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EP0948363A1 - Emplatre extremement souple a effet dermique ou transdermique et son procede de production - Google Patents

Emplatre extremement souple a effet dermique ou transdermique et son procede de production

Info

Publication number
EP0948363A1
EP0948363A1 EP97951945A EP97951945A EP0948363A1 EP 0948363 A1 EP0948363 A1 EP 0948363A1 EP 97951945 A EP97951945 A EP 97951945A EP 97951945 A EP97951945 A EP 97951945A EP 0948363 A1 EP0948363 A1 EP 0948363A1
Authority
EP
European Patent Office
Prior art keywords
carried out
foreign substance
skin
adhesive
open surface
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.)
Withdrawn
Application number
EP97951945A
Other languages
German (de)
English (en)
Inventor
Reinhard Von Kleinsorgen
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP0948363A1 publication Critical patent/EP0948363A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/44—Medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/50—Lubricants; Anti-adhesive agents

Definitions

  • the present invention relates to an extremely flexible, dermally or transdermally acting plaster for the controlled delivery of active substances to human or animal skin, which consists of a pressure-sensitive adhesive layer containing the active substance or substances, which removes their pressure-sensitive adhesive properties on the side facing away from the skin was, as well as a process for its preparation.
  • TTS transdermal therapeutic systems
  • TDS transdermal delivery systems
  • sachet or reservoir plasters the so-called matrix plasters.
  • matrix plasters the plasters consist of a flat bag or sachet containing the active ingredient, the side of which facing away from the skin is impermeable and the side facing towards the skin is designed as a control membrane which is coated with an adhesive for adhesion to the skin.
  • EP 0 285 563 describes e.g. B. a transdermal therapeutic system or patch this Type for the combined application of estrogens and progestogens.
  • plasters are very complicated since the active ingredient has to be microencapsulated and homogeneously distributed in order to then be embedded between the backing layer and the membrane.
  • the patch must be provided with an edge sticking to the skin and covered with a protective layer.
  • Matrix systems or plasters generally consist of a backing layer which is impermeable to the active ingredient, facing away from the skin, and an adhesive layer in which the active ingredient is distributed. To protect the adhesive layer, it is provided with an adhesive protective film that must be removed before application.
  • DE-OS 20 06 969 e.g. describes such a system in which contraceptive substances are incorporated into the adhesive components or the adhesive film. From this document it can be seen that the adhesive film can be an acrylate.
  • a disadvantage of known bag, reservoir, or matrix systems or plasters is a necessary thickness due to the manufacturing process, which adversely affects flexibility.
  • the flexibility of the system or plaster has a direct impact on its wearing properties, because the required comfort increases with decreasing thickness and decreases with increasing thickness.
  • the present invention is based on the object of specifying a method for producing an extremely flexible, dermally or transdermally acting plaster, which is provided with preferred wearing comfort, which completely dispenses with a separate backing layer and is consequently thinner and more flexible and, as a result of reduced expenditure in the production, a more cost-effective one Alternative to the previous systems.
  • the plaster according to the invention in contrast to conventional systems or plasters, is suitable for permanent application even to difficult parts of the body, e.g. in the area of the ear, in the genital area or on toenails and fingernails.
  • a preferred and exemplary embodiment of a plaster according to the invention is constructed as follows: It consists of a support layer, a pressure-sensitive adhesive part with a non-pressure-sensitive surface of an active substance-containing matrix and a removable protective layer.
  • the protective layer is removed and the plaster is applied to the application site with the aid of the support layer in such a way that the pressure-sensitive adhesive side faces the skin, and the support layer is then removed from the non-adhesive side.
  • All the methods that change the surface structure can be used to remove the superficial adhesive strength of pressure-sensitive adhesive layers: a) by changing the molecular bond of the pressure-sensitive adhesive system in the surface itself
