CN101171037A - Edible film for transmucosal delivery of nutritional supplements - Google Patents

Abstract

In one embodiment of the present invention a composition is provided comprising a film layer wherein the film layer rapidly dissolves in an oral cavity and a coating comprising a powder matrix, wherein the coating is applied to at least one side of the film layer and wherein the powder matrix comprises a nutritional supplement, an adhesive, a bulking agent, a flow agent, and a sweetener.

Description

The edible film of nutritional supplements mucosa absorption

Related application

[0001] the application requires priority: (a) U.S. Provisional Patent Application 60/677, No. 679, application on May 3rd, 2005, (attorney docket 57778.8005.US00), (b) U.S. Provisional Patent Application 60/677, No. 717, application on May 4th, 2005, (attorney docket 57778.8005.US01), (c) U.S. Patent application 10/713, No. 544, application on November 14th, 2003, (attorney docket 57778.8001.US01), it requires U.S. Provisional Patent Application 60/426, No. 598 priority, application on November 14th, 2002, (attorney docket 57778.8001.US00), and No. 60/497,186, U.S. Provisional Patent Application, application on August 22nd, 2003 (attorney docket 57778.8003.US00), (d) No. 10/402,273, U.S. Patent application, application on March 28th, 2003, (attorney docket 57778.8002.US00), (e) No. 10/921,770, U.S. Patent application, application on August 18th, 2004, (attorney docket 57778.8003.US01), it requires the priority of No. 60/497,186, U.S. Provisional Patent Application, application on August 22nd, 2003 (attorney docket 57778.8003.US00), and (f) U.S. Patent application 10/706, No. 810, application on November 12nd, 2003 (attorney docket 57778.8004.US00), it requires U.S. Provisional Patent Application 60/426, No. 598 priority, application (attorney docket 57778.8001.US00) in November 14 in 2002, above-mentioned document here is cited with for referencial use, comprises accompanying drawing.

Technical field

[0002] the present invention is relevant with the use of the edible film of the saturating mucosa absorption of supplementary.

Background technology

[0003] human vitamin, mineral, medicinal herbs and other nutrient substance of consuming had very long history.Along with the Graham cracker of Reverend Sylvester Graham invention and Kellogg to the corn package development, it is believed that at 19th-century health food industry to have occurred.

Behind [0004] 20 middle of century, consumer is encouraged one day three nutritious food of consumption and is avoided the negative influence of food to health.In the later stage in last century, emphasis has turned to the consumption of monitoring quantity from avoiding food to the negative influence of health.Just this time, the medical science of accelerated development and science have promoted nutraceutical group's understanding and have popularized.

[0005] mainly under the driving of the population interest of the life style of baby's demography and unsoundness consciousness, health food industry from 1992 to 1998 is grown up with 15% compound growth rate.Fully slow down and estimated that next three years is about 10% at this rate of increase during 1999.Various provide the source estimate domestic natural prodcuts in 1999 sale between 25,000,000,000 dollars and 35,000,000,000 dollars.

[0006] in the past in some years, the consumer that replaces enhancing that medical science popularizes and more and more many unsoundness consciousness has become the factor that the sale of supplementary increases.This trend is supposed to continue, along with the further increase of selling future.Vitamin and supplementary have been supported the extensive communications and reports raising of the science investigation of these judgements to the public awareness of the good effect of health.Demand to the non-elastic force of natural food product is also guaranteed by the growth of industry.We observe, and the requirement of the price sensitive of health food product is seemed less than the requirement to the price sensitive of conventional food.We believe that consumer is willing to mean the extra price of such production payment, and following two important reasons are arranged:

[0007] 1. they believe the health benefit that consumes such product.

[0008] 2. their busy life style requires the facility of vitamin and supplementary.

[0009] healthy professional person's the quantity that increases has gradually been affirmed the benefit of supplementary and has been advocated them in the application of avoiding aspect the disease, such as heart disease and heart attack.Similarly, government and health care supplier plan to lower health care costs and emphasize the health care that prevents.Routine consumption that the selectivity supplementary has been pointed out in nearest research and related between the symptom minimizing incident on a large scale, cancer, heart disease, heart attack and arthritis.

[0010] the aging and corresponding of U.S. population concentrates on variation on the preventative health detection with focus, comprises good diet significantly, will continue to increase the demand to vitamin and supplementary.According to the investigation of U.S. population generaI investigation administration, the consumer group at 36 years old and bigger age has accounted for the overwhelming majority of the conventional user of vitamin and supplementary, expects to increase above common population fast in 2010.Industry provides the source to report that also vitamin consumer is just using more vitamin and supplementary than in the past in every day.Unified, powerful demography trend and more the nutrition of science be desirably in the several years coming.

[0011], is necessary to provide a kind of replacement method that transmits supplementary based on aforementioned reason.

Summary of the invention

[0012] the present invention relates to various oral cavity/oral mucosal system, it is used for to mammal and/or human health transmission supplementary.

[0013] so saturating oral cavity/oral mucosal system comprises that quick dissolving band, film composite, powder, gel, spraying, time-delay discharge cough drop or slow release bag (reservoir packet) and other saturating oral cavity/oral mucosal medicine/substance delivery system.

[0014] a kind of so saturating oral cavity that can be used to transmit supplementary/oral mucosal system is 3M ^TMCydot ^TMSystem, it can adopt the multiple structure that comprises matrix and slow release design.Saturating oral cavity/oral mucosal system that supplementary is transmitted in another kind of such can being used to is " the oral cavity band two-layer system " of root (Zengen) company once, and it is used in Chloraseptic ReliefStrips ^TMAlso having a kind of system can be a kind of " tea bag " device, and it is similar to Skoal Bandit ^TMProduct.

[0015] such supplementary includes but not limited to ferrum, sodium, calcium, magnesium, carbohydrate, protein, sugar (glucose), zinc, molybdenum, copper, potassium, manganese, chloride, bicarbonate and carbonate, aluminum, arsenic, bromine, cadmium, chromium, chlorine, cobalt, fluorine, iodine, manganese, molybdenum nickel, phosphorus, selenium, silicon, vanadium, zinc, aminoacid, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, compound vitamin B, thiamine (vitamin 31), riboflavin (vitamin 132), nicotinic acid (niacin usp, vitamin B3), pyridoxol (vitamin B6), biotin, pantothenic acid and pantethin, folic acid, vitamin B12, " unofficially " B vitamin comprises choline and inositol, Citrin (bioflavonoids), and/or other important nutrition, add various homoeopathic/selectable material.

The specific embodiment

[0016] in order to understand other advantage and the purpose that mode that foregoing describes and the present invention obtain fully, the ensuing specific embodiment will be carried out more careful description.

[0017] therapeutic agent can be transmitted at the mucus thin film effectively.Saturating mucosa absorption is attractive especially to be because these mucus thin film are extremely thin and have an impregnability.Such characteristic allows medicine (material) to take in health rapidly.This effective absorption allows medicine (material) to walk around the natural defence of some healths and improves the effect of treatment.Saturating mucosa absorption system has more benefit than other medication, comprising:

[0018] directly absorb: the absorption that the mucus thin film is finished directly enters blood circulation.This allows medicine (material) to walk around gastrointestinal tract and the approach liver metabolism first time.This is extremely important to biopharmaceuticals.

