WO2011100935A1 - Substance sèche d'hydrogel pour pansement, et son procédé de préparation - Google Patents

Substance sèche d'hydrogel pour pansement, et son procédé de préparation Download PDF

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Publication number
WO2011100935A1
WO2011100935A1 PCT/CZ2011/000017 CZ2011000017W WO2011100935A1 WO 2011100935 A1 WO2011100935 A1 WO 2011100935A1 CZ 2011000017 W CZ2011000017 W CZ 2011000017W WO 2011100935 A1 WO2011100935 A1 WO 2011100935A1
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WO
WIPO (PCT)
Prior art keywords
hydrogel
pts
gelatin
wound dressing
dry material
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Application number
PCT/CZ2011/000017
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English (en)
Inventor
Nabanita Saha
Tomas Saha
Amarjargal Saarai
Original Assignee
Univerzita Tomase Bati Ve Zline
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Filing date
Publication date
Application filed by Univerzita Tomase Bati Ve Zline filed Critical Univerzita Tomase Bati Ve Zline
Publication of WO2011100935A1 publication Critical patent/WO2011100935A1/fr

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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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • 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
    • A61L26/0052—Mixtures of macromolecular compounds
    • 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
    • A61L26/008—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

  • the invention relates to dry substance of hydrogel for wound dressing used on bodies, in particular human bodies.
  • the presented invention also relates to the method of preparation of such hydrogel for wound dressing.
  • hydrogels for wound dressing from synthetic and natural polymers as well as methods of their preparation are known. They are oriented to obtain a product with best mechanical, swelling and. other important physical properties, as well as with antibacterial and wound-healing properties.
  • hydrogels for wound dressing There are several more requirements imposed on hydrogels for wound dressing. They should be soft and friendly to wounded body and at the same time they should resist the manipulations during application and thereafter. These requirements are rather contradictory and it is difficult to meet them sufficiently.
  • hydrogel for wound dressing Orie of the known methods for manufacturing hydrogel for wound dressing is described in the WO 03/034900 document which discloses an intradermal patch with a permeable backing coated with a gel based on polyvinylpyrrolidone with certain average molecular weight (pref. 900.000 - 1.500.000 Dalton) in an amount of pref. 15 - 20 % of weight.
  • the patches may comprise one or more additional components such as wound-healing agent, medicines, viscosity enhancing agents and humectants.
  • the hydrogel material is placed on a base made from. ⁇ a material with sufficient mechanical properties and therefore no extra mechanical requirements are imposed on the hydrogel. , . . .
  • the polyvinylpyrrolidone is the, appropriate synthetic polymer for the preparation of hydrogel for wound dressing, as can be seen from another, US patent No. 4,871 ,490.
  • the method of this patent is based on pouring the aqueous solution of synthetic polymer, e.g. polyyinylpyrrolidone, natural; , polymer,, e.g. agar, ; and .so-called plasticizing ; agent, e.g. polyethylene glycol, into a mould imparting a shape to the hydrogel.
  • agent e.g. polyethylene glycol
  • compositions such as the composition according to US patent No. 5,306,504.
  • This solution is based on cross-linked polyvinylpyrrolidone, which is mixed with water-soluble multifunctional amines containing polymer.
  • Polyvinyl-pyrrolidone has ring opened pyrrolidone acid groups which can react with the basics amine groups of the multifunctional amine-containing polymer to form a water-insoluble, water-swellable, cross-linked ampholyte salt.
  • the preparation takes place in an aqueous medium with the water content 40 - 80 % of weight.
  • a plasticizer - e.g. polyethylene glycol - can be used for tack development. The plasticizer may increase tack, however it decreases gel strength.
