MXPA00002933A - Method for preventing the misuse of a transdermal therapeutic system - Google Patents
Method for preventing the misuse of a transdermal therapeutic systemInfo
- Publication number
- MXPA00002933A MXPA00002933A MXPA/A/2000/002933A MXPA00002933A MXPA00002933A MX PA00002933 A MXPA00002933 A MX PA00002933A MX PA00002933 A MXPA00002933 A MX PA00002933A MX PA00002933 A MXPA00002933 A MX PA00002933A
- Authority
- MX
- Mexico
- Prior art keywords
- layer
- substance
- process according
- substances
- tts
- Prior art date
Links
- 230000001225 therapeutic Effects 0.000 title claims abstract description 11
- 239000000126 substance Substances 0.000 claims description 26
- 239000010410 layer Substances 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 12
- 239000004480 active ingredient Substances 0.000 claims description 11
- 235000019640 taste Nutrition 0.000 claims description 8
- 210000000214 Mouth Anatomy 0.000 claims description 5
- 231100000614 Poison Toxicity 0.000 claims description 5
- 239000003440 toxic substance Substances 0.000 claims description 5
- LNTHITQWFMADLM-UHFFFAOYSA-N Gallic acid Chemical compound OC(=O)C1=CC(O)=C(O)C(O)=C1 LNTHITQWFMADLM-UHFFFAOYSA-N 0.000 claims description 4
- LOUPRKONTZGTKE-WZBLMQSHSA-N Quinine Chemical compound C([C@H]([C@H](C1)C=C)C2)C[N@@]1[C@@H]2[C@H](O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-WZBLMQSHSA-N 0.000 claims description 4
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000000853 adhesive Substances 0.000 claims description 3
- 239000011247 coating layer Substances 0.000 claims description 3
- 238000011109 contamination Methods 0.000 claims description 3
- 239000003398 denaturant Substances 0.000 claims description 3
- 230000036425 denaturation Effects 0.000 claims description 3
- 238000004925 denaturation Methods 0.000 claims description 3
- MXYUKLILVYORSK-HKBOAZHASA-N 2-[(2S,6R)-6-[(2S)-2-hydroxy-2-phenylethyl]-1-methylpiperidin-2-yl]-1-phenylethanone Chemical compound C1([C@@H](O)C[C@@H]2N([C@@H](CCC2)CC(=O)C=2C=CC=CC=2)C)=CC=CC=C1 MXYUKLILVYORSK-HKBOAZHASA-N 0.000 claims description 2
- 240000007524 Camellia sinensis var. sinensis Species 0.000 claims description 2
- 235000001258 Cinchona calisaya Nutrition 0.000 claims description 2
- 241000434299 Cinchona officinalis Species 0.000 claims description 2
- 241000233866 Fungi Species 0.000 claims description 2
- 229940074391 Gallic acid Drugs 0.000 claims description 2
- 210000004400 Mucous Membrane Anatomy 0.000 claims description 2
- 229960000948 Quinine Drugs 0.000 claims description 2
- 210000003296 Saliva Anatomy 0.000 claims description 2
- 241000779819 Syncarpia glomulifera Species 0.000 claims description 2
- VXMKYRQZQXVKGB-CWWHNZPOSA-N Tannin Chemical compound O([C@H]1[C@H]([C@@H]2OC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)O[C@H]([C@H]2O)O1)O)C(=O)C1=CC(O)=C(O)C(O)=C1 VXMKYRQZQXVKGB-CWWHNZPOSA-N 0.000 claims description 2
- 229940036248 Turpentine Drugs 0.000 claims description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-N ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims description 2
- 229960001948 caffeine Drugs 0.000 claims description 2
- 235000004515 gallic acid Nutrition 0.000 claims description 2
- 229960002339 lobeline Drugs 0.000 claims description 2
- 229930013610 lobeline Natural products 0.000 claims description 2
- -1 narrowness Chemical compound 0.000 claims description 2
- 230000001264 neutralization Effects 0.000 claims description 2
- 239000001739 pinus spp. Substances 0.000 claims description 2
- 235000018553 tannin Nutrition 0.000 claims description 2
- 229920001864 tannin Polymers 0.000 claims description 2
- 239000001648 tannin Substances 0.000 claims description 2
- 210000004916 vomit Anatomy 0.000 claims description 2
- 206010013911 Dysgeusia Diseases 0.000 claims 1
- 235000019658 bitter taste Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drugs Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 229940035676 ANALGESICS Drugs 0.000 description 1
- 229940035674 ANESTHETICS Drugs 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000003444 anaesthetic Effects 0.000 description 1
- 230000000202 analgesic Effects 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 230000001055 chewing Effects 0.000 description 1
- 239000003193 general anesthetic agent Substances 0.000 description 1
- 230000018984 mastication Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000001681 protective Effects 0.000 description 1
- 230000002269 spontaneous Effects 0.000 description 1
Abstract
According to the invention, denaturing agents are added to a transdermal therapeutic system to prevent misuse in the form of unauthorised oral application.
