METHOD TO PROTECT A PERSON FROM THEPOLLUTION AS A RESULT OF AN APPLICATIONORAL MISTAKE OF TOXIC SUBSTANCES OF A SYSTEMTHERAPEUTIC PERCUTANEOUS, AS WELL AS SYSTEMSPERCUTANEOUS THERAPEUTICS WITH A DENATURALIZINGField of the InventionThe invention relates to a method for the protection of a person against contamination as a result of the undue oral application of toxic substances of a percutaneous therapeutic system (TTS), comprising at least one layer containing active ingredient, in particular with a self-adhesive liner, as well as at least one subsequent layer impermeable to the active principle, as well as a TTS with a denaturant.
Background of the InventionIn a series of TTS there is a serious risk that unwanted effects may occur in theIf people can have oral contact with an active ingredient that can be separated from the system - be it new systems orRef: 32947 systems that have been removed. For example, young children often put all the objects that get their attention in the mouth and at least suck or chew them. In particular, this can not be avoided when children have casual access to systems of this type, in particular without protective release liner. To date, there have been no known incidents of this type, but the health authorities are increasingly afraid of this and for this reason they demand that these containers be safe to avoid unforeseen openings. In fact, containers of this type have been developed in various forms. However, they do not prevent a child from putting a TTS in his mouth once the container is opened or if a used patch reaches his hands in some way. Particularly in the case of TTS with active ingredients such as anesthetics, analgesics, tranquillizers or ps i co-drugs, undue oral intake can be harmful to health. On the other hand, drug addicts may be tempted to extract these active ingredients from the percutaneous therapeutic systems by sucking or chewing them.
The denaturing process is already known, to which the ethyl alcohol suitable for consumption is subjected, to be released on the market in the form of alcohol to be burned. On the other hand, no case of denaturation of active pharmaceutical ingredients is known to date.
Description of the invention.
The aim of the present invention is to offer a method for the protection of a person, of the type mentioned in the generic term of claim 1, so that the aforementioned oral abuse is not possible, although it is otherwise avoided a disadvantageous alteration of the active therapeutic principle in the system and also preventing any damage to health as a consequence of an undue oral application.
To solve this problem, it is proposed with the method according to the invention, to add a therapeutically neutral and non-interacting substance with unpleasant taste.
Because this substance offers a highly unpleasant and unexpected taste, a first oral contact with the TTS according to the invention or with one of its denatured layers will suffice for a spontaneous reaction to force the immediate spitting of the patch in question, avoiding in this way, children or drug addicts orally use the active substance contained in the patch in an improper way.
One configuration foresees that, for the denaturing of a TTS, a substance is used that produces the urge to vomit and consequently prevents the person in question from being tempted to proceed to an oral application.
Another configuration of the method according to the invention provides that the substance is applied on the layer containing active ingredient in a separate, extremely thin layer and does not prevent the permeation of the active principle. This has the advantage that at the first contact of the buccal mucosa or tongue with the TTS, before the contamination with the active ingredient-containing layer occurs, the extremely unpleasant taste prevents a later oral contact.
It is also possible for the substance to be applied additionally on the back layer in a separate layer, preferably very thin. In this way, the denaturing effect is further intensified.
It is provided that the separated layer of the substance is applied in a thickness comprised between 10 and 100 μm, preferably between 5 and 20 μm.
A particularly preferred configuration of the invention also provides for the use of a substance that causes irritation, such as burning of the mucous membranes of the oral cavity and the tongue. A single negative experience should suffice to prevent, permanently, the child or drug addict from continuing to be tempted to enter into oral contact with a TTS. In addition, a similar effect can be achieved by using a substance that causes a very bitter and permanent taste.
An effective configuration of the method according to the invention provides that for the denaturing of at least one layer of a TTS it is used as a bitter substance or substance of unpleasant taste: gallic acid, quinine, tannin, narrowness, caffeine (pure), lobeline, essence of tea, certain crops of mold fungi, denatured or curdled substances, turpentine or ammonia.
To achieve an embodiment of the method, it has been foreseen that. the substances used for the denaturation are introduced into a coating layer, with which the active ingredient-containing layer is coated and, if necessary, the subsequent layer. The best solution is to use a coating of soluble coating in contact with saliva.
The method is non-complicated and effective and protects children and / or drug addicts from any undue oral use of toxic substances contained in a percutaneous therapeutic system. In this way, the method and the TTS according to the invention optimally solve the problem raised at the beginning. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Having described the invention as above, the content of the following is claimed as property.