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WO2008136699A1 - Patch transdermique à microcapsules et procédé de fabrication correspondant - Google Patents

Patch transdermique à microcapsules et procédé de fabrication correspondant Download PDF

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Publication number
WO2008136699A1
WO2008136699A1 PCT/RU2007/000226 RU2007000226W WO2008136699A1 WO 2008136699 A1 WO2008136699 A1 WO 2008136699A1 RU 2007000226 W RU2007000226 W RU 2007000226W WO 2008136699 A1 WO2008136699 A1 WO 2008136699A1
Authority
WO
WIPO (PCT)
Prior art keywords
microcapsules
patch
transdermal patch
polymer
substrate
Prior art date
Application number
PCT/RU2007/000226
Other languages
English (en)
Russian (ru)
Inventor
Igor Alexandrovich Bazikov
Pavel Anatolyevich Omelyanchuk
Original Assignee
Igor Alexandrovich Bazikov
Pavel Anatolyevich Omelyanchuk
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 Igor Alexandrovich Bazikov, Pavel Anatolyevich Omelyanchuk filed Critical Igor Alexandrovich Bazikov
Priority to PCT/RU2007/000226 priority Critical patent/WO2008136699A1/fr
Publication of WO2008136699A1 publication Critical patent/WO2008136699A1/fr

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
    • 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
    • A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
    • 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
    • A61K9/7092—Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
    • 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
    • A61F2013/00361—Plasters
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00646—Medication patches, e.g. transcutaneous
    • 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
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers
    • A61K9/1273—Polymersomes; Liposomes with polymerisable or polymerised bilayer-forming substances

