NO871720L - OXYALKYL CELLULOSE-CONTAINING GEL MATERIAL. - Google Patents

OXYALKYL CELLULOSE-CONTAINING GEL MATERIAL.

Info

Publication number
NO871720L
NO871720L NO871720A NO871720A NO871720L NO 871720 L NO871720 L NO 871720L NO 871720 A NO871720 A NO 871720A NO 871720 A NO871720 A NO 871720A NO 871720 L NO871720 L NO 871720L
Authority
NO
Norway
Prior art keywords
gel
cellulose
gel material
containing gel
active material
Prior art date
Application number
NO871720A
Other languages
Norwegian (no)
Other versions
NO871720D0 (en
Inventor
Walter Ambrosch
Michael Schneider
Original Assignee
Goedecke Ag
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 Goedecke Ag filed Critical Goedecke Ag
Publication of NO871720D0 publication Critical patent/NO871720D0/en
Publication of NO871720L publication Critical patent/NO871720L/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)
  • Jellies, Jams, And Syrups (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Description

Foreliggende oppfinnelse gjelder vandige, farma-søytiske gelmaterialer for lokal bruk. The present invention relates to aqueous pharmaceutical gel materials for local use.

For utvikling av lokalt anvendbare gelmaterialerFor the development of locally applicable gel materials

for å fremme sårheling, er det viktig å ha et bærermateriale som utøver en positiv virkning på forløpet av sårheling, men ikke har noen fysiologisk irriterende effekt eller ikke har en retarderende effekt på helbredelsesprosessen. to promote wound healing, it is important to have a carrier material that exerts a positive effect on the course of wound healing, but does not have a physiologically irritating effect or does not have a retarding effect on the healing process.

Dette er ikke lett siden vevet i åpne sår er eks-tremt følsomt og også irriteres av ikke-aggressive fremmede materialer, som forsinker helbredelsesprosessen og forårsaker smerte hos pasientene. This is not easy since the tissue in open wounds is extremely sensitive and is also irritated by non-aggressive foreign materials, which delays the healing process and causes pain to the patients.

Det er et formål med foreliggende oppfinnelse å til-veiebringe et bærermateriale for lokale gelpreparater som It is an aim of the present invention to provide a carrier material for local gel preparations which

ikke utøver en irriterende effekt på skadet vev hos varm-blodige dyr og mennesker og således fremmer sårheling. does not exert an irritating effect on damaged tissue in warm-blooded animals and humans and thus promotes wound healing.

Det er nu funnet at hydroxyalkylcellulose utgjør et slikt bærermateriale som, i form av en vandig gelblanding (hydrogel), ikke utøver noen irriterende virkning på vev og, under visse omstendigheter, selv oppviser en helbredelses-fremmende effekt selv uten aktive materialer. It has now been found that hydroxyalkyl cellulose constitutes such a carrier material which, in the form of an aqueous gel mixture (hydrogel), exerts no irritating effect on tissue and, under certain circumstances, even exhibits a healing-promoting effect even without active materials.

Ifølge foreliggende oppfinnelse tilveiebringes således et farmasøytisk, vandig gelpreparat for lokal admini-strasjon som, som bærermateriale for et farmasøytisk aktivt materiale, inneholder en C^-Cg-alkylhydroxy-C-^-Cg-alkyl-cellulose eller en hydroxy-C^-Cg-alkylcellulose. According to the present invention, a pharmaceutical, aqueous gel preparation for local administration is thus provided which, as a carrier material for a pharmaceutical active material, contains a C₁-C₆-alkylhydroxy-C-₆-C₆-alkyl cellulose or a hydroxy-C₆- C 6 -alkyl cellulose.

Hydrogelen ifølge foreliggende oppfinnelse inneholder fortrinnsvis et helbredelses-fremmende, aktivt materiale som, i sin tur, ikke har en irriterende virkning på vev for ikke å oppheve fordelene ved bærermaterialet. The hydrogel according to the present invention preferably contains a healing-promoting active material which, in turn, does not have an irritating effect on tissue so as not to nullify the benefits of the carrier material.