[0019] attack rapidly: medicine (material) directly enters blood circulation, and this allows therapeutic agent be sent to the position of needs apace.The target area that medicine/material arrives it more fast, what it can begin to draw it needs effect also more fast.

[0020] reduce dosage: avoid gastrointestinal tract and for the first time the approach metabolism mean that then medicine still less can reach identical effect, allow less dosage of use and less side effect.

[0021] saturating mucosal drug transmission is divided three classes usually:

[0022] product of saturating nasal membrane comprises nasal spray, pump and gel.The most drug that is transferred to nasal passage is an anti-inflammatory.

[0023] saturating oral cavity/oral mucosal system, it utilizes saliva to discharge therapeutic agent.This series products comprises oral cavity binding agent, quick-dissolving band or other fast dissolving transmission system, slow release pouch or forms such as parcel and solid antitussive soft sugar.

[0024] suppository vagina or urethra, this transmission system are fit to directly be absorbed by capillary bed vagina or penis.

[0025] a kind of viscosity polysaccharide matrix that is suitable for traping the outer particle that may enter this system is coated in mouth, nasal passage, vagina and urethra.This is the defence medicine, avoids the tissue that is positioned at the fragility below the epithelium and the injury of capillary bed.Though mucus thin film protection health avoids exterior materials and virus, should than mucus thin film impregnability be arranged more in the zone.The medicine that this impregnability allows to be transferred to the mucus thin film participates in circulation soon.

[0026] except the other factors of malnutrition, nutritive solution can be used to that the oral cavity replaces vomiting, diarrhoea, seriously perspires, the fluid loss of other form and/or other natural nutrition relevant with the hereditary nature of health or present genetic state nutritional losses during lacking, and also has other malnutrition reason.

[0027] saturating mucosa nutritive supplement can be used to slight, medium and/or serious nutritional losses situation.

[0028] when consider gastrointestinal pipeline, stomach, material digestion and absorbs, swallow, agreement is comply with and material is renderd a service negative results, and about gastrointestinal metabolic other as a result the time, the saturating mucosa absorption that supplementary is supplied with is better than the oral cavity and transmits.

[0029] a kind of suitable edible film of the specific embodiment of the present invention use can be selected according to following factor by those skilled in the art, comprises compatibility, restriction of production, cost or other the factor of required rate of dissolution, the oral cavity sense of touch of required user, thin-film carrier and active component.Thin film can also be selected thick or thin according to above-mentioned factor.

[0030] being used for dissolved desired rate can change according to the concrete application of edible film.For example, at the transmission immediately of active component, thereby thin film can be manufactured into apace all dosage that active component is once transmitted in oral cavity dissolving.Thereby thin film also can be manufactured into just to dissolve required through an extended period and transmit a certain amount of active substance to the oral cavity in long-time.

[0031] concrete form of film and manufacture method are that prior art is known, for example, No. the 5th, 948,430, people's such as ZERBE United States Patent (USP), here as reference.Every kind of form of film generally includes film forming agent, bulking agent (bulking agent), softening agent, strong man and makes sweeting agent, sugar alcohol, natural sweetener, flavoring agent, cooling medicament, surfactant, coloring agent, oils and desiccant.These compositions are widely known by the people in food industry and are extensive use of.

[0032] main component of edible film of the present invention is the film forming agent, and it can be any water miscible film forming agent under the situation of major part.The film forming agent includes but not limited to amylopectin, Gua Er (bean) glue, pectin (pectin), xanthan gum, alginate, gelatin, starch (comprising corn, Rhizoma Solani tuber osi, rice or Tapioca starch), modified starch, maltodextrin (matltodextrins), gluten, carboxymethyl cellulose, Rhizoma amorphophalli glucomannan (carrageenan Rhizoma amorphophalli) or locust Caragana arborescens glue.

[0033] example of a kind of edible film of the present invention comprises bilayer film.Thin film has the first water-soluble layer and second dry coating as basic unit or active layer.Second dry coating is placed in the basic unit that is attached on the bottom.Although active component can be included in arbitrary layer, preferably second dry coating will comprise one or more active component, such as menthol or benzocaine or above two kinds.Dry coating is applied in film surface after the processing of first (end) layer segment, it is attached to this bottom.Described dry coating is especially effective to low dosage active component (it needs low-down humidity environment to keep stable) with similar layer.The second layer also can comprise matrix and partitioning agent.

[0034] size of thin film is fit to dissolving apace.The weight of each band can change.The weight of band can be changed to about 10 to 80 milligrams, and preferably approximately 20 to 70 milligrams, more preferably about 30 to 60 milligrams and about 50 milligrams.The maximum dosage of each band can change according to the selection of active component.Preferably 12.5 milligrams of maximum dosages.Active component can be transmitted with the form of solid or liquid, and according to dosage level, active component can be an oil or water miscible.Stable active component in water system preferably.Yet, though be not first-selected, but still can adopt a kind of in water system unsettled active component.Preferably, the dosage of at every turn taking is the 1-2 band, but can change according to the size and the other factors well known by persons skilled in the art of indivedual bands.

[0035] in fact, single band can be made any size, and preferred band is 13/16 inch rectangle of taking advantage of 11/4 inch.The thickness of ground floor is preferably between about 0.040 to 1.1 micron (micrometer).The thickness of second dry coating is preferably between about 0.007 to 0.02 micron.The thickness of certain layer can more or less surpass value described herein, according to factor well known by persons skilled in the art, such as loading and difficulty of processing.

[0036] any standard manufacture program known in the art can be used for making this thin film.An example of this method can be with reference to No. the 5th, 948,430, people's such as ZERBE United States Patent (USP).

[0037] can be with further reference to the production method that discloses in No. the 5th, 948,430, people's such as ZERBE the United States Patent (USP), the production of edible film of the present invention also can comprise a ventilative step.This step is exposed in the air this material before being included in and being applied on the matrix.Ventilative most preferably breathing freely by mechanical agitation, mechanical retroaction or carbon dioxide reached.The edible film ratio that ventilative step is produced has bigger thickness and lower density when ventilative.

[0038] the further specific embodiment of the present invention comprises a kind of thin film and the method that is used to make such thin film of improvement.Thin film can be used on the cell alive.The form of the medicated layer of thin film does not need solvent and will heat and prune the probability of damaging and reduce to minimum.Rate of dissolution or can easily adjust by the medicine transmission of thin film.Although the probability that the medicine that heating is caused damages drops to minimum, medicated layer allows to be heated so that form coating on edible film.At the production period of medicated layer, hydrophilic component can easily add with bigger concentration.

[0039] further, the present invention includes the improved compositions that is used at oral cavity transmission medicine.Compositions comprises coating and the thin layer that is employed.

[0040] thin layer can be made by following arbitrary substance: polymer, softening agent, filler, matrix or other compositions.At specific film thickness, thin film has acceptable dissolution rate in the oral cavity.For example, if thin film has the thickness of 50 microns, it needs thin film to dissolve in the oral cavity in about 15 seconds.Or it can allow thin film dissolve slowlyer.As example, rather than restriction, thin film can be manufactured with amylopectin, modified starch, pectin, carrageenan, maltodextrin or alginate.