Definitions

  • the invention relates to medicine, in particular to transdermal therapeutic systems - patches, designed for prolonged delivery of biologically active substances (BAS) through the epidermal barrier.
  • BAS biologically active substances
  • Matrih-ture trapsdertal ratsh for steroid hortopes (WO99 / 66908, 29.12.1999) (Matrix transdermal patch for steroid hormones) in the polymer layer which contains oestradiol solution and 1 to 5% of the activated silicon oxide SiO 2.
  • the disadvantage of the patch is the uneven release of the hormone from the matrix and the insufficiently effective penetration enhancer SiO 2 .
  • the invention is known - a transdermal patch for the introduction of fentanyl (Application 2003127841, 03/27/2005 Bull. No. 9), containing a substrate and a reservoir located on the substrate, the contacting surface of the reservoir is sticky; moreover, the specified reservoir consists of a single-phase polymer composition free of undissolved components containing an amount of fentanyl or its analogue sufficient to cause and maintain analgesia in humans for at least three days.
  • the disadvantage of the above invention is the inconvenience of the practical use of the patch due to its thickness (up to 0.125 mm) and uneven surface.
  • Tank-type plasters Reservvoir ture
  • the most promising model is used - a matrix patch (Matrix tour), in which there is no reservoir
  • the principle of operation of the matrix patch is to create an “exclusive effect”, in which the adhesive layer of the patch is hydrated under the action of water constantly evaporating from the skin surface. Hydration of the stratum corneum allows the large molecules of biologically active substances to be introduced into the dermis.
  • the aim of the invention is the development of a transdermal patch with microencapsulated biologically active substances and the possibility of its production.
  • the patch consists of the following components: substrate 1 (Vakipg lauer), adhesive layer 2 (Adhesive lauer) with microcapsules 3 containing microencapsulated biologically active substances and a protective film 4 (Release liper) ( Figure 1).
  • substrate 1 Vakipg lauer
  • adhesive layer 2 Adhesive lauer
  • microcapsules 3 containing microencapsulated biologically active substances
  • a protective film 4 Release liper
  • Figure 1 Depending on the type of biologically active substances, polymers based on acrylic acid (Rodert ® brand, Roht apd Naas, USA) and silicone elastomers (DC 7-9800 ® brand, Dow Co-pipg, USA) were used as a polymer matrix.
  • the principal difference Rodert ® polymer from DC 7- 9800 ® is the presence of a solvent - ethyl acetate, distilled at which the polymer viscosity increases and the adhesive layer is formed.
  • the polymer DC 7- 9800 ® consists of two parts (Part A: Diethyl silochape, diethyl, test, one of them, one of them, one of them), it’s one, it’s got one, it’s got one, it’s one when two parts are mixed in a 1: 1 ratio, a polymerization reaction occurs and an adhesive layer forms.
  • SUBSTITUTE SHEET (RULE 26) To create lipid microcapsules, phospholipids (phosphatidylcholine, phosphatidylethanolamine, phosphadidylserine, phosphatidylinositol), sphingolipids, sphingophospholipids, sterols and glycerides were used. The amphiphilic properties of these lipids allow the formation of bilayer vesicles - liposomes.
  • One of the microcapsule variants was made from a non-ionic surface-active substance (SAS) of the organosilicon nature PEG-12 Dimethicone (PEG-12 Diethisope) (RF Application JVs 2006128323 dated 08/03/2006).
  • SAS surface-active substance
  • PEG-12 Dimethicone PEG-12 Diethisope
  • the amphiphilic properties of PEG-12 Dimethicone also allow the formation of bilayer vesicles, which are called niosomes.
  • Water-soluble polymers were used as biodegradable polymers: polyvinyl alcohol (ruluvipul alcohol), carboxymethyl cellulose (carbohutethul cellulose), gelatin (gelatip) and polylactide-glycolide polymer (polo-teroluta).
  • the polymer has a lactide glycolide ratio of 1: 1 and a molecular weight of 40000-75000 Da.
  • a method of manufacturing a transdermal patch with microencapsulated biologically active substances (hereinafter referred to as the patch) is carried out on special equipment and consists of the following operations:
  • SUBSTITUTE SHEET (RULE 26) The manufacture of microcapsules is carried out from biodegradable materials, which, when ingested in the deeper layers of the skin, do not adversely affect the human body.
  • microcapsules make it possible to include a wide range of biologically active substances used in medicine: analgesics, antibiotics, antihistamines, contraceptives and painkillers, hormones, immunomodulators, vaccines, extracts of plant and animal origin, as well as their possible combinations.
  • the microcapsules Before introducing into the polymer solution, the microcapsules are lyophilized (remove most of the moisture) to a solids content of at least 90%.
  • the prepared microcapsules with a size of 0.001-50 ⁇ m in an amount of 0.1-50% (mass%) are added to the polymer solution used to form the adhesive layer.
  • microcapsules depends on the type of polymer matrix and the composition of excipients.
  • the use of liposomes in a polymer containing a solvent of ethyl acetate is impossible, due to their destruction in the solvent, therefore, in this case, solvent-resistant niosomes are used. Liposomes are introduced into solvent-free DC 7-9800 ® silicone polymer.
  • excipients were introduced - enhancers (from the English word - strengthen) in the amount of 7-35% (wt.%).
  • Propylene glycol, tetra-glycol, polyvinylpyrrolidone, isopropyl myristate, ethanol, polyethylene glycol monolith were used as enhancers .
