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US20070190105A1 - Local system for the release of active principle and process for its manufacture - Google Patents

Local system for the release of active principle and process for its manufacture Download PDF

Info

Publication number
US20070190105A1
US20070190105A1 US11/620,172 US62017207A US2007190105A1 US 20070190105 A1 US20070190105 A1 US 20070190105A1 US 62017207 A US62017207 A US 62017207A US 2007190105 A1 US2007190105 A1 US 2007190105A1
Authority
US
United States
Prior art keywords
polymerisation
polymethyl methacrylate
paste
release
local 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.)
Abandoned
Application number
US11/620,172
Other languages
English (en)
Inventor
Klaus-Dieter Kuhn
Sebastian Vogt
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.)
Kulzer GmbH
Original Assignee
Heraeus Kulzer 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 Heraeus Kulzer GmbH filed Critical Heraeus Kulzer GmbH
Assigned to HERAEUS KULZER GMBH reassignment HERAEUS KULZER GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: VOGT, SEBASTIAN, KUHN, KLAUS-DIETER
Publication of US20070190105A1 publication Critical patent/US20070190105A1/en
Priority to US12/949,260 priority Critical patent/US8758827B2/en
Abandoned 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/20—Extrusion means, e.g. for producing pharmaceutical forms
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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

Definitions

  • the object of the invention is a locally effective system for the release of active principle which system consists of approximately spherical or rotation symmetrical bodies which are composed essentially of polymethyl methacrylate or polymethyl methacrylate co-methyl acrylate, zirconium dioxide or barium sulphate and one or more pharmaceutical active principles.
  • Osteomyelitis can be hematogenous, post-traumatic or postoperative. Particularly difficult to treat is the chronic form of osteomyelitis which, in extreme cases, can lead to the loss of limbs and even to septicaemia.
  • a common method is surgical remediation by radical surgical debridement. During this procedure, the infected or necrotic bone is excised extensively. Subsequently, the bone cavity is filled with a local carrier of antibiotics or treated by repeated rinse-suction drainage. As a result of the local release of large quantities of antibiotics, the bacterial germs remaining in the adjacent bone areas, too, are effectively controlled when using a sufficiently bone-accessible bactericidal antibiotic such as gentamicin sulphate and clindamycin hydrochloride.
  • a sufficiently bone-accessible bactericidal antibiotic such as gentamicin sulphate and clindamycin hydrochloride.
  • this active principle carrier it was proposed by Heuser and Dingeldein in 1978, to add glycine or other amino acids to improve the release of the antibiotic (DE 26 51 441). Following contact with the discharge from the wound, the incorporated amino acids are dissolved and form pore systems from which the active principle is able to diffuse out. In this way an improved release of active principle is achieved.
  • Gentamicin is an antibiotic which is extremely thermally stable. In view of the increasing spread of resistant and, in particular, multi-resistant bacteria, however, further antibiotics are desirable in local systems for the release of active principle. Unfortunately, these antibiotics, such as vancomycin and teicoplanin are thermally unstable. As a result, it has not been possible so far to produce local systems for the release of active principle with these antibiotics by injection moulding.
  • EP 796 712 An alternative in this respect is suggested in EP 796 712, according to which it is possible to produce implant materials using thermally labile active principles.
  • a conventional PMMA bone cement is mixed with one or several antibiotics and transferred into corresponding moulds made of plastic, for example.
  • Conventional PMMA bone cements consist of a powder component—composed of a polymer powder, an opaquer for x-ray beams and a polymerisations initiator—and a liquid monomer component containing methyl methacrylate, a stabilisator and a polymerisation activator. After mixing both components, the polymerisation activator and the polymerisation initiator meet each other and radical polymerisation of the methyl methacrylate is initiated.
  • the invention is based on the object of developing a locally effective system for the release of active principle which can be produced continuously.
  • the production process is to make it possible to integrate also thermally labile antibiotics into the systems for the release of active principle.
  • the disadvantages of the processes described in DE 23 20 373 and EP 796 712 are to be overcome.
  • the object has been achieved by developing a local system for the release of active principle which system consists of spherical bodies which are composed essentially of polymethyl methacrylate or polymethyl methacrylate co-methyl acrylate, zirconium dioxide or barium sulphate and a pharmaceutical active principle and which are produced by radical polymerisation, radical polymerisation activators effective in the temperature range of 10-80° C. or residues of such polymerisation activators, in particular from the groups of aromatic amines, heavy metal salts and barbiturates not being contained therein.
  • system for the release of active principle according to the invention does not contain N,N-dimethyl aniline, N,N-dimethyl-p-toluidine, N,N,-bis-hydroxyethyl-p-toluidine or their consequential products formed during the initiation of radical polymerisation.
  • the invention also relates to a process for the production of the local active principle system in the case of which
  • Heating can be effected e.g. by the effect of infrared radiation or by the effect of hot air or by the effect of microwaves.
  • Thermally decomposing radical initiators which the expert would consider as commonly used are in particular those from the group consisting of dibenzoyl peroxide, dilauroyl peroxide and azoisobutyrodinitrile.
  • a wire is preferably used which is preheated to a temperature in the region of the de-composition temperature of the thermal initiator.
  • the injection moulding tool is preferably made of Teflon or another inert plastic.
  • approximately spherical bodies with a diameter of 7 mm are injection moulded by means of an injection moulding device on a polyfilic, surgical steel wire. The spray moulding process takes place at room temperature. Subsequently, the bodies are hardened in a dryer tunnel at a temperature of 80° C.
  • the bodies formed have a mass of ⁇ 240 mg.
  • a paste of 570.0 g of polymethyl methacrylate co-methyl acrylate (molecular weight 800,000 g/mole), 285.0 g of methyl methacrylate, 89.0 g of zirconium dioxide, 45.0 g of vancomycin hydrochloride, 8.8 g of a mixture of dibenzoyl peroxide and water in a weight ratio of 3:1 and 15.0 g of glycine is produced by intense mixing.
  • approximately spherical bodies with a diameter of 7 mm are injection moulded by means of an injection moulding device on a polyfilic, surgical steel wire. Immediately afterwards, the bodies are hardened continually with a heating radiator while the injection-moulded bodies are heated to 60-70° C. by the effect of IR radiation and polymerisation is initiated.
  • the cured bodies have a mass of ⁇ 240 mg.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Transplantation (AREA)
  • Organic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Communicable Diseases (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
US11/620,172 2006-02-10 2007-01-05 Local system for the release of active principle and process for its manufacture Abandoned US20070190105A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/949,260 US8758827B2 (en) 2006-02-10 2010-11-18 Local system for the release of active principle and process for its manufacture

