WO2008040512A2 - Système d'élimination de déchets - Google Patents

Système d'élimination de déchets Download PDF

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Publication number
WO2008040512A2
WO2008040512A2 PCT/EP2007/008506 EP2007008506W WO2008040512A2 WO 2008040512 A2 WO2008040512 A2 WO 2008040512A2 EP 2007008506 W EP2007008506 W EP 2007008506W WO 2008040512 A2 WO2008040512 A2 WO 2008040512A2
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WO
WIPO (PCT)
Prior art keywords
disposal
inactivation
active substance
drug delivery
disposal system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2007/008506
Other languages
German (de)
English (en)
Other versions
WO2008040512A3 (fr
Inventor
Heinrich Kugelmann
Johannes Bartholomäus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gruenenthal GmbH
Original Assignee
Gruenenthal GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gruenenthal GmbH filed Critical Gruenenthal GmbH
Publication of WO2008040512A2 publication Critical patent/WO2008040512A2/fr
Publication of WO2008040512A3 publication Critical patent/WO2008040512A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
    • B09B—DISPOSAL OF SOLID WASTE NOT OTHERWISE PROVIDED FOR
    • B09B3/00—Destroying solid waste or transforming solid waste into something useful or harmless
    • B09B3/70—Chemical treatment, e.g. pH adjustment or oxidation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
    • B09B—DISPOSAL OF SOLID WASTE NOT OTHERWISE PROVIDED FOR
    • B09B2101/00—Type of solid waste
    • B09B2101/65—Medical waste
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
    • B09B—DISPOSAL OF SOLID WASTE NOT OTHERWISE PROVIDED FOR
    • B09B2101/00—Type of solid waste
    • B09B2101/65—Medical waste
    • B09B2101/68—Transdermal patches

