CA2265651C - Immediate wettability water soluble film or water soluble layer for oral application - Google Patents

Immediate wettability water soluble film or water soluble layer for oral application Download PDF

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Publication number
CA2265651C
CA2265651C CA002265651A CA2265651A CA2265651C CA 2265651 C CA2265651 C CA 2265651C CA 002265651 A CA002265651 A CA 002265651A CA 2265651 A CA2265651 A CA 2265651A CA 2265651 C CA2265651 C CA 2265651C
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Prior art keywords
composition according
agents
film
mixture
water soluble
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CA002265651A
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French (fr)
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CA2265651A1 (en
Inventor
Horst Georg Zerbe
Anthony J. Serino
Jian-Hwa Guo
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LTS Lohmann Therapie Systeme AG
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LTS Lohmann Therapie Systeme AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208—Tissues; Wipes; Patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/39—Derivatives containing from 2 to 10 oxyalkylene groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4906—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
    • A61K8/4926—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom having six membered rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/731—Cellulose; Quaternized cellulose derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/817—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
    • A61K8/8176—Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/90—Block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A preparation for application in the oral cavity with one layer or film which adheres to the mucous membrane, characterized in that the adhesive layer or film contains a homogenous mixture consisting of a water soluble polymer, a mixture of non-ionic surface active materials, a polyalcohol, a cosmetic or pharmaceutical active substance; and a food flavouring or aromatic agent.