  • a cross-linking inhibitor is preferably an antioxidant as ascorbic acid.
  • a humectant such as polyethylene glycol can be used so as to improve the physical properties of the hydrogel.
  • cross-linking promoter as is ethylene glycol dimethacrylate can be present. This method can provide hydrogel with at least 80 % gel value and absorptive capacity (measured by the gel ratio) at least 5. This sophisticated composition reaches further improvement inthe properties of hydrogel and allows to cross-link and to sterilize the product in one step.
  • the content of synthetic polymer and. the number of additives can lead to higher costs of obtained products.
  • the geWbrming system comprises an aqueous mixture of at least three polymeric components.
  • the first of them is a water-soluble polymer, e.g. polyvinylpyrrolidone, in an amount of 3 - 5 % of weight.
  • This component can be mixed with polyethylene, oxide in a weight ratio from 10: 1 up to 25: 1.
  • the second .polymeric component is an acid-containing polymer and the third polymeric component is an , ammo-containing polymer, e.g. heparin and . agar.
  • the composition can also include additional components as bactericides and antibiotics for the curative actions, and humectant for increasing the solubility of the third or second component in the mixture.
  • Such humectant is preferably polyethylene glycol.
  • content of polyvinylpyrrolidone in examples there is presented the content of 10 % of weight of the mixture.
  • the gel ratio as a measure of the absorption capacity of hydrogels is able to exceed 5. This gel-forming system contains a great portion of polymeric components and manifold number of further components and so it can be rather expensive as well as the previous one.
  • This method of preparing hydrogel for wound dressing comprises the step of providing initial aqueous solution containing at least 15 % of synthetic polymer cross-linkable by irradiation (based on the weight of the mixture) at least one humectant,.
  • a natural polymer and water pouring the initial aqueous solution into a mould for shaping, allowing the aqueous solution to mature in the mould during a period of time sufficient to obtain a semi-product having a content of at least 35 % of synthetic polymer, removing the semi-product thus shaped from the mould and subjecting the semi-product to irradiation in order to cross-link an sterilize the semiproduct.
  • the aqueous solution comprises at least 15 % of synthetic polymer, which is cross-linkable by irradiation.
  • the hydrogel for wound dressing according to CZ utility model 18770 has been developed.
  • the principle of the related technical solution consists in that the hydrogel contains polyvinylpyrrolidone having molecular weight of 30 -50,000 Dalton, carboxymethyl cellulose or collagen, agar, polyethylene glycol having molecular weight of 200 - 20,000 Dalton, glycerin, and respectively contains at least one antibacterial and/or antiseptic agent, advantageously boric acid, whereas all the mentioned components together gain 0 - 10 w/v % of hydrogel and the remaining part onto 100 w/v % amount of water.
  • Hydrogel for wound dressing has got advantageously a round or square shape, thickness of 2 - 3 mm and the area of 500 - 6000 mm 2 .
  • the resultant product has about 94-90 % moisture content.
  • the weight decrease in final product (hydrogel) from the initial weight of solution is about 10 - 30 %.
  • the main polymers it is possible to complement polyvinylpyrrolidone by using either carboxymethyl cellulose or collagen to achieve more or less similar performance.
  • agar acts as a gelling agent
  • polyethylene glycol performs as a healing component
  • glycerin represents humectant.
  • Boric acid - if used - acts as antiseptic cum antibacterial agent. Presence of boric acid within hydrogel for wound dressing resists microbial infection on minor burns and cuts of skin besides providing cool feelings.
  • hydrogel for wound dressing The considerable advantage of the hydrogel for wound dressing according to this utility model is its cost effectiveness.
  • This hydrogel is eco-friendly and easy to store and use.
  • this hydrogel for wound dressing due to its semi transparent character allo ws instant monitoring of healing process w hich is a very important advantage.