Aktive materialblandinger ifølge DE patentActive material mixtures according to DE patent

3 416 777 er eksempelvis enestående egnet for dette formål, siden disse materialer i isotoniske preparater ikke bare har en virkning som i sterk grad hemmer sårhelbredelsen, men også på samme tid er forenelig med vevene uten noen irriterende virkning. 3 416 777 is, for example, uniquely suitable for this purpose, since these materials in isotonic preparations not only have an effect which strongly inhibits wound healing, but are also compatible with the tissues without any irritating effect.

Hydroxyalkylcelluloser skal forståes å være de celluloser som inneholder lavere alkylradikaler, dvs. de med opp til 4 og fortrinnsvis 1 eller 2 carbonatomer eller hydrogen- atomer og en lavere alkylradikal. Disse omfatter for eksempel methylhydroxymethylcellulose, methylhydroxypropyl-cellulose, butylhydroxymethylcellulose, ethylhydroxypropyl-cellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose og methylhydroxyethylcellulose er foretrukket. Hydroxyalkylcelluloses shall be understood to be those celluloses which contain lower alkyl radicals, i.e. those with up to 4 and preferably 1 or 2 carbon atoms or hydrogen atoms and a lower alkyl radical. These include, for example, methylhydroxymethylcellulose, methylhydroxypropylcellulose, butylhydroxymethylcellulose, ethylhydroxypropylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose and methylhydroxyethylcellulose are preferred.

Med celluloser skal det forståes de" som har et polymerisasjonstall på fra 120 til 1200, for eksempel slike som er kommersielt tilgjengelige under varenavnet "Tylose". Celluloses are to be understood as having a polymerization number of from 120 to 1200, for example those that are commercially available under the trade name "Tylose".

Disse danner klare geler med vann, kan belegges og, kan i en steril form som er så isotonisk som mulig, lett på-føres, sammen med passende doserte, aktive materialer, på såroverflater. These form clear gels with water, can be coated and, in a sterile form that is as isotonic as possible, can be easily applied, together with suitably dosed active materials, to wound surfaces.

Gelen kan fremstilles ved langsomt å innføre hydroxyalkylcellulosen i varmt vann under omrøring og tillate den å gelere inntil den er homogen. Midler for justering av den isotoniske tilstand, f.eks. natriumklorid, glycerol eller sorbitol, såvel som konserveringsmidler, f.eks. PBB-estere, kan på forhånd være tilsatt til vannet. The gel can be prepared by slowly introducing the hydroxyalkyl cellulose into hot water with stirring and allowing it to gel until it is homogeneous. Means for adjusting the isotonic state, e.g. sodium chloride, glycerol or sorbitol, as well as preservatives, e.g. PBB esters can be added to the water in advance.

Gelpreparatet kan vanligvis også blandes med andre blandinger, f.eks. olje-i-vann- eller vann-i-olje-emulsjoner, avhengig av bruksformålet, for å meddele en viss grad av lipofili til preparatene som kan hindre skorpedannelse på såroverflaten. The gel preparation can usually also be mixed with other mixtures, e.g. oil-in-water or water-in-oil emulsions, depending on the purpose of use, to impart a certain degree of lipophilicity to the preparations that can prevent crusting on the wound surface.

Ved fremstilling av gelpreparatet må det også ut-vises forsiktighet slik at et pH-område som er fordelaktig for sårhelbredelse på ca. 3,5 til 7,5 og fortrinnsvis fra 4 til 7 ikke underskrides eller overstiges. I forforsøk er det påvist at en sorbitol-holdig gel med pH på 4 er meget lett forenelig. When preparing the gel preparation, care must also be taken so that a pH range that is beneficial for wound healing of approx. 3.5 to 7.5 and preferably from 4 to 7 is not undercut or exceeded. In preliminary tests, it has been shown that a sorbitol-containing gel with a pH of 4 is very easily compatible.

Viskositeten skal, på basis av forholdet mellom cellulose og vann, være justert slik at gelen ikke strømmer for lett på den varme hudoverflate, og på den annen side. lett kan fordeles. En viskositet på fra 30 til 60 Pa.s later til å være fordelaktig. The viscosity must, on the basis of the ratio between cellulose and water, be adjusted so that the gel does not flow too easily on the warm skin surface, and on the other side. can easily be distributed. A viscosity of from 30 to 60 Pa.s appears to be advantageous.

