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Pharmaceutical compositions for topical application for the above-mentioned complaints or diseases with minde least one drug on the basis of heparin have been available for lan gem known and commercially. Erkrankungen lokal auf den jeweils erkrankten bzw. Here, however, the known compositions are formulated as a cream or ointment, so that they will be locally applied to the complaints or diseases mentioned above on each sick or injured skin area or rubbed there.
Diese bekannten cremeartigen bzw. These known creamy and unctuous pharmaceuti rule compositions, however, have the disadvantage that their local application, the least stress with a View and additionally verbun with a slight rubbing is the, always presents serious problems if the before mentioned complaints or to diseases cause in the affected body surface contact pain or tenderness, there is what is reported on a number of patients.
The present invention has for its object to provide a pharmaceutical composition of the specified type to avail supply, which is locally very als Thrombophlebitis verschmieren to applizie ren. This object is achieved by a pharmaceutical composition with the characterizing features of claim 1. Here, in a concentration of at least the composition of the invention contains the active substance least 20, IU per g ready for use composi tion.
The composition according to the invention has a number of advantages parts. It should be noted first that the fiction, modern composition is locally be applied due to their liquid formulation significantly helfen, das Thrombophlebitis wird and more accurate compared to the salbenar term or cream-like known products, since it is only required in the liquid composition of the invention to spray a predetermined volume, while the unctuous and creamy any known products memenge or require the removed ointment train a http://m.skv-neuwied.de/ulcus-cruris-trophic.php estimation of the extracted Cre.
Also, it can not easily come to a smearing or staining of clothes in the liquid composition according to the invention, since a directional spraying we much simpler in hard to click to see more areas of the body as possible is a large-scale spread and rubbed the known ointment or cream.
Furthermore, in the inventions to the invention als Thrombophlebitis verschmieren just this always required spreading or rubbing len entfal in the known products, since on the body surface by evaporation or Ver evaporation of the liquid formed composition already has an ideal fine distribution of the active ingredients, so that when the local application the composition of the invention is therefore also triggered no pressure pain.
In addition, perceived by many patients, caused by the evaporation or vaporization of the liquid from the merger tion inventive cooling as particularly pleasant and soothing, als Thrombophlebitis verschmieren the co inventive composition als Thrombophlebitis verschmieren the first local application at Pati ents the impression causes that an immediate Healing is a directed.
In addition, connected to the local application of the inventions to the invention composition further advantages. This is especially important for those active substances to be emulsified only by the addition of suitable emulsifiers or Dispergiermit tel in the respective liquid or yaw als Thrombophlebitis verschmieren as derivatives applies for example to certain Heparinderi.
Also located in the liquid composition according to the invention the at least one active ingredient according to the als Thrombophlebitis verschmieren fenartigen spraying the liquid composition in the then formed on the respective body surface preparation in an ideal als Thrombophlebitis verschmieren distribution before, so that this finely distributed active substance having an extremely small particle size, which in turn transport of the drug, gene, for example, by skin barriers or tissue cell walls, als Thrombophlebitis verschmieren and so with the healing of the complaints listed above, Verletzun or promotes disease.
A further substantial advantage of the co composition according to the invention lies in the fact that in the simplest case of a drug after evaporation or evaporation of the liquid in the thus formed preparation al lein and without any excipients to the respective body surface at least is present, so that then this als Thrombophlebitis verschmieren least one active ingredient bound to substances with no adverse influence of such auxiliary, which are inevitably contained in the known ointments or creams, diffuses or als Thrombophlebitis verschmieren into the body, which tongues in the known cream-like or ointment-like composi is not the case.
This is often observed that such. As the ointment base or cream base the Migra tion or diffusion of the drug difficult in the body with the active ingredient prevents teraction by Als Thrombophlebitis verschmieren or so that in this way the Thrombophlebitis cavernosus is delayed or extended significantly in the inventive composition does not occurs.
A first embodiment of als Thrombophlebitis verschmieren inventive composition pharmaceuti rule provides that in this case the composi tion within a period of less than 2 seconds, preferably, als Thrombophlebitis verschmieren a time between 1 second and 0.
In this case, therefore takes place during the local application or immediately thereafter within the times previously mentioned evaporation or evaporation of the liquid contained in the liquid erfindungsge the composition according to place, so that due to the aforementioned relatively short periods even with an undesired overdose or the application of strong curved or als Thrombophlebitis verschmieren surfaces of the body is prevented that a part of the liquid composition of the respectively sprayed body surface according to the invention runs or runs undesirable.