Definitions

  • the invention relates to a disposal system with controlled disposal comprising a drug delivery system to be disposed of containing an active substance with abuse potential and at least one of the disposable drug delivery system initially separated present, multi-layer disposal device for controlled destruction of the drug immediately after the first contact of the drug delivery system with the Entsorgungsmittei.
  • unused pharmaceutical drug delivery systems such as drug-containing patches are usually disposed of with household waste or hospital garbage. However, these drug delivery systems may still contain large amounts of a pharmacologically active ingredient.
  • US Patent US-B-5804215 a system for disposing of transdermal patches is described in US Patent US-B-5804215.
  • This disposal is in one tear-resistant, foldable, planar disposal means, which has a larger surface area than the plaster to be disposed and is designed on one side with a sticky surface, including the patch to be disposed of.
  • the drug is not destroyed with abuse potential, but only included, so that an effective, final protection against misuse of the amount of active substance still contained in the patch is not guaranteed.
  • the patch containing an active substance with potential for abuse is enclosed in a disposal means which has an impermeable deposit for a compound suitable for inactivating the active substance. Only in an opening attempt to allow drug abuse this depot is mechanically destroyed, so that the inactivating compound released and inactivated after mixing with the active ingredient.
  • This disposal system also has the disadvantage that the amount of active substance present in a transdermal system with abuse potential is not destroyed in a controlled manner after use or shelf life of the active substance delivery system, so that prevention of the abuse is not ensured.
  • the known abuse prevention should be improved, according to the drug delivery system to be disposed containing an active substance with abuse potential only included in a disposal and uncontrolled without destruction of the drug with drug potential with the waste disposed of to prevent misuse, preferably preclude.
  • the object of the present invention is encompassed by the provision of the disposal system according to the invention for the controlled abuse prevention of an active substance with abuse potential A) at least one to be disposed of, preferably sheet-like drug delivery system containing at least one drug with abuse potential
  • Destruction according to the invention is the inactivation of the drug with abuse potential to at least one unsuitable for the abuser conversion, preferably the complete destruction or minimization of the concentration of the active ingredient, more preferably at least the chemical change of the drug to a stage in which no possibility of abuse more is, most preferably understood the complete destruction of the drug.
  • the disposal system according to the invention preferably comprises a disposal means which is planar, wherein the effective area of the disposal means, d. H. the area which the inactivation system delivers is preferably at least as large as the area of the active substance-containing area of the active substance delivery system.
  • the disposal means preferably has a layered structure comprising
  • a cover layer impermeable to the inactivation system as a surface layer a layer, possibly adhesive, having the inactivation system and having a permeable layer, in which the inactivation system is distributed in a matrix material, taken up in a porous material or in a reservoir optionally having a membrane permeable to the inactivation system, is present,
  • the permeable layer containing the inactivation system is preferably bonded on one of its surfaces to a capping layer impermeable to the inactivation system, its delivery is controlled only in one direction.
  • the removable protective film preferably has release properties, so that a simple peeling is guaranteed.
  • the permeable layer comprising the inactivation system is provided with a full-area adhesive layer permeable to the inactivation system, especially when the inactivation system is distributed in a matrix, or at least one adhesive edge around the reservoir containing the inactivation system around the corresponding porous portion of the layer.
  • This reservoir is preferably chamber-shaped and may have at least two compartments separated from one another.
  • the reservoir may be closed with a permeable membrane for the inactivation system or only with the removable protective film. Insofar as it is necessary for the destruction of the active ingredient by the inactivation system, by simple handling any separation between the compartments of the reservoir can be eliminated, so that the contents of the compartments can be brought together for mixing.
  • the inactivation system can also be distributed in a matrix layer which is permeable to it, which may optionally also contain adhesives, so that the adhesive layer and this matrix layer produce a layer.
  • the inactivating agent has an adhesive edge or an adhesive layer or is self-adhesive, it is preferably covered with a removable protective film before use.
  • the inactivation system can be accommodated in a section of the layer which is permeable to the inactivation system and which is made of a porous, preferably flexible material whose areal extent is at least as large as the area of the active substance-containing area of the active substance delivery system to be disposed of.
  • the porous material is an absorbent material, preferably having a sponge-like structure, from which the inactivation system, e.g. B. can already be released by light pressure
  • absorbent material is understood as meaning materials which are capable of absorbing liquid or gel-like substances and, if appropriate, over a relatively long period of time, preferably 1-24 months, more preferably 1-12 months, even more preferably 1-8 months, most preferably 1-6 months, especially 1-4 months.
  • absorbent materials sponges or absorbent textiles that are physiologically harmless may preferably be used. It is obvious to a person skilled in the art that, depending on the inactivation system used, absorbent materials with the corresponding necessary absorption capacity are used. This can be determined by simple preliminary tests.