  • the mixture was heated under vacuum on a rotary evaporator to remove most of the solvent (ethyl acetate).
  • the mixture was introduced into a glass round bottom flask, and the evaporation process was carried out at a temperature of 40-50 0 C to
  • SUBSTITUTE SHEET (RULE 26) a certain viscosity of the mixture (1000 - 3000 Centipoise), at which it is possible to pour the contents from a glass flask. Vacuum evaporation avoids the formation of bubbles in the polymer matrix. In both types of polymers, heating accelerates the process of increasing the viscosity of the mixture, which leads to an increase in the stickiness of the polymer.
  • the evaporated mixture was deposited on a substrate with a thin layer of up to 150 ⁇ m.
  • the above substrates differ in the degree of occlusivity, that is, the degree of penetration of oxygen through a fixed surface of the material within 24 hours.
  • the choice of material depends on the purpose of the patch and the time of use.
  • the remaining solvent is removed by heating the substrate to 40-55 0 C.
  • a protective film was applied to the substrate with adhesive and lamination was performed to a predetermined thickness of 200-300 ⁇ m.
  • fluoropolymers with a polyester layer were used (Fliooroluter Composit Rolutester fils, Sotscrap ® 1020, 1022, 9741.9742, 9744, ZM Comrap, USA).
  • the resulting tape was sterilized by UV radiation from possible contamination by microorganisms and sent to the cutting of the patches.
  • the size of the patch ranges from 5-60 cm 2 depending on the type of biologically active substances and the necessary therapeutic dose.
  • Cut plasters were packaged in a moisture-proof package to preserve consumer properties.
  • SUBSTITUTE SHEET (RULE 26) The essence of the method is illustrated by a specific example, in which microcapsules include stem cell extract from pig placenta.
  • Stem cell extract from pig placenta (hereinafter referred to as the extract) can be used to replace damaged cells of the skin and mucous membranes.
  • the extract can be used to replace damaged cells of the skin and mucous membranes.
  • Superficial application of the extract of cells from healthy placental tissue of porcine tissue ensures the regeneration and restoration of the epidermis due to the growth factors of keratinocytes, cytokines and other biologically active substances contained in the extract (RF application JVs 2006105864/15 from 02.26.2006.).
  • Microcapsules are prepared on the basis of PEG-12 Dimethicone (PEG-12 Diethisope), which can form bilayer vesicles - niosomes.
  • PEG-12 Dimethicone PEG-12 Diethisope
  • the inclusion of the extract in niosomes is done by adding 4% PEG-12 dimethicone to the extract solution in a separate container. The process is carried out at room temperature and intensive mechanical shaking for 5 minutes. A niosome suspension of 0.001 -5 ohm ⁇ m containing 15% stem cell extract is lyophilized to a solids content of at least 90%.
  • Lyophilized niosomes in an amount of 15% (wt.%) Were introduced into the acrylic polymer Roderm brand ®.
  • SUBSTITUTE SHEET (RULE 26) polymer with a thickness of 120-150 microns. The substrate was heated to 45-50 ° C for 5-10 minutes until complete evaporation of ethyl acetate.
  • the protective film was applied from a fluoropolymer with a layer of polyester (Flororuloter Composite rostester, Shothrask ® 1020) was carried out immediately after evaporation of the solvent and the tape was laminated with adhesive to a thickness of 220-250 ⁇ m.
  • a fluoropolymer with a layer of polyester (Flororuloter Composite rostester, Shothrask ® 1020) was carried out immediately after evaporation of the solvent and the tape was laminated with adhesive to a thickness of 220-250 ⁇ m.
  • the tape was sterilized by UV irradiation for 5 minutes to eliminate possible contamination by microorganisms and sent to cutting the patches.
  • the size of the patch was 30 cm 2 , which provided the necessary therapeutic effect.
  • Cut plasters were packaged in a moisture-proof package to preserve consumer properties.
  • a patch with stem cell extract is used to prevent and treat various skin diseases by improving the regeneration of skin cells.
  • the transdermal route of administration of AB is an alternative to injections and allows you to dose biologically active substances for a long time, providing the necessary therapeutic effect.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne la médecine et notamment des systèmes thérapeutiques transdermiques (des patchs) destinés à l'administration prolongée de matériaux bioactifs à travers la barrière épidermique. Le patch transdermique comprenant un substrat, une bande de protection et une couche polymère dotée de microcapsules dans laquelle sont inclus un matériau bioactif et des agents (des facilitateurs) de pénétration, ainsi que le procédé correspondant, comprennent ce qui suit: a) préparer des microcapsules avec le matériau bioactif; b) préparer une base adhésive avec des microcapsules; c) appliquer la base adhésive au substrat; d) éliminer le solvant (ou effectuer une réaction de polymérisation dans le cas des polymères à catalyser); e) effectuer le laminage; g) effectuer la stérilisation par les rayons UV; h) effectuer le découpage de patchs; i) conditionner le produit dans des emballages étanche à l'humidité.
PCT/RU2007/000226 2007-05-04 2007-05-04 Patch transdermique à microcapsules et procédé de fabrication correspondant WO2008136699A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/RU2007/000226 WO2008136699A1 (fr) 2007-05-04 2007-05-04 Patch transdermique à microcapsules et procédé de fabrication correspondant

