FR2814959A1 - Atomiser for pharmaceutical products based on antiinflammatory agents comprises pressurized container, dosing pouch and metering valve - Google Patents
Atomiser for pharmaceutical products based on antiinflammatory agents comprises pressurized container, dosing pouch and metering valve Download PDFInfo
- Publication number
- FR2814959A1 FR2814959A1 FR0100263A FR0100263A FR2814959A1 FR 2814959 A1 FR2814959 A1 FR 2814959A1 FR 0100263 A FR0100263 A FR 0100263A FR 0100263 A FR0100263 A FR 0100263A FR 2814959 A1 FR2814959 A1 FR 2814959A1
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- nozzle
- valve
- pressurized container
- dosing
- spraying
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
- B65D83/44—Valves specially adapted therefor; Regulating devices
- B65D83/52—Valves specially adapted therefor; Regulating devices for metering
- B65D83/54—Metering valves ; Metering valve assemblies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- 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]
Abstract
Description
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NOUVEAU DISPOSITIF DE PULVERISATION POUR FORMES PHARMACEUTIQUES A BASE D'AGENT ANTI-INFLAMMATOIRE ET LES FORMES AINSI REALISEES La présente invention se rapporte au domaine de la chimie thérapeutique et plus particulièrement au domaine de la formulation pharmaceutique. NEW SPRAYING DEVICE FOR PHARMACEUTICAL FORMS BASED ON ANTI-INFLAMMATORY AGENT AND THE FORMS THUS PRODUCED The present invention relates to the field of therapeutic chemistry and more particularly to the field of pharmaceutical formulation.
Elle concerne plus spécifiquement des formes pharmaceutiques liquides contenant un agent anti-inflammatoire, susceptible d'être projetées par pulvérisation sur la zone ou la région nécessitant l'application d'un agent anti-inflammatoire. It relates more specifically to liquid pharmaceutical forms containing an anti-inflammatory agent, capable of being sprayed onto the area or region requiring the application of an anti-inflammatory agent.
L'invention concerne spécifiquement un dispositif de pulvérisation pour préparations pharmaceutiques, qui consiste à répartir une solution à base d'agent anti-inflammatoire dans des bidons propres à la pressurisation, à saturer l'atmosphère existant au-dessus de la phase liquide par injection d'un gaz inerte non miscible à l'eau et à un alcanol, à placer au sommet du bidon une valve obturatrice comportant un bouton poussoir actionnant ladite valve. The invention relates specifically to a spray device for pharmaceutical preparations, which consists in distributing a solution based on anti-inflammatory agent in cans suitable for pressurization, in saturating the atmosphere existing above the liquid phase by injection. of an inert gas immiscible with water and an alkanol, to be placed at the top of the container a shut-off valve comprising a push button actuating said valve.
L'application de produits anti-inflammatoires s'effectue en général sous forme d'une crème, d'un gel, d'un liniment ou d'une pommade sur la zone enflammée. The application of anti-inflammatory products is generally carried out in the form of a cream, gel, liniment or ointment on the inflamed area.
L'application de telles préparations ne nécessite pas de modalités particulières si ce n'est le massage de la région pour assurer un bon étalement de la composition et en outre pour en assurer la pénétration à travers l'épiderme. Cette pénétration nécessite en outre l'addition d'un promoteur qui facilite le passage de la préparation à travers l'épiderme. Sans cela, une fraction très faible de la préparation passe à travers la peau et il en résulte une perte considérable de préparation. The application of such preparations does not require any particular modalities except massaging the region to ensure good spreading of the composition and furthermore to ensure penetration thereof through the epidermis. This penetration also requires the addition of a promoter which facilitates the passage of the preparation through the epidermis. Without it, a very small fraction of the preparation passes through the skin and this results in a considerable loss of preparation.
L'étalement d'une pommade ou d'une crème sur une zone enflammée peut être douloureux en raison de la rubéfaction de cette zone et de la manipulation mécanique plus ou moins énergique rendue nécessaire. Spreading an ointment or cream on an inflamed area can be painful due to the reddening of this area and the more or less energetic mechanical manipulation made necessary.
C'est pourquoi il est apparu souhaitable de procéder différemment à l'administration, par voie topique, des préparations destinées à être appliquées sur des zones This is why it appeared desirable to proceed differently with the administration, by topical route, of the preparations intended to be applied to areas
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articulaires ou tendineuses, douloureuses et/ou enflammées sans qu'il soit nécessaire d'avoir recours à des manipulations physiques. joint or tendon painful and / or inflamed without the need for physical manipulation.