  • the inactivation system may be in solid, semi-solid or liquid form, preferably in solid or liquid form in the disposal means.
  • the inactivation system may be distributed in the form of crystals, granules, pellets, lozenges, in powder form, in microcapsules, as a solution or as a gel in a matrix material, in a porous material, preferably a sponge, or in a reservoir.
  • the inactivation system can be present in undissolved or in dissolved form. If the inactivation system is in dissolved form, it may preferably be contained in a porous, flexible material.
  • the inactivation system is in dissolved form, it may preferably be provided with a viscosifier.
  • the anti-drug efficacy of the inactivation system is physically, e.g. B. by dissolving in a suitable solvent, or chemically, for. B. by hydrolysis, to improve or only to produce.
  • the inactivation system may preferably consist of at least two components which are mixed together only upon contact of the initially separately present inactivating agent with the drug delivery system.
  • Such components may, for. B. a salt with the destructive action and a suitable solvent, particularly preferably water, be present initially in separate compartments of the reservoir of the disposal agent.
  • a suitable solvent particularly preferably water
  • the amounts or concentrations of the inactivation system are to be selected so that the destruction of the active substance begins immediately after contact of the disposal agent with the active substance delivery system and is completed within days, preferably within hours, without health risks if handled appropriately.
  • the inactivation system comprises a compound which chemically destroys the active substance.
  • a compound is preferably a compound selected from the group comprising inorganic or organic oxidizing agents, inorganic or organic reducing agents, the active substance with Abuse potential derivatizing compounds, acids, bases, organic salts and inorganic salts.
  • the inactivation system comprises an alkali salt, preferably a sodium or potassium salt, preferably an oxidative acid or H 2 O 2 .
  • the inactivation system comprises at least one compound selected from the group comprising sodium perborate, potassium perborate, sodium peroxide, benzoyl peroxide, carbamide peroxide, sodium percarbonate, potassium percarbonate, sodium persulfate, potassium persulfate, sodium peroxodisulfate, potassium peroxodisulfate, sodium perphosphate, potassium perphosphate, H 2 O 2 , peracetic acid and potassium permanganate.
  • TAED tetraacetyl-ethylenediamine
  • the drug delivery system of the disposal system according to the invention is preferably a sheet-like system for transdermal and / or topical drug delivery, preferably a patch.
  • active ingredient delivery systems such as patches
  • a controlled abuse-preventive disposal of used drug delivery systems, such as patches a controlled disposal of expired, unused patches is also possible.
  • the drug delivery system to be disposed of is a used drug delivery system which still has a residual content of drug with abuse potential.
  • the drug delivery system may be constructed according to the reservoir or matrix system.
  • Bauer KH, Frömming K.-H., 5.3 C, Pharmazeutician Technologie, pp. 381-383; Müller RH, Hildebrand GE, Pharmaceutical Technology: Modern Dosage Forms, Chapter 8, are referenced. The corresponding description of the systems is considered part of the present disclosure.
  • the drug delivery system may preferably comprise a carrier layer, an active agent-containing layer and an adhesive layer, wherein the active substance-containing layer may simultaneously be the adhesive layer in which the active ingredient is dissolved and / or dispersed in a matrix optionally together with the adhesive is present.
  • Adhesives for the adhesive layer of the active substance delivery system are preferably pressure-sensitive adhesives, for example polymers such as polyacrylates, polyvinyl ethers, polyisobutylenes (PIB), styrene / isoprene or butadiene / styrene copolymers or polyisoprene rubbers.
  • PIB polyisobutylenes
  • silicone adhesives such as, for example, optionally crosslinked polydimethylsiloxanes.
  • Also based on esters of glycines, glycerol or pentaerythrol, or hydrocarbons, such as polyterpenes are suitable.
  • Acrylate-based adhesives are by polymerization of acrylates, methacrylates, alkylacrylates and or alkyl methacrylates, with optionally further ⁇ , ⁇ -unsaturated monomers, such as acrylamide, dimethylacrylamide, dimethylaminoethyl acrylate, hydroxyethyl acrylate, hydroxypropyl acrylate, methoxyethyl acrylate, methoxyethyl methacrylate, acrylonitrile and / or vinyl acetate Fe can also be used for the production of the adhesive layer or an adhesive edge of the disposal agent described above.
  • the carrier layer or covering layer of the active substance delivery system is preferably impermeable and inert for the substances contained in the active substance-containing layer and in the adhesive layer, in particular for the active substance, and may be based on polymers, such as polyesters, preferably polyethylene terephthalate, polyolefins, such as polyethylenes, polypropylenes or polybutylenes , Polycarbonates, polyethylene oxides, polyurethanes, polystyrroles, polyamides, polyimides, polyvinyl acetates, polyvinyl chlorides, polyvinylidene chlorides and / or copolymers such as acrylonitrile / butadiene / styrrole copolymers and / or mixtures thereof, optionally containing paper fibers or textile fibers, which may be metallized or pigmented if necessary.
  • polymers such as polyesters, preferably polyethylene terephthalate, polyolefins, such as polyethylenes, poly
  • the inactivation system impermeable cover layer of the above described disposal means may be identically constructed.
  • the carrier layer or covering layer of the active substance delivery system or the inactivation system impermeable covering layer of the disposal agent may also consist of a combination of a metal foil and a polymer layer.
  • the active ingredient-containing matrix layer of the active substance delivery system may contain matrix-forming polymers, skin penetration enhancers, solubilizers, crosslinkers, stabilizers, emulsifiers, preservatives, thickeners and / or further customary auxiliaries.