[0041] coating of Ying Yonging is the powder matrix that comprises one or more medicines.Medicine can be contained in the dust carrier, or can itself be exactly powder.A benefit of powder matrix is that it does not need to use solvent usually.Another benefit of powder matrix is that it is canned usually, if need, can increase multiple different aid composition in medicine.The further benefit of powder matrix is that it can be mixed at fluid bed, and this can minimize the generation of pruning and heating.Dry air or other gas are upwards scattered by a plurality of openings so that suspend and hybrid fine particles on fluid bed.Arbitrarily required method can be used for making powder mixes.Another benefit of mixing or suspended powder is the caking that dry air suspended powder microgranule is avoided microgranule easily on fluid bed.Apply mixed powder matrix to thin layer before, mixed powder matrix can also be stored (just, suspending) on fluid bed.The powder matrix can be employed in any required mode, comprise filtration, screen out, atomizing, static, mechanical agitation, or the like.For example, the powder matrix can or adopt compressed-air actuated similar electrostatic gun to be atomized by Nordson.A kind of spray gun can produce the very thin spraying of powder particle.Rifle makes the powder particle static electrification, and thereby they are attached to the surface of the thin layer of accepting powder particle.The another one method that applies powder particle is that microgranule and liquid-carrier are mixed formation microgranule-liquid solution.Microgranule-liquid solution is sprayed on thin layer.The liquid-carrier evaporation stays powder particle on thin film.Liquid-carrier preferably can not make powder particle dissolve in liquid-carrier.

[0042] aid composition that can be included in the powder matrix with medicine is a kind of through one section slowly dissolved compositions of the scheduled time.Such assist in dissolving control combination thing can be used in the release of the medicine that slows down in the oral cavity.The example of this aid composition is, but is not limited to, as gel form compositions, gelatin, alginate, amylopectin, PVP and other the hydrophilic material of carrageenan; Cyclodextrin; And, as the inert material of calcium and fiber.For example, fiber can comprise carboxymethyl cellulose.

[0043] the other aid composition that can be included in the powder matrix with medicine is the absorbing composition that absorbs water or saliva.Also can be used for the slowing down release of medicine of such additional absorption compositions, and/or, a gel formed.If necessary, it is masticable that gel can make band become, similar very soft fruit jelly-bean or pea.Herein, aid composition is called as gel, when contacting in the time of in it is placed in the oral cavity or with other source of body fluid, (1) aid composition absorbs at least four times water or the saliva or other the aqueous solution of its weight at least in one section selection time, or expand at least in one section selection time its three times of thickness of (2) aid composition.This section selection time can change, but preferably from five seconds to 15 minutes, most preferably five seconds to five minutes.The example of gel aid composition includes but not limited to, carboxymethyl cellulose, pectin, modified starch, gelatin and carrageenan.These compositionss can be by by oneself or be used in combination.A benefit of gel is its slow down easily dissolving of medicine and keeping in the oral cavity one long period of medicine.

[0044] aid composition that further can be included in the powder matrix is, when contacting with mucosa in it is placed on the oral cavity, it is attached on the mucosa.Thereby the concentration of those accessory attachment compositionss in the powder matrix can be adjusted change thin film be attached on mucosa time length or change the bonding force that between thin film and mucosa, produces.The accessory attachment compositions is attached on oral mucosa or other mucosa or tissue partly of health, comprises mouth, nose, eyes, vagina and rectum.The example of accessory attachment compositions comprises carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone (povidone), sodium alginate, methylcellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, Polyethylene Glycol, carbopol (carbopol), polycarbophil, carboxy vinyl copolymer (carboxyvinyl copolymer), propylene glycol alginate, alginic acid, methylmethacrylate copolymer, Tragacanth, guar gum, karaya gum, ethylene-vinyl acetate copolymer (ethylene vinyl acetate), two menthyl polysiloxanes (dimenthylpolysiloxanes), polyethyleneglycol block copolymer and hydroxyethyl meth acrylate copolymer.Here all examples of the compositions that provides without limits other quite or the use of the compositions that equates of function or comprise, although those compositionss suitable or that function equates are not listed.

[0045] another aid composition that can be contained in the powder matrix is a flow composition, and when its processed processing, it flows so that form slick or bright coating in the outside of thin layer.Thereby the selected temperature that first-selected processed is the thin layer that will have powder coating is heated to above 76 degrees Fahrenheits makes the auxiliary flow compositions softening and flow.The example of this aid composition is oils and fats (fat that comprises various animal and vegetable) wax, special low melt wax and polyol, special low melting point polyol is can be with powder type mixed or can be included in the powder particle, and powder particle comprises medicine or other compositions.Medicine itself also can have mobile characteristic so that form slick or bright coating under the temperature of the rising that surpasses 76 degrees Fahrenheits.

[0046] other the aid composition that can be contained in the powder matrix includes but not limited to, bulking agent, filler, pigment (coloring), flavoring agent and sweeting agent.

[0047] combination of aid composition can be contained in the powder matrix so that reach a required function.For example, the dissolving of the medicine that slows down if desired, less solubilized filler and fiber can be contained in and be accompanied by polymeric high concentration in the powder matrix, and this polymer has the very strong ability that attaches to intraoral mucosa.

[0048] after thin layer is manufactured, the powder matrix is administered on the thin layer usually so that form the coating that applies.

[0049] the powder matrix of Ganing will comprise usually than water maintenance in a small amount or that retrain or other liquid, usually is less than about 10 of weight.Humidity level in the powder matrix should not cause usually powder particle powder mixes with form the powder matrix during and the powder matrix is applied to thin layer during cohere or stick each other.

[0050] as example, rather than restriction, thin layer can be produced uses the high water soluble polymer to comprise a kind of natural or synthetical water-soluble poly zoarium.Polymer preferably has good thin film moldability, produces the soft flexible thin film that has, and the mankind are consumed is safe.A kind of such polymer can be the salt of water-soluble cellulose derivative as hydroxypropyl cellulose (HPC), methylcellulose, hydroxypropylalkylce,lulose, carbo methylcellulose or carbo methylcellulose.Or polymer can comprise acrylate rubber or its sodium, potassium or ammonia salt.Acrylate rubber or its salt can make up as comonomer with methylpropanoic acid olefin(e) acid, styrene or vinyl-type ether, polyvinyl ethanol, polyvinyl pyrrolidone, polyglycols (polyalkyleneblycol), hydroxypropyl starch, alginic acid or its salt, polysaccharide class or its derivant such as Tragacanth, low-quality gelatin, collagen protein, metagelatin and the collagen protein of handling with succinic acid or anhydrous phthalandione.As example, following can be contained in the powder matrix as binding agent: the cellulose derivative of poorly water-soluble comprises ethyl cellulose, cellulose acetate and butyl chloride; Lac; Higher fatty acids comprises stearic acid and Palmic acid.Followingly also can be used for producing thin layer: amylopectin, maltodextrin, pectin, alginate, carrageenan, guar gum, other gelatin, or the like.