Description

CA 02265651 l999-03- 11Water Soluble Film For Oral Administration With InstantWettabilityA composition containing therapeutic agents and/or breathfreshening agents for use in the oral cavity is disclosed.The carrier comprises water-soluble polymers in combinationwith certain ingredients and provides a therapeutic and/orcosmetic effect. The film is coated and dried utilizingexisting coating technology and exhibits instant wettabilityfollowed by rapid dissolution/disintegration uponadministration in the oral cavity.Mucoadhesive dosage forms for application to the oral cavitywhich are designed to deliver therapeutic and/or cosmeticagents to the oral mucosa are known in the art. US patent5,047,244 describes a mucoadhesive carrier allowing thecontrolled release of a therapeutic agent via the mucosaltissue comprising an anhydrous but hydratable polymer matrixand amorphous fumed silica. An optional water-insoluble filmcan be added to provide a non-adhering surface. In W091/06270, the same authors disclose a trilaminate filmsuitable for prolonged delivery of an active ingredient inthe oral cavity. .In a similar way, US patent 4,876,092 discloses a sheet-shaped adhesive preparation comprising an adhesive layercontaining certain water-soluble and water-insoluble polymersand a water-insoluble carrier which can adhere to the oralmucosa thereby releasing an active agent to the oral cavity.All the devices so far cited are not completely water solubleand will stay in the oral cavity even after the therapeuticgoal has been achieved leaving the patient with a certainCA 02265651 2002-12-24diccmtuzt in the mouth resulting mainly Ercm the supportlayer which leave: an insoluble residue in the mouth.A number of attempts have been made to reduce the adversefeeling in the oral cavity caused by the rigidity andinflexibility of the support layer by introducing sort filmsupports» 1:? o 200 503 51 and ma 0 33:. 194 B1 diecloee the’use or polyethylene tilme, polyvinyl acetate. ethylene-vinylacetate ccpolynera, metal toils. laminates of cloth or paperand a plastic film, and similar material: as ectt filmsupports, whereby synthetic resin: like polyethylene. vinylacetate homopolymere, and ethlene-vinyl acetate are thepreferred materials. In a similar way, CA 1 263 313 disclosesthe use of polyolofinea such as polyethylene, polypropylene.polyesters, PVC, and non—woven tabrice as eefit supportmaterials.However. these devices still leave the patient with aconsiderable amount of residue frdm the water-insolublesupport film thereby still causing a feeling 0! discomfort.who obvious solution to overcome this problem was to developmnccadhosive films which ccpletely disintegrate, or evencmpletely dissolve in the saliva. Fuchs and Hilmann(DE 24 49 865_) prepared haogeneoue. water—coluble filmsintended tor buccal administration of hornonee. They proposedthe use or water-soluble cellu1cae—derivativea. likehydroxyethyl cellulose, hydroxypropyl cellulose, or methylhydrcmypropyl cellulose, as rilm forming auente.Both DE 36 30 603 and EP 0 219 763 disclose the use ofswellahle polymers such as gelatin: or corn starch as filmforming aqente, which upon application to the oral cavityslowly disintegrate, thereby releasing an active ingredientCA 02265651 l999-03- llincorporated in the film. The same polymers can also be usedto prepare films which are intended for dental cleansing, asdescribed in EP 0 452 446 B1.These preparations still create an adverse feeling in themouth which is mainly caused by their initial rigidity anddelayed softening. Thus, there has still been a demand for acomposition for use in the oral cavity which meets therequirement of providing a pleasant feeling in the mouth.The present invention discloses methods and compositions thatare capable of avoiding an adverse feeling by providing thefilm which is intended for application to the oral mucosawith instant wettability, while achieving adequate tensilestrength in the free film to allow for easy coating,converting, and packaging of a consumer-friendly product.The present invention contemplates a rapidly dissolving filmwhich can be adhered to the oral cavity thereby releasing apharmaceutically or cosmetically active agent, said filmcomprising water—soluble polymers, one or more polyalcohols,and one or more pharmaceutically or cosmetically activeingredients. Optionally, the formulation may contain acombination of certain plasticizers or surfactants,colorants, sweetening agents, flavors, flavor enhancers, orother excipients commonly used to modify the taste offormulations intended for application to the oral cavity. Theresulting film is characterized by an instant wettabilitywhich causes the film to soften imediately after applicationto the mucosal tissue thus preventing the patient fromexperiencing any prolonged adverse feeling in the mouth, anda tensile strength suitable for normal coating, cutting,slitting, and packaging operations.CA 02265651 l999-03- 11The mucoadhesive film of the present invention contains asessential components a water-soluble polymer or a combinationof water-soluble