In order to achieve the inventive composition particularly rapid evaporation als Thrombophlebitis verschmieren vaporization of liquids to composition contained in the liquid, which on the one hand, the particle size of at least one active substance and its extremely fine, in the forming on the local behan punched skin surface preparation determines als Thrombophlebitis verschmieren has the composition of the invention in addition to the at least one active ingredient in such liquids, which make it possible that the inventive composition as droplets having a droplet diameter of between 1 micron and 1, microns, preferably as droplets with a droplet diameter of between As already stated above in connection with the main claim, comprises least one active ingredient only, only at least one liquid or als Thrombophlebitis verschmieren liquid mixture to a particularly suitable embodiment of the liquid composition according to the invention next to min, so that the formed on the sprayed body surface preparation after evaporation or evaporation of the liquid or the liquid keitsgemisches only from the at least one active ingredient is.
In als Thrombophlebitis verschmieren case, then this active ingredient is present als Thrombophlebitis verschmieren a high concentration and an extreme fine distribution Thrombophlebitis Krankheit und Behandlung the body surface treated locally, whereby the migration and the diffusion of said at least one active substance is accelerated in the body.
It is also possible to provide as an organic solvent propylene glycol al flax or especially in source mixture with the aforementioned Al als Thrombophlebitis verschmieren. If the liquid according to the invention to composition as the organic solvent butanols contained th, so it is recommended that the concentration of these butanols in the composition according to the invention als Thrombophlebitis verschmieren upper limit of about 15 als Thrombophlebitis verschmieren. With respect to the total concentration of the alcohol or of the Alko holgemisches in the inventive liquid composi tion is to be noted that this is preferably between 5.
Alkoholgemisches zwischen 13 Gew. In order for particularly sensitive patients in whom als Thrombophlebitis verschmieren irritation can be caused by alcohols, to avoid the occurrence of these skin irritations, the Ge can be weight fraction of the alcohol or the alcohol mixture still white reduced ter, so that in this particularly preferred embodiment, the liquid composition tion according to the invention the concentration of the alcohol or alcohol mixture als Thrombophlebitis verschmieren from 13 wt.
Of course, the aforementioned pharmaceutically acceptable organic solvents may be in the liquid composition erfindungsge MAESSEN replaced by water or mixed with water. Assigns the co inventive composition no alcohol but only water, so this may result in the occurrence of skin irritation at be particularly sensitive patients is completely eliminated, so that then the composition of the invention in addition to the water only, only the least in this case contains an active ingredient, if this is not additionally the subsequently described ingredients, in particular gelling agent composition of the invention may be added.
However, if the composition of the invention an Ge mixture of alcohols and water, the als Thrombophlebitis verschmieren concen varied concentration in the composition according to the invention in the light of the above weight versions from 5.
It could be found, surprisingly, als Thrombophlebitis verschmieren the addition of at least one gelling agent promotes the formation of mist-like droplets during spraying the liquid composition according to the invention and causes further that to composition after spraying within a very short time, especially within the aforementioned time, continue reading the sprayed surface a gel-like preparation ausbil det.
A gel-like preparation in this preferred embodiment, the liquid composition to thus on the sprayed body surface adapted to the at least one gelling agent and possible as yet certain amounts of liquids contained in the original liquid composition includes at least one active ingredient. In the above-described development of the inventive Shen liquid composition, wherein after the fog-like spraying on the body surface treated locally one gelar term preparation is formed, the concentration of the at least one gelling agent als Thrombophlebitis verschmieren the composition varies inter mediate 0.
With respect als Thrombophlebitis verschmieren the above-mentioned pharmaceutically unbedenkli chen organic solvent or solvent mixture also als Thrombophlebitis verschmieren to Krampfadern, stehen die wenn Arbeit embodiment of the inventive liquid composition identical to the embodiments as described above.
Such phospholipid gel formers have the additional advantage to that they als Thrombophlebitis verschmieren the one hand, a high skin and tissue compatibility, the penetration of the support at least one active ingredient into the skin and, furthermore, effectively protect the at least one active against a rule chemical degradation.
The phospholipid als Thrombophlebitis verschmieren formers als Thrombophlebitis verschmieren not that they turn dry in the spray nozzle and thus the nozzle opening verschlie Shen, which is attributed to the fact that the als Thrombophlebitis verschmieren gel formers, of which the following are particularly preferred embodiments are described, a high resistance due to their read more possess and also still even if the bound therein liquid has evaporated, as the can be easily absorbed when re-spraying the liquid contained als Thrombophlebitis verschmieren the liquid composition, so that accordingly exempt the nozzle with a renewed spraying immediately from the dried composi tion will.
In a particularly suitable embodiment of the previously be described further development of the composi tion according to the invention, the als Thrombophlebitis verschmieren liquid composition as gel-forming agent a phospholipide, respectively a phospholipide mixture in which at least 60 wt. In particular, when, in another embodiment of the composition according to the invention, the composition comprises a phospholipid or a phospholipid mixture as at least one gelling agent, at least 95 wt.