  • it improves the conditions of healing process thanks to its praiseworthy absorption capability.
  • this hydrogel is not sticky on the skin.
  • hydrogel represents a very good and successful alternative in the field of healing hydrogels.
  • this one as well as all the previously known hydrogels for medical use are delivered on the market in the wet form, with the great content of water. This fact is caused by the effort to reach the highest user comfort enabling the promptness of using; however, on the other hand, it has more considerable disadvantages.
  • the main common disadvantage of all so called “wet hydrogels” is the fact that they cannot be stored for a long time (loss of water, germs proliferation). Simultaneously the wet hydrogels are very sensitive and demanding so as to maintain the sterilized, germ free conditions during the handling and storage.
  • wet hydrogels contain usually up to 95% water, which is almost state equilibrium, thus they are not able to absorb much exudates during the healing process, which is their considerable disadvantage.
  • the high weight content of water by wet hydrogels leads to multiple increasing of their delivery costs and thus the increase of final price of product.
  • hydrogel substance contains gelatin and Sodium alginate in weight ration of 3:7 - 7:3, where both these components represent 100 of wt. pts. of the mixture; parallel to this the dry substance also contains polyethylenglykol in the amount of 15-25 wt. pts., 15-25 wt. pts. of glycerine, nanofibres of polyvinyl alcohol in the amount of 10-40 wt.
  • the dry substance of the hydrogel may further contain sea buckthorn oil in the amount of up to 15 wt. pts. This dry substance has a flat shape, pref. round of square, is usually l-2mm thick and has area of 40-200 000 mm 2 .
  • the preparation method of the dry hydrogel material according to the invention lies preparation of a base water polymer solution of gelatin by continuous stirring of gelatine in 180-220 wt. pts. of water at constant temperature between 75 and 85 Celsius degrees. After complete dissolving of the gelatine volume other components are being added (except for nanofibres) and the mixture is again continuously stirred for 5 to 6 minutes at the speed of 250-350 r.p.m., whereby a viscid substance is created.
  • Gelatine helps regeneration of damaged tissues and absorbs blood of detached body fluids.
  • Sodium alginate holds back water and acts as antimicrobial agent.
  • Polyethylenglykol acts as a substitute of damaged skin membrane, glycerine as a humectant agent, natrium chloride as surfactant.
  • Nano fibres of polyvinyl alcohol create a fibre matrix and improve mechanical strength of the achieved whole.
  • Sea buckthorn oil acts as a healing agent and also helps to diminish subsequent scarves of healed wounds.
  • the main advantage of the dry material of hydrogel for wound dressing according to this invention is its' long term storage capacity/ability, in comparison to the known "wet" hydrogels. There are two main reasons for its prolonged longevity: there is no danger of loss of water and, moreover, in the dry substance the germ proliferation is extremely reduced.
  • Another important advantage of the dry material of hydrogel for wound dressing according to this invention is the fact that the weight of dry hydrogels is reduced under 50% (ca 40%) compared to wet hydrogels.
  • the products of the invention are light and so their delivery costs are lowered, too.
  • dry hydrogels as per the invention is the fact that they can be prepared before use with lower degree of saturation by water - under the equilibrium point - and so they can absorb subsequently absorb a lot of exudates during the healing process.
  • the described hydrogels according to this invention can contain some additional medicines - water soluble means for wound protection, healing acceleration and prevention of wound infection.
  • the resulting wet matrix prepared before use is macroporous and has therefore good oxygen diffusion properties. Thanks to the presence of polyvinyl alcohol nanofibres, the hydrogel according to the invention can be used as gauze pad or sponge dressing for external use. Examples