polymers, one or more plasticizers orsurfactants, one or more polyalcohols, and a pharmaceuticallyor cosmetically active ingredient.The polymers used for the mucoadhesive film include polymerswhich are hydrophilic and/or water-dispersible. Preferredpolymers are water-soluble cellulose—derivatives.Hydroxypropylmethyl cellulose, hydroxyethyl cellulose, orhydroxypropyl cellulose, either alone, or mixtures thereof,are particularly preferred. other optional polymers, withoutlimiting the invention, include polyvinyl pyrrolidone,carboxymethyl cellulose, polyvinyl alcohol, sodium alginate,polyethylene glycol, natural gums like xanthane gum,tragacantha, guar gum, acacia gum, arabic gum, water-dispersible polyacrylates like polyacrylic acid,methylmethacrylate copolymer, carboxyvinyl copolymers.The concentration of the water-soluble polymer in the finalfilm can vary between 20 and 75 % (w/w), preferably between50 and 75 % (w/w).The surfactants used for the mucoadhesive film may be one ormore nonionic surfactants. When a combination of surfactantsis used, the first component may be a polyoxyethylenesorbitan fatty acid ester or a a-hydro—m-hydroxypoly(oxyethylene)poly(oxypropylene)poly(oxyethylene) blockcopolymer, while the second component may be apolyoxyethylene alkyl ether or a polyoxyethylene castor oilderivative. Preferably, the HLB value of the polyoxyethylenesorbitan fatty acid ester should be between 10 and 20,........ ....................u..—........._...u.......«..........,,. . ,CA 02265651 l999-03- 11whereby a range of 13 to 17 is particularly preferred. The a-hydro-w-hydroxypoly(oxyethylene)poly(oxypropylene)poly(oxyethylene) block copolymer should contain at least 35oxypropylene-units, preferably not less than 50 oxypropy1ene-units.The polyoxyethylene alkyl ether should have an HLB valuebetween 10 and 20, whereby an HLB value of not less than 15is preferred. The polyoxyethylene castor oil derivative hasto have an HLB value of 14 - 16.In order to achieve the desired instant wettability, theratio between the first and second component of the binarysurfactant mixture should be kept within 1:10 and 1:1, morepreferably between 1:5 and 1:3.The total concentration of surfactants in the final filmdepends on the properties of the other ingredients, butusually has to stay between 0.1 and 5 % (w/w).The polyalcohol is used to achieve the desired level ofsoftness of the film. Examples of polyalcohols includeglycerol, polyethylene glycol, propylene glycol, glycerolmonoesters with fatty acids or other pharmaceutically usedpolyalcohols. The concentration of the polyalcohol in the dryfilm usually ranges between 0.1 and 5 % (w/w).The film is well suited for the delivery of a wide range ofpharmaceutically active ingredients via the mucous membranesof a patient, particularly the buccal mucosa. Therapeuticagents which exhibit absorption problems due to solubilitylimitations, degradation in the gastro-intestinal tract, orextensive metabolism, are particularly well suited. Withoutlimiting the invention, examples of the therapeutic agentsinclude hypnotics, sedatives, antiepileptics, awakeningagents, psychoneurotropic agents, neuromuscular blocking V ...............................-¢.._..........m...... .CA 02265651 l999-03- 11agents, antispasmodic agents, antihistaminics, antiallergics,cardiotonics, antiarrhythmics, diuretics, hypotensives,vasopressors, antitussive expectorants, thyroid hormones,sexual hormones, antidiabetics, antitumor agents, antibioticsand chemotherapeutics, and narcotics.The amount of drug to be incorporated into the film dependson the kind of drug and is usually between 0.01 and20 % (w/w), but it can be higher if necessary to achieve thedesired effect.cosmetically active agents may include breath fresheningcompounds like menthol, other flavors or fragrances comonlyused for oral hygiene, and/or actives used for dental and/ororal cleansing like quarternary ammonium bases. The effect offlavors may be enhanced using flavor enhancers like tartaricacid, citric acid, vanillin, or the like. Colorants which mayoptionally be mixed in the film must be safe in terms oftoxicity and should be accepted by the Food And DrugAdministration for use in cosmetics.The mucoadhesive film according to the present invention can.be prepared as follows: The polyalcohol, surfactants,plasticizers, and possible other ingredients except thewater-soluble or water-dispersible polymer(s) are dissolvedin a sufficient amount of a solvent which is compatible withthem. Examples of compatible solvents include water, alcoholsor mixtures thereof. After a clear solution has been formed,the water-dispersible polymer or mixture of water-dispersiblepolymers is slowly added with stirring, and heat ifnecessary, until a clear and homogeneous solution has beenformed, followed by the addition of active ingredients andflavors. The solution is coated onto a suitable carrier, ...,-,.,..................,............................... . . . . . .. .....4.......4..............._......‘..........