition. Similarly, by lowering the viscosity of the component is non-volatile silicone fluids is possible to obtain a composition, which can more easily be applied to the target tissue and remove it. Using a full range of viscosity silicone oil composition according to the present invention can be adapted to the specific needs of each case. Especially preferred silicone fluid having a viscosity of approximately 30,000 cSt at 25°because they provide a balance between the residual durability and ease of application. Particularly preferred non-volatile silicone fluid is Dow Corning 200 - linear polydimethylsiloxanes the viscous polymer with the Tue at 25° With approximately 30,000 cSt, manufactured by Dow Corning Inc. (Midland, Michigan).

Preferred non-volatile silicone fluid is present in amount greater than or equal to 20 wt.%, more preferably greater or equal to 25 wt.%, even more preferably greater or equal to 30 wt.%, most preferably greater or equal to 35% wt. calculated on the total weight of the composition according to the present invention.

Preferred non-volatile silicone fluid is present in a quantity less than or equal to 65 wt.%, more preferably less than or equal to 60 wt.%, even more preferably less than or equal to 55% wt. calculated on the total weight of the composition according to the present invention. Especially preferred composition according to the present invention comprises from 40 to 50 wt.%. non-volatile silicone fluid, calculated on the total weight of the composition according to the present invention.

It should be understood that if the silicone elastomer is in the form of a mixture of silicone elastomer and non-volatile silicone fluid, the total number of non-volatile silicone fluid in the composition according to the present invention (that is, non-volatile silicone fluid in a mixture of silicone elastomer and non-volatile silicone fluids plus non-volatile silicone fluid as such) preferably falls in Viseu Azania preferred intervals.

Acceptable if colloidal silicon dioxide (white carbon black) provides microscale structure, when it is dispersed in the non-volatile silicone fluid to obtain a gel. Preferably colloidal silicon dioxide is amorphous. The viscosity of the non-volatile silicone fluids can be dramatically increased when mixing (mix) with the corresponding quantities of colloidal silicon dioxide, with the formation of, for example, non-leaking fat-like gel. You can use any of amorphous, colloidal silicon dioxide, which is appropriately saguday component is non-volatile silicone fluid. These types of colloidal silica include both raw types, and types that are subjected to chemical treatment for the purpose of surface modification of colloidal silicon dioxide.

Examples of suitable types of colloidal silica include, but are not limited to, AEROSIL- 90, 130, 200, 300, 380, R202, R805, R812, R972, R974 (Degussa Corporation, RIDGEFIELD Park, New Jersey) and CAB-O-S1L TS-720 and M-5 (Cabot Corporation, Tuscola, Illinois). In General, the preferred AEROSIL 200, AEROSIL R974, CAB-0-S1L TS-720, and any other generally equivalent products of other manufacturers colloidal silicon dioxide, because they appropriately is infilled non-volatile silicone fluids. As a rule, the greater the amount of colloidal silicon dioxide is contained in the mixture, the more viscous is the resulting gel.

Preferably colloidal silicon dioxide is present in amounts greater than or equal to 0.25 wt.%, more preferably greater or equal to 0.5 wt.%, even more preferably greater or equal to 1% wt., most preferably greater or equal to 2% wt. calculated on the total weight of the composition of the present invention. Preferably colloidal silicon dioxide is present in a quantity less than or equal to 10 wt.%, more preferably less than or equal to 8 wt.%, even more preferably less than or equal to 6 wt.%, most preferably less than or equal to 5% wt. calculated on the total weight of the composition of the present invention.

Particularly preferred composition of the present invention comprises from 2.5% to 3.5% wt., in particular 3% by weight. colloidal silicon dioxide, calculated on the total weight of the composition of the present invention.

Preferably the composition according to the present invention a mixture of non-volatile silicone fluids and colloidal silica comprises colloidal silicon dioxide in a quantity greater than or equal to 0.25%, more preferably greater or equal to 0.5%, most preferably greater or equal to 1% wt.

Preferably the composition of the present invention a mixture of non-volatile silicone fluid and the number of aigaleo silica comprises colloidal silicon dioxide in a quantity less than or equal to 12%, more preferably less than or equal to 9%, most preferably less than or equal to 5% wt. Such compositions typically provide the necessary balance between the thickness and processability.

Preferably the composition of the present invention a mixture of non-volatile silicone fluids and colloidal silicon dioxide includes non-volatile silicone fluid in a quantity less than or equal to 99.75 per cent more preferably less than or equal to 99.5%, most preferably less than or equal to 99 wt.%. Preferably, in the composition of the present invention a mixture of non-volatile silicone fluids and colloidal silicon dioxide includes non-volatile silicone fluid in an amount greater than or equal to 88%, more preferably greater or equal to 91%, most preferably greater or equal to 95% wt.

Preferably the composition of the present invention a mixture of non-volatile silicone fluids and colloidal silicon dioxide is present in amounts greater than or equal to 1%, preferably greater or equal to 22%, more preferably greater or equal to 24.9 percent, more preferably greater or equal to 47%, more preferably greater or equal to 49.9%, more preferably greater or equal to 57%, more preferably greater or equal to 59.9%, more preferably greater and the and equal to 62%, more preferably greater or equal to 64,9% wt. calculated on the total weight of the composition of the present invention. Preferably the composition of the present invention a mixture of non-volatile silicone fluids and colloidal silicon dioxide is present in a quantity less than or equal to 98.9 per cent, preferably less than or equal to 96%, more preferably less than or equal to 94,9%, more preferably less than or equal to 92%, more preferably less than or equal to 89.9%, more preferably less than or equal to 87%, more preferably less than or equal to 84,9%, more preferably less than or equal to 82%, more preferably less than or equal to 79.9%of, more preferably less than or equal to 77%, more preferably less than or equal to 74,9%, more preferably less than or equal to 72% wt. calculated on the total weight of the composition of the present invention.

