FR2546066A1 - Process for the manufacture of a dose of sterile gel for echography - Google Patents
Process for the manufacture of a dose of sterile gel for echography Download PDFInfo
- Publication number
- FR2546066A1 FR2546066A1 FR8308665A FR8308665A FR2546066A1 FR 2546066 A1 FR2546066 A1 FR 2546066A1 FR 8308665 A FR8308665 A FR 8308665A FR 8308665 A FR8308665 A FR 8308665A FR 2546066 A1 FR2546066 A1 FR 2546066A1
- Authority
- FR
- France
- Prior art keywords
- gel
- echography
- manufacture
- sterile
- dose
- 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.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims abstract description 11
- 238000004519 manufacturing process Methods 0.000 title abstract description 3
- 229920000642 polymer Polymers 0.000 claims abstract description 4
- 230000001954 sterilising effect Effects 0.000 claims abstract description 4
- 239000007864 aqueous solution Substances 0.000 claims abstract 2
- 239000000243 solution Substances 0.000 claims abstract 2
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- 238000002604 ultrasonography Methods 0.000 claims description 6
- 229920002521 macromolecule Polymers 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 239000002253 acid Substances 0.000 claims description 2
- 230000003472 neutralizing effect Effects 0.000 claims description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 claims 2
- 239000011707 mineral Substances 0.000 claims 2
- 230000002378 acidificating effect Effects 0.000 claims 1
- 239000000470 constituent Substances 0.000 claims 1
- 238000009459 flexible packaging Methods 0.000 claims 1
- 230000001476 alcoholic effect Effects 0.000 abstract description 2
- 239000000499 gel Substances 0.000 description 7
- 238000006386 neutralization reaction Methods 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 150000001412 amines Chemical class 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 2
- 229920000178 Acrylic resin Polymers 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000936 Agarose Polymers 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000002542 deteriorative effect Effects 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 238000005886 esterification reaction Methods 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- YLGXILFCIXHCMC-JHGZEJCSSA-N methyl cellulose Chemical compound COC1C(OC)C(OC)C(COC)O[C@H]1O[C@H]1C(OC)C(OC)C(OC)OC1COC YLGXILFCIXHCMC-JHGZEJCSSA-N 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 150000007530 organic bases Chemical class 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/42—Details of probe positioning or probe attachment to the patient
- A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
- A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
- A61K49/222—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by a special physical form, e.g. emulsions, liposomes
- A61K49/226—Solutes, emulsions, suspensions, dispersions, semi-solid forms, e.g. hydrogels
-
- 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Physics & Mathematics (AREA)
- Chemical & Material Sciences (AREA)
- Radiology & Medical Imaging (AREA)
- Acoustics & Sound (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Surgery (AREA)
- Pathology (AREA)
- Medical Informatics (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Dispersion Chemistry (AREA)
- Cosmetics (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
La présente invention concerne la réalisation de doses stériles à usage unique pour échographie
Ce type de produit n'existe pas actuellement.The present invention relates to the production of sterile single-use doses for ultrasound
This type of product does not currently exist.
L'échographie médicale est une technique médicale permett l'instauration de certains diagnostics par la propriété qu'ont ondes ultrasonores d'être réfléchies par certains organes ou tissus. Ces ondes ultrasonores traversent les milieux#aqueux s altération mais sont fortement modifiées par leur passage au travers d'une mince couche d'air. Aussi, il est d'usage d'empl une solution fluide assurant une continuité entre la peau et 1 sonde émettrice-réceptrice d'ultrasons. Medical ultrasound is a medical technique allowing the establishment of certain diagnoses by the property that ultrasonic waves have of being reflected by certain organs or tissues. These ultrasonic waves pass through the deteriorating aqueous media but are greatly modified by their passage through a thin layer of air. Also, it is customary to use a fluid solution ensuring continuity between the skin and 1 ultrasound transmitter-receiver probe.
Les utilisateurs utilisent des gels obtenus le plus souve par des macromolécules d'origine naturelle ( agarose, cellulos modifiée : Tylose ) ou des macromolécules synthétiques comme d résines acryliques. C'est ainsi qu'on trouve sur le marché des gels acryliques obtenus par neutralisation de la résine acide par une base organique. Ces gels n'existent qu'en gros conditi nement ( à partir de 200 g. ). Il n'est pas possible de les pr enter dans certains conditionnements souples en matière plasti du fait de l'attaque par les amines basiques du plastique. Users use gels most often obtained by macromolecules of natural origin (agarose, modified cellulos: Tylose) or synthetic macromolecules such as acrylic resins. This is how we find on the market acrylic gels obtained by neutralization of the acid resin with an organic base. These gels are only available in bulk (from 200 g.). It is not possible to enter them in certain flexible plastic packaging due to the attack by the basic amines of the plastic.
D'autre part il n'est paz possible de les stériliserw caest ail qu'il n'éxiste pas de produit stérile permettant de réaliser de actes médicaux en milieu aseptique ( ponctions piqûres...) à travers ces gels sous echographe. Les gels neutralisés par les amines, stabilisés par l'méthanol ne sont pas stérilisables par
-l'oxyde d'éthylène : non pénétration du gaz dans la tota:
de la masse et temps de desorbtion trop long.On the other hand, it is not possible to sterilize them because it does not exist a sterile product allowing medical procedures to be carried out in an aseptic environment (puncture punctures, etc.) through these gels under an ultrasound system. Amine neutralized gels stabilized by methanol cannot be sterilized by
- ethylene oxide: non-penetration of gas into the tota:
too long mass and desorbtion time.
- L'irradiationg ou e : modifications des macromolécules:
pontage ou rupture des macromolécules entralnant des moc
fications des caractères rhéologiques du gel.- Irradiationg or e: modifications of the macromolecules:
bridging or rupture of macromolecules entrainant moc
fications of the rheological characteristics of the gel.
- La chaleur : distillation de l'alcool ou de l'amine neut
lisanteavec réactions d'esterification qui rendent la mc
romolécule partiellement insoluble dans l'eau.- Heat: distillation of alcohol or neutral amine
reading with esterification reactions that make mc
romolecule partially insoluble in water.
Nous décrivons ci-après un procédé utilisable pour obteni un gel hydroalcooliquue à titre d'exemple non limitatif. We describe below a process which can be used to obtain a hydroalcoholic gel by way of nonlimiting example.
L'attaque de l'emballage est évitez par l'emploi d'une base min comme agent neutralisant. Celle -ci est ajoutéede te manière q le pH final de la solution soit compris entre 6,5 et 7,5. Attack on the packaging is avoided by using a min base as a neutralizing agent. This is added so that the final pH of the solution is between 6.5 and 7.5.
La stérilisation est conduite sur le produit avant adjonction
de la partie alcoolisée. Cette adjonction peut être réalisée soit
avant la neutralisation, soit après la neutralisation.Sterilization is carried out on the product before addition
of the alcoholic part. This addition can be carried out either
before neutralization, or after neutralization.
A titre d'exemple -Carbomère de P.M. 3 000 000 ( Carbopol 940 Po ) en solution
aqueuse à 0,84 %.As an example - PM 3,000,000 (Carbopol 940 Po) carbon solution
0.84% aqueous.
-Stérilisation à chaud de cette solution, refroidissement.-Hot sterilization of this solution, cooling.
adjonction d'une quantité d'ethanol pur telle que le titre final
de la solution soit de 200. La concentration du polymère sera
alors de 0,5% environ.addition of a quantity of pure ethanol such as the final titer
of the solution is 200. The concentration of the polymer will be
then about 0.5%.
-débullage et neutralisation par ane solution d'hydroxyde de soude
en quantité suffisante pour un pH de 7.- deburring and neutralization with a sodium hydroxide solution
in sufficient quantity for a pH of 7.
-Conditionnement stérile en dose unitaire souple. - Sterile packaging in flexible unit dose.
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR8308665A FR2546066A1 (en) | 1983-05-20 | 1983-05-20 | Process for the manufacture of a dose of sterile gel for echography |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR8308665A FR2546066A1 (en) | 1983-05-20 | 1983-05-20 | Process for the manufacture of a dose of sterile gel for echography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| FR2546066A1 true FR2546066A1 (en) | 1984-11-23 |
Family
ID=9289171
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FR8308665A Pending FR2546066A1 (en) | 1983-05-20 | 1983-05-20 | Process for the manufacture of a dose of sterile gel for echography |
Country Status (1)
| Country | Link |
|---|---|
| FR (1) | FR2546066A1 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0531421A1 (en) * | 1990-06-01 | 1993-03-17 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US5236609A (en) * | 1989-05-03 | 1993-08-17 | Chas F Thackray Limited | Sterilizable lubricant |
| US5420176A (en) * | 1990-06-01 | 1995-05-30 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| FR2770402A1 (en) * | 1997-11-05 | 1999-05-07 | Pierre Cohen | Ultrasound-conducting gel with antimicrobial activity |
| US5948387A (en) * | 1990-06-01 | 1999-09-07 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4323077A (en) * | 1980-03-12 | 1982-04-06 | General Electric Company | Acoustic intensity monitor |
-
1983
- 1983-05-20 FR FR8308665A patent/FR2546066A1/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4323077A (en) * | 1980-03-12 | 1982-04-06 | General Electric Company | Acoustic intensity monitor |
Non-Patent Citations (2)
| Title |
|---|
| CHEMICAL ABSTRACTS, vol. 61, no. 11, 23 novembre 1964, colonne 13126, point g, Columbus Ohio (US) * |
| CHEMICAL ABSTRACTS, vol. 79, no. 26, 31 décembre 1973, résumé no. 149311r, page 181, Columbus Ohio (US) * |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5236609A (en) * | 1989-05-03 | 1993-08-17 | Chas F Thackray Limited | Sterilizable lubricant |
| EP0531421A1 (en) * | 1990-06-01 | 1993-03-17 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| EP0531421A4 (en) * | 1990-06-01 | 1993-08-18 | Evan C Unger | Contrast media for ultrasonic imaging |
| US5420176A (en) * | 1990-06-01 | 1995-05-30 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US5639442A (en) * | 1990-06-01 | 1997-06-17 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US5714528A (en) * | 1990-06-01 | 1998-02-03 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US5714529A (en) * | 1990-06-01 | 1998-02-03 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US5948387A (en) * | 1990-06-01 | 1999-09-07 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| US6024939A (en) * | 1990-06-01 | 2000-02-15 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
| FR2770402A1 (en) * | 1997-11-05 | 1999-05-07 | Pierre Cohen | Ultrasound-conducting gel with antimicrobial activity |
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