De følgende eksempler gies for å illustrere foreliggende oppfinnelse: The following examples are given to illustrate the present invention:

Eksempel 1Example 1

Fremstilling av en gel som er fri for aktive materialer.Preparation of a gel that is free of active materials.

75 g av en 70 vekt%-ig sorbitolløsning oppløses i 883 ml vann inneholdende 2 g PHB-ester som konserveringsmid-del. Denne løsning oppvarmes til 60° C og blandes langsomt under omrøring med 40 g methylhydroxyethylcellulose. Blan-dingen omrøres i 1 - 2 timer inntil den blir homogen og avkjøles i løpet av samme tidsperiode til omgivelsestempera-tur. På denne måte oppnås en gjennomsiktig gel med et pH på 4 og en viskositet på 50 Pa.s ved 20° C som har følgende sammensetning: 75 g of a 70% by weight sorbitol solution is dissolved in 883 ml of water containing 2 g of PHB ester as preservative. This solution is heated to 60° C and mixed slowly with stirring with 40 g of methylhydroxyethylcellulose. The mixture is stirred for 1 - 2 hours until it becomes homogeneous and cooled during the same time period to ambient temperature. In this way, a transparent gel with a pH of 4 and a viscosity of 50 Pa.s at 20° C is obtained which has the following composition:

Eksempel 2 Example 2

Farmasøytisk preparat inneholdende en K<+>/Ca<++->blanding som aktivt materiale (ifølge DE patent 3 416 777). Pharmaceutical preparation containing a K<+>/Ca<++->mixture as active material (according to DE patent 3 416 777).

Ifølge eksempel 1 fremstilles en vandig løsning med en temperatur på 60° C med 30 mmol kalsiumklorid og 40 mmol kaliumklorid som aktiv materialblanding, såvel som med sorbitol for isotonisk justering og PHB-ester som konserve-ringsmiddel og blandes med methylhydroxyethylcellulose. Det oppnås en gel med en pH-verdi på 4,0 og en viskositet på 40 Pa.s. Gelen hadde følgende sammensetning: According to example 1, an aqueous solution with a temperature of 60° C is prepared with 30 mmol calcium chloride and 40 mmol potassium chloride as active material mixture, as well as with sorbitol for isotonic adjustment and PHB ester as preservative and mixed with methylhydroxyethyl cellulose. A gel with a pH value of 4.0 and a viscosity of 40 Pa.s is obtained. The gel had the following composition:

Eksempel 3 Example 3

Farmasøytisk preparat inneholdende en K<+>/Ca<++->blanding som aktivt materiale (ifølge DE patent 3 416 777) . Pharmaceutical preparation containing a K<+>/Ca<++->mixture as active material (according to DE patent 3 416 777).

Ifølge Eksempel 1 fremstilles en vandig løsning ved en temperatur på 60° C med 30 mmol kalsiumklorid og 40 mmol kaliumklorid som aktiv materialblanding, såvel som med sorbitol for isotonisk justering og PHB-ester som konserverings- middel og blandes med methylhydroxyethylcellulose. 0,01 N saltsyre tilsettes så og løsningen omrøres under avkjøling til omgivelsetemperatur for å oppnå en gel med en pH-verdi på 4,0 og en viskositet på 35 Pa.s. Gelen har følgende According to Example 1, an aqueous solution is prepared at a temperature of 60°C with 30 mmol of calcium chloride and 40 mmol of potassium chloride as active material mixture, as well as with sorbitol for isotonic adjustment and PHB ester as preservative and mixed with methylhydroxyethylcellulose. 0.01 N hydrochloric acid is then added and the solution is stirred while cooling to ambient temperature to obtain a gel with a pH value of 4.0 and a viscosity of 35 Pa.s. The gel has the following

sammensetning:composition:

Claims (2)