[0051] bulking agent that can be contained in the powder matrix comprises, as example rather than restriction, microcrystalline Cellulose (avicel), sugar alcohol comprise mannitol (manitol) and sorbitol and xylitol and hydroxyl isomaltulose (isomalt), lactose, sorbitol dextrin, starch, anhydrous calcium phosphate, calcium carbonate, magnesium trisilicate, tripoli and amylase.

[0052] size of the microgranule in the powder matrix can change as required, and still preferably about 10 orders are to 400 orders or more very thin, and preferably 40 orders are to 300 orders.

[0053] thickness of thin layer can change as required, but generally is the scope at 0.01 millimeter to 3.00 millimeters, preferably 0.03 millimeter to 1.00 millimeters.

[0054] the powder matrix can be applied to the one or both sides of thin layer.Thin layer comprises the last outer surface at the top that is positioned at thin layer and comprises following outer surface on the bottom that is positioned at thin film.Last outer surface is parallel to outer surface down usually.The top of thin film is parallel to the bottom of thin film usually.The thickness of powder base layer can change as required, but preferably 0.001 millimeter to 3.00 millimeters scope, more preferably 0.01 millimeter to 1.00 millimeters.

[0055] if desired, after the powder base layer is applied in thin layer, one or more additional layers can on the powder base layer, be applied in case seal the powder base layer and the powder base layer that slows down in the dissolving of medicine, or the like.

[0056] if desired, a plurality of powder base layer can be applied in thin layer.Thin layer can comprise the stacked of two layers or multilayer.Produce thin layer and in thin layer, mix plasticizer, bulking agent, correctives, pigment, or the like method be as known in the art, here be not described in detail.Because medicine is to be applied in thin layer with the powder type of doing, the unfavorable reciprocal action between medicine and the compositions (comprising thin layer) can be reduced.

[0057] unless context point out specially or requirement, otherwise, word used herein " edible " can replace with " but orally consumable ", and generally is meant and can be placed on mouth, oral cavity, the tongue or similar article, and the receiver is not had major deterious effect.

[0058] in the specific specific embodiment, compositions of the present invention and thin film can comprise a kind of flavoring agent at least and/or make compositions or thin film becomes delicious odorization composite.Effectively taste or abnormal smells from the patient can be used arbitrarily.Flavoring agent or abnormal smells from the patient medicament or various medicaments can be any effectively quantity, comprise, for example, and from about 0.5 to 40wt.%, 1 to 30wt.%, 5 to 15wt.%, 0.5 to 15wt.%.Flavoring agent can be natural or synthetical, or the combination of the two.

[0059] unless context points out specially or requirement that otherwise edible film of the present invention can adopt any effective means manufactured.No. the 20010022964th, U.S. Patent application, No. 20020131990 and No. 20020019447 and United States Patent (USP) 6,419,903,3,931,146,5,411,945,6,010,716,5,629,003,5,948,430,6,177,096,6,284,264,5,700,478,6,449,925,4,072,551,4,083,741, here all quoted with for referencial use, disclosed the method that is used to make edible film.These and other method known in the art, or describe here, can be used for the present invention.

Embodiment

The malnutrition that Application Example 1-is caused by the excess flow loss

[0060] nutritional losses that is particularly caused by diarrhoea and vomiting can cause serious symptom, especially to baby and teenager, even can cause death.Diarrhoea generally include small intestinal dust cloth Salmonella cause the enteropathy strain infection, it generates heat-stable and/or heat labile enterotoxin.Relevant enterotoxin such as cholera production, and is caused diarrhoea by other enteropthogens.These enterotoxins stimulate the fluid secretion in the enteral chamber and cause diarrhoea.Related fluid loss can cause death.

[0061] under the situation of serious dehydration, corrigent parenteral (intravenous) treatment is normally essential.Under the situation of moderate dehydration, the oral cavity ORS provides a kind of treatment safe, economy and replaces intravenous therapy.The oral cavity electrolyte solution that is used to oral cavity maintenance or rehydration treatment comprises the mixture of electrolyte and carbohydrate composition (such as glucose or dextrose).

[0062] saturating mucosa nutritive supplement can be used to by diarrhoea and vomit nutrient-deprived slight, moderate and/or the serious situation that causes.

The Application Example 2-aged's malnutrition

[0063] 3,000,000 of the U.S. are had some dysphagias by nursing 50% among resident to 75%.Nursing-home of Canada studies show that to 349 patients' 68% shows the sign of dysphagia, and 40% shows moving difficulty when being required to swallow medicine.

[0064] be a great challenge for this millions of patient makes up a prescription to nursing-home, servant mechanism even general hospital.

[0065] Jian Kang ﹠amp; The research report that mankind service department submitted to parliament on February 17th, 2002 is found to be not good at above nursing home's nursing of 90%, so and must spend 7,800,000,000 yuan of treatment standards that reach the edge that do not budget in 1 year.Because the deficiency that medication management is supported, what chronic disease patient suffered is painful maximum.

[0066] is in and takes care of and in nursing-home, the spiritual influence of ageing process often makes the complex managementization of fixed dosage form.The popular scope of the anxiety in nursing home's environment is 75-90%; The spiritual sickness rate benchmark of suffering from the Alzheimer disease patient is annual 20%, three year 50%.Attempt at home to allow care-giver and exhausted to the arguement of these patient's dispensers by oral cavity fixed dosage form, and, the institutionalization of sufferer.Typical disorder comprises does not correctly estimate dysphagia.

[0067] Parkinson's disease: a topmost manifest symptom of Parkinson's disease is a sialorrhea, and this influences the patient of 80-90%.Sialorrhea results from can not swallow saliva, is not that overproduction-in fact, the saliva that in fact Parkinson's disease patient produces is lacked than the normal person.Anticholinergic is prescribed usually to " doing clothes ", has surpassed actual saliva, has caused more viscosity of saliva, makes to be difficult to more swallow.

[0068] there is other patient of chronic dysphagia to comprise those people that suffer from chronic impairment lung disease, apoplexy and Alzheimer disease, also has ill and head and neck are carried out those people of radiation cure.

[0069] considers that other reason that mucosal drug transmits may be the metabolic minimizing of liver or avoid.Liver seriously changes some medicines, as hormone.With regard to other, for the first time-metabolism of approach liver may slacken the metabolism of the other medicines that patient is treated.

[0070] can simulate the difficulty of making up a prescription at the early stage test of healthy volunteer's mouth cavity medicine, when being used for actual patient and receiving treatment.This test will generate medicine (metabolism) kinetic curve of normal volunteer's oral cavity 5-HT3 antagonistic drug-and use these curves to go the anticipation patient that how many medicines are vomitted because of chemotherapy after taking in capsule to absorb, and this is difference fully.

[0071] last, some medicines when transmitting with oral cavity fixed dosage form, are exposed to unacceptable levels of drugs with whole health or certain organs, are like this for some patients at least.The example of those medicines comprises NSAIDs, treatment of erectile dysfunction and antifungal agent.

[0072] in the NSAIDs situation, the system management of oral cavity fixed dosage form is generally used for treating a kind of height local pain, causes the blood level of inducing the responsibility of bleeding, and annual about 76,000 hospitalization persons are injured and 7,600 death.