  • Solid particles with a particle size in the range of 0.5-20 ⁇ m which are either spherical or platelet-shaped.
  • Starch flours or layered silicates such as bentonite or mica may be mentioned as an example.
  • the crucial factor is the powdery nature of these particles, which facilitate even application.
  • Liquid media which, after application a) physically form a liquid, semi-solid or solid film by themselves - (eg silicone oil, fats, aqueous acrylate dispersions or polymer solutions), b) form a new interface by chemical crosslinking.
  • a) physically form a liquid, semi-solid or solid film by themselves - eg silicone oil, fats, aqueous acrylate dispersions or polymer solutions
  • the pressure-sensitive adhesive matrix layer can be made of polymers such as hydroxypropyl cellulose, hydroxypropyl ethyl cellulose, polyvinyl pyrrolidone, vinyl pyrrolidone-vinyl acetate copolymer 60:40, ethyl cellulose, acrylic and methacrylic acid ester copolymers with trimethylammonium methyl acrylate, copolymers of dirnethylamino methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, methacrylic acid methacrylic acid, and methacrylic acid methacrylate , Hydroxypropyl ethyl cellulose phthalate, polymers of methacrylic acid and methacrylic acid esters,
  • plasticizers inevitably results from the required flexibility of the film.
  • the following may be added or applied as further substances to supplement a film to be crosslinked: acrylic- and / or methacrylic-modified polysiloxanes with a high content of non-polar methyl groups, which contain at least one reactive terminal acrylic and / or methacrylic acid group, furthermore mono-, bi- and trifunctional acrylic or methacrylic acid esters.
  • Perfluoroalkyl or perfluoroalkenyl groups containing vinyl or epoxy compounds or epoxy polysiloxanes are also suitable.
  • Suitable powdery substances are, in particular, additives of Si0 2 , zinc stearate, mica, bismuth oxychloride, titanium dioxide, magnesium oxide, talc, magnesium stearate and other metal salts of fatty acids, furthermore triglycerides and the color pigments used especially in decorative cosmetics.
  • the surface of the PSA matrix layer containing the active ingredient that is turned away from the skin can also be deactivated, for example by the powdery foreign substances listed above, after application to the skin.
  • active ingredient in connection with the present invention is understood to mean organic and inorganic chemical substances which can migrate out of the constituents of the device according to the invention containing them and thereby produce a desired therapeutic or cosmetic effect.
  • the areas of application of the plaster according to the invention are human - and veterinary medicine and the application to plants of particular importance.
  • the active ingredients to be dispensed are preferably used for the dermal treatment of local skin diseases, the intra- and transdermal treatment of diseases, and for wound treatment or skin care in cosmetic preparations.
  • Local anesthetics local antibiotics, antiseptics, antimycotics, antihistamines and antipruritic drugs, keratolytics and caustic drugs, antivirals, anti-cabbage drugs, steroids, as well as various substances for the treatment of acne, psoriasis, pre-cancerous diseases, light dermatoses are used for the dermal treatment of local skin diseases.
  • the active substances that are administered intradermally include, for example, steriodal and non-steroidal anti-inflammatory drugs, local anesthetics, blood circulation-promoting substances or vasoprotectors and constrictors for the treatment of vascular diseases as well as active substances for influencing processes in the subcutaneous fatty tissue.
  • transdermally administered active ingredients include, for example, analgesics, anti-arrhythmic drugs, narcotics and their antagonists, neuroleptics, "hormones or hormone substitutes, antidepressants, tranquilizers, hypnotics, psychostimulants, anti-Parkinson agents, ganglionic blockers, Sympatomimetics, alpha-sympatholytics, beta-sympatholytics, antisympathotonics, anti-asthetics, antie etika, appetite suppressants, diuretics or active ingredients for weight loss etc.
  • analgesics include, for example, analgesics, anti-arrhythmic drugs, narcotics and their antagonists, neuroleptics, "hormones or hormone substitutes, antidepressants, tranquilizers, hypnotics, psychostimulants, anti-Parkinson agents, ganglionic blockers, Sympatomimetics, alpha-sympatholytics, beta-sympath
