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
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/02—Adhesive bandages or dressings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/465—Nicotine; Derivatives thereof
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system

Definitions

• the changes mentioned are usually based on oxidative decomposition processes, which in particular during storage or while wearing the active substance patch on the skin in contact with atmospheric oxygen and moisture progress and can be promoted by exposure to light.
• Pharmaceutical active substances, antioxidants, various enhancers (that is to say substances which support or accelerate the transdermal absorption of active substances) and oxidation-sensitive constituents of the pressure-sensitive adhesive present in the active substance patch, in particular, are affected by such processes.
• the patch may be provided with an opaque backing layer. During the application period, the optical perception of staining or discoloration is prevented by this backing layer.
• One known and commonly used measure in the art is to paint the opaque backing skin-colored.
• Person is the brightness color value of a person with dark, negroid skin color, or vice versa.
• the active substance patches according to the invention which are composed of a matrix and overlying backing layer, are substantially transparent or at least translucent (i.e., translucent), in any case not opaque.
• the backing layer is also substantially transparent or translucent.
• the active ingredient patches according to the invention contain one or more substances from the group of dyes and pigments in at least one of their layers.
• the staining is adequately adapted or adapted to the skin tone of the application site, so that the patch appears unremarkable on a wide variety of skin color types.
• the optical mass is / are the used in the matrix layer or in at least one of the matrix layers of a multi-layer plaster used substance (s) selected from the group of dyes and pigments.
• the optical masking is effected in that the transparent or translucent backing layer has a content of at least one substance selected from the group of dyes and pigments.
• the transparent or translucent backing layer has a content of at least one substance selected from the group of dyes and pigments.
• the backing layer of the plaster on the outside, d. H. on the side facing away from the skin, coated with a coating or a lacquer containing at least one dye and / or at least one color pigment.
• This variant has the additional advantage that the coloring can come into contact neither with the skin nor with the active ingredient-containing matrix.
• both the matrix layer (s) and the backing layer have a content of dye (s) or / and pigment (s).
• a further improvement in the visual appearance of active substance patches applied to the skin can be achieved by providing at least the surface of the back layer facing away from the skin with reduced reflection properties according to a particularly preferred embodiment. This can be done either by physical methods or by applying an antireflective technique or technique. Such a layer or coating preferably contains an optical matting agent or a combination of at least two matting agents. This antireflection layer can at the same time contain dye (s) or / and pigment (s) for masking the contents of the plaster, as described above.
• the matting can also eliminate or mitigate that cause of the visual conspicuity of an active substance patch, which is based on light reflections. Such light reflexes often occur in drug patches, which with a transparent reminds ⁇ hicht with smoother Surface structure are provided.
• the reflection properties of these backing materials are very different from the reflective properties of the human H ⁇ t which is why such a patch on the skin German lent visually noticeable.
• the said active substance patches are transdermal therapeutic systems. These are characterized by the fact that they allow a constant delivery of drugs through the skin over a certain period of time.
• the construction and the production of such systems are generally known to the person skilled in the art.
• the teaching of the present invention enables the production of drug patches which, despite being a colored or discoloring ingredient when worn on the skin, are not readily apparent to an observer and are not visually apparent, regardless of whether the patch is on the skin of a fair-skinned or a dark-skinned person is attached.
• Skin plasters were prepared using the backing layers mentioned under 1. To this was Durotak ® 2052 ((Fa. National Starch & Chemical BV) with a basis weight of 80 g / m 2 streaked with one of the mentioned under 1. backing layers covered. Subsequently, individual patches were each with a size of 1 cm 2 punched out.
• Durotak ® 2052 (Fa. National Starch & Chemical BV) with a basis weight of 80 g / m 2 streaked with one of the mentioned under 1. backing layers covered. Subsequently, individual patches were each with a size of 1 cm 2 punched out.
• the color tones of the color charts are characterized in PowerPoint by the six parameters hue, red, green, blue, saturation, intensity as follows and can be reproduced on the basis of these parameters:
• the color plates Nos. A-H were measured with a "three-range colorimeter CP-320" from Techkon GmbH (DE-61 ⁇ ä62 Königstein). The values (in degrees) for the brightness L, the red-green axis a and the yellow-blue axis b are determined. Ten measurements were made per color chart and the averages were formed. The mean values are shown in Table 2 below.
• the color value of the brightness L varies the most, whereas the a value varies only slightly.
• Test plaster (1 to 8) glued on color plates A to H. These color plates were under standardized conditions (Illumination, distance, observation time) presented to a group of subjects. The number of plasters not perceived by the test persons serves - after statistical analysis of the data - as a measure of the optical conspicuity or the effectiveness of the optical masking of a plaster.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Dermatology (AREA)
• Biomedical Technology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Neurosurgery (AREA)
• Neurology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Cosmetics (AREA)
• Spectrometry And Color Measurement (AREA)
• Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Materials For Medical Uses (AREA)

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Citations (3)

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• 2003
  • 2003-04-17 DE DE10317692A patent/DE10317692A1/de not_active Withdrawn
• 2004
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  • 2004-04-08 US US10/553,708 patent/US10653636B2/en active Active
  • 2004-04-08 PT PT04726478T patent/PT1615628E/pt unknown
  • 2004-04-08 CN CNB2004800102813A patent/CN100450472C/zh not_active Expired - Lifetime
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• 2005
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• 2009
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• 2011
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• 2019
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• 2020
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