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006006510.7 2006-02-10
DE102006006510A DE102006006510A1 (de) 2006-02-10 2006-02-10 Lokales Wirkstofffreisetzungssystem und ein Verfahren zu seiner Herstellung

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/949,260 Division US8758827B2 (en) 2006-02-10 2010-11-18 Local system for the release of active principle and process for its manufacture

Publications (1)

Publication Number Publication Date
US20070190105A1 true US20070190105A1 (en) 2007-08-16

Family

ID=38080014

Family Applications (2)

Application Number Title Priority Date Filing Date
US11/620,172 Abandoned US20070190105A1 (en) 2006-02-10 2007-01-05 Local system for the release of active principle and process for its manufacture
US12/949,260 Expired - Fee Related US8758827B2 (en) 2006-02-10 2010-11-18 Local system for the release of active principle and process for its manufacture

Family Applications After (1)

Application Number Title Priority Date Filing Date
US12/949,260 Expired - Fee Related US8758827B2 (en) 2006-02-10 2010-11-18 Local system for the release of active principle and process for its manufacture

Country Status (9)

Country Link
US (2) US20070190105A1 (de)
EP (1) EP1818039B1 (de)
JP (1) JP4686488B2 (de)
CN (1) CN101015697B (de)
AU (1) AU2007200072B2 (de)
BR (1) BRPI0700258A (de)
CA (1) CA2572764A1 (de)
DE (1) DE102006006510A1 (de)
ZA (1) ZA200701174B (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110112210A1 (en) * 2008-06-30 2011-05-12 Heraeus Medical Gmbh Pmma paste

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007052116B4 (de) * 2007-10-22 2013-02-21 Heraeus Medical Gmbh Einkomponenten-Knochenzementpasten, deren Verwendung und Verfahren zu deren Aushärtung
DE102007050762B3 (de) * 2007-10-22 2009-05-07 Heraeus Medical Gmbh Pastenförmiger Polymethylmethacrylat-Knochenzement und seine Verwendung
DE102008030312A1 (de) * 2008-06-30 2010-01-14 Heraeus Medical Gmbh PMMA-Paste
CA2797904C (en) * 2011-12-20 2015-01-27 Heraeus Medical Gmbh Paste-like bone cement
DK2664349T3 (en) * 2012-05-16 2016-05-02 Heraeus Medical Gmbh BONE LETTER IN PASTAFORM