In order for the als Thrombophlebitis verschmieren liquid composition comprising the above-mentioned phospholipids there with the listed high concentration of phosphatidylcholine to as gel-forming agent comprises a drug reproducibly ensure the fine distribution of the minde least initially described, als Thrombophlebitis verschmieren a variation of the composition of the invention that in this case the concentration of lysophosphatidylcholine in the phospholipidic gel-forming agent.
Phosphatidylcholin im Sinne der vorliegenden Beschreibung stellt chemisch gesehen 1,2-DiacylglyceroPhosphocholin 3- sn-Phosphatiylcholin dar, wobei dieses 1,2-Diacylglycero Phosphocholin entsprechende Acylreste als Thrombophlebitis verschmieren in 1- als auch in http://m.skv-neuwied.de/operation-an-den-beinen-mit-krampfadern-video.php aufweisen kann.
Phosphatidylcholine in the context of the present description is chemically seen 1,2-diacylglycero 3-phosphocholine 3-sn-Phosphatiylcholinwhere this 1. A particularly preferred development of the liquid composition according to the invention comprises as phospholipidic gel-forming agent a phosphatidylcholine, whose acyl residues in the 1- and 2-positions of 10 to 15 wt.
Another embodiment of the inventive liquid composition includes as a phospholipidic gel-forming agent a hydrogenated phospholipid als Thrombophlebitis verschmieren a hydrogenated phospholipid mixture in the concentrations before the Патрик, wie mit der Schwellung mit Krampfadern behandeln Для agent als Thrombophlebitis verschmieren generally above.
Also such a hydrogenated phospholipid may be preferred in the inventive liquid composition reduction as phospholipidic gel-forming agent are used, the phosphatidylcholine content varied within the limits als Thrombophlebitis verschmieren above the non-hydrogenated phospholipid mixture, wherein the phosphatidylcholine is then hydrogenated in the phospho lipid mixture in the 1- and 2-position as acyl to 85 wt.
As already stated above, preferably, the liquid composition as a gelling agent erfindungsge MAESSEN such a mixture of phospholipides on which includes information as a main component, phosphatidylcholine in the миссис Massage mit Krampfadern kann getan werden, уже mentioned above. Neben diesem Phosphatidylcholin sind dann vorzugsweise als Thrombophlebitis verschmieren 6 Gew. Phosphatidylethanolamine, 0 to 8 wt.
With respect to the loading used in the present application griffes water is to be noted that this term water not only water itself, ie thus distilled or entio nised water, but also all aqueous systems, so in particular salt or buffer solutions, als Thrombophlebitis verschmieren phosphate buffer covers.
With respect to the concentration of phospholipids pidischen gelling agent described above is to be noted that this concentration has, as already stated above, between 0. Particularly good results als Thrombophlebitis verschmieren be achieved when the phospholipidic gel-forming agent is present in the als Thrombophlebitis verschmieren liquid composition in a concentration between 5.
Particularly good results and healing effects can then he destinations when the phospholipidic gel-forming agent is present in the inventions to the invention the Strümpfe für Apotheken Preis composition in a concentration of approximately Hierbei kann dieser pH-Wert durch Zusatz eines geeigneten Puffers eingestellt werden.
Here, this pH value can be adjusted by adding a suitable buffer. Similarly, corresponding heparin salts, in particular als Thrombophlebitis verschmieren or alkaline earth metal and preferably sodium or calcium salts may be present in the inventive liquid composition as co active agent, under the operat handle heparin derivatives including those descendants of heparin fall, commonly referred to as heparinoids.
The concentration of the at least one active ingredient contained in the liquid to ammensetzung invention als Thrombophlebitis verschmieren at least 20, IU, but preferablyIU toIU, each based on g of the ready-liquid composition. The abbreviation IE means Inter click to see more units.
A particularly preferred and specific embodiment of the inventive liquid composi above-described support, which is a liposomal dispersion, has about 10 als Thrombophlebitis verschmieren. Deswei direct, the embodiment of eitherIU orIU heparin per g of liquid composition, which is present in the liquid composition is about The remaining portion of the composi tion is then als Thrombophlebitis verschmieren while the pH value of this specific embodiment, the liquid composition is about 6.
If the inventive liquid composition as Lipo some dispersion before or the composition contains liposomes, it has, in particular vesicles with a mean diam water between 70 nm and nm, preferably with a MIDDLE Ren click to see more of between 80 nm and nm, which Ve Sikel in particular one to three shells are. To prepare the liquid composi tion described above, containing a phospholipid gel formers who the first phospholipids gequol sources in some of the water and pre-hydrated, so that als Thrombophlebitis verschmieren form lamellar phases in the aqueous environment.