  • the matrix-forming polymer used is preferably at least one film-forming polymer selected from the group comprising hydroxypropylcellulose, carboxymethylcellulose, polyethylenes, chlorinated polyethylenes, polypropylenes, polyurethanes, polycarbonates, polyacrylates, polyacrylates, polymethacrylates, polyvinyl alcohols, polyvinyl chlorides, polyvinylidene chlorides, polyvinylpyrrolidones, polyethylene terephthalates, polytetrafluoroethylenes, ethylene / propylene Copolymers, ethylene / ethyl acrylate copolymers, ethylene / vinyl acetate copolymers, ethylene / vinyl alcohol copolymers, ethylene / vinyl oxanol copolymers, vinyl chloride / vinyl acetate copolymers, vinyl pyrrolidone / ethylene / vinyl acetate copolymers, rubbers, rubbery, synthetic homo-, co- or block polymers, silicones,
  • matrix-forming polymers and optionally adhesives can also be used for the preparation of the inactivation system-containing matrix layer of the above described disposal means.
  • Antioxidants such as vitamin E, butylhydroxytoluene, butylated hydroxyanisole, ascorbic acid, ascorbyl palmitate, and / or chelating agents, such as, for example, can be used as stabilizers for the active substance-containing matrix or the active substance-containing reservoir of the active substance delivery system.
  • B. Dinatriurnethylendiamintetraessigkladre, potassium or sodium citrate can be used.
  • the active ingredient-containing matrix or the active substance-containing reservoir of the active substance delivery system may also contain conventional skin penetration enhancers.
  • the drug delivery system may also include, in one or more layers, at least one plasticizer or skin permeation enhancer selected from the group consisting of long chain alcohols such as dodecanol, undecanol, octanol, esters of carboxylic acids with polyethoxylated alcohols, diesters of aliphatic dicarboxylic acids such as adipic acid, and caprylic acid medium chain triglycerides / or capric acid, coconut oil, polyhydric alcohols, such as 1, 2-propanediol, esters of polyhydric alcohols, such as glycerol with levulinic or caprylic, and etherified polyhydric alcohols.
  • plasticizer or skin permeation enhancer selected from the group consisting of long chain alcohols such as dodecanol, undecanol, octanol, esters of carboxylic acids with polyethoxylated alcohols, diesters of aliphatic dicarboxylic acids such as adipic
  • the peelable protective film of the drug delivery system or the disposal agent described above can be selected from polyethylene, polyester, polyethylene terephthalate, polypropylene, polysiloxane, polyvinyl chloride or polyurethane and optionally from treated paper fibers such.
  • As cellophane and preferably have a silicone, fluorosilicone or fluorine-carbon coating as a release coating.
  • Substances with abuse potential in particular those with a psychotropic effect, which are also suitable for transdermal and / or topical delivery, are known to the person skilled in the art.
  • Many drugs with abuse potential especially those with psychotropic effect, have the property of being able to influence mental processes, i. they have a specific effect on mental functions. Such agents can thus affect mood, either whitening or cushioning.
  • the active substances with potential for abuse are preferably active substances which, especially in the case of non-intended type of application, are accelerated in comparison with the intended topical or transdermal application Influencing the drug with the result desired by an abuser, namely the kick.
  • This kick can z. B. can be achieved when the drug is extracted from the drug delivery system and then z. B. administered parenterally or orally.
  • drugs with abuse potential in particular those drugs with psychotropic effect, which influence the human mind and / or sensory perception in a manner that they are in principle suitable for abuse with appropriate dosage, dosage form and Darreichungsart.
  • the active substances with potential for abuse are especially active substances which have an effect on or via the nervous system according to the ATC index.
  • These agents preferably include transdermally and / or topically administrable anesthetics [N01], analgesics [N02], antielectics [N03], antiparkinson agents [N04], psycholeptics [N05], psychoanaleptics [N06] and / or other nervous system agents [N07] , and corresponding stereoisomeric compounds, in each case their corresponding derivatives, physiologically acceptable enantiomers, stereoisomers, diastereomers and racemates and their physiologically acceptable derivatives, for example ethers, esters or amides, and in each case their physiologically acceptable compounds, in particular their salts and solvates, for example hydrochlorides.
  • brackets correspond to the ATC index as used by the WHO for the classification of the drugs (preferred status: January 2005 or 2006).
  • ATC index refers to U. Fricke, Anatomisch-Therapischchemische Klasstechnische with Paindosen: Official version of the ATC Index with DDD data for Germany in 2006, Scientific Institute of the AOK referenced.
  • Derivatives in each case corresponding physiologically compatible enantiomers, stereoisomers, Diastereomers, racemates, in each case physiologically acceptable derivatives, such as ethers, esters or amides, and in each case physiologically acceptable compounds, in particular salts and solvates understood
  • the substance to be disposed of according to the invention with abuse potential or psychotropic effect is at least one transdermally and / or topically administrable active ingredient selected from the group comprising alfentanil, allobarbital, allylprodin, alphaprodine, alprazolam, amfepramone, amfetamine, amfetaminil, amobarbital, anileridine , Apocodein, barbital, bemidone, benzylmorphine, bezitramide, bromazepam, Brotizolam, buprenorphine, butobarbital, butorphanol, camazepam, carfentanil, cathin / D-norpseudoephedrine, chlordiazepoxide, clobazam, clofedanol, clonazepam, clonitazene, clorazepate, clotiazepam, cloxazolam, cocaine, codeine
  • the active substance with abuse potential or psychotropic action to be disposed of according to the invention is particularly preferably at least one transdermally and / or topically administrable opioid selected from the group comprising allylprodin, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, Cyclazocine, desomorphine, dextromoramide, decocin, diampromide, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, Eptazocine, ethoheptazine, ethorphine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine
  • the active ingredient according to the invention with abuse potential to at least one transdermally and / or topically administrable opioid selected from the group comprising buprenorphine, fentanyl and sufentanil, a corresponding stereoisomeric compound, a corresponding derivative, a physiologically acceptable enantiomer, stereoisomer , Diastereomeres, racemate, a physiologically acceptable derivative thereof, such as an ether, ester or amide, and in each case a physiologically acceptable compound, in particular a salt and solvate, for example hydrochloride.
  • a transdermally and / or topically administrable opioid selected from the group comprising buprenorphine, fentanyl and sufentanil, a corresponding stereoisomeric compound, a corresponding derivative, a physiologically acceptable enantiomer, stereoisomer , Diastereomeres, racemate, a physiologically acceptable derivative thereof, such as an ether, ester or amide, and in each case a
  • the active ingredient to be disposed of according to the invention with abuse potential or psychotropic effect is buprenorphine.
  • Essential to the invention is that the controlled destruction of the drug with abuse potential is achieved only by applying the disposal agent on the drug-containing surface of the drug delivery system and begins immediately after the first contact of the drug delivery system with the disposal.
  • the drug delivery system it is not necessary to include the drug delivery system to be disposed of in an inactivating agent, which still poses a risk of Abuse by the existing, not destroyed drug amount is given.
  • the known inclusion of the drug delivery system to be disposed of without destruction of the active ingredient is avoided according to the invention, as by surface contact of the disposal agent with the active ingredient-containing region of the drug delivery system
  • Another object of the invention therefore also relates to a method for the controlled disposal and controlled abuse prevention of a present in a drug delivery system to be disposed amount of an active substance with abuse potential, which is characterized in that to destroy the located in the drug-containing portion of the drug delivery system amount of an active ingredient multi-layer, inventive disposal means is applied and immediately after the application of the inactivating agent on the active substance-containing area destruction of the active ingredient is continued at least up to a completely unsuitable for abuse concentration of the active ingredient, preferably until complete destruction of the remaining amount of active ingredient.
  • inventive disposal means is applied and immediately after the application of the inactivating agent on the active substance-containing area destruction of the active ingredient is continued at least up to a completely unsuitable for abuse concentration of the active ingredient, preferably until complete destruction of the remaining amount of active ingredient.
  • the necessary duration of action of an inactivation system on the active ingredient or on the amount of active ingredient present can be determined by simple preliminary tests.
  • Figure 1 shows a cross-section of the disposal means (C) comprising an inactivation system impermeable cover layer (1) having an adhesive layer (6) pervious to the inactivation system with a reservoir (2) containing an inactivation system (7).
  • the reservoir (2) is closed by a membrane (8) permeable to the inactivation system.
  • a protective film (3) impermeable to the inactivation system covers the adhesive layer.
  • Figure 2 shows a cross section of the disposal means (C) with an inactivation system impermeable cover layer (1) and a matrix layer (5) containing and permeable to the inactivation system, covered with a protective film (3) impermeable to the inactivation system.
  • Figure 3 shows a cross-section of the disposal means (C) comprising a capping layer (1) impermeable to the inactivation system and a porous sub-layer (9) containing the inactivation system, in which the inactivation system is incorporated.
  • the porous sublayer (9) is bordered by an adhesive edge (10).
  • the porous sub-layer (9) and the adhesive edge (10) are covered with a protective film (3) impermeable to the inactivation system.
  • Figure 4 shows an embodiment of the disposal means (C) with a capping layer (1) impermeable to the inactivation system.
  • the chamber-shaped reservoir (2) has two separate compartments (2a, 2b) and a membrane (8) permeable to the inactivation system.
  • the compartments are separated by a wall (4) impermeable to the inactivation system, each containing one component (A or B) of the inactivation system.
  • the membrane-shaped, permeable for the inactivation system layer is covered with a protective film (3).
  • the partition (4) can be folded in the reservoir, whereby the two components A and B are mixed together, for. B. by dissolving a salt (A) in water (B) to an aqueous solution of the salt whereby the inactivation system is obtained.
  • a cover layer a 420 mm wide, transparent polyester film is coated with the above-described mixture so that the weight per unit area of the dried adhesive layer is 80 g / m 2 .
  • the solvents are removed by drying with heated air which is passed over the wet web.
  • the heat treatment evaporates the solvents.
  • the active ingredient-containing adhesive layer is covered with a 15 ⁇ m thick polyester film as a protective film, which can be removed again by silicone treatment. Using suitable cutting tools, a surface corresponding to the intended amount of active substance is punched out.
  • a buprenorphine plaster produced according to a) is prepared in each case with a disposal agent according to the invention prepared according to b) (after detachment of the peelable protective film) for 2, 6 or 24 hours at 25 ° C.
  • the residual content of buprenorphine in the patch is determined by conventional HPLC method.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Engineering & Computer Science (AREA)
  • Environmental & Geological Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Processing Of Solid Wastes (AREA)