1. Farmasøytisk, vandig gelpreparat for lokal bruk, karakterisert ved at det som bærermateriale for farmasøytisk aktive materialer inneholder en C-^-Cg-alkyl-hydroxy-C-^-Cg-alkylcellulose eller en hydroxy-C^ -Cg-alkyl-cellulose.1. Pharmaceutical, aqueous gel preparation for local use, characterized in that it contains a C-^-Cg-alkyl-hydroxy-C-^-Cg-alkyl cellulose or a hydroxy-C^-Cg-alkyl- cellulose. 2. Preparat ifølge krav 1, karakterisert ved at bærermaterialet er methylhydroxyethylcellulose .2. Preparation according to claim 1, characterized in that the carrier material is methylhydroxyethylcellulose.
NO871720A 1986-04-25 1987-04-24 OXYALKYL CELLULOSE-CONTAINING GEL MATERIAL. NO871720L (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19863614095 DE3614095A1 (en) 1986-04-25 1986-04-25 OXYALKYLCELLULOSE CONTAINING GEL PREPARATION

Publications (2)

Publication Number Publication Date
NO871720D0 NO871720D0 (en) 1987-04-24
NO871720L true NO871720L (en) 1987-10-26

Family

ID=6299560

Family Applications (1)

Application Number Title Priority Date Filing Date
NO871720A NO871720L (en) 1986-04-25 1987-04-24 OXYALKYL CELLULOSE-CONTAINING GEL MATERIAL.

Country Status (14)

Country Link
EP (1) EP0247362A3 (en)
JP (1) JPS62254763A (en)
CN (1) CN87103139A (en)
AU (1) AU7196487A (en)
DD (1) DD262530A5 (en)
DE (1) DE3614095A1 (en)
DK (1) DK209087A (en)
FI (1) FI871811A (en)
HU (1) HUT43783A (en)
IL (1) IL82325A0 (en)
NO (1) NO871720L (en)
PT (1) PT84738B (en)
YU (1) YU75187A (en)
ZA (1) ZA872934B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658592A (en) * 1994-05-13 1997-08-19 Kuraray Co., Ltd. Medical crosslinked polymer gel of carboxylic polysaccharide and diaminoalkane
CA2906682C (en) 2013-03-15 2024-05-14 Synedgen Inc. Compositions comprising poly(acetyl,arginyl) glucosamine (paag) and use thereof for wound healing

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE943793C (en) * 1955-03-16 1956-06-01 Kade Pharmazeutische Fabrik Dr Process for the preparation of an agent for treating burn wounds
AU7776275A (en) * 1974-04-11 1976-08-05 Warner Lambert Co Production of base for topical steroids
US4226849A (en) * 1979-06-14 1980-10-07 Forest Laboratories Inc. Sustained release therapeutic compositions
DE3376957D1 (en) * 1982-06-24 1988-07-14 Robert Alan Smith Pharmaceutical gel composition
DE3243546A1 (en) * 1982-11-25 1984-05-30 Bayer Ag, 5090 Leverkusen ANTIMYCOTIC AGENTS IN GEL FOR TREATING FUNGAL INFECTIONS OF THE ORAL CAVES
DE3435113A1 (en) * 1984-05-07 1986-04-03 Gödecke AG, 7800 Freiburg PHARMACEUTICAL TOPICAL PREPARATIONS FOR PROMOTING WOUND GRANULATION AND EPITHELISATION
BE902226R (en) * 1985-04-18 1985-08-16 Kowa Co Analgesic and antiinflammatory ointments - contg. indomethacine and neutralised with ammonia

Also Published As

Publication number Publication date
PT84738B (en) 1989-06-08
EP0247362A2 (en) 1987-12-02
HUT43783A (en) 1987-12-28
JPS62254763A (en) 1987-11-06
YU75187A (en) 1988-12-31
DD262530A5 (en) 1988-11-30
FI871811A0 (en) 1987-04-24
DK209087A (en) 1987-10-26
AU7196487A (en) 1987-10-29
DE3614095A1 (en) 1987-10-29
IL82325A0 (en) 1987-10-30
FI871811A (en) 1987-10-26
CN87103139A (en) 1987-11-18
PT84738A (en) 1987-05-01
DK209087D0 (en) 1987-04-24
ZA872934B (en) 1987-10-19
EP0247362A3 (en) 1988-10-26
NO871720D0 (en) 1987-04-24

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