En conséquence il s'est avéré particulièrement intéressant de réaliser des compositions pressurisées à base d'agent anti-inflammatoire et de les pulvériser sur la zone à traiter à une pression suffisante pour que la préparation pulvérisée s'étale sur la totalité de la zone à traiter et pénètre au maximum dans le derme. Consequently, it has been found to be particularly advantageous to produce pressurized compositions based on anti-inflammatory agent and to spray them on the area to be treated at a pressure sufficient for the sprayed preparation to spread over the entire area to be treated. treat and penetrate as much as possible into the dermis.
L'agent anti-inflammatoire selon l'invention est un acide arylacétique et en particulier le Kétoprofène sous forme (R), sous forme (S) ou sous forme (RS). The anti-inflammatory agent according to the invention is an arylacetic acid and in particular Ketoprofen in form (R), in form (S) or in form (RS).
L'agent anti-inflammatoire peut être également sous forme de sel et notamment de sel de métal alcalin ou alcalinoterreux comme un sel de sodium, de potassium, de lithium, de magnésium ou de calcium. Il peut être également sous forme de sel de base organique comme une amine, un aminoalcool, un aminoacide basique ou un sel d'ammonium quaternaire. The anti-inflammatory agent can also be in the form of a salt and in particular of an alkali or alkaline earth metal salt such as a sodium, potassium, lithium, magnesium or calcium salt. It can also be in the form of an organic base salt such as an amine, an amino alcohol, a basic amino acid or a quaternary ammonium salt.
Parmi ceux-ci on citera tout particulièrement les sels de diethylamin, de diethylaminoéthanol, de triethanolamine, de N-méthyl glucamin, de trométhamine, de trométhamol, de lysine, d'arginine, de N-méthyl benzylamine, de pipéridino éthanol, de pyrolidino éthanol, de N-méthyl pipérazine ou bien encore de cétyl pyridinium. Among these, mention will be made most particularly of the salts of diethylamin, diethylaminoethanol, triethanolamine, N-methyl glucamin, tromethamine, tromethamol, lysine, arginine, N-methyl benzylamine, piperidino ethanol, pyrolidino ethanol, N-methyl piperazine or even cetyl pyridinium.
Les sels avec une base organique présentent l'avantage d'être plus solubles dans les solvants organiques que les sels avec une base minérale et peuvent ainsi être plus aisément dissous en milieu organique. On peut également réaliser des solutions plus concentrées. Salts with an organic base have the advantage of being more soluble in organic solvents than salts with an inorganic base and can thus be more easily dissolved in an organic medium. It is also possible to produce more concentrated solutions.
Le solvant organique utilisé pour disperser ou dissoudre le principe actif est un alcanol et de préférence un alcanol ayant de 1 à 6 atomes de carbone. On pourra citer à cet égard le méthanol, l'éthanol, le propanol, l'isopropanol, les n et i-butanols, le terbutanol, le néopentanol ou le n-hexanol. Ces alkanols peuvent être dilués par addition d'eau de manière à réaliser des véhicules hydroalcooliques comme de l'alcool éthylique à 50 % ou à 95 %, ou de l'isopropanol ou du terbutanol à 20 % d'eau. The organic solvent used to disperse or dissolve the active principle is an alkanol and preferably an alkanol having from 1 to 6 carbon atoms. Mention may be made in this regard of methanol, ethanol, propanol, isopropanol, n and i-butanols, terbutanol, neopentanol or n-hexanol. These alkanols can be diluted by adding water so as to produce hydroalcoholic vehicles such as 50% or 95% ethyl alcohol, or isopropanol or terbutanol at 20% water.
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Le soluté peut être avantageusement additionné d'un agent de pénétration comme par exemple le solketal, l'azone, le méthylal, le monocaprylate de propylèneglycol (Caprisol 90), l'octyl-2 dodecanol ou le 2-n-nonyl 1, 3-dioxolane. La proportion d'agent de pénétration varie de 3 à 8 % de la composition totale et d'une manière davantage préférée de 4 à 6 % en poids.
The solute can advantageously be added with a penetrating agent such as for example solketal, azone, methylal, propylene glycol monocaprylate (Caprisol 90), 2-octyl dodecanol or 2-n-nonyl 1, 3 -dioxolane. The proportion of penetrating agent varies from 3 to 8% of the total composition and more preferably from 4 to 6% by weight.