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/RU2007/000226 WO2008136699A1 (fr) 2007-05-04 2007-05-04 Patch transdermique à microcapsules et procédé de fabrication correspondant

Publications (1)

Publication Number Publication Date
WO2008136699A1 true WO2008136699A1 (fr) 2008-11-13

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2007/000226 WO2008136699A1 (fr) 2007-05-04 2007-05-04 Patch transdermique à microcapsules et procédé de fabrication correspondant

Country Status (1)

Country Link
WO (1) WO2008136699A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108685879A (zh) * 2018-08-01 2018-10-23 深圳市泛谷药业股份有限公司 一种卡巴拉汀透皮贴及其制备方法
RU2816908C1 (ru) * 2023-06-01 2024-04-08 Василиса Игоревна Шляпкина Трансдермальная терапевтическая система с антигистаминным эффектом и способ её получения

Citations (8)

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Publication number Priority date Publication date Assignee Title
RU2001635C1 (ru) * 1991-06-04 1993-10-30 Соколов Владимир Анатольевич; Цеткин Владислав Алексеевич Медицинска пов зка
RU2044541C1 (ru) * 1989-03-29 1995-09-27 Шеринг Аг Способ получения лечебного средства для трансдермального применения
RU2140784C1 (ru) * 1993-05-06 1999-11-10 ЛТС Ломанн Терапи-Зюстеме ГмбХ унд Ко. КГ Содержащая эстрадиол трансдермальная терапевтическая система
RU2154455C2 (ru) * 1994-02-18 2000-08-20 Шеринг Аг Чрескожные терапевтические системы, содержащие половые стероиды
RU2186579C2 (ru) * 1994-09-30 2002-08-10 ПРО-НЕЙРОН, Инк. Ингибитор пролиферации стволовой клетки и способ его применения
RU2193397C2 (ru) * 1994-11-19 2002-11-27 Квадрант Холдингс Кембридж Лимитед Приготовление полых микрокапсул
WO2005025548A1 (fr) * 2003-09-10 2005-03-24 Dow Corning Corporation Preparations topiques comprenant un excipient hydrophile et une matrice de silicone
RU2254130C2 (ru) * 1999-05-21 2005-06-20 Лтс Ломан Терапи-Системе Аг Фармацевтический препарат с биологически активным веществом диаморфином и его применение в способе лечения опиатомании

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2044541C1 (ru) * 1989-03-29 1995-09-27 Шеринг Аг Способ получения лечебного средства для трансдермального применения
RU2001635C1 (ru) * 1991-06-04 1993-10-30 Соколов Владимир Анатольевич; Цеткин Владислав Алексеевич Медицинска пов зка
RU2140784C1 (ru) * 1993-05-06 1999-11-10 ЛТС Ломанн Терапи-Зюстеме ГмбХ унд Ко. КГ Содержащая эстрадиол трансдермальная терапевтическая система
RU2154455C2 (ru) * 1994-02-18 2000-08-20 Шеринг Аг Чрескожные терапевтические системы, содержащие половые стероиды
RU2186579C2 (ru) * 1994-09-30 2002-08-10 ПРО-НЕЙРОН, Инк. Ингибитор пролиферации стволовой клетки и способ его применения
RU2193397C2 (ru) * 1994-11-19 2002-11-27 Квадрант Холдингс Кембридж Лимитед Приготовление полых микрокапсул
RU2254130C2 (ru) * 1999-05-21 2005-06-20 Лтс Ломан Терапи-Системе Аг Фармацевтический препарат с биологически активным веществом диаморфином и его применение в способе лечения опиатомании
WO2005025548A1 (fr) * 2003-09-10 2005-03-24 Dow Corning Corporation Preparations topiques comprenant un excipient hydrophile et une matrice de silicone

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"Pressure sensitive adhesives. Adhesives and sealants", 2006, pages 1 - 3, Retrieved from the Internet <URL:htp://www.rohmhaas.com/AdhesivesSealants/pdfjnedical/Roderm_581.pdf> *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108685879A (zh) * 2018-08-01 2018-10-23 深圳市泛谷药业股份有限公司 一种卡巴拉汀透皮贴及其制备方法
CN108685879B (zh) * 2018-08-01 2021-06-08 深圳市泛谷药业股份有限公司 一种卡巴拉汀透皮贴及其制备方法
RU2816908C1 (ru) * 2023-06-01 2024-04-08 Василиса Игоревна Шляпкина Трансдермальная терапевтическая система с антигистаминным эффектом и способ её получения

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