Preferably the composition of the present invention includes from 1 to 50 parts by weight of silicone elastomer, from 1 to 100 parts by weight of colloidal silicon dioxide, from 400 to 600 parts by weight of a volatile diluent and from 400 to 600 parts of non-volatile silicone fluids. More preferably the composition of the present invention includes from 1 to 20 parts by weight of silicone elastomer, from 10 to 50 parts by weight of colloidal silicon dioxide, from 400 to 600 parts by weight of a volatile diluent and from 400 to 600 parts by weight of non-volatile is ilikonovoi liquid.

Acceptable, if the composition of the present invention has a lower viscosity than comparable composition not including the volatile diluent, that is, the composition comprising a mixture of non-volatile silicone fluids, colloidal silicon dioxide and silicone elastomer. Therefore, the composition according to the present invention can be prepared in a form capable of applying the cream, gel, oil or light grease that can be applied to the wound without causing additional damage and discomfort. Acceptable, if, after the composition of the present invention applied to the wound, evaporation from her volatile diluent leads to the formation of the final composition, usually having increased viscosity, essentially equivalent to the viscosity of the mixture, consisting only of non-volatile silicone fluid, a silicone elastomer and colloidal silicon dioxide. In other words, the coating having a viscosity of thick cream, grease or film, can be obtained from capable of applying the cream, thus providing improved adhesion to the wound and resistance to smearing, without causing additional damage to the wound or excessive pain and discomfort during application.

Professionals it is clear that the consistency of the composition of the present invention can adjust potamianou amount of volatile diluent, silicone elastomer, non-volatile silicone fluids and colloidal silicon dioxide. Consequently, the composition according to the present invention may be in the form of films and sheets, and is also capable of applying the cream, gel, oil or light grease. Typically, the physical and chemical properties of the residual mixture of non-volatile silicone fluid, a silicone elastomer and colloidal silicon dioxide remain unchanged after evaporation of the volatile diluent. However, it is clear, especially for mixtures of high viscosity silicone fluid, silicone elastomer, and colloidal silicon dioxide in the composition after application, there can be traces of volatile diluent, which eventually can be removed under the action of heat of a body.

Preferably the composition of the present invention is in the form of gel or cream. Typically, this provides a balance between the residual strength of the final composition after evaporation of the volatile diluent and ease of application of the composition.

Preferably the composition of the present invention (e.g., colloidal silicon dioxide, non-volatile silicone fluid, a volatile solvent and a silicone elastomer) has a kinematic viscosity greater than or equal to 1000 cSt, preferably greater than or equal to 5000 cSt, is more preferably greater than or equal to 10000 cSt when measured using a glass capillary viscometer using test method ASTM D-445, IP71 at 25°C. Preferably, the composition of the present invention has a kinematic viscosity of less than or equal to 25,000 Centistokes, more preferably less than or equal to 22000 cSt, most preferably less than or equal to 20,000 cSt at 25°when measured using a glass capillary viscometer using test method ASTM D-445, IP71.

Preferably, the final composition after evaporation of the volatile solvent from the composition according to the present invention (that is, after application) has a kinematic viscosity greater than or equal to 27000 cSt, more preferably greater than or equal to 30,000 Centistokes measured at 25°using a glass capillary viscometer using test method ASTM D-445, IP71 at 25°C.

Preferably, the final composition according to the present invention has a kinematic viscosity of less than or equal to 45000 cSt, more preferably less than or equal to 40,000 Centistokes, most preferably less than or equal to 35000 cSt after evaporation of the volatile diluent, measured using a glass capillary viscometer using test method ASTM D-445, IP71 at 25°C.

Conveniently, if the composition of the present invention (the example include colloidal silicon dioxide, non-volatile silicone fluid, a volatile solvent and a silicone elastomer)having initial specific viscosity within the above limits, usually reaches the desired end viscosity (i.e. after evaporation of her volatile diluent) within the above limits faster than a comparable composition having the same initial specific viscosity, but not comprising silicone elastomer.

Acceptable, if the composition of the present invention in the form of a gel/cream that has an initial kinematic viscosity of from 15,000 to 20,000 cSt at 25°C (ASTM D-445, IP71) results in a final composition having a kinematic viscosity of 30,000 to 35,000 cSt at 25°C (ASTM D-445, IP71) in a period of time less than or equal to 10 minutes, more preferably less than or equal to 8 minutes, more preferably less than or equal to 6 minutes, even more preferably less than or equal to 4 minutes, most preferably less than or equal to 3 minutes after the evaporation of her volatile solvent after application of the composition of the present invention to the target tissue (i.e., when the composition is subjected to a temperature of about 38°).

Highly preferred composition of the present invention comprises: from 1 to 5% wt. colloidal silicon dioxide, for which it is defined here; from 35 to 65 wt.%. non-volatile silicone fluid as defined herein; from 25 to 65 wt.%. volatile diluent as defined here; and from 1 to 5% wt. a mixture of silicone elastomer and silicone fluids of lower viscosity, as defined here, and the sum of the components of the composition is 100 wt.%.

Another highly preferred composition of the present invention consists essentially of: from 1 to 5% wt. colloidal silicon dioxide, as defined herein; from 35 to 65 wt.%. non-volatile silicone fluid as defined herein; from 25 to 65 wt.%. volatile diluent as defined herein; from 1 to 5% wt. a mixture of silicone elastomer and silicone fluids of lower viscosity, as defined here; and from 0 to 30 wt.%. pharmaceutical active agent, as defined here.

