WO2009083263A2 - Système de transport, de distribution et/ou actif en administration aseptique - Google Patents

Système de transport, de distribution et/ou actif en administration aseptique Download PDF

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Publication number
WO2009083263A2
WO2009083263A2 PCT/EP2008/011155 EP2008011155W WO2009083263A2 WO 2009083263 A2 WO2009083263 A2 WO 2009083263A2 EP 2008011155 W EP2008011155 W EP 2008011155W WO 2009083263 A2 WO2009083263 A2 WO 2009083263A2
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WO
WIPO (PCT)
Prior art keywords
collagen
transport
active
layer
osteoinductive
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/EP2008/011155
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German (de)
English (en)
Other versions
WO2009083263A3 (fr
Inventor
Arne Briest
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.)
Ossacur AG
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Ossacur AG
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Filing date
Publication date
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Publication of WO2009083263A2 publication Critical patent/WO2009083263A2/fr
Publication of WO2009083263A3 publication Critical patent/WO2009083263A3/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
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0028—Polypeptides; Proteins; Degradation products thereof
    • A61L26/0033—Collagen
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0066—Medicaments; Biocides
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0085—Porous materials, e.g. foams or sponges
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/009—Materials resorbable by the body
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures

Definitions

  • the invention relates to a transport, transfer and / or active system, which, inter alia, has a nonwoven fabric, its use, a process for its preparation and an aseptic dosage form of the system.
  • Biomaterials in the form of polymers as carrier materials for the controlled in vivo release of drugs or other active substances have been intensively researched for some time.
  • Such systems usually consist of substantially spherical, polymeric matrices (microparticles) as carrier materials which contain an active ingredient which is intended to be released at a defined point in the body of a patient in a time-controlled manner.
  • polyurethanes are preferably used when it comes to uses in which the highest possible elasticity is required, polysiloxanes are used because of their insulating or shielding properties, polymethyl (meth) acrylates stand for material strength and transparency, Polyvinyl alcohols show a pronounced hydrophilic property and strength, polyethylenes are characterized for certain applications by their resilience and their lack of swelling power and polyvinylpyrrolidones are used because of their good suspensibility.
  • polylactide PLA
  • polyglycolidene PGA
  • polylactide-co-glycolide PLGA
  • polyanhydride polyorthoester-based excipients
  • Active substances which are to be transported in combination with such bioresorbable polymers to specific locations in a body can be of diverse nature. These include e.g. Medicines, such as analgesics, antibiotics, cytostatics and / or anticoagulants, to name a few groups of drugs. Another field of application is in the field of osteoinductive or chondroinductive agents.
  • carrier materials are of importance, which are implanted at the site of the damaged bone, cartilage or organ, which allow the immigration of required for the healing process cells and possibly also specify a structure that facilitate the bone, cartilage or organ regeneration or the structure of the same , and then but after a certain time of the body degraded, ie be metabolized.
  • the research of carrier materials, including the development of new carriers or the improvement of existing systems, has in this area commonly found under the name Tissue Engineering entrance into the professional world.
  • Denture implants of this type serve to replace missing bones or bone areas and to stabilize fractures. They themselves are unable to form bones. The missing or defective bone area must be regenerated on its own. This often requires too much time for convalescence or bone regeneration is limited.
  • US-A-4,950,483 discloses a porous collagen matrix for wound healing consisting of uncrosslinked collagen fibers. This wound healing matrix may also serve to release a synergistic combination of the growth factors FGF and TGF- ⁇ . This supports and accelerates the body's own healing process.
  • the object of the present invention was therefore to provide a transport, transfer and / or active system which can be used in a variety of ways to deliver medicaments or other active substances in vivo to a location in the
  • it is capable of promoting and inducing bone formation in an organism by supplementing a targeted selection of one or more active substances, thereby providing a structure, which for a defined
  • Period of time can be used in the area of the bone defect.
  • a transport, transfer and / or active system with a layer or sandwich structure which has a nonwoven fabric as a builder, is incorporated into the collagen for forming the layer and / or is attached to the collagen for forming the sandwich structure, and that is at least partially bioresorbable, wherein at least one of the surfaces of the transport, transfer and / or active system has a substantially porous surface.
  • the carrier system and thus the transport, transfer and / or active system according to the invention preferably have at least one porous surface.
  • Such a system allows z. B. the delayed release of drugs such. B. of different drugs.
  • Active ingredients and / or active pharmaceutical ingredients are not only transported to the desired site of action in the organism, but additionally released there in a targeted manner.