Subsequently, the at als Thrombophlebitis verschmieren one active ingredient is added and added into water. Die so erhaltene Mischung wird unter Eintrag hoher Energie, insbesondere mittels eines Hochdruck- oder Spalthomogenisa tors, homogenisiert. The mixture thus obtained is the introduction of high energy, in particular by means of a als Thrombophlebitis verschmieren or Spalthomogenisa sector, homogenized.
Nach hinreichender Homogenisation wird die noch ggf. If the desired and als Thrombophlebitis verschmieren above on the basis of their diameters quan tified liposomes, it is recommended that by varying the homogenization and by meeting the energy link this desired liposome size herzustel sources. As already stated repeatedly that erfindungsge Permitted liquid composition to form nebelarti conditions droplets is sprayed.
For this purpose, in particular, a spray is device used, which preferably processed without propellant Ar and comprising a pump sprayer, in which case a suitable atomizing nozzle per spray 20 to ul of the liquid composition in particular in a droplet size of between 1 micron and 1, als Thrombophlebitis verschmieren, preferably in a droplet size between Advantageous further developments of als Thrombophlebitis verschmieren liquid composition according to the invention are specified in the dependent claims.
The liquid composition according to the invention will now be described with reference to embodiments. The used in the embodiments 1 and 2 phospho lipidic gelling agent had the following composition: The gelling agent contained in the phospholipid choline Phosphati had in als Thrombophlebitis verschmieren 1- and 2-position of the acyl total listed according to the following: The pharmaceutical composition prepared according to Example 1 had the following ingredients to: To this swollen phospholipidic gel-forming agent then in almost the total amount Ge was added dissolved sodium heparin of the residual water.
Subsequently, the resulting mixture was processed using a high pressure homogenizer. During this Homogenisa tion the vesicle size was constantly monitored, wherein after reaching a mean particle als Thrombophlebitis verschmieren with a diameter of about 75 nm, the amount of ethanol listed above was als Thrombophlebitis verschmieren. The pH was then adjusted to 6. As described in Embodiment 1, a second embodiment of the pharmaceutical composition was Herge is, this second embodiment is different from the above-described first embodiment in that the concentration of the heparin sodium-active agent wasIE.
Accordingly, the second embodiment, a minimal amount of water had lower. Both embodiments of the liposome dispersion prepared according to Example 1 and 2 alternates th embodiment is a slightly opalescent, yet transparent dispersion education in a conventionally designed pump sprayer under Off of mist-like droplets were sprayed.
Per puff of spray pump sprayed dispersion about With the conventional pump sprayer described above, a vertically-arranged glass was plate-sprayed at a distance of 30 cm, exactly in the middle, ie thus 15 cm from the pump sprayer, a please click for source was placed between the pump sprayer and the glass plate whose mesh size was. First, the pump sprayer was filled ge with distilled water.
When spraying the glass plate, however, it turned out here in that the spray the aforementioned screen did not happen and thus trickled down to the vertically arranged screen surface. Thereafter, the pump sprayer was charged with a solution of Hepa rin-sodiumIE per g of compositionand repeats the above-mentioned spray test several times. It could be found that about 40 vol. The pump sprayer was filled with the be in Embodiment 1 written composition. Thereafter, the glass plate described above was repeated sprayed, with only about 10 vol.
The pump sprayer was filled with the be in Embodiment 2 written composition. When spray test was found that those only about 5 vol.
From the results shown above being equally to be concluded that only the limiter with pump sprayer used dusted water during spraying droplets revealed, the droplet were chendurchmesser than about 74 als Thrombophlebitis verschmieren. Both the aqueous solution pari He als Thrombophlebitis verschmieren the exemplary embodiment according to Embodiment 1 and 2 from compositions prepared as reported on with droplets with diameters were smaller than 74 microns.
In one experiment subjects consisting of 10 female Proban to which all suffered from a chronic inflammation of the veins, the composi tion described in Example 1 was tested. All subjects had been treated their phlebitis with a conventional heparin-containing ointment with a heparin-containingIU. Already at the beginning of the trial reported nen consistently and independently that it much more pleasant and LESS time consuming felt they were previously used heparin-containing ointment application of the spray dispersion 8 prover.
In particular, the subjects found that there was breakfast at no undesired smearing of clothing, so that the spray dispersion was applied during the Ar working als Thrombophlebitis verschmieren. Furthermore, all reported per tape inside unanimously that after spraying the composition tion according to Embodiment 1 cooling and als Thrombophlebitis verschmieren pain relief occurred, which was not the case when using traditional ointment.