In accordance with a preferred embodiment of the present invention, the composition includes one or more active pharmaceutical agents.

The term "pharmaceutically active agent", the authors see any connection, including pharmaceutical acceptable derivatives of compounds such as salt, MES and the prodrug, and any song that can be used for therapeutic and/or prophylactic effect on the medical condition of a person or animal.

Preferably pharmaceutically and the active antibacterial agent, anti-inflammatory, antiviral and/or antifungal activity. Essentially the preferred pharmaceutically active agent comprises an antibacterial agent. An alternative particularly preferred pharmaceutically active agent comprises an anti-inflammatory agent.

Preferably pharmaceutically active agent is present in a quantity less than or equal to 50%, more preferably less than or equal to 30%, even more preferably less than or equal to 10%, most preferably less than or equal to 3% wt. calculated on the total weight of the composition of the present invention. Preferably pharmaceutically active agent is present in amount greater than or equal to 0.1%, more preferably greater or equal to 0.5%, in particular greater or equal to 1.0% wt. calculated on the total weight of the composition of the present invention.

Valid if the pharmaceutically active agent may be in the form of a liquid, gel or powder. Preferably pharmaceutically active agent is in powder form, especially powder, which is insoluble in typical pharmaceutical acceptable diluent such as water or alcohol.

Preferred antimicrobial agents include antibiotics-zeolites, chlorhexidine, polymyxin In sulfate, pentagrama chloride, benzamycin, clindamycin, erythromycin, those whom recyclin, mupirocin, bacitracin zinc and semicircular. Particularly preferred antimicrobial agents include antibiotics-zeolites.

The preferred antibiotic zeolites include those in which ions of the zeolite capable of ion exchange, ions such as sodium, potassium, calcium, magnesium and iron, partially or completely replaced by ion exchange ions antibiotics. Examples of appropriate ion-antibiotics include ions of silver, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium. Preferred metal ions-antibiotics are ions of silver, copper and zinc. These ions can be used individually or in combination. Particularly preferred ion-antibiotic ion is silver.

As "zeolite component can be used natural or synthetic zeolites. Examples of such zeolites are described in U.S. patent 5556699, which is included here by reference. Getting antibiotics-zeolites for use in the compositions of the present invention can be made by methods known to experts in this field, for example as described in U.S. patent 5556699.

Preferred metal ions-antibiotic present in the zeolite in an amount greater than or equal to 0.1%, preferably greater or equal to 0.25%, more preferably greater or equal to 0.75%, most predpochtitel what about - greater or equal to 1% wt. by weight of zeolite. Preferred metal ions-antibiotic zeolite is present in a quantity less than or equal to 15%, more preferably less than or equal to 10%, most preferably less than or equal to 5% wt. by weight of zeolite. The term wt.%. by weight of zeolite, the authors indicate % calculated on the weight of the zeolite, weighted after drying at a temperature of 110°C.

Professionals it is clear that although zeolites-antibiotics possess the appropriate antibiotic activity, they usually require complex formulations, which enable their external application on the target tissue. It was unexpectedly found that the antibiotic zeolite may be included in the composition of the present invention without the need for sophisticated technologies further processing. Moreover, the resulting composition of the present invention, including the antibiotic zeolite, can be enhanced antibacterial activity compared with one antibiotic-zeolite.

Preferred anti-inflammatory agents include non-steroidal anti-inflammatory drugs (NCPUL, NSAlDs). Preferred NCPUL include phenylpropionate acids such as ibuprofen, naproxen, Ketoprofen and flurbiprofen. Other preferred NCPUL is acetylsalicylic acid. The most preferred N is BES include ibuprofen and acetylsalicylic acid especially acetylsalicylic acid.

It is possible that the composition of the present invention may include one or more pharmaceutically acceptable adjuvants (additives).

In particular, the composition of the present invention may include an antioxidant. In the presence of the antioxidant is present in amount less than or equal to 15%, more preferably less than or equal to 10% wt. calculated on the total weight of the composition of the present invention. Preferably the antioxidant is present in amount greater than or equal to 1% wt., more preferably greater or equal to 3% wt. calculated on the total weight of the composition of the present invention.

Preferred antioxidants include alpha-tocopherol, gamma-tocopherol, Delta-tocopherol extracts of natural origin, rich in tocopherol, L-asorrow new acid and its sodium or calcium salt, palmityl-DL-ascorbic acid, propylgallate, octisalate, dodecylsulfate, gallate of butylhydroxyanisole (BHA, BHA) and gallate of butylhydroxytoluene (OSH, BHT). The most preferred antioxidant is alpha-tocopherol (vitamin E).

According to the next aspect of the present invention, a method for delivery of a pharmaceutically active agent, as defined above, to the target tissue by injecting the compositions of the present invention, including Pharma is efticiency active agent, in the target tissue.

Conveniently, the composition of the present invention, as defined here, is suitable for use in medicine, particularly to reduce and/or prevent the formation of scars or scars, by introducing the composition to the wound, cut and/or skin damage. Conveniently, the composition of the present invention can be introduced for local application to the target tissue.

Conveniently, when applied to existing scars or scars composition of the present invention is able to mitigate or reduce.

According to another aspect of the present invention, a method for reducing and/or preventing the formation of scars or scars, especially hypertrophic or keloid scars, including the introduction of the compositions of the present invention, as defined here, to the wound, injury or damage to the skin. Also in the present invention is proposed dressings, including composition of the present invention, as defined here.

Allowable that the dressing material may be in the form as described here, for example, gel, thick cream, film, etc.