  • the system according to the invention provides not only for the
  • Transfer system may, for. B. in an application in the field of
  • Osteogenesis the penetration of necessary for bone growth cells from the environment in which it has been implanted, allow and thus provide a framework for bone (re) education.
  • the property of the system according to the invention as an effective system to bear.
  • the name of the system according to the invention as a transport, transfer and / or active system takes into account the fact that its special
  • Embodiment allows both the transport of drugs of all kinds in an organism, as well as their release and thus their transmission to specific, selected sites in an organism allowed, then depending on the nature of the selected drug or the selected drugs and / or drugs a partially longer ongoing interaction between the invention
  • the transport, transfer and / or active system according to the invention can also serve as a local supplier of analgesics. As such, it may be used exclusively or additionally in conjunction with a bone or skin rejuvenation system or other active system.
  • the nonwoven fabric of the transport, transfer and / or active system preferably comprises fibers which are selected from cellulose, polyester, polyacrylonitrile, optionally in combination with at least one superabsorber or as a combination of two or more of said components.
  • cellulose fibers is to be understood very comprehensively. It comprises pulp-based fibers such as viscose. As part of the present
  • suitable materials are in addition to the viscose but also includes products that have become known under the name of nanocellulose, here in particular as bacterially synthesized cellulose under the trade name BASYC of Jenpolymers.
  • Other fibers made of cellulose and made from natural pulp can also be modal, tencel or lyocell fibers.
  • the nonwoven fabric is a nonwoven based on cellulose and polyester fibers, in particular viscose and polyester fibers.
  • the nonwoven fabric is a nonwoven based on viscose and polyacrylonitrile fibers, optionally in combination with a superabsorber.
  • said nonwoven fabric based on viscose and polyacrylonitrile fibers has the capability of a particularly high liquid absorption, measured with respect to water as a liquid at least 5000 g / qm, preferably also more than 5400 g / qm, is.
  • the collagen of the transport, transfer and / or active system according to the invention is preferably selected from type I collagen. Also to be mentioned as advantageous collagens are those of type II, III, V and XI, all of which are known as so-called fibrillar collagens.
  • the system according to the invention contains, in addition to other active substances, a medicament which is selected from the group of analgesics, antibiotics, cytostatics, anticoagulants or mixtures thereof.
  • a medicament which is selected from the group of analgesics, antibiotics, cytostatics, anticoagulants or mixtures thereof.
  • the transport, transfer and / or active system according to the invention additionally has at least one osteoinductive or chondroinductive active ingredient, it can be used as a
  • the osteoinductive or chondroinductive active ingredient may be selected from at least one of the differentiation and / or growth factors of the TGF- ⁇ superfamily, and more preferably selected from the group of Bone Morphogenic Protein (BMP), in which case the growth factors BMP-7 , BMP-2 and BMP-4 are to be emphasized.
  • BMP Bone Morphogenic Protein
  • the selected osteoinductive or chondroinductive active ingredients may preferably be prepared recombinantly.
  • the agent according to the invention can optionally also contain at least one drug which may be selected, for example, from the group of analgesics, antibiotics, cytostatics, anticoagulants or mixtures thereof.
  • the system according to the invention proves to be a combined transport, transfer and active system and proves to be particularly effective in order to ensure a release of active ingredient delayed over a specific time interval or a delayed release of active substance such as drug release.
  • the system according to the invention proves to be a combined transport, transfer and active system and proves to be particularly effective in order to ensure a release of active ingredient delayed over a specific time interval or a delayed release of active substance such as drug release.
  • it also has the special ability to serve as a delivery system with triggered drug release.
  • the transport, transfer and / or active system according to the invention can not only additionally have at least one osteoinductive or chondroinductive active ingredient, it can also be provided to use a precursor thereof in the form of a gene-activated material. Intracellular protein synthesis is then initiated by locally applying one or more genes, specifically BMP-2 and BMP-7 encoding plasmids.
  • the transport, transfer and / or active system according to the invention has a double-layer structure and very particularly preferably has a sandwich structure.
  • the double-layeredness proves to be important with regard to the periosteum.
  • This outermost layer of the bone which has mainly protective and nutritional function for the bone, is extremely thin, while well-supplied with blood and supplied with many nerve endings. It is also known that bone fracture healing originates from this periosteum.
  • one side of the transport, transfer and / or active system which preferably consists of the nonwoven, faces this periosteum, while the other side of the double-layered system faces outwards and thus has an outer surface Demarcation and separation of the various components from the environment on the one hand and the release of the active substance or substances, such as the bone or cartilage-forming agent on the other hand allows.