Description
METHOD TO PROTECT A PERSON FROM THE
POLLUTION AS A RESULT OF AN APPLICATION
ORAL MISTAKE OF TOXIC SUBSTANCES OF A SYSTEM
THERAPEUTIC PERCUTANEOUS, AS WELL AS SYSTEMS
PERCUTANEOUS THERAPEUTICS WITH A DENATURALIZING
Field of the Invention
The 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 Invention
In a series of TTS there is a serious risk that unwanted effects may occur in the
If people can have oral contact with an active ingredient that can be separated from the system - be it new systems or
Ref: 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.
Claims (12)
1. A process to protect a person from contamination, as a consequence of the undue oral application of toxic substances contained in a percutaneous therapeutic system (TTS), comprising at least one layer containing active substance, in particular with self-adhesive coating, as well as at least one other subsequent layer impermeable to the active principle, characterized in that a therapeutically neutral and non-interacting substance with an unpleasant taste is added.
2. The process according to claim 1, characterized in that the unpleasant taste substance is added to at least the active ingredient containing layer.
3. The process according to claim 1 or 2, characterized in that the substances used for the denaturation are introduced into a coating layer with which the active ingredient-containing layer and, where appropriate, the back layer is coated.
4. The process according to claim 3, characterized in that a coating layer is used, which dissolves in contact with the saliva.
5. The process according to one or more of claims 1 to A, characterized in that a substance that makes you want to vomit is used.
6. The process according to one or more of the rei indications 1 to 5, characterized in that the substance is applied on the layer containing the active ingredient in a separate, very thin layer and does not prevent the permeation of the active principle.
7. The process according to one or more of claims 1 to 6, characterized in that the substance is also applied on the back layer in a very thin, separate layer.
8. The process according to one or more of claims 1 to 7, characterized in that the separated layer of the substance is applied in a thickness comprised between 10 and 100 μm and preferably between 5 and 20 μm.
9. The process according to one or more of claims 1 to 8, characterized in that a substance is used that produces an irritation, such as burning of the mucous membranes of the oral cavity and the tongue.
10. The process according to one or more of claims 1 to 9, characterized in that a substance which produces an intense bitter taste and in particular leaves a bad taste in the mouth is used.
11. The process according to one or more of claims 1 to 10, characterized in that for the denaturing of at least one layer of a TTS it is used as bitter substances or substances of unpleasant taste: gallic acid, quinine, tannin, narrowness, caffeine (pure ), lobeline, tea essence, cultivation of mold fungi, denatured or curdled substances, turpentine or ammonia.
12. A TTS, characterized in that it comprises at least one active ingredient-containing layer, in particular with self-adhesive coating, as well as at least one other subsequent layer impermeable to the active principle, which contains a denaturant. METHOD OF PROTECTING A PERSON FROM POLLUTION AS A RESULT OF AN UNDUE ORAL APPLICATION OF TOXIC SUBSTANCES OF A SYSTEM PERCUTANEOUS THERAPEUTIC, AS WELL AS PERCUTANEOUS THERAPEUTIC SYSTEMS WITH A DENATURALIZER Summary of the Invention. The invention is to avoid an undue oral application by adding denaturants to a percutaneous therapeutic system.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19743484.3 | 1997-10-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA00002933A true MXPA00002933A (en) | 2002-05-09 |
Family
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