According to the next aspect of the present invention, a method for preparation of compositions of the present invention, as defined here, includes bringing into contact, preferably by mixing, letocha silicone liquid with a colloidal silicon dioxide, volatile diluent and a silicone elastomer (and pharmaceutically active agent, if present).

Preferably the volatile solvent and a silicone elastomer (as well as the pharmaceutically active agent, if present) are added to a mixture of non-volatile silicone fluids and colloidal silicon dioxide.

Preferably the preparation of compositions according to the present invention is carried out by methods known in the art, such as agitators, mixers, rolls or mills and similar devices, as well as other methods suitable for mixing silicone oils and colloidal silicon dioxide. In addition, to preserve the volatile diluent in the composition of the present invention, it is possible to use a pressure vessel and condensing system.

Valid, if initially the mixture of non-volatile silicone fluid and kolloidales silicon dioxide, and then it is mixed with a volatile solvent and a silicone elastomer. An alternative mixture of non-volatile silicone fluids, colloidal silicon dioxide and volatile diluent can be obtained in one stage, and add the silicone elastomer. Professionals it is clear that the pharmaceutically active agent, when present, can be added at any stage prepared with the composition I of the present invention.

Typically, when the composition of the present invention includes a pharmaceutically active agent or pharmaceutically acceptable adjuvant, initially prepare a concentrate that includes a pharmaceutically active agent or adjuvant, a mixture of non-volatile silicone fluids, colloidal silicon dioxide, silicone elastomer and a volatile diluent. Acceptable if the concentrate includes a pharmaceutically active agent and/or adjuvant in the amount of 20% wt. by weight of the concentrate. Then, the concentrate can be diluted with a mixture of non-volatile silicone fluids, colloidal silicon dioxide, volatile diluent and a silicone elastomer with obtaining compositions of the present invention, having the desired concentration of the pharmaceutically active agent and/or adjuvant as described herein (typically from 1 to 5% wt. by weight of the composition for antibiotic-zeolite).

It is useful that this technique of treatment can ensure proper dispersion of a pharmaceutically active agent in the composition of the present invention, while minimizing agglomeration pharmaceutically active agent, thus leading to enhanced activity of the pharmaceutically active agent in the composition of the present invention.

Alternative or in addition to the concentrate can be added disingenuous the th agent, such as magnesium stearate, keeping the dispersion pharmaceutically active agent in the composition of the present invention.

Typically, anhydrous dispersing agent is mixed with anhydrous pharmaceutically active agent prior to the preparation of the mixture. Preferably introduced 10% wt. dispersing agent. Pharmaceutically active mixture agent/dispersant can in this case be used with the formation of a concentrate as described above. Preferably, especially in the case of the antibiotic zeolite, to prepare compositions of the present invention in anhydrous conditions, since the inclusion of water in the composition of the present invention can contribute to the discoloration and agglomeration pharmaceutically active agent, thus leading to reduced efficiency of the composition.

Professionals it is clear that the composition of the present invention can be applied not medical personnel. It is possible that the composition of the present invention is applied to the target tissue by a method known in the art, such as application spatula, ball (roller or spray application device (applicator).

According to the next aspect of the present invention, a method for treatment of a wound comprising applying to the wound a composition of the present invention.

According to the following TSA is KTU in the present invention proposed a pharmaceutical delivery system for the topical application, including composition of the present invention and a pharmaceutically active agent.

According to further aspect the present invention is proposed dressings, including composition of the present invention. It is clear that the dressing material can be considered as sambusaidi dressings for wounds, as once applied to the target tissue only body heat required for the evaporation of the volatile diluent.

According to further aspect the present invention proposed the use of silicone elastomer for making dressings for wounds, especially sambusaidi dressings for wounds, after application to a target area tissue of the body.

The invention will be further described by the following non limiting examples.

Used the following raw materials: Dow Corning 200 with a viscosity at 25°With approximately 30,000 cSt (non-volatile silicone fluid); colloidal silicon dioxide Aerosil 200; Dow Corning 245, including decamethylpentasiloxane with a viscosity of 4 mm2with-1at 25°With (volatile solvent); Dow Corning 246, including Dodecamethylcyclohexasiloxane with a viscosity of 7.7 mm2with-1at 25°With (volatile solvent); Dow Corning 9040 - based blend of silicone elastomer comprising dimethiconol cross-polymer in cyclomethicone, with a viscosity of from 250,000 to 580000 the Article at 25° With; Dow Corning 9041 - based blend of silicone elastomer comprising dimethiconol cross-polymer dimethiconol silicone fluid having a viscosity of 300,000 to 500,000 cSt at 25°s; antibiotic zeolite Agionin which ions of the zeolite capable of ion exchange, partially or completely replaced by silver ions supplied by Agion Technologies, 60 Audubon Road, Wakefield, MA 01880, USA.

Example 1

Preparation of compositions according to the present invention

A mixture comprising 45 wt.%. Dow Corning 245, 50% wt. Dow Corning 200, 3% wt. colloidal silicon dioxide (Aerosil 200) and 2% wt. Dow Corning 9040 - mix on the basis of silicone elastomer, was stirred at ambient temperature using a mixer JH Day Pony Mixer in anhydrous conditions for 2 hours. The resulting product was a gel having a viscosity of 19000 to 21000 cSt at 25°measured glass capillary viscometer using test method ASTM d-445, IP71.