Le véhicule alcoolique est en outre additionné d'un agent épaississant comme par exemple un poly éthylène glycol et notamment un PEG 400 ou un PEG 600. The alcoholic vehicle is also added with a thickening agent such as for example a polyethylene glycol and in particular a PEG 400 or a PEG 600.
Le pH du véhicule est légèrement acide (valeur 4, 5-5). On l'ajuste aux alentours de 5,5 par addition de la quantité minimale d'hydroxyde de sodium, tout en respectant les zones de pH compatibles avec la stabilité du principe actif et la durabilité de la suspension, en fonction des caractéristiques chimiques des autres ingrédients. En particulier l'utilisation de sels de Kétoprofène très basiques nécessite l'ajustement du pH à l'aide d'acides minéraux ou organiques. The vehicle pH is slightly acidic (value 4, 5-5). It is adjusted to around 5.5 by adding the minimum quantity of sodium hydroxide, while respecting the pH zones compatible with the stability of the active principle and the durability of the suspension, depending on the chemical characteristics of the others. ingredients. In particular, the use of very basic Ketoprofen salts requires adjustment of the pH using mineral or organic acids.
Le soluté à disperser peut avantageusement être additionné d'un parfum comme un produit aromatisant ou odoriférant. On pourra citer à cet égard l'essence de roses, l'essence de neroli, l'essence de petit-grain, l'essence de lavande, l'essence de lavandin, l'essence de thym, l'essence d'eucalyptus ou l'essence d'ylang-ylang, ainsi que des produits synthétiques comme la vetivone, la damascone, l'irone ou les ionones. The solute to be dispersed can advantageously be added with a perfume such as a flavoring or odorant product. We can cite in this regard the essence of roses, the essence of neroli, the essence of petit-grain, the essence of lavender, the essence of lavandin, the essence of thyme, the essence of eucalyptus or the essence of ylang-ylang, as well as synthetic products like vetivone, damascone, irone or ionones.
Le produit aromatisant ou odoriférant est additionné en quantité de 0,05 à 1 % de la composition totale. Une quantité préférée s'échelonne de 0,1 à 0,6 %. The flavoring or fragrance product is added in an amount of 0.05 to 1% of the total composition. A preferred amount ranges from 0.1 to 0.6%.
L'angle de pulvérisation assuré par la valve du dispositif de pulvérisation varie entre 40 et 500. Il permet de couvrir à chaque projection une zone plus ou moins étalée. The spray angle provided by the valve of the spray device varies between 40 and 500. It makes it possible to cover a more or less spread out area with each spraying.
L'évaporation rapide du solvant organique assure un moindre écoulement de la préparation sur l'épiderme et une meilleure adhésion sur les zones traitées. The rapid evaporation of the organic solvent ensures less flow of the preparation on the epidermis and better adhesion on the treated areas.
La valve sert également de moyen de dosage. Une poussée sur le bouton-poussoir permet la délivrance d'un volume de solution variant de 0,2 à 0,8 ml et de préférence de 0,4 à 0,6 ml. Le volume projeté dépend de la pression gazeuse régnant dans le bidon pressurisé. La valve utilisée de préférence est celle commercialisée par la société Sofab. The valve also serves as a metering means. A push on the push-button allows the delivery of a volume of solution varying from 0.2 to 0.8 ml and preferably from 0.4 to 0.6 ml. The projected volume depends on the gas pressure prevailing in the pressurized container. The valve preferably used is the one sold by the company Sofab.
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La concentration en principe actif dans la solution alcanolique s'échelonne de 1 à 10 % et de préférence de 2 à 5 %. De cette façon, chaque poussée permet la délivrance de 0,02 g à 0,8 g de principe actif. The concentration of active ingredient in the alkanolic solution ranges from 1 to 10% and preferably from 2 to 5%. In this way, each push allows the delivery of 0.02 g to 0.8 g of active principle.
La pompe doseuse selon l'invention qui permet la pulvérisation comprend, outre la solution hydroalkanolique d'agent anti-inflammatoire, un corps plongeant dans le liquide à pulvériser, une poche doseuse surmontée d'un clapet de mesure, un corps de soutien de la poche doseuse, des coupelles symétriques en aluminium sur lesquelles reposent, symétriquement disposés, une partie obturatrice serrée contre la coupelle par un joint interne, ainsi que deux amortisseurs en élastomère, disposés de part et d'autre de l'axe de l'obturateur, et le corps du gicleur mobile dans le sens vertical maintenu en place par des ressorts, sur lequel vient se fixer la buse de pulvérisation. The dosing pump according to the invention which allows spraying comprises, in addition to the hydroalkanolic solution of anti-inflammatory agent, a body immersed in the liquid to be sprayed, a dosing bag surmounted by a measuring valve, a body for supporting the dosing pocket, symmetrical aluminum cups on which rest, symmetrically arranged, a shutter part tightened against the cup by an internal seal, as well as two elastomer dampers, arranged on either side of the axis of the shutter, and the body of the nozzle movable in the vertical direction held in place by springs, on which is fixed the spray nozzle.
