US20070116647A1 - Medicinal preparation particularly for the treatment of slipped discs hernias - Google Patents

Medicinal preparation particularly for the treatment of slipped discs hernias Download PDF

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Publication number
US20070116647A1
US20070116647A1 US10/513,592 US51359203A US2007116647A1 US 20070116647 A1 US20070116647 A1 US 20070116647A1 US 51359203 A US51359203 A US 51359203A US 2007116647 A1 US2007116647 A1 US 2007116647A1
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United States
Prior art keywords
preparation
ethanol
compound
treatment
ethylcellulose
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
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US10/513,592
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English (en)
Inventor
Jacques Theron
Marc d'Aboville
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Individual
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Individual
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Publication of US20070116647A1 publication Critical patent/US20070116647A1/en
Assigned to THERON, JACQUES reassignment THERON, JACQUES ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: D'ABOVILLE, COME PHILIPPE GUY (ON BEHALF OF MARC D'ABOVILLE, DECEASED), D'ABOVILLE, CHRISTINE MARIE JOSEPH (ON BEHALF OF MARC D'ABOVILLE (DECEASED), D'ABOVILLE, CHRISTINE MARIE JOSEPH (ON BEHALF OF MICHEL SEVERIN D'ABOVILLE, A MINOR, ON BEHALF OF MARC D'ABOVILLE, DECEASED), D'ABOVILLE, QUENTIN BRUNNO PIERRE (ON BEHALF OF MARC D'ABOVILLE, DECEASED), D'ABOVILLE, SOLINE ALIX MARIE (ON BEHALF OF MARC D'ABOVILLE, DECEASED)
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/04—X-ray contrast preparations
    • A61K49/0409—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
    • 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
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the invention concerns a viscous injectable medicinal preparation containing ethanol and a compound opaque to X-rays.
  • Discal hernias are the main causes of back pains and sciaticas. They are usually related to multiple ergonomic and anatomic factors such as poor posture, abdominal and paraspinal muscle weakness, etc.
  • nucleolysis enzymatic alteration of an intervertebral disc
  • absolute alcohol anhydrous ethanol
  • sclerosis of the ganglia and nerves has been used as an effective therapeutic agent in many interventional procedures such as sclerosis of the ganglia and nerves; ablation of liver tumours and kidney tumours; preoperative treatment for vertebral tumours; arteriovenous, peripheral, visceral and brain malformations, etc.
  • the use of alcohol in the treatment of hepato-cellular tumours can cause thrombosis of the portal vein by diffusion of the product into the venous system.
  • One of the applicant's objectives is to avoid the side effects of ethanol in this disorder, in other words necrosis of healthy tissues which occurs as a result of diffusion at a distance from the target as well as to reinforce effectiveness.
  • an injectable medicinal preparation which comprises at least one compound used to make the preparation viscous, ethanol and at least one compound making said preparation opaque to X-rays in order to manage its administration and action.
  • viscosity limits diffusion of the preparation to a specific area and reinforces its therapeutic effect.
  • This preparation thus has the dual advantage of offering an active principle with limited diffusion and a marker to be able to better monitor injection as the therapist performs the procedure and, most importantly, for post-treatment monitoring of the exact location of the injected product with the aid of a scanner.
  • the compounds used to make the preparation opaque to X-rays can be inert compounds such as tungsten oxide or tantalum oxide.
  • These compounds can be added for example in powder form either at the end of the preparation manufacturing process or immediately prior to injection.
  • Ethylcellulose was selected as the compound (excipient) used to achieve the required viscosity. This choice is based on several criteria:
  • the preparation according to the invention fulfils the required criteria which are safety of use in all phases of the process and the ability to produce stable and selective sclerosis.
  • FIG. 1 represents measurement of viscosity expressed in pharmaceutical units as a function of concentration given as the percentage of ethylcellulose weight with respect to total weight;
  • FIG. 2 represents measurement of viscosity expressed in pharmaceutical units as a function of temperature given in degrees Celsius.
  • ethylcellulose is used at a concentration ranging from 0.5 to 15%, preferably 5.88%, by weight of the preparation's total weight.
  • the preparation was manufactured in three stages: gel preparation, aseptic distribution and sterilisation of the product in the final packaging.
  • the excipient ethylcellulose
  • the mixture was stirred and refluxed for 15 minutes then stirred until it cooled down completely in order to allow recondensation of the alcohol in the flask. It was then packaged under a horizontal laminar flux hood into 5 mL sterile bottles (bioblock 42065).
  • the bottles were sterilised in a autoclave using saturated vapour at 121° C. for 20 minutes.
  • the final step in the manufacturing process of the preparation is the addition of a powdered opacifying compound such as tantalum oxide or tungsten oxide in varying proportions so as to obtain good opacity.
  • a powdered opacifying compound such as tantalum oxide or tungsten oxide in varying proportions so as to obtain good opacity. This addition can take place either at the end of the manufacturing process prior to packaging or just before carrying out the injection.
  • the conformity of the preparation was verified by means of a sterility test and chemical and physico-chemical tests.
  • Alcohol content was determined after dilution of a sample and incorporation of the internal standard, propanol-1, by gas chromatography with detection by flame ionisation. Separation was by means of a Porapak Q column (80-100 mesh, length 3 m) with nitrogen as the carrier gas (1.2 bar) on a Delsi DN200 apparatus. The alcohol assay gave a value of 802 g.L ⁇ 1 .
  • the specific assay for the viscosity additive was not performed but the concentration was estimated by means of the dry residues method, a process which consists in evaporating ethanol in a tank whose temperature was maintained at 110° C. until the sample reached constant weight.
  • the dry residues method allowed a correlation to be made between the theoretical ethylcellulose concentration and the experimentally measured concentration, that is 5.88% by weight of the sample's total weight.
  • the viscosity of the preparation was measured by means of a Baumé capillary viscosimeter (Prolabo). Several series of measurements were performed at different temperatures and different concentrations of the thickener. The viscosity measurements showed that, at constant temperature, the preparation increased exponentially as a function of ethylcellulose content ( FIG. 1 ). However, it decreased, also exponentially, when the temperature increased ( FIG. 2 ).