Example 2

Preparation of comparative composition

A mixture comprising 45 wt.%. Dow Corning 245, 52% wt. Dow Corning 200 and 3% wt. colloidal silicon dioxide (Aerosil 200)was stirred at ambient temperature using a mixer JH Day Pony Mixer in anhydrous conditions for 2 hours. The resulting product was a gel having a viscosity in the range from 18000 to 20000 cSt at 25°measured glass capillary viscometer with application of test method ASTM d-445, IP71.

Example 3 - determination of the drying time of the compositions of examples 1 and 2

Selected ten people. The composition of example 1 was added in a quantity sufficient to close the area 2 inches, and the composition of example 2 was applied to the area of the same size, respectively, on the forearm of each person. Each of the persons proposed to control the perceived curing and adhesion of each of the compositions to the skin and to note the time (called "time to completion"), after which there was no further increase the curing and adhesion (i.e. the effective time of the compositions evaporate essentially all of the volatile diluent).

The results for each composition for ten subjects were averaged ("time to completion") and are presented below in table. 1.

Table 1
The average time to completion
Example 14,4 min
Example 215,2 min

The results show that the composition of example 1, comprising a silicone elastomer, dries much faster than a comparable composition not comprising silicone elastomer (example 2), when applied to both songs on the target tissue area of the body.

Example 4

Sentence shall Olenye compositions of the present invention, containing antibacterial agent

Concentrate comprising 20 wt.%. Agionthe rest of the concentrate (80% wt.) is a mixture of Aerosil 200, Dow Corning 200, Dow Corning 245, and silicone elastomer Dow Corning 9040 (3% wt. Aerosil 200: 50% wt. Dow Corning 200: 45% wt. Dow Corning 245: 2% wt. Dow Corning 9040) were prepared by adding the powder Agionto a mixture of non-volatile silicone fluids, colloidal silicon dioxide, volatile silicone solvent and silicone elastomer. The concentrate was mixed with JH Day Pony Mixer at ambient temperature in anhydrous conditions, for a time up to 2 hours to effect the dispersion of the powder Agion™. Then the concentrate was diluted with the desired amount of the mixture of Aerosil 200, Dow Corning 200, Dow Corning 245, Dow Corning 9040 (3% wt.: 50% wt.: 45% wt.: 2% wt. (Aerosil: Dow Corning 200: Dow Corning 245: Dow Corning 9040) to obtain the following compositions of the present invention in the form of a gel having a viscosity of 19000 to 21000 cSt at 25°measured glass capillary viscometer using test method ASTM D-445, IP71.

Agion, % wt. by weight of the compositionAerosil: Dow Corning 200: Dow Corning 245: Dow Corning 9040 (3:50:45:2), % wt. by weight of the composition
Example 4A199
Example 4b2 98
Example 4C595

Example 5

Wound healing/antibacterial activity of "in-vivo"

Were selected by a three - man volunteer with the wound, which began to develop in keloid scars.

The composition of example 4A (2 g) was applied on the scar of the first volunteer so that the composition was maintained at the site of tissue.

A control composition (2 g)comprising a mixture of 3 wt.%. Aerosil 200, 50% wt. Dow Corning 200, 45% wt. Dow Corning 245 and 2% wt. Dow Corning 9040, put on the scar of the second volunteer so that the resulting composition was maintained at the site of tissue.

Only powder Agion(40 mg) was applied on the scar of the third volunteer and recorded the powder on the tissue transparent adhesive tape.

Each patient was monitored for a period of 1 month and recorded a decrease in redness (meaning the reduction of infection) and smoothing the scar (meaning mitigate and/or prevent and/or reduce scar). The results are presented below in table 2.

Table 2
SampleReduce rednessSmoothing scars (scars)
Example 4AImmediate reduction in redness after 1-2 days, then also there is the reduction of redness A steady decrease of the level of the scar. One month scar showed visible signs of extinction
controlThe slight decrease in redness after 1 monthReducing scar after 1 month, but not as significant as the scar in example 4A 1 month and no signs of the disappearance of the scar
Only AgionReducing redness was observed after 4 daysThe scar was developed

The results show that the composition of the present invention, including antibacterial agent, not only reduces the redness of the scar (figure antibacterial activity), but also prevents and/or reduces the formation of scar. In addition, there appeared to be a synergistic effect on antibacterial activity and/or effect of reduction of the scar using a combination of the antibiotic zeolite and compositions of the present invention.

Example 6

The following compositions presented in table 3, were prepared in accordance with the above example 4, except that the antibiotic zeolite Agion was replaced with the respective pharmaceutically active agent.

Table 3
Pharmaceutically active agent (% by weight. by weight of the composition)Aerosil: Dow Corning 200: Dow Corning 245: Dow Corning 9040 (3:50:45:2) (% wt. by weight of the composition)
Example 6AChlorhexidine acetate (2% wt.)98% wt.
Example 6bBenzamycin (3% wt.)97% wt.
Example 6CErythromycin (3% wt.)97% wt.
Example 6dAcetylsalicylic acid (5% wt.)95% wt.
Example 6EVitamin E (4% wt.)96% wt.
Example 6fIbuprofen (20% wt.)80% wt.

Example 7

The following compositions presented in table 4, were prepared in accordance with example 1, as described above.

4
Aerosil, % wt.Dow Corning 245, % wt.Dow Corning 246, % wt.Dow Corning 200, % wt.Dow Corning 9040, % wt.Dow Corning 9041, % wt.
Example 7a150-454-
Example 7b44540-501-
Example 7C645-45-
Example 7d6-45454-
Example 7E348-45-4

The reader's attention is drawn to all documents that are registered simultaneously with the description or in connection with this application and which are open for public viewing in connection with this description, and content of all these documents is included here by reference.

All the features disclosed herein, and/or all stages of any of the disclosed here, the method or process can be combined in any combination, except combinations where at least some of such features and/or stages are mutually exclusive.