  • the fleece of the sandwich structure thus formed acts as a membrane, as an interface or partially permeable barrier, which serves as a shield for soft tissue ingrowth, for example.
  • the surface of the transport, transfer and / or active system which is preferably porous on both sides of the flat nonwoven fabric and thus at least partially permeable, serves on the one hand for the transfer of cells to the place where the new bone formation is to take place and on the other hand serves for a delayed release of the active ingredient. to stimulate new bone formation over a longer period of time.
  • it also represents a barrier between the two different fabrics, namely the nonwoven fabric and the bone tissue.
  • the nonwoven fabric also acts as a separating layer, as mentioned above, it secures the system according to the invention in its capacity as an active system. a protected place for undisturbed and therefore efficient new bone formation.
  • the invention therefore also relates to the use of the transport, transfer and / or active system, which has at least one osteoinductive or chondroinductive active ingredient, as a bone inducing agent.
  • the bone formation stimulating effect of the system of the present invention can be targeted to a predetermined site of action over a predetermined period of time.
  • the invention also relates to a method for the production of said transport, transfer and / or active system according to one of its embodiments according to the invention, wherein the collagen consists of a natural one
  • the quality of the forming pore structure can be controlled by the choice of the temperature during freeze-drying and the speed during cooling down. The faster the temperature drops and the further it is cooled down, the more uniform pores are formed.
  • the directional pore structure is obtained by setting a defined temperature gradient.
  • the transport, transfer and / or active system is to have a drug or another active substance, according to one embodiment of the method according to the invention before precipitation, such a drug or another active substance is added by mixing.
  • a Colyophil may deleted it.
  • the active ingredient is preferably selected from at least one osteoinductive or chondroinductive agent, drug or mixtures thereof.
  • a further variant is that initially the collagen is mixed with the at least one osteoinductive or chondroinductive active substance and applied and subsequently in a further step at least one drug is applied to the carrier system of the transport, transfer and / or active system.
  • a multilayer system can be obtained as a sandwich structure.
  • the medicament for example, which is preferably an antibiotic.
  • various drugs are applied to the respective different surfaces of the carrier system of the transport, transfer and / or active system.
  • a drug species preferably mixed with the collagen and the osteoinductive or chondroinductive agent and the other drug species, eg the antibiotic, applied to the other surface.
  • the other drug species eg the antibiotic
  • the invention also relates to a transport, transfer and / or active system whose features according to the invention have already been described above, in the form of an aseptic administration.
  • the system or carrier system is in a container, which in turn is closed by means of a plastic film molding in the form of a membrane-like film.
  • the film acts as a sterile barrier, so that the introduced under sterile conditions in the container transport, transfer and / or active system is protected from damaging external influences in the form of bacterial or other contaminants.
  • said film used for the closure of the container is vapor diffusion open.
  • the container is preferably a visual packaging, which is also referred to as blister.
  • This blister package may be bonded to the plastic film molding in the form of a weld to form a weld package. Then, the plastic film molding is welded to the edges of the opening provided for filling the container.
  • the plastic material of the membranous film is a polyolefin, a combination of polyolefins or a combination of one
  • Polyolefin formed with another polymer As a particularly preferred
  • Plastic material is high density polyethylene (HDPE) or polytetrafluoroethylene (PTFE), preferably called expanded PTFE (ePTFE).
  • PTFE membranes are known by the name "Gore-Tex”.
  • the plastic material of the membrane-like film is selected from a PE spunbonded nonwoven, preferably from a HDPE spunbonded nonwoven.
  • HDPE membrane films are commercially available under various trademarks "Tyvek.” Tyvek films are tear-resistant, puncture-resistant, high-abrasion and chemical-resistant, and are made from very fine interwoven fibers that are heat and pressure bonded. In general, they are easy to process, which is very much in accordance with the purpose of the present invention.As compared to PTFE membranes, the HDPE film has the advantage that it is easier to weld, but the water vapor diffusion of the PTFE-made membranes is excellent.
  • the transport, transfer and / or active system preferably additionally contains a drug and / or an osteoinductive or chondroinductive active ingredient.
  • Collagen I is preferably used as the main constituent of the collagen suspension, which is obtained starting from tendons, since they have a particularly high proportion of collagen I.
  • skin can also be used as a starting material for collagen production.
  • the tendons (alternatively the skin) of a young cattle, the tendons (or its skin layer) are cleaned and optionally freed from epidermal components.
  • the starting material is then with Chloroform / methanol degreased 1: 1, deep-frozen in liquid nitrogen and ground in a freezer mill to a particle size of 400-1000 microns.