La valve est terminée par un embout légèrement arrondi sur lequel vient s'emboîter la valve doseuse. The valve is terminated by a slightly rounded tip on which the metering valve fits.
Les bidons de remplissage sont remplis sous atmosphère d'un gaz inerte comme l'azote, l'hélium, l'argon, le protoxyde d'azote, le gaz carbonique ou un hydrocarbure. The filling cans are filled under an inert gas atmosphere such as nitrogen, helium, argon, nitrous oxide, carbon dioxide or a hydrocarbon.
La pression exercée sur la valve doseuse fait descendre la tige du gicleur en contact avec le clapet de mesure de sorte que le liquide sous pression dans le tube plongeur pénètre dans le gicleur et est évacué par la valve dès que la pression se relâche. The pressure exerted on the metering valve lowers the nozzle rod in contact with the measuring valve so that the liquid under pressure in the dip tube enters the nozzle and is evacuated by the valve as soon as the pressure is released.
Le gicleur est en copolymère acétal. Le tube plongeur est en polyéthylène. Le tube plongeur présente une longueur de 4 à 5 mm et un diamètre de 0,15 à 0,20 mm. The nozzle is made of acetal copolymer. The dip tube is made of polyethylene. The dip tube has a length of 4 to 5 mm and a diameter of 0.15 to 0.20 mm.
La figure 1 annexée montre une coupe du bidon pressurisé comportant la tige du gicleur (2), l'extrémité de la tige du gicleur (1), les deux amortisseurs symétriques (3) (3'), les supports de base de la tige du gicleur (4) encastrés dans le corps du gicleur (2) par un évidement (19) et reposant sur deux pivots (11) (11') montés sur un capot d'étanchéité (12). Ils sont assujettis au clapet de mesure (8) par deux ressorts (13) (13') fixés à leur extrémité inférieure sur un rebord (14) (14') du clapet. Le clapet (15) comporte en son centre un orifice (16) par lequel monte le liquide sous pression, contenu dans le bidon pressurisé (non figuré) par l'intermédiaire de la poche doseuse (9) en élastomère, fermée par un joint d'étanchéité (17) à sa base. Le tube plongeur Figure 1 attached shows a section of the pressurized container comprising the nozzle rod (2), the end of the nozzle rod (1), the two symmetrical dampers (3) (3 '), the base supports of the rod nozzle (4) embedded in the body of the nozzle (2) by a recess (19) and resting on two pivots (11) (11 ') mounted on a sealing cover (12). They are fixed to the measurement valve (8) by two springs (13) (13 ') fixed at their lower end on a flange (14) (14') of the valve. The valve (15) has in its center an orifice (16) through which the pressurized liquid rises, contained in the pressurized container (not shown) by means of the dosing bag (9) made of elastomer, closed by a seal d seal (17) at its base. The dip tube
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(18) assure la montée du liquide (13) dans la poche doseuse (9) puis dans le corps du clapet (15). (18) ensures the rise of the liquid (13) in the dosing bag (9) then in the body of the valve (15).
Après relâchement de la valve doseuse, le liquide redescend par le tube plongeur (18) dans le bidon pressurisé. After releasing the metering valve, the liquid descends through the dip tube (18) into the pressurized container.
Les exemples suivants illustrent l'invention sans toutefois la limiter. The following examples illustrate the invention without, however, limiting it.