[0073] therefore, saturating mucosa nutritive supplement are beneficial in some cases, can not be other situation of preferred manner such as old people, baby and oral cavity transmission.

Application Example 3-malnutrition and hyponatremia (hyponatremia)

[0074] in JIUYUE, 1999,19 years old USAF new recruit is 5.8 miles falls down suddenly on the march, and body temp is Fahrenheit 108 degree.The doctor concludes him because the heatstroke that causes of overhydration and low blood sodium level and death.

In January, [0075] 2000,20 years old AUS new recruit has drunk about 12 quarts water during 2 to 4 hours, attempt to generate urine sample so that drug test.She has experienced acathexia, loss of consciousness and has become irritated then, then the death owing to hang down brain that blood sodium causes and pulmonary distension water.

[0076] March calendar year 2001,19 years old naval dies from and drunk too many water after 26 miles march, and he carries march period and surpass 90 pounds knapsack and equipment.Though he seems fine in the initial stage of march in 8 hours, during to terminal point, he has begun vomiting and has seemed excessively tired.He is sent to hospital then, and he has been absorbed in stupor there, the swollen water of brain has taken place and death in second day.Do not know how much water he has drunk at march period, but marine corps has " strict regulation " to drinking-water before activity and in the active procedure, the Judd is contained in the up-to-date event of military medicine and writes.

[0077] therefore, saturating mucosa nutritive supplement (sodium replenishes) have benefit aspect the prevention hyponatremia.

Application Example 4-iron deficiency

[0078] anemia is a kind of symptom, and wherein erythrocyte does not provide enough oxygen to bodily tissue.Have many types and cause of anemia.The iron deficiency anemia is that the erythrocyte quantity in the blood that causes very little owing to ferrum reduces.

[0079] the iron deficiency anemia is modal form of anemia.About 20% woman, 50% anemia of pregnant woman and 3% man are that ferrum is insufficient.Ferrum is the necessary composition of hematochrome, takes the oxygen pigment in the blood.Tie Tong often obtains and recirculation ferrum from old erythrocyte by the food of diet.Without it, blood just can not carry oxygen effectively, and oxygen is that to keep the normal function of each cell of health necessary.

[0080] sideropenic reason be in the diet ferrum very little, health is to the absorption difference of ferrum and blood loss (comprising serious menstrual bleeding).It can also with cause child to poison connecting.

[0081] iron loss of anemia basic stock in health and bone marrow to the greatest extent after slower development.The woman usually, is less than man's ferrum deposit and the loss of increase is arranged because of menstruation, and the risk of their anemia is above the man.

[0082] for the woman of man and menolipsis, anemia usually by the gastrointestinal related with ulcer lose blood, aspirin or the use of non-steroidal anti-inflammatory drug thing (NSAJDS) or the cancer (esophagus, stomach, colon) of some type caused.

[0083] excessive risk colony comprises the woman of childbearing age, and it is lost blood because of menstruation; Woman pregnancy or suckling, it has the ferrum demand of increase; Be in baby, child and the teenager of the quick stage of growth; And the people of the poor ferrum of diet.About the risk factor of losing blood is that gastric ulcer, long-term aspirin use and colon cancer.

[0084] reason of Que Faing must be identified, particularly for the old people who suffers from intestinal cancer easily.

[0085] oral cavity ferrum is additional is feasible (ferrous sulfate).Empty stomach is best to the absorption of ferrum, and needs and food are eaten together but many people can't stand this.Thereby milk and antacid can disturb the absorption of ferrum should not replenish edible simultaneously with ferrum.Vitamin C can increase absorption and be necessary during hematochrome is produced.

[0086] because the intake of normal diet is less than demand, so must replenish ferrum in pregnancy with between age of sucking.

[0087] hematocrit should return to normality after the treatment of 2 months ferrum, but ferrum should be continued to use 6 to by 12 months so that supply the ferrum deposit of health, this mainly is included in the bone marrow.

[0088] vein or inner muscle ferrum can be used for the patient that those can't stand buccal forms.

[0089] rich ferrum food comprises dried Fructus Vitis viniferae, meat (liver is the highest source), fish, poultry, egg (egg yolk), beans (Semen Pisi sativi and bean or pea) and full paddy bread.

[0090] therefore, saturating mucosa nutritive supplement (ferrum replenishes) have the benefit as the ferrum supplier, and prevent iron deficiency/anemia.

Application Example 5-calcium deficiency

[0091] calcium all is necessary to many body functions, comprises heart beating rule, nerve stimulation conduction, the stimulation of hormone secretion and condensing of blood, also has for building the skeleton of building and keep a health.

[0092] calcium is found mineral in many foods, and enough calcium pickups are very important because human health can not be produced calcium.Even after finishing whole bone growths, enough calcium pickups are also very important, because health can also have urine and drainage etc., and lose calcium by mucus thin film, fingernail, hair and the perspiration of coming off every day.The calcium that loses every day must replenish by diet.When diet does not comprise competent calcium when finishing this task, calcium just is extracted from bone, the Storage of calcium.

[0093] national science academy and national osteoporosis foundation recommend adult men and women to absorb calcium 1000-1200 mg/day every day.According to expert's saying, food is the best source that provides of calcium; Yet most American does not have competent calcium at their diet.Fortunately, food that calcium is strengthened and calcium replenish can remedy this breach, guarantees that the calcium demand of every day meets the requirements.Quantity required in replenishing provides the quantity that consumes calcium in the source based on food.

[0094] calcium in fact only be present in the bonded chemical compound of other material in.Some different calcium compounds are used to replenish, and comprise calcium carbonate, calcium phosphate and calcium citrate.These chemical compounds comprise not commensurability element calcium, and this is the substantial amount of calcium in replenishing.How many element calcium label reading to have in determine replenishing and to take how much dosage or pill is extremely important in earnest.

[0095] to replenish be available and do not need the prescription of a big piece of writing about ingredients and effect to calcium, and it is enough to allow the selector violate muddle.Many people ask which kind of calcium they should use replenish; Best additional be aspect drug resistance, convenience, cost and practicality, to be fit to the sort of of individual.When selecting calcium to replenish, following is important consideration:

[0096] purity-selection calcium of being proved reliable famous brand name replenishes.Searching is about the mark of " purity " or have USP (U.S.'s pharmacopeia) symbol.Because application USP symbol is voluntary,, many good products do not show this symbol.Avoid using from not refining oyster shell, bone meal, not having the calcium of the dolomite of USP, because may comprise higher lead or other toxic metals before these calcium.

[0097] absorbability-most brand calcium product is absorbed by health easily.If product information does not illustrate that it is to absorb easily, by fritter calcium is placed in a spot of hot water 30 minutes and the time mix up the absorbability that can determine it.If not dissolving during this period of time, it may not can dissolve in the stomach.Masticable and calcium complement lysis liquid must be got well, because broken before they enter stomach.Calcium no matter from diet or replenish, is taken several times and total amount is 500mg or still less the time when every day, can both be absorbed best by health, but all take immediately better than all not taking.When eating with food, calcium carbonate absorbs best.Calcium citrate can be taken at any time.