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Massaging Devices (AREA)
US10/513,592 2002-05-07 2003-05-07 Medicinal preparation particularly for the treatment of slipped discs hernias Abandoned US20070116647A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR02/05819 2002-05-07
FR0205819A FR2839450B1 (fr) 2002-05-07 2002-05-07 Preparation medicamenteuse notamment pour le traitement des hernies discales
PCT/FR2003/001412 WO2003097108A1 (fr) 2002-05-07 2003-05-07 Preparation medicamenteuse notamment pour le traitement des hernies discales

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2003/001412 A-371-Of-International WO2003097108A1 (fr) 2002-05-07 2003-05-07 Preparation medicamenteuse notamment pour le traitement des hernies discales

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/870,258 Division US8153696B2 (en) 2002-05-07 2010-08-27 Medicinal preparation particularly for the treatment of slipped discs hernias

Publications (1)

Publication Number Publication Date
US20070116647A1 true US20070116647A1 (en) 2007-05-24

Family

ID=29286406

Family Applications (3)

Application Number Title Priority Date Filing Date
US10/513,592 Abandoned US20070116647A1 (en) 2002-05-07 2003-05-07 Medicinal preparation particularly for the treatment of slipped discs hernias
US12/870,258 Expired - Fee Related US8153696B2 (en) 2002-05-07 2010-08-27 Medicinal preparation particularly for the treatment of slipped discs hernias
US13/681,175 Abandoned US20130143970A1 (en) 2002-05-07 2012-11-19 Medicinal preparation particularly for the treatment of slipped discs hernias

Family Applications After (2)

Application Number Title Priority Date Filing Date
US12/870,258 Expired - Fee Related US8153696B2 (en) 2002-05-07 2010-08-27 Medicinal preparation particularly for the treatment of slipped discs hernias
US13/681,175 Abandoned US20130143970A1 (en) 2002-05-07 2012-11-19 Medicinal preparation particularly for the treatment of slipped discs hernias

Country Status (15)

Country Link
US (3) US20070116647A1 (el)
EP (1) EP1503803B1 (el)
CN (1) CN100402020C (el)
AT (1) ATE402719T1 (el)
AU (1) AU2003262617A1 (el)
CA (1) CA2498976C (el)
CY (1) CY1108413T1 (el)
DE (1) DE60322530D1 (el)
DK (1) DK1503803T3 (el)
ES (1) ES2309334T3 (el)
FR (1) FR2839450B1 (el)
HK (1) HK1081849A1 (el)
PT (1) PT1503803E (el)
SI (1) SI1503803T1 (el)
WO (1) WO2003097108A1 (el)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2839450B1 (fr) * 2002-05-07 2006-04-07 Aboville Marc D Preparation medicamenteuse notamment pour le traitement des hernies discales
FR2891461B1 (fr) * 2005-09-30 2010-09-03 Jacques Theron Preparation medicamenteuse visqueuse injectable comprenant de l'ethanol et un compose liposoluble opaque aux rayons x.
EP3679140B1 (en) 2017-09-08 2022-11-16 MiNA Therapeutics Limited Stabilized cebpa sarna compositions and methods of use
TW201920669A (zh) 2017-09-08 2019-06-01 英商美納治療公司 ＨＮＦ４ａ ｓａＲＮＡ組成物和使用方法
EP4017539A1 (en) 2019-08-19 2022-06-29 MiNA Therapeutics Limited Oligonucleotide conjugate compositions and methods of use
CN117222405A (zh) * 2021-03-04 2023-12-12 苏州医本生命科技有限公司 一种含乙醇的药物组合物及其用途