Each characteristic disclosed in this specification (including any claims, abstract and drawings)may be replaced by alternative features, which are the same, equivalent or similar tasks, unless otherwise noted. Thus, unless expressly stated otherwise, each open sign is just one example of a generic series of equivalent or similar features.

The invention is not limited to the details above variant (variants) it is sushestvennee. The invention extends to any new feature or any novel combination of features, disclosed in this specification (including any claims, abstract and drawings), or to any stage or any new combination of stages of any of the disclosed here may be the mode or process.

1. Dressings containing composition that includes a non-volatile silicone fluid mixed with the colloidal silicon dioxide, volatile diluent and a silicone elastomer.

2. The dressing material according to claim 1, in which the silicone elastomer is a silicone cross-polymer.

3. The dressing material according to claim 2, in which the silicone cross-polymer is dimethiconol cross-polymer.

4. The dressing material according to claim 1, in which the silicone elastomer is in the form of a mixture comprising a silicone elastomer in the silicone fluid of lower viscosity.

5. The dressing material according to claim 4, in which the silicone fluid of lower viscosity includes a linear Dimethicone or cyclomethicone.

6. The dressing material according to claim 4, in which the mixture of silicone elastomer and silicone fluids of lower viscosity has a viscosity greater than or equal to 220,000 Centistokes, measured at 25°C.

7. The dressing material according to claim 4, in which the mixture of silicone elastomer and silicone fluid is STI lower viscosity has a viscosity less than or equal to 800,000 Centistokes, measured at 25°C.

8. The dressing material according to claim 4, in which the mixture of silicone elastomer and silicone fluids of lower viscosity is present in an amount greater than or equal to 1 wt.% by weight of the composition.

9. The dressing material according to claim 4, in which the mixture of silicone elastomer and silicone fluids of lower viscosity is present in a quantity less than or equal to 10 wt.% by weight of the composition.

10. The dressing material according to claim 1, in which the mixture comprising 15% by volume of silicone elastomer and 85% by volume of a linear polydimethylsiloxane with a viscosity of 5 Centistokes at 25°has a kinematic viscosity of greater than or equal to 220,000 Centistokes, measured according to ASTM D-1084.

11. The dressing material according to claim 1, in which the mixture comprising 15% by volume of silicone elastomer and 85% by volume of a linear polydimethylsiloxane with a viscosity of 5 Centistokes at 25°has a kinematic viscosity of greater than or equal to 800,000 Centistokes, measured according to ASTM D-1084.

12. The dressing material according to claim 1, in which colloidal silica is present in amount greater than or equal to 1 wt.% by weight of the composition.

13. The dressing material according to claim 1, in which the volatile solvent is present in amount greater than or equal to 25 wt.% by weight of the composition.

14. The dressing material according to claim 1, in which etuce the diluent includes a volatile silicone fluid.

15. The dressing material 14, in which the volatile silicone fluid comprises a silicone polymer, in particular cyclomethicone.

16. The dressing material according to claim 1, in which the non-volatile silicone fluid has a kinematic viscosity of less than or equal to 200,000 Centistokes, measured at 25°C.

17. The dressing material according to claim 1, in which the non-volatile silicone fluid comprises a silicone polymer, in particular a linear Dimethicone.

18. The dressing material according to claim 1, in which the non-volatile silicone fluid is present in amount greater than or equal to 20 wt.% by weight of the composition.

19. The dressing material according to any one of claims 1 to 18, containing 1-5 wt.% colloidal silicon dioxide; 35-65 wt.% non-volatile silicone fluid; 25-60 wt.% volatile diluent; and 1-5 wt.% a mixture of silicone elastomer and silicone fluids of lower viscosity, and the components of the dressing adds up to 100 wt.%

20. The dressing material according to claim 1, where the dressing material is in a form suitable for application of a cream, gel, light grease or low-viscosity aerosol or liquid.

21. The dressing material according to claim 1, which further comprises a pharmaceutically active agent, preferably pharmaceutically active agent that possesses antibacterial, anti-inflammatory, antiviral and/or protivogribkovi activity.

22. The dressing material according to item 21, in which the pharmaceutically active agent is selected from the group comprising: an antibiotic zeolite, chlorhexidine, polymyxin In sulfate, pentagram, clindamycin, erythomycin, tetracycline, mupirocin, bacitracin zinc, neomycin sulphate, ibuprofen, naproxen, Ketoprofen, flurbiprofen and acetylsalicylic acid or combinations thereof.

23. The dressing material according to item 21, in which the pharmaceutically active agent is selected from the group comprising: an antimicrobial agent, in particular an antibiotic zeolite, or nonsteroidal anti-inflammatory drug (NSAID), in particular acetylsalicylic acid.

24. The dressing material according to claim 1, where the dressing material additionally contains an antioxidant.

25. The dressing material according to claim 1 for use in medicine.

26. The method of preparation of the dressing material according to any one of claims 1 to 25, comprising effecting contact of non-volatile silicone liquid with a colloidal silicon dioxide, volatile diluent and a silicone elastomer.

27. Application of the dressing material according to any one of claims 1 to 25 in the manufacture of medicinal products for preventive and/or therapeutic treatment of the medical condition for which illustrates the application of the dressing material to the target tissue such as a wound, cut or damage the skin.

28. How is menichini and/or prevent the formation of scars, including dressing material according to any one of claims 1 to 25 on the wound, cut and/or skin damage.

29. Method of treatment of a wound comprising applying to the wound dressing material according to any one of claims 1 to 25.