[0098] though drug resistance-calcium replenish usually can be random for many people selection, for some individualities, some preparation may cause side effect, rise gas or constipation.If simple measure such as increasing liquid and absorbing fiber and can not deal with problems, should attempt using the calcium of other form.Simultaneously, it is important little by little increasing additional picked-up; Take 500 milligrams every day to a week, increase more calcium then at leisure.

[0099] the calcium reciprocal action-to doctor or pharmacists seek advice from prescription or the medicine directly bought with calcium the reciprocal action between additional extremely important.For example, calcium replenishes the absorption that can also reduce the antibiosis tetracycline.Calcium also disturbs ferrum to absorb, and therefore, calcium replenishes should not replenish with ferrum and takes simultaneously.Exception is to replenish when taking with vitamin C or calcium citrate when ferrum.The medicine that the empty stomach of any needs is taken should not replenish with calcium and take.

[00100] compound products-calcium replenishes and may reside in the series of compounds with vitamin and other mineral of numerous names.Although vitamin D is essential to the absorption of calcium, but it be not must be present in calcium replenish in (please refer to 1998 publication) about the osteoporosis report of vitamin D information.Mineral, also very important such as magnesium and phosphorus, but can obtain by food or multivitamin usually.Most expert recommends the nutrition of balanced diet, simultaneously the multivitamin of supplements shortage.

[00101] most of publication studies show that low calcium pickup is relevant with low sclerotin, quick bone loss and high fracture rates.Enough calcium pickups will assist in ensuring that calcium deficiency can not cause the skeleton reduction; Yet, the first step that this just requires bone health.High calcium pickup can not protected the individual to avoid by estrogen deficiency, health inertia, smoking, excessive drinking or the imbalance of various medical science or treat caused bone loss.

[00102] therefore, saturating mucosa nutritive supplement (calcium replenishes) have the benefit that the source is provided as calcium, and prevent calcium deficiency.

Application Example 6-micronutrient is to the influence of muscle contraction (crick)

[00103] crick is initiatively to shrink like the excited electric shock unexpectedly that causes of motor neuron, and perhaps myosin can not be discharged into the moving noggin of flesh from its attraction.Some supposed once that hard cramp may be the abnormal result of electrolyte flow.Modern studying science had difference on the importance that the perspiration of sodium, chloride, potassium and magnesium is lost, and thinks that they are inappreciable, therefore can not prove the first cause of " Rigor syndrome ".Yet some primary evidences show, ATP displacement and sodium, potassium ,-the ATP enzyme is relevant.Being under the existence of adenosine triphosphate hydrochlorate and adenosine triphosphate hydrochlorate enzyme, with extracellular balance, is necessary for keeping of best muscle function in fluid ratio and the electrolyte cell.National tennis player has experienced unaccountable muscle heat cramp during the games.Health check-up and history are to lack uniqueness, and this serum profile by the inpatient is proved.The food analysis of the official comment of loss syndrome and 3-days of perspiring has shown at during the games sodium loss and has surpassed the diet intake out and away.Increase diet sodium chloride every day and eliminated the generation once more of heat cramp.

[00104] in the old people, provide an extreme model by the caused frequent cramps of harm circulation, but the athlete has experienced similar physiological environment in the process of thermal stress.Sudden cramp among the old people is found with electrolyte shortage, thermal stress, metabolism myopathy, thyroid disease, dystonia, drug reaction and hemodialysis direct relation.Recommended therapy comprises that stretching, oral cavity vitamin E and/or quinine sulfate replenish.In addition, there is not single treatment to cure effectively.

[00105] it is as follows that T.D.Noakes doctor (1991) has summed up violent cramp: (1) exhausted glycogen loss additional with being used for fresh ATP is relevant, and (2) Fluid Volume for electrolyte is too much.His suggestion before each durable training that prolongs or during, absorb 16 fluid ounce and use 60-120 gram carbohydrate.

[00106] calcium: important ionizing mineral-during special muscular energy metabolism, the mineral flow may exhaust or change normal electrolyte homeostasis ratio.Calcium is the abundantest mineral and is in the element the 5th of enriching most who finds in the mankind's health.Therefore it is vital to muscle contraction, neural transmission, blood coagulation and multiple metabolic function.Bone is served as the calcium slow release, and calcium is provided when blood serum values drops to 10 milligrams/100 milliliters, and this is controlled by the parathyroid gland hormone and manages.The serum calcium that surpasses half is ionized, and remaining then is protein bound or related with organ and mineral acid.Protein bound calcium is as weak electrolyte, and metabolic active ion calcium is used for muscle contraction by blood and serum.

[00107] blood calcium reduces in the exercise process, wakes the vitamin D activation of parathyroid gland with the excitation ionized calcium up, and discharges from the bone deposit.When calcium level recovered, parathyroid stimulation stopped, and was released from thyroid calcitonin, absorbed/discharged thereby stop bone.(Garrison ﹠amp; Somer 1995) the calcium loss makes the nerve muscle twitches become responsive.Calcium discharges most important to the synapse of neurotransmitters material, it can make neural excited and loosen during muscle contraction.Neurotransmitters burst size and terminal thin film intermediate ion calcium concentration are proportional, and are inversely proportional to magnesium density.For striped muscle and smooth muscle contraction, the enzyme that the transmission level that is contained in varies, acetylcholine and noradrenaline in the blood is subjected to calcium and magnesium helps to change the influence of power.The calcium that does not have appreciable amount, glycogen enzyme, phosphorylase kinase can not weaken into glucose-6P with glycogen so that the energy metabolism.Calcium also adenosine triphosphate enzyme enzyme is used for the hydrolysis of ATP.The crick that Balch doctor (1990) describes is " imbalance and/or the vitamin E deficiency by calcium-magnesium causes usually ".He recommend every day diet or the vitamin E that replenishes 2: 1 calcium (1500 milligrams) of picked-up and magnesium (750 milligrams) and 400-1000IU to prevent crick.The considerable cramp in the leg that studies show that is caused by the metabolic change of calcium at phenolics.(Pitikin 1983) Hammar (1987), Knowles (1981), Odendahl (1974) and Page (1953) research advise that further calcium replenishes or the phosphorus minimizing can prevent and alleviate leg cramp.About calcium balance, reduce serum magnesium and connect with tic and crick.Similarly investigation is verified, can alleviate the muscle spasm symptom when calcium and the additional picked-up of magnesium.

[00108] electrolyte balance: meticulous never static with cation and anion prepared-electrolyte flow compositions, but it is proportional equilibrated in cell and in the extracellular metabolic activity replacement ratio.The consumption of the intracellular cation deposit of the fluid dehydration that causes by the loss of the key of muscle calcium that causes tired out and magnesium, by the loss of perspiring, the extracellular cation deposit of sodium or potassium is the key factor that causes muscle fault (incident just knots).Although previously mentioned nationally ranked tennis player's case study, their serious crick replenish by diet sodium and obtained solution, modern science thinks that a kind of solution is not the condition that is used for the Scientific Methodology of definite conclusive evidence.Crick associates with the hypokalemia organizational environment, and uses potassium to replenish very willingly to alleviate.(Portier 1973) Glatzel (1980) have successfully treated the cramp at night by diet sodium chloride.Strong evidence has shown the related of electrolyte loss and muscle spasm, cramp and top epilepsy, but clear and definite by present investigation document.In fact, it also is very suspicious at present that the shortage during the loss of muscle glycogen, fluid overhydration and nutriment are selected has the vitamin medium that enzyme helps to change power.

[00109] vitamin be nutriment change and free radical purify essential: vitamin 8-6, vitamin E, vitamin E replenish to be found in several clinic observation of Lotzof (1977) and Cathcart (1972) and can alleviate crick.Ayres (1969﹠amp; 1974) two routine tests that carry out have confirmed the discovery of Catheart and Lotzof.Balch doctor's research document (1990) is added to aforesaid scholarship recently.In the research of Ellis and Presley (1973), crick at night and tip/peripheral little crick is alleviated by the oral cavity picked-up of vitamin B-6 (Pyrodoxine).

[00110] therefore, saturating mucosa nutritive supplement have benefit aspect the muscle contraction outbreak alleviating or delay.

The saturating oral cavity of Application Example 7-/oral mucosal nutrition transmission can be moved additional at the nutritional losses that too much fluid loss causes

[00111] another scheme of the present invention is to be used for supplying nutrition and additional composition being provided to the target of strenuous exercise about saturating mucosa method and product, comprise eletrolytes, its avoided many sports drinks and other oral cavity to absorb nourishment limitation that supplement have.

[00112] scheme of the present invention is that quick-dissolving band (or slow release pouch/parcel) is used for giving and nutrition in other period of training process or height energy expenditure.

[00113] nutrition directly is transferred to blood flow from quick band, and they can provide keeping of essential energy of health or homeostasis state there.Do not need nutrition through gastrointestinal tract, absorbing there will be a limiting factor.

[00114] adopt fast-dissolve the additional relative conventional transportation method of transmission of motion of band to have multiple advantage.For example, fast-dissolve the gastrointestinal metabolism that band has avoided motion to replenish, reduced approach influence for the first time, and, if need, can provide the release of the composition that the motion than the traditional method longer time replenishes, such as sports drink or other oral cavity supplement that absorb nourishment.

[00115] quick-dissolving band can comprise the composition of many variable concentrations that motion replenishes.

[00116] fast-the dissolving band can be any traditional type fast-the dissolving band, such as saturating mucosa fast-dissolving band, sublingual gland fast-dissolving band or oral cavity fast-the dissolving band.In the specific embodiment of first-selection, quick-dissolving band comprises that at least a mucus thin film soaks into the enhancing amount of soaking into of reinforce.

[00117] saturating mucosa fast-the dissolving band can be an arbitrary shape, such as oval, square, circular and rectangle or the like.Saturating mucosa fast-the dissolving band can also have multiple size.

[00118] fast-the dissolving band can provide kinestate all nutrition, carbohydrate and the energy requirement down of human body stress, and can not cause the gastrointestinal upset.

[00119] therefore, saturating mucosa nutritive supplement (electrolyte/other replenish) have and replace the too much fluid loss that body movement causes and the nutritional losses that causes.

The saturating mucosa nutritive product of Application Example 8-mixes (compositions)

[00120] following is a kind of prescription (at excessive loss of body fluids) of mucosa nutritive supplement composition

[00121] 1 part of potassium chloride

[00122] 1.93 part of trisodium citrate

[00123] 2.33 part of sodium chloride

[00124] 13.33 part of glucose

[00125] described prescription combines with suitable fluid (water) by the rehydration method.

Application Example 9-vitamin deficiency, micro nutrient deficit

[00126] diet of vitamin and mineral lack-they earn a bare living and need a small amount of (therefore, being micronutrient)-cause learning disorder, intellectual retardation, ill-health, inefficiency, blind, with dead early.This is a kind of destructive public health problem: in all developing countries, be subjected to nearly 1,000,000,000 people that this diet lacks to be influenced, and other billions of people have the danger that develops into above-mentioned crowd.

[00127], studies the wherein South Asian nation of 50,000,000 populations with micro nutrient deficit symptom in order to grasp this huge association from country level.Because lacking this country of symptom, these will suffer following loss:

[00128] 20,000 people's death

[00129] 11,000 child's birth is exactly idiot or blind during preschooler

[00130] 130 ten thousand people is owing to the not good enough or serious incapability of spirit is unemployed

(student overall 3%) fallen into disuse in [00131] 360,000 student's school work

[00132] in the loss that for want of causes, because vitamin A deficiency surpasses 1,003 million peoples and suffers nyctalopia or as blind as a bat.The zone that does not have enough iodine in those diet, because iodine deficiency, five to ten sons and daughters among per 1,000 anemia of pregnant woman die from birth or very fast afterwards death.Serious iron deficiency causes that a death is arranged among five mothers, and simultaneously, entering the mortality rate that hospital do not obtain the child that transfuses blood is 30% (those obtain the danger that then are exposed to other of blood transfusion).

[00133] therefore, saturating mucosa nutritive supplement (micronutrient replenishes) have benefit aspect worldwide internal therapy vitamin/micro nutrient deficit.

[00134] although the present invention here is described with the specific embodiment, those skilled in the art can easily change and other embodiment.Therefore, scope of the present invention is only limited by ensuing claim.

Claims (50)

1. a compositions comprises:

Thin layer;

Coating, wherein, described coating puts at least one side of described thin layer; And

Supplementary.

2. compositions as claimed in claim 1, wherein, described coating comprises the powder matrix.

3. compositions as claimed in claim 1, wherein, described thin layer comprises described supplementary.

4. compositions as claimed in claim 2, wherein, described powder matrix comprises described supplementary.

5. compositions as claimed in claim 4, wherein, described supplementary is selected from in next group material: ferrum, sodium, calcium, magnesium, carbohydrate, protein, zinc, molybdenum, copper, potassium, manganese, chloride, bicarbonate and carbonate, aluminum, arsenic, bromine, cadmium, chromium, chlorine, cobalt, fluorine, iodine, molybdenum nickel, phosphorus, selenium, silicon, vanadium, aminoacid, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, compound vitamin B, thiamine (vitamin 31), riboflavin (vitamin 132), nicotinic acid (vitamin B3), pyridoxol (vitamin B6), biotin, pantothenic acid and pantethin, folic acid, vitamin B12, " unofficially " B vitamin comprises choline and inositol, Citrin (bioflavonoids).

6. compositions as claimed in claim 4, wherein, described supplementary comprises electrolyte.

7. compositions as claimed in claim 4, wherein, described supplementary comprises vitamin.

8. compositions as claimed in claim 6, wherein, described powder matrix comprises assist in dissolving control component.

9. compositions as claimed in claim 8, wherein, described assist in dissolving control component comprises one or more in carrageenan, gelatin alginate, amylopectin, PVP, cyclodextrin, calcium or the fiber.

10. compositions as claimed in claim 6, wherein, described powder matrix comprises absorbent components.

11. compositions as claimed in claim 10, wherein, described absorbent components comprises one or more in carboxymethyl cellulose, pectin, modified starch, gelatin or the carrageenan.

12. compositions as claimed in claim 6, wherein, described powder matrix comprises binding agent.