  • bovine bone is used for the preparation of the collagen suspension. Then the procedure is as described for the bovine tendon or skin. However, this is followed by a demineralization step by treatment with about 0.1 N hydrochloric acid.
  • the tendons or the skin or bone particles are then dried under high vacuum at about 0.05 Torr with cooling, suspended in a 4 M aqueous solution of guanidinium chloride and stirred for about 12 hours at room temperature.
  • the soluble fraction obtained therefrom contains the desired collagen which, in a further step, is mixed with the desired active ingredients and then precipitated in a suitable manner.
  • a commercially available collagen may also be used, e.g. sold under the name "Vitrogen 100".
  • the collagen solution thus prepared is then treated with a recombinantly produced osteoinductive agent and BMP-7 is used as such an osteoinductive agent. Furthermore, an antibiotic is added to the solution.
  • the solution or suspension obtained in this way is then applied to a nonwoven fabric prepared in suitable size, the fibers of which are made of viscose and polyester and which are used as dry nonwoven under the name "Vilmed Ml 550 Basis". from Freudenberg Nonwovens KG in Weinheim, Germany.
  • the nonwoven fabric has a thickness of about 2.9 mm and a weight of about 150 g / m 2.
  • the amount of applied solution or suspension of collagen with active ingredients is just chosen so that after the subsequent freeze-drying results in an accumulation of the collagen mixed with the active ingredients, which leads to the formation of a coating of the web.
  • Freeze-drying also produces pores whose size and structure can be varied and adjusted by a specific temperature setting during freeze-drying. In the present case, undirected, uneven pores are preferred.
  • the freeze-drying is therefore carried out by targeted adjustment of a temperature gradient down to -30 ° C. Basically, experiments were carried out at an interval of -20 ° C to -50 ° C.
  • the collagen solution becomes an osteoinductive agent
  • the nonwoven fabric After lyophilization, the nonwoven fabric has a porous structure with a coating of collagen, BMP-7 and / or BMP-2.
  • a bilayer is made as a sandwich by first adding the collagen solution or suspension comprising BMP-7 and / or BMP-2 to the web and then freeze-drying. Subsequently, a further antibiotic is applied aseptically as a further surface.
  • nonwoven fabric a fiber system of viscose, polyacrylonitrile and a superabsorbent was chosen as the nonwoven fabric.
  • This is also a dry nonwoven, which is also available from Freudenberg Nonwovens KG in Weinheim, Germany, under the name "Vilmed M66 / 031.”
  • This nonwoven is characterized by a particularly high water absorption capacity of more than 5400 g / sqm. Its thickness is about 1.2 mm and its weight is 270 gsm.
  • the particularly high water storage capacity is particularly preferred in the application provided here.
  • the bone or cartilage growth promoting agent made in accordance with one of the variants described above was placed in a blister pack for use under sterile conditions, and then the blister opening was covered with a membranous film with the edges of the blister welded to the foil were.
  • a membranous film As a membrane-like film on the one hand, an HDPE film was used, which is available under the brand name Tyvek and on the other hand, a PTFE existing film in the form of a Gore-Tex membrane.
  • compositions according to the invention are obtained from the following constituents: Table 1
  • the transport, transfer and / or action system according to the invention is suitable for application to all types of wounds, i. both those that have been surgically generated and those that are caused by a disease.
  • wounds i. both those that have been surgically generated and those that are caused by a disease.
  • the diabetic foot and open wounds of all kinds resulting from deficient circulation should be mentioned here.
  • the transport, transfer and / or action system according to the invention can e.g. also be used on bleeding liver wounds and is by the inventively provided fleece, e.g. in combination with a superabsorber, especially suitable for this application.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Materials Engineering (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Laminated Bodies (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne un système, au moins partiellement biorésorbable, de transport, de distribution et/ou actif, à structure en couche ou sandwich, présentant un matériau non-tissé en tant que matériau de structure, dans lequel du collagène est incorporé pour la formation de la couche, et/ou sur lequel du collagène est lié pour la configuration de la structure sandwich. Au moins l'une des surfaces dudit système de transport, de distribution et/ou actif présente une surface sensiblement poreuse. En outre, un médicament peut être contenu dans ledit système. De plus, le système peut comprendre au moins une substance ostéo-inductice ou chondroï-inductive, telle que, par exemple, l'un des facteurs de différentiation et/ou de croissance de la superfamille TGF β. Le matériau non-tissé comprend des fibres qui sont sélectionnées à partir de fibres de cellulose, telles que viscose, polyester, polyacrylnitrile, éventuellement en combinaison avec un super-absorbeur. L'invention concerne en outre un procédé de production du système, ainsi que le système en tant qu'administration aseptique. A cet effet, le système est logé dans un conteneur qui est fermé au moyen d'une pièce moulée en film de plastique, sous la forme d'un film du type membrane, en tant que barrière stérile.
PCT/EP2008/011155 2007-12-31 2008-12-31 Système de transport, de distribution et/ou actif en administration aseptique Ceased WO2009083263A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200710063395 DE102007063395A1 (de) 2007-12-31 2007-12-31 Transport-, Weitergabe- und/oder Wirksystem in aseptischer Darreichung
DE102007063395.7 2007-12-31