  • Preferred active substances are steroids such as estradiol, estriol, progesterone, norethisterone, norethindrone, levonorgestrel and their derivatives as well as ethynodiol diacetate, norgestamate, gestadene, desogestrel, demegestrone, promegestrone, testosterone, hydro ⁇ ortisone and their derivatives; Nitro compounds such as amyl nitrate, nitrogylcerin, isosorbide dinitrate; Amine compounds such as nicotine, chlorpheniramine, terfenadine and triprolidine; Oxicam derivatives such as Piroxica; Mucopolysaccharidases such as thiomucase; Opioids such as buprenorphine, morphine, fentanyl and their salts, derivatives or analogs, naloxone, codeine, dihydroergotamine, lysergic acid derivatives, pizotilin, salbutamol,
  • hemostatic agents and wound cleansing agents such as enzymes, antiseptics, disinfectants and antibiotics, analgesics and anesthetic agents as well as agents that promote wound healing are used to stimulate granulation, to induce vascularization or to promote epithelialization.
  • the patch for the delivery of estradiol can also be used on chronic wounds, for example ulcera cruris, for wound treatment.
  • the adhesive contains Layer a eutectic mixture of the local anesthetics lidocaine and prilocaine.
  • a eutectic mixture of the local anesthetics lidocaine and prilocaine With this mixture of active substances, an effect can be achieved both in intradermal analgesia prior to venipunctures, for example, and in the treatment of rheumatoid arthritis, which cannot be achieved with the commonly used active substances and combinations of active substances from the group of topical anesthetics.
  • the film layer contains herbal preparations such as extracts or tinctures.
  • herbal preparations such as extracts or tinctures. These can be used for the treatment of local skin diseases, such as, for example, oak bark extract, walnut extract, arnica flower tincture, Haelelis bark extract, ribwort extract, pansy extract, thyme or sage extract, for the treatment of damaged and damaged skin, such as St. John's wort tincture,
  • Chamomile flower extract or marigold flower tincture as well as for the care of stressed and damaged skin, such as birch leaf extract, nettle extract, coltsfoot extract, comfrey tincture, horsetail extract or aloe vera extract.
  • Herbal preparations can also be dispensed from the film layer for intradermal treatment of diseases such as horse chestnut and butcher's broom extracts for venous disorders, or arnica, marigold and capsicum extracts and tinctures for bruises, sprains or bruises.
  • Herbal preparations in the system according to the invention can, however, also be used in transdermal therapy, for example ginsin extract for old age complaints, valerian tincture, lemon balm and hop extract for calming overexcitement, sleep disorders and stress, cola and tea extracts to achieve a stimulating effect or hawthorn extract for stabilizing the circulation.
  • Another particular embodiment relates to the use of the plaster according to the invention as a carrier of narcotics, psychotropic drugs and agents for the treatment of Alzheimer's disease and senile dementia. These highly potent drugs require a system with guaranteed wearing properties over several days.
  • Methacrylic acid copolymer 5.0 g of wench ethyl phthalate 0.25 g
  • the laminate obtained passes through a spray tunnel in which magnesium stearate powder is sprayed onto the surface of the pressure-sensitive adhesive layer (matrix). Magnesium stearate powder not adhering to the surface of the matrix layer is removed by a polishing roller.
  • Transdermal therapeutic plasters are punched out of this laminate obtained in this way, consisting of a protective layer, powder-sprayed polymer matrix and support layer, using known methods.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne un procédé permettant de produire un emplâtre extrêmement souple à effet dermique ou transdermique, comportant une couche matricielle adhésive contenant un principe actif, qui est pourvue, sur son côté faisant face à la peau, d'une couche de protection séparable. Ledit procédé se caractérise en ce que la couche matricielle n'est pas recouverte sur son côté opposé à la peau mais que l'on fait en sorte que sa surface ouverte ne soit pas adhésive.
EP97951945A 1996-12-27 1997-11-21 Emplatre extremement souple a effet dermique ou transdermique et son procede de production Withdrawn EP0948363A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19654468 1996-12-27
DE19654468A DE19654468C1 (de) 1996-12-27 1996-12-27 Extrem flexibles, dermal oder transdermal wirkendes Pflaster und Verfahren zu seiner Herstellung
PCT/EP1997/006530 WO1998029143A1 (fr) 1996-12-27 1997-11-21 Emplatre extremement souple a effet dermique ou transdermique et son procede de production