13. compositions as claimed in claim 12, wherein, described binding agent comprises the cellulose derivative of one or more poorly water-solubles, described cellulose derivative comprises ethyl cellulose, cellulose acetate, butyl cellulose, Lac or fatty acid, and wherein said fatty acid comprises stearic acid and Palmic acid.

14. compositions as claimed in claim 6, wherein, described powder matrix further comprises the mucosa adhesive.

15. compositions as claimed in claim 14, wherein, described mucosa adhesive be selected from next the group material one or more: carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, sodium alginate, methylcellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, Polyethylene Glycol, carbopol, polycarbophil, the carboxy vinyl copolymer, propylene glycol alginate, alginic acid, methylmethacrylate copolymer, Tragacanth, guar gum, karaya gum, ethylene-vinyl acetate copolymer, two menthyl polysiloxanes, polyethyleneglycol block copolymer and hydroxyethyl meth acrylate copolymer.

16. compositions as claimed in claim 6, wherein, described powder matrix comprises flowable.

17. compositions as claimed in claim 16, wherein, described flowable is oils and fats, wax or polyol.

18. compositions as claimed in claim 6, wherein, described powder matrix comprises bulking agent.

19. compositions as claimed in claim 19, wherein, described bulking agent comprises as next group one or more in material: microcrystalline Cellulose, sugar alcohol, lactose, sorbitol dextrin, starch, anhydrous calcium phosphate, calcium carbonate, magnesium trisilicate, tripoli and amylase, wherein said sugar alcohol comprises mannitol, sorbitol, xylitol and hydroxyl isomaltulose.

20. compositions as claimed in claim 6, wherein, described powder matrix further comprises one or more in bulking agent, filler, pigment, flavour enhancer or the sweeting agent.

21. compositions as claimed in claim 6, wherein, described powder matrix comprises that weight is less than about 10% water.

22. compositions as claimed in claim 6, wherein, the thickness range of described thin layer is at about 0.01 millimeter to about 3 millimeters.

23. compositions as claimed in claim 6, wherein, the thickness range of described thin layer is at about 0.03 millimeter to about 1 millimeter.

24. compositions as claimed in claim 6, wherein, described thin layer comprises at least two layers.

25. a compositions, it comprises:

Thin layer, wherein, described thin layer can dissolve in the oral cavity apace; And

The powder coating that comprises supplementary, wherein, described powder coating puts at least one side of described thin layer.

26. compositions as claimed in claim 25, wherein, described thin layer is dissolving in 30 seconds after being placed into the oral cavity.

27. compositions as claimed in claim 25, wherein, described thin layer is dissolving in 15 seconds after being placed into the oral cavity.

28. compositions as claimed in claim 25, wherein, described supplementary is selected from in next group material: ferrum, sodium, calcium, magnesium, carbohydrate, protein, molybdenum, copper, potassium, manganese, chloride, bicarbonate and carbonate, aluminum, arsenic, bromine, cadmium, chromium, chlorine, cobalt, fluorine, iodine, molybdenum nickel, phosphorus, selenium, silicon, vanadium, zinc, aminoacid, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, compound vitamin B, thiamine (vitamin 31), riboflavin (vitamin 132), nicotinic acid (vitamin B3), pyridoxol (vitamin B6), biotin, pantothenic acid and pantethin, folic acid, vitamin B12, " unofficially " B vitamin comprises choline and inositol, Citrin (bioflavonoids).

29. compositions as claimed in claim 25, wherein, described supplementary comprises electrolyte.

30. compositions as claimed in claim 25, wherein, described supplementary comprises vitamin.

31. compositions as claimed in claim 25, wherein, described thin layer comprises one or more in amylopectin, modified starch, pectin, carrageenan, maltodextrin or the alginate.

32. compositions as claimed in claim 25, wherein, described thin layer comprises water-soluble polymer natural or synthetic.

33. a compositions, it comprises:

Thin layer, wherein, described thin layer can dissolve in the oral cavity apace; And

The coating that comprises the powder matrix;

Wherein, described coating puts at least one side of described thin layer, and described powder matrix comprises supplementary, binding agent, bulking agent, flowable and sweeting agent.

34. compositions as claimed in claim 33, wherein, described thin layer is dissolving in 30 seconds after being placed into the oral cavity.

35. compositions as claimed in claim 33, wherein, described thin layer is dissolving in 15 seconds after being placed into the oral cavity.

36. compositions as claimed in claim 33, wherein, described supplementary is selected from in next group material: ferrum, sodium, calcium, magnesium, carbohydrate, protein, molybdenum, copper, potassium, manganese, chloride, bicarbonate and carbonate, aluminum, arsenic, bromine, cadmium, chromium, chlorine, cobalt, fluorine, iodine, molybdenum nickel, phosphorus, selenium, silicon, vanadium, zinc, aminoacid, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, compound vitamin B, thiamine (vitamin 31), riboflavin (vitamin 132), nicotinic acid (vitamin B3), pyridoxol (vitamin B6), biotin, pantothenic acid and pantethin, folic acid, vitamin B12, " unofficially " B vitamin comprises choline and inositol, Citrin (bioflavonoids).

37. compositions as claimed in claim 33, wherein, described supplementary comprises electrolyte.

38. a method of making quick dissolving films, it comprises the steps:

Thin layer is provided;

Apply a coating to described thin layer, wherein, described coating comprises the powder matrix, and described powder matrix comprises supplementary, binding agent, bulking agent, flowable and sweeting agent.

39. method as claimed in claim 38, wherein, described thin layer is dissolving in 15 seconds after being placed into the oral cavity.

40. method as claimed in claim 38, it further comprises the step of dry film layer and powder matrix.

41. method as claimed in claim 40, wherein, described drying steps is to carry out under the softening point temperature of described flowable greatly.

42. method as claimed in claim 38, wherein, described flowable comprises oils and fats, wax or polyol.

43. method as claimed in claim 38, wherein, described supplementary is selected from in next group material: ferrum, sodium, calcium, magnesium, carbohydrate, protein, molybdenum, copper, potassium, manganese, chloride, bicarbonate and carbonate, aluminum, arsenic, bromine, cadmium, chromium, chlorine, cobalt, fluorine, iodine, molybdenum nickel, phosphorus, selenium, silicon, vanadium, zinc, aminoacid, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, compound vitamin B, thiamine (vitamin 31), riboflavin (vitamin 132), nicotinic acid (vitamin B3), pyridoxol (vitamin B6), biotin, pantothenic acid and pantethin, folic acid, vitamin B12, " unofficially " B vitamin comprises choline and inositol, Citrin (bioflavonoids).

44. method as claimed in claim 38, wherein, described supplementary comprises electrolyte.

45. method as claimed in claim 38, wherein, described supplementary comprises vitamin.

46. method as claimed in claim 38, it further is included in the step of preparation coating in the fluid bed.

47. method as claimed in claim 38, wherein, described coating by filter, screen out, atomizing, static or mechanical agitation be applied in.

48. method as claimed in claim 38, wherein, described powder particle is recharged.

49. method as claimed in claim 48, wherein, described coating is applied in by electrostatic gun.

50. method as claimed in claim 49, wherein, described electrostatic gun makes described powder particle charged, thereby makes described powder particle be attached to the surface of described thin layer.