  • the initial polymer solution containing 40 wt. pts of gelatin in 190 vvt. pts of water was achieved through continuous stirring at the constant temperature of 75°C. As soon as the entire volume of gelatin has been dissolved, further components were added: sodium alginate 60 wt. pts, polyethylene glycol 16 wt. pts, sodium chloride 1 ,5 wt. pts, glycerin 16 wt. pts; stirring of this mixture continued for 5 min at 250 rpm. To the resulting viscous hydrogel mass then slowly a fraction of polyvinyl alcohol nanofibres in an amount of 15 wt.
  • the viscous mass was dosed in aseptic environment to set of acrylic dishes with diameter of 25 mm and thickness 2 mm. Afterwards the hydrogel was removed from the dishes and was left to dry at room temperature of 20°C. During the incubation process the whole volume of water was removed from the viscous mass and the final dry material of hydrogel has been achieved. The resulting product of pale yellow colour has got the thickness of 1.4 mm and area of 490 mm 2 .
  • the initial polymeric solution containing 60 vvt. pts of gelatin in 210 vvt. pts of water was achieved through continuous stirring at the constant temperature of 85°C. As soon as whole volume of gelatin has been dissolved further components were added: sodium alginate 40 wt. pts, polyethylene glycol 24 wt. pts, sodium chloride 2,5 wt. pts, glycerin 24 wt. pts; stirring of this mixture continued for 6 min at 350 rpm. To the resulting viscous hydrogel mass then slowly a fraction of polyvinyl alcohol nanofibres in an amount of 35 wt.
  • the viscous mass was under aseptic environment dosed to a set of acrylic dishes with diameter 25 mm and thickness 2 mm where it incubated and dried at room temperature of 25°C. During the incubation process whole volume of water was removed from the viscous mass and the final dry substance of hydrogel has been achieved. The resulting product of pale yel low colour has got the thickness of 1 .6 mm and area of 490 mm 2 .
  • the hydrogel for wound dressing according to this invention will be used for medical purposes for treating burns and large wounds. It can be applied in the area of surgery in the postoperative care as it enables easy and painless monitoring of the healing process. Thanks to its absorption capability it will find use also in special purposes like covering of slowly healing or very damaged tissues.
  • the hydrogel wound covering according to this invention can help also in crisis situations for prompt first-aid treatment of wounded persons. Applications in veterinary medicine are possible, too.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La substance sèche d'hydrogel pour pansement, fabriquée à partir de polymères synthétiques et naturels, contient de la gélatine et de l'alginate de sodium selon un rapport en poids de 3:7 à 7:3, ces deux constituants formant 100 parties en poids et contenant simultanément 15 à 25 parties en poids de polyéthylène glycol, 15 à 25 parties en poids de glycérine, 10 à 40 parties en poids de nanofibres d'alcool polyvinylique, 1 à 3 parties en poids de chlorure de natrium, et éventuellement d'autres additifs usuels. Dans un procédé de préparation de la substance sèche d'hydrogel pour pansement, cette solution polymérique aqueuse initiale de gélatine est agitée en continu dans 180 à 220 parties en poids d'eau à une température constante de 75-85°C. Après dissolution du volume total de gélatine, d'autres constituants, tels que l'alginate de sodium, le polyéthylène glycol, le chlorure de sodium, la glycérine, et respectivement l'huile d'argousier, sont ajoutés à la solution polymérique aqueuse initiale de gélatine. L'agitation de ce mélange se poursuit encore pendant 5-6 min à 250-350 tr/min pour obtenir une masse visqueuse d'hydrogel, après quoi une fraction de nanofibres d'alcool polyvinylique est ajoutée lentement, avec réduction à 150-50 tr/min de la vitesse d'agitation de la masse visqueuse. La masse visqueuse est enfin versée dans des cuvettes acryliques de 25 mm de diamètre dans lesquelles elle est incubée à la température ambiante de 20-25°C jusqu'à l'élimination de la totalité du volume d'eau et l'obtention de la substance sèche finale d'hydrogel.
PCT/CZ2011/000017 2010-02-18 2011-02-15 Substance sèche d'hydrogel pour pansement, et son procédé de préparation WO2011100935A1 (fr)