EXEMPLE 1 Soluté de Kétoprofène On dissout 5 g de Kétoprofène dans 80 g d'éthanol à 95-96 %. On ajoute 30 g de poly éthylène glycol 400 (commercialisé sous la dénomination Lutrol E 400). On ajoute avec précaution quelques gouttes de solution d'hydroxyde de sodium à 30 %, à la solution acide (pH 4,7) pour obtenir un pH de 5,5. On complète la solution avec de l'eau purifiée à 200 g. La solution est alors introduite dans des flacons sous pression de 15 ml. On ferme le flacon avec le gicleur et on injecte de l'azote jusqu'à ce que la pression gazeuse à l'intérieur s'élève à 7 bars. On place alors la valve que l'on sertit sur l'embout du gicleur. EXAMPLE 1 Ketoprofen solution 5 g of Ketoprofen are dissolved in 80 g of 95-96% ethanol. 30 g of polyethylene glycol 400 (sold under the name Lutrol E 400) are added. Carefully add a few drops of 30% sodium hydroxide solution to the acid solution (pH 4.7) to obtain a pH of 5.5. The solution is made up with purified water to 200 g. The solution is then introduced into 15 ml pressure vials. The bottle is closed with the nozzle and nitrogen is injected until the gas pressure inside is 7 bars. Then place the valve that is crimped on the nozzle tip.
EXEMPLE 2 Soluté de Kétoprofène, sel de Trométhamine On dissout 6,65 g de sel de Trométhamine de Kétoprofène dans 80 g d'éthanol à 50 %. On ajoute 12 g de poly éthylène glycol 400 et on ajuste le pH du milieu à 5,5 par addition d'une solution d'acide chlorhydrique à 1 %. On complète la solution à 200 g avec de l'eau de roses. On répartit après homogénéisation la solution hydroalcoolique dans des flacons pressurisés de 15 ml. On obture le flacon par insertion du gicleur monté sur le tube plongeur. On injecte de l'azote jusqu'à ce que la pression interne s'élève à 7 bars. On dispose alors la valve que l'on sertit sur l'embout du gicleur. EXAMPLE 2 Ketoprofen solution, Tromethamine salt 6.65 g of Trethamine salt of Ketoprofen is dissolved in 80 g of 50% ethanol. 12 g of polyethylene glycol 400 are added and the pH of the medium is adjusted to 5.5 by addition of a 1% hydrochloric acid solution. The solution is made up to 200 g with rose water. The hydroalcoholic solution is distributed after homogenization in 15 ml pressurized bottles. The bottle is closed by inserting the nozzle mounted on the dip tube. Nitrogen is injected until the internal pressure rises to 7 bars. We then have the valve that is crimped on the nozzle tip.
EXEMPLE 111 Soluté de Kétoprofène avec agent pénétrant On prépare une solution prête à la pulvérisation, de formule : - Kétoprofène 2, 5 % - Lutrol E 400 10% - Huile essentielle de Lavandin 0, 1 % EXAMPLE 111 Ketoprofen solution with penetrating agent A solution ready for spraying is prepared, of formula: - Ketoprofen 2.5% - Lutrol E 400 10% - Lavandin essential oil 0.1%
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- Solkétal 5% - Alcool 95-96 % 40 % - Eau purifiée qsp 100% - Hydroxyde de sodium à 30 % qsp pH 5, 5 La solution est répartie après homogénéisation dans des flacons pressurisés de 15 ml.
- Solkétal 5% - Alcohol 95-96% 40% - Purified water qs 100% - Sodium hydroxide at 30% qs pH 5, 5 The solution is distributed after homogenization in pressurized bottles of 15 ml.
On ferme le flacon avec le gicleur et on injecte de l'azote jusqu'à ce que la pression gazeuse à l'intérieur s'élève à 7 bars. On place alors la valve que l'on sertit sur l'embout du gicleur. The bottle is closed with the nozzle and nitrogen is injected until the gas pressure inside is 7 bars. Then place the valve that is crimped on the nozzle tip.
Les compositions selon l'invention trouvent une utilisation dans le traitement des phénomènes douloureux ou inflammatoires de l'appareil locomoteur notamment en cas de tendinites ou dans la traumatologie.The compositions according to the invention find use in the treatment of painful or inflammatory phenomena of the musculoskeletal system, in particular in the case of tendonitis or in trauma.
Claims (8)
Priority Applications (1)
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FR0100263A FR2814959A1 (en) | 2000-10-09 | 2001-01-10 | Atomiser for pharmaceutical products based on antiinflammatory agents comprises pressurized container, dosing pouch and metering valve |
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FR0012881A FR2814954B1 (en) | 2000-10-09 | 2000-10-09 | NOVEL PHARMACEUTICAL COMPOSITIONS IN THE SPRAY FORM AND THE FORMS THUS PRODUCED |
FR0100263A FR2814959A1 (en) | 2000-10-09 | 2001-01-10 | Atomiser for pharmaceutical products based on antiinflammatory agents comprises pressurized container, dosing pouch and metering valve |
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