Abstract

L'invention concerne un système d'élimination de déchets servant à éliminer de façon contrôlée une substance active à potentiel d'abus. Ce système comprend au moins un système d'administration de substance active comprenant une substance active à potentiel d'abus et au moins un moyen d'élimination multicouche séparé du système d'administration de substance active, ce moyen d'élimination étant destiné à détruire de façon contrôlée la substance active dès l'entrée en contact du système d'administration de substance active avec le moyen d'élimination.
PCT/EP2007/008506 2006-10-04 2007-10-01 Système d'élimination de déchets Ceased WO2008040512A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006047270.5 2006-10-04
DE102006047270A DE102006047270A1 (de) 2006-10-04 2006-10-04 Entsorgungssystem

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WO2008040512A2 true WO2008040512A2 (fr) 2008-04-10
WO2008040512A3 WO2008040512A3 (fr) 2008-08-28

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Cited By (2)

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CN102596438A (zh) * 2009-08-07 2012-07-18 Lts勒曼治疗系统股份公司 透皮治疗系统中药物活性物质的销毁性处理
US11679084B2 (en) 2019-08-09 2023-06-20 Nopioid, Llc Method and compositions for rendering opioids safe

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DE202008004785U1 (de) * 2008-04-04 2009-08-13 Grünenthal GmbH Entsorgungsvorrichtung

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US5804215A (en) * 1997-03-21 1998-09-08 L. Perrigo Company Transdermal patch disposal system and method
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US20050112068A1 (en) * 2003-10-28 2005-05-26 Warner Kevin S. Systems and methods for reducing unintended use of active ingredients in dermal delivery devices
US7867511B2 (en) * 2004-01-23 2011-01-11 Travanti Pharma Inc. Abuse potential reduction in abusable substance dosage form

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102596438A (zh) * 2009-08-07 2012-07-18 Lts勒曼治疗系统股份公司 透皮治疗系统中药物活性物质的销毁性处理
US11679084B2 (en) 2019-08-09 2023-06-20 Nopioid, Llc Method and compositions for rendering opioids safe

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