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3882858A (en) * 1973-04-21 1975-05-13 Merck Patent Gmbh Surgical synthetic-resin material and method of treating osteomyelitis
US4191740A (en) * 1976-11-11 1980-03-04 Merck Patent Gesellschaft Mit Beschrankter Haftung Synthetic resin-base, antibiotic compositions containing amino acids
US4782118A (en) * 1985-06-20 1988-11-01 Ceraver, S.A. Cement for fixing a bone prosthesis
US5958465A (en) * 1996-02-22 1999-09-28 Merck Patent Gesellschaft Apparatus for the production of drug-containing implants in the form of strings of beads
US6160033A (en) * 1996-08-22 2000-12-12 Merck Patent Gesellschaft Mit Beschrankter Haftung Process for producing bone cement containing active substances
US20040109894A1 (en) * 2002-12-09 2004-06-10 Adi Shefer PH triggered targeted controlled release systems for the delivery of pharmaceutical active ingredients
US6759449B2 (en) * 2000-11-28 2004-07-06 Tokuyama Dental Corporation Dental adhesive composition

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US616033A (en) * 1898-12-13 sturcke
DE2651441C2 (de) * 1976-11-11 1987-01-08 Merck Patent Gmbh, 6100 Darmstadt Antibioticahaltiges Mittel
DE2917037C2 (de) * 1979-04-27 1980-12-11 Josef Dipl.-Chem. Dr. 8000 Muenchen Gaensheimer Parenteral arzneimittelhaltige partiell resorbierbare Mehrkomponentenmasse auf Basis von polymeren Stoffen
EP0061108B1 (de) * 1981-03-19 1986-12-30 mundipharma GmbH Knochenimplantat aus Tricalciumphosphat mit mikro-und makroporöser Struktur, Verfahren zu seiner Herstellung und seiner Verwendung
US5286791A (en) * 1992-05-29 1994-02-15 Himont Incorporated Impact modified graft copolymer compositions containing broad molecular weight distribution polypropylene
KR0139235B1 (ko) * 1994-01-29 1998-04-28 조세현 정형외과용 세멘트 비드조성물 및 그의 제조방법
US5968999A (en) * 1997-10-28 1999-10-19 Charlotte-Mecklenburg Hospital Authority Bone cement compositions

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3882858A (en) * 1973-04-21 1975-05-13 Merck Patent Gmbh Surgical synthetic-resin material and method of treating osteomyelitis
US4191740A (en) * 1976-11-11 1980-03-04 Merck Patent Gesellschaft Mit Beschrankter Haftung Synthetic resin-base, antibiotic compositions containing amino acids
US4782118A (en) * 1985-06-20 1988-11-01 Ceraver, S.A. Cement for fixing a bone prosthesis
US5958465A (en) * 1996-02-22 1999-09-28 Merck Patent Gesellschaft Apparatus for the production of drug-containing implants in the form of strings of beads
US6160033A (en) * 1996-08-22 2000-12-12 Merck Patent Gesellschaft Mit Beschrankter Haftung Process for producing bone cement containing active substances
US6759449B2 (en) * 2000-11-28 2004-07-06 Tokuyama Dental Corporation Dental adhesive composition
US20040109894A1 (en) * 2002-12-09 2004-06-10 Adi Shefer PH triggered targeted controlled release systems for the delivery of pharmaceutical active ingredients

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110112210A1 (en) * 2008-06-30 2011-05-12 Heraeus Medical Gmbh Pmma paste

Also Published As

Publication number Publication date
CN101015697A (zh) 2007-08-15
US8758827B2 (en) 2014-06-24
JP4686488B2 (ja) 2011-05-25
AU2007200072A1 (en) 2007-08-30
CN101015697B (zh) 2012-05-23
DE102006006510A1 (de) 2007-08-23
ZA200701174B (en) 2008-07-30
EP1818039B1 (de) 2013-07-31
US20110062637A1 (en) 2011-03-17
EP1818039A2 (de) 2007-08-15
AU2007200072B2 (en) 2009-09-10
CA2572764A1 (en) 2007-08-10
EP1818039A3 (de) 2012-07-04
JP2007209763A (ja) 2007-08-23
BRPI0700258A (pt) 2007-11-06

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Legal Events

Date Code Title Description
AS Assignment

Owner name: HERAEUS KULZER GMBH, GERMANY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KUHN, KLAUS-DIETER;VOGT, SEBASTIAN;REEL/FRAME:018912/0658;SIGNING DATES FROM 20070116 TO 20070118

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION