KR101790666B1 - Orally Disintegrating Film for Pet - Google Patents

Abstract

The present invention provides a multi-layered structure comprising a base layer containing a medicament for treating pet diseases or a health-aid drug, and an outer layer comprising a lactic acid bacterium or a lactic acid bacterium that has been heat-treated on the lower surface thereof. (CMC-Na) as a disintegrant, at least one selected from pullulan and modified starch as a disintegrant, and at least one selected from the group consisting of carboxymethylcellulose sodium A base layer comprising a plasticizer, an emulsifier, a sweetener, titanium dioxide, a pharmacologically active agent for the treatment or aphasia of a pet; Wherein the base layer is laminated on the surface of the base layer and at least one selected from carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch, plasticizer, emulsifier, sweetener, titanium dioxide, And an outer skin layer containing Lactobacillus lacta bacteria (L. plantarum) lactic acid bacteria isolated from the cells or kimchi.

Description

{Orally Disintegrating Film for Pet}

More particularly, the present invention relates to a medicament for treating pet diseases or an upper surface of a base layer containing a health supplement such as red ginseng, goji berries, lutein, and omega-3 It has a multi-layered structure with laminated layers of heat-treated lactic acid bacteria or lactic acid bacteria, which are heat-treated on the undersurface, and can be taken without any feeling of pets. The pet is adhered to the tongue or palate in the oral cavity and quickly dissolves, The present invention relates to an oral dissolution film for pets, which can effectively ingest microbial cells or lactic acid bacteria.

In modern society, pets are animals that live together with people. They are also called companion animals. Typical pets include dogs and cats.

These pets are closely related to one another and grow up to receive more care and care from animals than animals.

Therefore, when a pet animal is sick and is sick, when it is sick, it is diagnosed in a veterinary hospital, and the drug is taken. However, the drug is formed into a solid form and administered through the oral cavity, They frequently refuse to take the drug due to the smell of the drug, which makes the administration of the drug through the oral route uncomfortable.

In order to solve such problems, a method of mixing drugs with water and then liquidifying them and forcibly administering them to the oral cavity of a pet through a drug infusion spoon or a syringe was used. However, Because of its bitter taste, it can not be swallowed properly and the drug is spit out again, which makes it difficult to effectively treat the drug.

In order to solve such a problem, in the Utility Model No. 20-2017-0000112, a storage space portion is formed in a pet food, and a solid, capsule, or powder type drug can be stored in the storage space portion, And a drug contained in the feed is administered to the animal, thereby allowing the animal to take the drug without a sense of resistance.

However, feedstuffs capable of storing such drugs have a problem in that, when the pet chews the drug together with the feed, the bitter taste or smell causes the pet to spit it out and still effectively administer effective drugs or medicines.

Korean Public Utility Model No. 20-2017-0000112 (Published on 2017.01.09.) Korean Patent Publication No. 10-2012-0079836 (published on July 13, 2012)

Disclosure of Invention Technical Problem [8] Accordingly, the present invention has been made keeping in mind the above problems occurring in the prior art, and an object of the present invention is to provide a pharmaceutical composition for treating a pet disease or a health supplement containing a lactic acid bacterium, The present invention provides a multi-layered structure comprising a skin layer formed by laminating two or more layers of a skin layer on a pet's tongue or palate to prevent damage to the pet during handling or handling. It is an object of the present invention to provide an orally dissolvable film for pet which can dissolve rapidly after it is applied and can not effectively spit the medicines and can take medicines and lactic acid bacteria or lactic acid bacteria effectively.

In addition, since the lactic acid bacteria and the health supplement components contained in the lactic acid bacteria or the lactic acid bacteria layer can be quickly and effectively absorbed into the body of the pet, it is possible to suppress the occurrence of constipation in the pet and improve the health The present invention provides an oral dissolution film for animals.

In order to attain the above object, the oral dissolution film for pet of the present invention may comprise at least one disintegrant selected from carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch, a plasticizer, an emulsifier, A base layer comprising titanium dioxide, a pharmacologically active agent for the treatment or aphasia of a pet; Wherein the disintegrant is one or more selected from the group consisting of carboxymethyl cellulose sodium (CMC-Na), pullulan and modified starch, a plasticizer, an emulsifier, a sweetener, titanium dioxide, And an outer covering layer containing Lactobacillus lacta bacteria (L. plantarum) lactic acid bacteria isolated from kimchi.

The oral dissolution film according to the present invention has a multilayer structure in which a base layer and an outer skin layer are laminated to each other and has a high tensile strength and can simultaneously take lactic acid bacteria or lactic acid bacteria together with a pharmacologically active agent (for example, nutrition or health supplement) The difficulty in allowing the pet to separately take the pharmacologically active agent and the lactic acid bacteria or the lactic acid bacteria is remarkably reduced.

In addition, since the base layer containing the pharmacologically active pharmacologically active agent has a structure coated with the lactic acid bacterium cells or the outer layer containing the lactic acid bacteria, the release of the pharmacologically active agent to the outside is minimized, Since it is dissolved and ingested, it is not a big objection to the ingestion of pets with excellent olfactory sense.

In addition, once the oral dissolution film is put into the oral cavity of a pet such as a dog or a cat, it sticks to the tongue or the mucous membranes of the mouth of the mouth and dissolves rapidly without falling off. Therefore, the pet can not spit out the oral dissolution film, It is possible to take a microorganism or a lactic acid bacterium.

1 is an exploded perspective view of an oral dissolution film according to an embodiment of the present invention.
2 is a sectional view of the oral dissolution film shown in Fig.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of an oral dissolution film for a pet according to the present invention will be described in detail with reference to the accompanying drawings.

1 and 2 show an oral dissolution film for a pet according to an embodiment of the present invention.

The oral dissolution film for a pet according to an embodiment of the present invention shown in FIGS. 1 and 2 comprises a base layer 10 containing a pharmacologically active agent for the treatment of pet diseases or for assisting health, And two outer skin layers 20 laminated on the upper and lower surfaces of the layer 10 and containing lactic acid bacterium cells or lactic acid bacteria. The thickness of the base layer 10 is approximately 300 to 400 μm, and the thickness of the shell layer 20 is 150 to 300 μm.

The base layer 10 may contain at least one selected from carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch as a disintegrant, a plasticizer, an emulsifier, a sweetener, poly- gamma- glutamic acid (γ- PGA, titanium dioxide, chitosan fiber powders, and pharmacologically active agents for pet disease treatment or health aids.

The outer layer 20 may be formed of a disintegrant such as carboxymethylcellulose sodium (CMC-Na), at least one selected from pullulan and modified starch, a plasticizer, an emulsifier, a sweetener, titanium dioxide, Or lactobacillus L. plantarum lactic acid bacteria isolated from kimchi.

The disintegrant is a polymer substance forming a film, and one or more selected from carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch, which are rapidly dissolved by water, can be used. The above carboxymethylcellulose sodium (CMC-Na) is excellent in strength and plasticity even when added in a low proportion, and is rapidly dissolved in the oral cavity of a pet. Therefore, the content of a pharmacologically active agent or lactic acid bacteria or lactic acid bacteria can be increased do. Polyvinylpyrrolidone may be used in combination with sodium carboxymethylcellulose to allow the sodium carboxymethylcellulose to dissolve more rapidly in the mouth.

The pullulan is a water-soluble polysaccharide produced by Aureobasidium pullulans, a kind of fungi, in which maltotriose units are linked by α-1, 6 bonds. Modified starches can be acid-modified starch, hydroxypropylated starch, alpha-modified starch, cross-linked modified starch, modified starch as starch hydrolyzate, and the advantage of having good film forming ability together with pullulan have.

The disintegrant is a combination of carboxymethyl cellulose sodium (CMC-Na), pullulan, carboxymethyl cellulose sodium (CMC-Na) and modified starch, or carboxymethyl cellulose sodium (CMC-Na), pullulan and modified starch Is preferably used. The disintegration may be carried out in a total weight of the entire base layer 10 of the base layer 10 or the total weight of the shell layer 20 or the total weight of the entire base layer 10 or the total weight of the shell layer 20 of the shell layer 20, Weight% is preferably used.

The plasticizer is used to supplement the strength of the oral dissolution film, and the flexibility of the oral dissolution film can be remarkably improved. The plasticizer is preferably one or more selected from the group consisting of glycerin, glycerol oleate, medium chain fatty acid, polyethylene glycol, propylene glycol, propylene glycol monocaprylate, propylene glycol dicaprylate, saccharides, sugar alcohols and triacetin And 10 to 15% by weight based on the total weight of the entire base layer 10 of the base layer 10 or the total weight of the shell layer 20 or the total weight of the shell layer 20 is preferably used.

The emulsifier may be at least one selected from the group consisting of polysorbate, sorbitan oleate, sodium lauryl sulfate, polyoxyethylene hydrogenated castor oil, polyoxyethylene octylphenyl ether, and mixtures thereof. , For example polysorbate. The emulsifier is preferably used in an amount of 0.1 to 2.0% by weight based on the total weight of the base layer 10 or the total weight of the shell layer 20.

The sweetener may be one or more selected from the group consisting of enzyme-treated stevia, aspartame, acesulfame salt, sucralose, saccharin salt, neo time, cyclamate salt, tau martin, Nahan and extract and licorice extract. The sweetener is preferably used in an amount of 0.1 to 0.5% by weight based on the total weight of the base layer 10 or the total weight of the outer layer 20.

The titanium dioxide is used in an amount of 0.1 to 1.0% by weight based on the total weight of the base layer 10 or the total weight of the outer skin layer 20 to reduce the slipperiness of the film in the oral cavity, And serves to control the decomposition rate of the film and the dissolution rate of the pharmacologically active agent.

The chitosan fiber powder 12 included in the base layer 10 has a rod-shaped fiber form having a width to length ratio of 1: 3 to 1: 5 and a length of 20 to 50 m, It is preferable that 1 to 3% by weight is used based on the total weight. The chitosan fiber powder is a water-soluble chitosan which acts not only to improve the immunity of pets but also to improve the strength of the whole film. When the base layer 10 is uniaxially stretched or biaxially stretched as described below, the chitosan fiber powder 12 and other components are peeled off and the micro slit 11 is formed well when the micro slit 11 is formed.

The orally dissolvable film of the present invention is a structure in which a base layer 10 and an outer layer 20 are laminated. First, the base layer 10 is formed into a film, and then the outer layer 20 is coated thereon, . The base layer 10 was manufactured so that the base layer 10 and the outer layer 20 were not separated from each other and stably adhered after the outer layer 20 was laminated on the base layer 10 The chitosan fiber powders 12 and other components are separated from the chitosan fiber powders 12 starting from the base layer 10 with a weak tensile force applied to the base layer 10 immediately after the base layer 10 is uniaxially or biaxially stretched. A plurality of micro-slits 11 having a length of 탆 are formed.

The micro slit 11 is formed on the base layer 10 and then the material of the outer layer 20 is applied to the surface of the base layer 10 while the material of the outer layer 20 is applied to the surface of the micro slit 11 The bonding strength between the base layer 10 and the outer covering layer 20 can be increased.

Stable lamination and strength enhancement of the base layer 10 and the sheath layer 20 of the oral dissolution film can be improved by increasing the strength of the oral dissolution film which may be caused by the resistance or movement of the pet when the oral dissolution film is consumed by the pet It plays an important role in preventing separation and damage.

In order to increase the bonding strength between the base layer 10 and the outer covering layer 20, the base layer 10 or the outer covering layer 20, or the poly-gamma-glutamate- γ-glutamic acid, γ-PGA). The polygamma glutamic acid is a? -Polypeptide in which the? -Amino group of glutamic acid is bonded to the? -Amino group of glutamic acid and has a high viscosity, so that it functions as an adhesive between the base layer 10 and the outer skin layer 20, And inhibits calcium from becoming insoluble by binding to phosphorus in the small intestine, and promotes calcium absorption, as well as physiologically active proteins such as interferon-alpha and interferon-beta that effectively inhibit influenza virus.

The polygamma glutamic acid is preferably added in an amount of 2 to 5% by weight based on the total weight of the base layer 10 or the total weight of the shell layer 20.

The pharmacologically active agent contained in the base layer 10 may be a pharmacologically active ingredient effective for the treatment or prevention of pet diseases such as alprazolam, pludiazepam, lorazepam, zolpidem, but are not limited to, rabeprazole, famotidine, acetaminophen, el-menthol, nicotine, benzocaine, ascorbic acid, pentamine hydrochloride, caffeine, phenylhexrine hydrochloride, pseudoephedrine hydrochloride, baclofen, The present invention relates to a pharmaceutical composition comprising at least one compound selected from the group consisting of nitroglycerin, simethicone, diphenhydramine hydrochloride, sumatriptan, diclofenac, ramosetron hydrochloride, alprazolam, desloratadine, olanzapine, levonorgestrel, , Topiramate, cetylpyridinium chloride, tartaric acid fendimetrazine, triazolam, omeprazole, toracamide, graciliside hydrochloride, ranitidine hydrochloride, meloxicam, lansoprazole, etc. There.