30. Pharmaceutical delivery system for the topical application, including dressing material according to any of p-25.

31. The use of silicone elastomer to accelerate evaporation of the volatile solvent from the dressing material according to any one of claims 1 to 25.

32. The applicator includes a reservoir containing dressing material according to any one of claims 1 to 25, and the valve associated with the liquid reservoir, for the distribution of aid material from the reservoir.

33. Applicator for p, in which the dispenser includes a spray gun, roller or nozzle of the applicator.



 

Same patents:

FIELD: medicine.

SUBSTANCE: the present composition includes nonvolatile, a silicone, fluid substance in the mixture with finely divided silicon dioxide and antibacterial active substance. Pharmaceutically active substance is a nondecomposing one and manifests physical stability in the composition.

EFFECT: higher efficiency.

31 cl, 5 ex, 2 tbl

FIELD: medicine, in particular experimental and clinical surgery and transplantation methods.

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EFFECT: more effective method for reduction of skin wound defects.

2 tbl, 1 ex, 1 dwg

The invention relates to pharmaceutical industry

FIELD: medicine.

SUBSTANCE: wound covering is three-layered: first wound-adjacent layer is made of water-soluble polymer, second one - of biologically degradated material and third protective layer is microfilter membrane, second layer contains pharmacological solution of medicinal agents containing agent selected from antibiotics - perphloxacine (abactale) 400 mg. If applied to pantreatojejunoanastomosis area, and to pancreas section area pharmacological solution is added with medicinal agent selected from proteolysis inhibitors - contrical 10000 "УД". If applied to areas of intervascular, interintestinal, gastrointestinal, ureteric anastosmosis, as well as area of suture plication in viscera walls pharmacological solution is added with medicinal agent selected from agents stimulating interstitial microcirculation and blood rheological characteristic - calcium nordroparine (fraxiparine) 11400 "МЕ". If applied to haemostasia at moderate capillary bleeding of parenchyma organs rheological pharmacological solution is added with medicinal agent selected from coagulants - thrombin 250 EA. Offered covering has wide functionality and can be used for various applications: abdominal, thoracic, vascular surgery, urology, and gynecology.

EFFECT: provided stable haemostasis, reliable fixation of anastomosis line, prevent suppurative complications.

4 cl, 4 ex

FIELD: medicine.

SUBSTANCE: the present innovation deals with binding material out of alginate foamy composition which should be manufactured at applying or without applying a foundation. The suggested foamy binding material is of unique property to include soluble or insoluble medicinal preparations as the part of alginate foamy composition being not characteristic of alginate binding materials manufactured due to formation of fiber. Such binding materials, also, exclude the necessity to apply adhesives and secondary bandages for keeping alginate bandage in wound area.

EFFECT: higher efficiency.

65 cl, 8 ex

Wound cover // 2314834

FIELD: medicine.

SUBSTANCE: wound cover is manufactured from woven and nonwoven natural or synthetic materials containing metal particles possessing biological activity with respect to pathogenic flora. Silver nanoparticles are available in the amount of 80-99.9%, iron nanoparticles 0.1-20%, aluminum 0.1-20%, copper 0.1-20%. Metal particles are sprayed in vacuum chamber by means of magnetron deposition. .The nanoparticles do not exceed 0.1 mcm in size. Metal nanoparticles optionally are deposited on both sides of the cover. The wound cover optionally has additional layer optionally having drugs in its turn. The additional layer optionally has antiseptic and antimicrobial drugs or medicinal herbal infusions, or vitamins, or antifungal preparations, or local anesthetics, or proteolytic enzymes. The wound cover is optionally manufactured as napkin, or bandage, or powder-like sorbents, or turundas, or tampons, or plaster.

EFFECT: painless wound dressing; reduced risk of surrounding tissue injuries; improved sterility; high activity of metals; reduced luminous halation; minimized volume of withdrawn eye tissues.

10 cl

FIELD: medicine, veterinary.

SUBSTANCE: claimed method includes material impregnation with sorbent having high absorbing properties in relates to gaseous xenon. Then material is fed in sealed chamber, chamber is filled with gaseous xenon and held under excessive pressure up to full material saturation with xenon.

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5 cl

First-aid bandage // 2308294

FIELD: medicine, particularly medical article production.

SUBSTANCE: first-aid bandage for open wounds and wound cavities includes non-woven base of viscous fibers impregnated with siloxane rubber having dynamic viscosity of 0.1-0.2 Pa·sec.

EFFECT: improved drainage ability, decreased injuries at any treatment stage and prevention of wound fragmentation.

1 tbl, 4 ex

FIELD: medicine, in particular, production of medicinal articles such as therapeutic band-plasters capable of recovering continuity function of skin and invaded subdermal tissues.

SUBSTANCE: therapeutic band-plaster has matrix made from biologically inert materials and adapted for dosed releasing of medicinal drugs. Band-plaster of such structure does not require utilization of retention layer.

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1 tbl, 5 ex

FIELD: medicine.

SUBSTANCE: the present composition includes nonvolatile, a silicone, fluid substance in the mixture with finely divided silicon dioxide and antibacterial active substance. Pharmaceutically active substance is a nondecomposing one and manifests physical stability in the composition.

EFFECT: higher efficiency.

31 cl, 5 ex, 2 tbl

Absorbing product // 2287349

FIELD: medicine, hygiene.