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2162028A (en) * 1938-06-25 1939-06-13 Pittsburgh Plate Glass Co Cellulose ether coating composition
US2903396A (en) * 1957-05-08 1959-09-08 Ciba Pharm Prod Inc Therapeutic compositions and method for treating parkinsonism
US5177056A (en) * 1987-08-21 1993-01-05 Ciba-Geigy Corporation Plastics composition containing superconductors
US5830178A (en) * 1996-10-11 1998-11-03 Micro Therapeutics, Inc. Methods for embolizing vascular sites with an emboilizing composition comprising dimethylsulfoxide
US6015541A (en) * 1997-11-03 2000-01-18 Micro Therapeutics, Inc. Radioactive embolizing compositions
US6150022A (en) * 1998-12-07 2000-11-21 Flex Products, Inc. Bright metal flake based pigments
US20020115904A1 (en) * 2001-02-21 2002-08-22 Brooke Ren Magnetically controllable embolic materials
US6476070B2 (en) * 1997-09-11 2002-11-05 Provasis Therapeutics Inc. Compositions useful for remodeling body spaces

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02157029A (ja) * 1988-12-09 1990-06-15 Dainippon Pharmaceut Co Ltd アニオン系界面活性剤含有組成物の安定化
EP1180051A4 (en) * 1999-05-21 2004-06-30 Micro Therapeutics Inc METHODS FOR EMBOLIZING BLOOD VESSELS WITH AN EMBOLIZING CONNECTION
JP5148030B2 (ja) * 1999-05-21 2013-02-20 タイコ ヘルスケア グループ リミテッド パートナーシップ 新規の高粘度塞栓形成組成物
US6355058B1 (en) * 1999-12-30 2002-03-12 Advanced Cardiovascular Systems, Inc. Stent with radiopaque coating consisting of particles in a binder
FR2839450B1 (fr) * 2002-05-07 2006-04-07 Aboville Marc D Preparation medicamenteuse notamment pour le traitement des hernies discales

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2162028A (en) * 1938-06-25 1939-06-13 Pittsburgh Plate Glass Co Cellulose ether coating composition
US2903396A (en) * 1957-05-08 1959-09-08 Ciba Pharm Prod Inc Therapeutic compositions and method for treating parkinsonism
US5177056A (en) * 1987-08-21 1993-01-05 Ciba-Geigy Corporation Plastics composition containing superconductors
US5830178A (en) * 1996-10-11 1998-11-03 Micro Therapeutics, Inc. Methods for embolizing vascular sites with an emboilizing composition comprising dimethylsulfoxide
US6476070B2 (en) * 1997-09-11 2002-11-05 Provasis Therapeutics Inc. Compositions useful for remodeling body spaces
US6015541A (en) * 1997-11-03 2000-01-18 Micro Therapeutics, Inc. Radioactive embolizing compositions
US6150022A (en) * 1998-12-07 2000-11-21 Flex Products, Inc. Bright metal flake based pigments
US20020115904A1 (en) * 2001-02-21 2002-08-22 Brooke Ren Magnetically controllable embolic materials

Also Published As

Publication number Publication date
CN1665546A (zh) 2005-09-07
US20130143970A1 (en) 2013-06-06
FR2839450A1 (fr) 2003-11-14
WO2003097108A1 (fr) 2003-11-27
CA2498976A1 (fr) 2003-11-27
CY1108413T1 (el) 2014-02-12
DK1503803T3 (da) 2008-11-10
EP1503803A1 (fr) 2005-02-09
CN100402020C (zh) 2008-07-16
EP1503803B1 (fr) 2008-07-30
FR2839450B1 (fr) 2006-04-07
ATE402719T1 (de) 2008-08-15
CA2498976C (fr) 2011-09-06
HK1081849A1 (en) 2006-05-26
DE60322530D1 (de) 2008-09-11
ES2309334T3 (es) 2008-12-16
PT1503803E (pt) 2008-10-16
AU2003262617A1 (en) 2003-12-02
US20100329991A1 (en) 2010-12-30
US8153696B2 (en) 2012-04-10
SI1503803T1 (sl) 2008-12-31

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AS Assignment

Owner name: THERON, JACQUES, FRANCE

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:D'ABOVILLE, CHRISTINE MARIE JOSEPH (ON BEHALF OF MARC D'ABOVILLE (DECEASED);D'ABOVILLE, SOLINE ALIX MARIE (ON BEHALF OF MARC D'ABOVILLE, DECEASED);D'ABOVILLE, COME PHILIPPE GUY (ON BEHALF OF MARC D'ABOVILLE, DECEASED);AND OTHERS;REEL/FRAME:019774/0203;SIGNING DATES FROM 20050625 TO 20050725

STCB Information on status: application discontinuation

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