Applications Claiming Priority (2)

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CZPV2010-126 2010-02-18
CZ20100126A CZ2010126A3 (cs) 2010-02-18 2010-02-18 Suchá substance hydrogelu pro krytí ran a zpusob její prípravy

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9456991B2 (en) 2011-12-22 2016-10-04 Erik Baes Gelatin/alginate delayed release capsules comprising omega-3 fatty acids, and methods and uses thereof
CN110144051A (zh) * 2019-05-15 2019-08-20 长春工业大学 一种pva海藻酸钠双网络耐寒导电水凝胶及其制备方法
CN110546189A (zh) * 2018-03-06 2019-12-06 裴乐科技公司 水凝胶的制造方法
CZ308641B6 (cs) * 2020-07-02 2021-01-20 České vysoké učení technické v Praze Krycí prostředek rány pro umístění terapeutického prostředku v místě léčby chronické rány
CN115252885A (zh) * 2022-07-26 2022-11-01 湖北大学 一种多重氢键交联的水凝胶敷料及其制备和应用

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US5135755A (en) * 1989-02-08 1992-08-04 Lohmann Gmbh & Co. Kg Cross-linked hydrogels and their use as wound dressings
US5306504A (en) 1992-12-09 1994-04-26 Paper Manufactures Company Skin adhesive hydrogel, its preparation and uses
US5480717A (en) 1992-12-15 1996-01-02 Johnson & Johnson Consumer Products, Inc. Hydrogel laminate bandages and composites
US5540033A (en) 1994-01-10 1996-07-30 Cambrex Hydrogels Integrated Manufacturing process for hydrogels
US5578661A (en) 1994-03-31 1996-11-26 Nepera, Inc. Gel forming system for use as wound dressings
WO2003034900A2 (fr) 2001-10-19 2003-05-01 Epicept Corporation Timbre sterile respirant pour le traitement de la douleur au niveau d'une plaie
WO2006028364A1 (fr) * 2004-09-09 2006-03-16 Broockeville Corporation N. V. Revetements hydrogels pour blessures
CZ18770U1 (cs) 2008-05-16 2008-08-04 Univerzita Tomáše Bati ve Zlíne Hydrogel pro krytí ran

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US6753454B1 (en) * 1999-10-08 2004-06-22 The University Of Akron Electrospun fibers and an apparatus therefor
WO2008010199A2 (fr) * 2006-07-18 2008-01-24 Nanopeutics S.R.O. Produit nanofibreux

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US4871490A (en) 1986-12-30 1989-10-03 Politechnika Lodzka, Lodz, Ul. Zwirki Method of manufacturing hydrogel dressings
US5135755A (en) * 1989-02-08 1992-08-04 Lohmann Gmbh & Co. Kg Cross-linked hydrogels and their use as wound dressings
US5306504A (en) 1992-12-09 1994-04-26 Paper Manufactures Company Skin adhesive hydrogel, its preparation and uses
US5480717A (en) 1992-12-15 1996-01-02 Johnson & Johnson Consumer Products, Inc. Hydrogel laminate bandages and composites
US5540033A (en) 1994-01-10 1996-07-30 Cambrex Hydrogels Integrated Manufacturing process for hydrogels
US5578661A (en) 1994-03-31 1996-11-26 Nepera, Inc. Gel forming system for use as wound dressings
WO2003034900A2 (fr) 2001-10-19 2003-05-01 Epicept Corporation Timbre sterile respirant pour le traitement de la douleur au niveau d'une plaie
WO2006028364A1 (fr) * 2004-09-09 2006-03-16 Broockeville Corporation N. V. Revetements hydrogels pour blessures
US20080033064A1 (en) 2004-09-09 2008-02-07 Broockeville Corporation N.V. Hydrogel Wound Coverings
CZ18770U1 (cs) 2008-05-16 2008-08-04 Univerzita Tomáše Bati ve Zlíne Hydrogel pro krytí ran

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9456991B2 (en) 2011-12-22 2016-10-04 Erik Baes Gelatin/alginate delayed release capsules comprising omega-3 fatty acids, and methods and uses thereof
CN110546189A (zh) * 2018-03-06 2019-12-06 裴乐科技公司 水凝胶的制造方法
CN110144051A (zh) * 2019-05-15 2019-08-20 长春工业大学 一种pva海藻酸钠双网络耐寒导电水凝胶及其制备方法
CN110144051B (zh) * 2019-05-15 2022-03-15 长春工业大学 一种pva海藻酸钠双网络耐寒导电水凝胶及其制备方法
CZ308641B6 (cs) * 2020-07-02 2021-01-20 České vysoké učení technické v Praze Krycí prostředek rány pro umístění terapeutického prostředku v místě léčby chronické rány
CN115252885A (zh) * 2022-07-26 2022-11-01 湖北大学 一种多重氢键交联的水凝胶敷料及其制备和应用
CN115252885B (zh) * 2022-07-26 2023-08-22 湖北大学 一种多重氢键交联的水凝胶敷料及其制备和应用

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CZ2010126A3 (cs) 2011-04-20

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