SUBSTANCE: the present innovation deals with an absorbing product chosen out of the group consisted of a hygienic shield and a protective product indicated to be applied between large and small pudendal lips and in case of menstruations, moreover, it is useful to introduce pharmaceutical substance. The latter is efficient for treating, weakening and/or preventing pre-menstrual syndrome. The product consisted of an absorbing body and has got, as a rule, prolonged shape. The product has got the first surface facing the consumer, and the second surface which should face opposite side. The first surface is, at least, partially covered with therapeutic system for transdermal injection that contains a compound being efficient for treating and/or preventing pre-menstrual syndrome, moreover, while applying the present product it occurs the transdermal introduction of the consumer's compound for the user in modified product.

EFFECT: higher efficiency.

6 cl, 5 ex, 2 tbl

FIELD: medicine, in particular gynecology.

SUBSTANCE: claimed filler contains 1 % hydrogel of chitosan with molecular mass of 300-700 kDa and deacetylation ratio of at least 89 %, as well as metronidazole and dioxydine; and 1 l of composition contains (g): dry chitosan chlorohydrate 10; metronidazole 1.250-1.665; dioxydine 2.5; and balance: distilled water. Method for filler production includes stirring of 10 g dry chitosan chlorohydrate in 300 ml of distilled water heated up to 50°C for 20-30 min until full dissolution. Then gradually under intense agitation 250-333 ml of metronidazole for intravenous injection is added, mixture is thoroughly stirred for 5 min, further gradually under intense agitation 250 ml of 1% dioxydine solution is added, mixture is thoroughly stirred for 10 min and packed in container made of dark glass or plastics for storage. Methods for treatment of female genitals diseases by using absorbent articles containing filler of present invention also are disclosed.

EFFECT: non-toxic filler with prolonged antiinflammation and antibacterial effects.

3 cl, 3 tbl

FIELD: medicine, pharmacy.

SUBSTANCE: invention relates to porous spongy cellulose material for its using in treatment of wounds and/or burns. Cellulose material comprises zinc, copper, selenium and/or iron bound with the matrix material and/or absorbed on its in the amount providing granulation and revascularization processes of the wound base wherein the amount of zinc, copper, selenium and/or iron is at least 0.1 mcg/g of dry material. The porous spongy cellulose material is effective by consumptions for its preparing and can be used easily in treatment of wounds and/or burns.

EFFECT: enhanced effectiveness and valuable medicinal properties of material.

12 cl, 3 ex

FIELD: biotechnology, microbiology, medicine.

SUBSTANCE: invention relates to novel probiotic strains of lactobacilli: Lactobacillus acidophilus DSM 14869, Lactobacillus paracasei DSM 14870, Lactobacillus acidophilus DSM 15525, Lactobacillus plantarum DSM 15524, Lactobacillus sp. DSM 11526 and the strain Lactobacillus sp. DSM 15527. Strains shows similar favorable properties used separately or in combination as probiotics or in common with prebiotic as symbiotic. Also, invention relates to pharmaceutical compositions, dairy foodstuffs, functional foodstuffs, nutrient supplements and agents for personal hygiene comprising strains in separately or in combination, and to using strain for prophylaxis or treatment of vaginal infections, urogenital infections and gastrointestinal diseases.

EFFECT: valuable properties of strains.

43 cl, 12 ex

FIELD: medicine.

SUBSTANCE: the present composition includes nonvolatile, a silicone, fluid substance in the mixture with finely divided silicon dioxide and antibacterial active substance. Pharmaceutically active substance is a nondecomposing one and manifests physical stability in the composition.

EFFECT: higher efficiency.

31 cl, 5 ex, 2 tbl

FIELD: medicine, special additives.

SUBSTANCE: invention relates to hygroscopic additive that represents particles of hygroscopic additive containing particles of hygroscopic resin (α) and additive improving penetrability for liquid (β) wherein particles of hygroscopic resin (α) represent particles of cross-linked polymer formed from a monomer comprising acrylic acid and/or its salt and subjected for treatment resulting to formation of cross-links on its surface. Particles of the proposed hygroscopic additive show average-mass diameter (D50) in the range from 234 to 394 mcm, logarithm standard deviation (σξ) for distribution of particles by sizes in the range from 0.25 to 0.45, absorbing capacity without loading 15 g/g, not less, and the level of the water-extractive component content 15 wt.-%, not above, and, except for, the level of the additive content improving penetrability of liquids (β) in the range from 0.01 to 5 mass parts per 100 mass parts of particles of hygroscopic resin (α). Proposed hygroscopic additive combines exploitation indices describing both capillary absorption strength and penetrability for a liquid.

EFFECT: improved and valuable properties of additive.

8 cl, 7 dwg, 29 ex

Medicinal bandage // 2245164

FIELD: medicine.

SUBSTANCE: invention relates to dressing materials based on polymeric compositions and can be used in surgery and traumatology for closing wounds of different etiology. The polyol component-base medicinal bandage based on propylene oxide or ethylene oxide comprises water, catalyst for urethane formation and isocyanate complex consisting of isomers of diphenylmethane diisocyanate. High-molecular simple polyetherpolyol with molecular mass 3000-10000 Da is used, and isocyanate complex comprises additionally oligourethane isocyanate based on low-chain oligoetherpolyol with the content of isocyanate groups 26.0-29.5 wt.-%. Also, the bandage comprises activation additive consisting of polyurethane chain lengthener, foam-opening agent and foam-hardening agent. Bandage provides exclusion additional pain senses in the patient, enhancing absorption effect and provides absence of skin sticking.

EFFECT: valuable medicinal properties of bandage.

7 ex

The invention relates to medicine, specifically to material intended for use in absorbent products, and absorbent product containing such material

The invention relates to medicine and can be used as dressings for wounds

Polymer dressings // 2216358
The invention relates to medicine, in particular to surgery, and can be used as a dressing material for repair of soft tissue defects after organolead operations and correction of congenital anomalies
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