‘.. . . ,CA 02265651 l999-03- llmaterial and dried to form a film. The carrier material musthave a surface tension which allows the polymer solution tospread evenly across the intended coating width withoutsoaking in to form a destructive bond between the two.Examples of suitable materials include non—siliconizedpolyethylene terephthalate film, non—siliconized kraft paper,polyethylene-impregnated kraft paper, or non—siliconizedpolyethylene film.The coating of the solution onto the carrier material can beperformed using any conventional coating equipment. A morepreferred coating technique would involve a knife-over-rollcoating head.The thickness of the resulting film depends on theconcentration of solids in the coating solution and on thegap of the coating head and can vary between 5 and 200 um.Drying of the film is carried out in a high-temperature air-bath using a drying oven, drying tunnel, vacuum drier, or anyother suitable drying equipment, which does not adverselyaffect the active ingredient(s) or flavor of the film. Inorder to reliably avoid an adverse feeling in the mouth, adry film thickness of 70 um should not be exceeded.For better ease of use, the dry film can be cut into piecesof suitable size and shape and packed into a suitablecontainer.The invention will now be explained more specifically withreference to the following examples, which are given forillustration of this invention and are not intended to belimiting thereof.CA 02265651 2002-12-24EMAMPLE 1:15 o of soxbitol, 6 g of glycerol, 0.5 g of polyaorbata B0(Tween 90)‘; 2 g of 3:15 353 25 g of lemon mint £1a.vor, 3 q ofaspartafih. 15 9 of 1-menthol, and 3 g of citric acid arestirred at 60 SC in a_mixture of 250 g water and250 g ethanol until e clear uolution.hns been foznod. To thesolution. 30 g of hydrofiypropylnethyl cellulose are addedslowly under stirring until e clear and homogonooue solutionhas been formed. The resulting solution is allowed to cool toroam tamparetura and coated onto e suitable carrier materiel.for exnmplo non—ailiconizod, po1yotny1one—ooatad-kreft paperusing oonventionnl coating/drying equipment. coating gap andweb speed have to he adjustable to achieve a dry filmthickness betwaen 20 and so um. The drying tmporeturedepends on the length of the drying even end the web epacdend has to be adjusted to remove the solvent: oomplotoly, oralmost cump1ete1y,_£rum the film. The resulting film inpeeled off the carrier web and cut into piocoa of a shape andsize suitable for the intended ueo.EXAMPLE 2:3 g corbitol, 1.5 g Kollidon Sottsuppliazx BASE),5 g glycerol, 5 g propylene glycol, S g polyethylene glycol,4 g polysorbato 90 (Tween B63, 8 9 Bzij,3$: 12 g peppermintflavor, and 0.8 g nuparteme are dissolved in a mixturecontaining 400 9 water and 400 9 ethanol at 60 ac understirring. To the clear solution, 28 g hydroaypropylmothyloollulosa are added slowly under etirring. After the polymor*='T'Nf-.._.._.._._— ‘.....r.jp——....._.. _...- -.:...——-—«—_aj—_. ._——.——-——-CA 02265651 2002-12-24is completely dissolved, the solution is cooled to roomtemperature and coated onto a suitable carrier web using thecoating and drying conditions as described in the previousexample. The dry film is again out into nieces of suitablesize and shape.EIIIIPLB 3:15 g sorhitol, 22.5 g glycerol. 2.5 9 propylene glycol,2.5 g Brij 35, 2.5 g poloxamer 401. 3.5 g Crolnophor an 402'9 g herb mint flavor, and 0.5 g espertame are dissolved understirring at so no in a mixture containing 250 9 Meter and250 9 ethanol. To the clear solution, 75 g hydrcxyprcpylcellulose are added slowly under continuous stirring. wheolear solution is again coated and dried under the conditionsas described in mxnnpnn 1 end the dry film is out into pieceso! a shape and size suitable for the intended use.zxnupnt 4:3.6 U Tween 80: 3.6 9 glycerol, 39 g menthol, and171 g Kollidon 30*aro diaeolved.in a solution of 600 ml waterand 2800 ml ethanol at ambient tempereture with stirring.247.5 9 hydroxyprcpylmethyl cellulose in then added slowly‘and portionwiae at 50-55 °c and stirred until completelydissolved. The mixture is then allowed to cool and added insuccession are 90 q lnon mint flavor followed by_esolution/suspension c! 27.13 g espartame, 1B 9 citric acid.and 0.17 q FDEC yellow #5 in 120 ml water with stirring. Theclear solution is coated and dried under the conditioa asdescribed in EXAMPLE and the dry film is out into pieces of ashape and size suitable for the intended use.CA 02265651 2002-12-2410EXAMPLE 5 I165.4 g xollidon 30*are dissolved in a solution of720 ml water and 2660 ml ethanol at ambient tomuraturo withstirring. 220.5 g hydroxypropylmathyl cellulose in then addedII: 55-50 ‘C and Itirzbd vigorously until 3103:‘ andhomogwnnoun. The mixture is than allowed to cool and added inIuaoolnion are 78.75 g filavor followed by I. mixture of28.88 a nicotine salioylata and 31.5 g caramel liquid in120 ml water with stirring. The olonr. tan-colorld solutionis coated on dried undor tho conditions as dilcribed innxnupnn 1 and tho dry film in out into pieces o! a lhapi and' Iizo suitable for tho intended use so as to dolivor anicotine dole between 1-2 mg per piece.*