Publications (1)

Publication Number Publication Date
EP0948363A1 true EP0948363A1 (fr) 1999-10-13

Family

ID=7816286

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97951945A Withdrawn EP0948363A1 (fr) 1996-12-27 1997-11-21 Emplatre extremement souple a effet dermique ou transdermique et son procede de production

Country Status (9)

Country Link
US (1) US6299899B1 (fr)
EP (1) EP0948363A1 (fr)
JP (1) JP2001506637A (fr)
KR (1) KR20000062348A (fr)
AU (1) AU738678B2 (fr)
CA (1) CA2275769A1 (fr)
DE (1) DE19654468C1 (fr)
NO (1) NO993155D0 (fr)
WO (1) WO1998029143A1 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19829713C1 (de) * 1998-07-03 2000-01-05 Lohmann Therapie Syst Lts Therapeutisches System mit Zusatz von Perglanzpigmenten
CN1198603C (zh) 1998-08-20 2005-04-27 3M创新有限公司 形成绷带和药物输递系统的喷雾液体
DE19923551A1 (de) * 1999-05-21 2000-11-30 Lohmann Therapie Syst Lts Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht
SI1299104T1 (sl) 2000-02-08 2009-10-31 Euro Celtique Sa Oralne formulacije opioidnih agonistov, varne pred zlorabo
DE20005402U1 (de) 2000-03-22 2000-07-20 Schilling Johann Georg Mittel zur äußerlichen Behandlung von Hautrötungen und Schuppenflechten
DE10056014A1 (de) * 2000-11-11 2002-05-16 Beiersdorf Ag Mehrschichtige Trägerkonstruktion für wirkstofhaltige Pflastersyteme
DE50310279D1 (de) * 2002-03-06 2008-09-18 Hexal Ag Transdermalsystem mit fentanyl
DE10211832A1 (de) * 2002-03-16 2003-10-02 Lohmann Therapie Syst Lts Hormonhaltiges transdermales therapeutisches System mit einem Wirkstoffreservoir auf der Basis von Vinylacetat-Vinylpyrrolidon-Copolymer mit verbesserter Kohäsion
DE10237057A1 (de) * 2002-08-09 2004-03-25 Grünenthal GmbH Opioid-Rezeptor-Antagonisten in Pflasterformulierungen
US20040147534A1 (en) * 2003-01-23 2004-07-29 Foote Mary Ann Topical composition and method for treating occlusive wounds
MY141815A (en) 2003-04-30 2010-06-30 Purdue Pharma Lp Tamper-resistant transdermal dosage form comprising an active agent component and an adverse agent component at the distal site of the active agent layer
US8790689B2 (en) 2003-04-30 2014-07-29 Purdue Pharma L.P. Tamper resistant transdermal dosage form
ITMI20042111A1 (it) * 2004-11-04 2005-02-04 Biofarmitalia Spa Cerotto contenenti una sostanza scelta tra i catrami aventi caratteristiche riducenti in dermatologia
US20070264487A1 (en) * 2006-05-12 2007-11-15 Dean Georgiades Treated film strips
CN114425104B (zh) * 2021-12-21 2023-03-03 中国人民解放军空军军医大学 一种载药骨引导/诱导复合结构及其制备方法和应用

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JPS5911563B2 (ja) * 1980-02-27 1984-03-16 日本原子力研究所 多層構造の徐放性複合体を製造する方法
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Also Published As

Publication number Publication date
AU738678B2 (en) 2001-09-27
JP2001506637A (ja) 2001-05-22
AU5554798A (en) 1998-07-31
DE19654468C1 (de) 1998-01-22
NO993155L (no) 1999-06-24
US6299899B1 (en) 2001-10-09
NO993155D0 (no) 1999-06-24
WO1998029143A1 (fr) 1998-07-09
CA2275769A1 (fr) 1998-07-09
KR20000062348A (ko) 2000-10-25

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