Publications (2)

Publication Number Publication Date
WO2009083263A2 true WO2009083263A2 (fr) 2009-07-09
WO2009083263A3 WO2009083263A3 (fr) 2010-05-27

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WO (1) WO2009083263A2 (fr)

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DE102022119473A1 (de) 2022-08-03 2024-02-08 Universität Rostock, Körperschaft des öffentlichen Rechts Faservliesstoff und Verfahren zur Herstellung eines Faservliesstoffes

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DE3429038A1 (de) * 1984-08-07 1986-02-20 B. Braun Melsungen Ag, 3508 Melsungen Wirkstoff-depot
US4950483A (en) 1988-06-30 1990-08-21 Collagen Corporation Collagen wound healing matrices and process for their production
US5222987A (en) 1989-04-12 1993-06-29 Imperial Chemical Industries Plc Composite material for use in a prosthetic device
DE4404018A1 (de) * 1994-02-09 1995-08-10 Merck Patent Gmbh Protrahiert freisetzende Darreichungsformen enthaltend Clindamycin-Palmitat
DE19503336C2 (de) * 1995-02-02 1998-07-30 Lohmann Therapie Syst Lts Arzneiform zur Abgabe von Wirkstoffen an Wunden, Verfahren zu ihrer Herstellung und ihre Verwendung
TW501934B (en) * 1996-11-20 2002-09-11 Tapic Int Co Ltd Collagen material and process for making the same
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US20060085063A1 (en) * 2004-10-15 2006-04-20 Shastri V P Nano- and micro-scale engineering of polymeric scaffolds for vascular tissue engineering
WO2006106506A2 (fr) * 2005-04-04 2006-10-12 Technion Research & Development Foundation Ltd. Structure medicale d'accrochage, procedes de fabrication et d'utilisation de cette derniere
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DE102006026592A1 (de) * 2005-12-01 2007-06-06 Ossacur Ag Träger mit Colloss

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DE102007063395A1 (de) 2009-07-02

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