Claims (10)

CLAIMS:
1. A mucoadhesive composition applicable to the oral cavity in the form of a mucoadhesive film or sheet which rapidly softens and disintegrates in the oral cavity, wherein said mucoadhesive film comprises a homogeneous mixture consisting of at least one water-soluble polymer, a mixture of nonionic surfactants, at least one polyalcohol, at least one cosmetically or pharmaceutically active agent, and optionally at least one flavor, characterized in that the mixture of nonionic surfactants consists of two components, the first component being a polyoxyethylene sorbitan fatty acid ester or a .alpha.-hydro-.omega.-hydroxypoly (oxyethylene) poly (oxypropylene) poly (oxyethylene) block copolymer, and the second component being a polyoxyethylene alkyl ether or a polyoxyethylene castor oil derivative, wherein the ratio between the first and second component of the binary surfactant mixture is between 1:10 and 1:1.
2. Composition according to Claim 1, characterized in that the ratio between the first and second component of the binary mixture is between 1:5 and 1:3.
3. Composition according to Claim 1 or 2, characterized in that the HLB value of the polyethoxyethylene sorbitan fatty acid ester is between 10 and 20.
4. Composition according to any one of claims 1 to 3, characterized in that the HLB value of the polyoxyethylene alkyl ether is between 10 and 20.
5. Composition according to any one of claims 1 to 4, characterized in that the polyoxyethylene castor oil derivative has an HLB
value of 14 to 16.
6. Composition according to any one of claims 1 to 5, characterized in that the .alpha.-hydro-.omega.-hydroxypoly (oxyethylene) poly (oxypropylene) poly (oxyethylene) block copolymer contains at least 35 oxypropylene-units.
7. Composition according to any one of claims 1 to 6, characterized in that the water soluble polymer is selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolldone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthane gum, tragacantha guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, or mixtures thereof.
8. Composition according to any one of claims 1 to 7, characterized in that the polyalcohol is selected from the group consisting of glycerol, polyehtylene glycol, propylene glycol and glycerol monoesters with fatty acids.
9. Composition according to any one claims 1 to 8,characterized in that the pharmaceutically active agent is selected from the group consisting of hypnotics, sedatives, antiepileptics, awakening agents, psychoneurotropic agents, neuromuscular blocking agents, antispasmodic agents, antihistaminics, antiallergics, cadlotonics, antiarrhythmics, diuretics hypotensives, vasopressors, antitussive expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumor agents, antibiotics, chemotherapeutics, and narcotics.
10. Composition according to any one of claims 1 to 6, characterized in that the cosmetically active ingredient is selected from the group consisting of breath freshening compounds, flavors used for oral hygiene, fragrances used for oral hygiene, active agents used for oral cleansing, and active agents used for dental cleansing.
CA002265651A 1996-11-11 1997-10-22 Immediate wettability water soluble film or water soluble layer for oral application Expired - Lifetime CA2265651C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19646392.0 1996-11-11
DE19646392A DE19646392A1 (en) 1996-11-11 1996-11-11 Preparation for use in the oral cavity with a layer containing pressure-sensitive adhesive, pharmaceuticals or cosmetics for dosed delivery
PCT/EP1997/005820 WO1998020862A1 (en) 1996-11-11 1997-10-22 Immediate wettability water soluble film or water soluble layer for oral application

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CA2265651A1 CA2265651A1 (en) 1998-05-22
CA2265651C true CA2265651C (en) 2004-03-16

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EP (2) EP1362584B1 (en)
JP (3) JP4063331B2 (en)
KR (2) KR100569847B1 (en)
AT (2) ATE247954T1 (en)
AU (1) AU739698B2 (en)
CA (1) CA2265651C (en)
CZ (1) CZ297354B6 (en)
DE (4) DE19646392A1 (en)
DK (2) DK1362584T3 (en)
ES (2) ES2206692T3 (en)
HK (1) HK1035316A1 (en)
HU (2) HU228464B1 (en)
ID (1) ID22526A (en)
IL (2) IL129819A0 (en)
MY (1) MY125548A (en)
NO (2) NO325073B1 (en)
NZ (1) NZ335063A (en)
PL (1) PL190376B1 (en)
PT (2) PT1362584E (en)
SI (1) SI0936905T1 (en)
SK (2) SK285999B6 (en)
TR (1) TR199901633T2 (en)
TW (2) TWI250029B (en)
WO (1) WO1998020862A1 (en)
ZA (1) ZA9710093B (en)

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US5800832A (en) * 1996-10-18 1998-09-01 Virotex Corporation Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
DE19646392A1 (en) * 1996-11-11 1998-05-14 Lohmann Therapie Syst Lts Preparation for use in the oral cavity with a layer containing pressure-sensitive adhesive, pharmaceuticals or cosmetics for dosed delivery
US20050048102A1 (en) * 1997-10-16 2005-03-03 Virotex Corporation Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
DE19832169A1 (en) * 1998-07-17 2000-01-27 Jenapharm Gmbh Treating or preventing oral atrophic symptoms, e.g. marginal periodontal disease, by local administration of estrogen such as estriol
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