Also, as the above-mentioned pharmacologically active agent, a component for nutrition and health promotion of pet such as red ginseng, high fat berry, lutein, omega 3, glucosamine, provitamin A carotene, vitamin C, vitamin E, anti- , Bioflavonoids, L-carnitine, alpha-lipoic acid, fatty acids, gamma linolenic acid, evening primrose oil, creatine, gill gyeong, gyeongryeong,

Such a pharmacologically active agent may be used in an amount of 30 to 40% by weight based on the total weight of the base layer 10.

On the other hand, as described above, the outer layer 20 includes Lactobacillus lacta bacteria (L. plantarum) isolated from heat-treated lactic acid bacterium cells or kimchi.

Heat Killed Probiotics is a microbial component of lactic acid bacteria killed by heat treatment of lactic acid bacteria. It lowers the intestinal pH of pets and acts to suppress harmful bacteria, detoxify harmful substances, increase the immunity of host, , And provides the effect of promoting liver function and the like.

Lactobacillus plantarum was cultured under the condition of pH 5 to 7, and the culture broth of this strain was sterilized by heating at 80 ° C for a certain period of time and lyophilized to obtain uniform particles, And the improvement of the intestinal environment through the activation of immune function, and the prevention and treatment effect of colonic diseases including colitis and colon cancer is excellent.

As described above, since the oral dissolution film of the present invention has a structure in which the outer layer 20 including the lactic acid bacteria or the lactic acid bacteria is laminated on the surface of the base layer 10 containing the pharmacologically active agent, And lactic acid bacterium cells or lactic acid bacteria.

Also, since it has a plurality of layers and has a high strength, it is possible to prevent damage to the oral dissolution film due to movement of a pet or external impact when the composition is applied to a pet, and once put into a pet's mouth, Because it sticks to the palate, it does not fall off easily and it is quickly dissolved and absorbed. Therefore, a certain amount of pharmacologically active agent and lactic acid bacteria or lactic acid bacteria can be administered to the pet.

Example

Hereinafter, embodiments of the present invention will be described in detail to facilitate understanding of the present invention. However, the embodiments according to the present invention can be modified into various other forms, and the scope of the present invention should not be construed as being limited to the following embodiments. Embodiments of the invention are provided to more fully describe the present invention to those skilled in the art.

A composition of the base layer 10 and the outer skin layer 20 was prepared by the ingredients and contents described below. A base layer 10 having a thickness of 330 탆 and an outer layer 20 having a thickness of 185 탆 were laminated using a continuous film forming equipment (model name: PA 460-16 m) manufactured by C. Zimmermann GmbH to prepare an oral dissolution film of Example 1 Respectively. The outer layer 20 is laminated only on the upper surface of the base layer 10 and the base layer 10 is uniaxially stretched to form a plurality of micro slots in the base layer 10 and dried, The composition was applied and dried to form a laminate.

ingredient Example 1 Comparative Example 1 (% by weight)
Base layer (% by weight) (% By weight) Carboxymethylcellulose sodium (CMC-Na) 12.5 12.5 - Pullulan 18.2 18.2 36.8 Modified starch 14.1 14.1 7.4 glycerin 12.7 12.7 14.7 Polysorbate 80 1.5 1.5 1.5 Enzyme treatment Stevia 0.5 0.5 1.0 Titanium dioxide 0.7 0.7 0.8 Chitosan fiber powder 2.0 - - Polygamma glutamic acid 3.4 3.4 - Pharmacologically active agent 34.4 - - Lactic acid bacterium - 36.4 33.4 Citric acid - - 4.4

The oral dissolution films of Example 1 and Comparative Example 1 were prepared by dissolving carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch in water, adding glycerin as a plasticizer, polysorbate as an emulsifier, Stichia, titanium dioxide, chitosan fiber powders of 1: 3 ~ 1: 5 and length of 20 ~ 50 ㎛ were added and mixed. The mixture was homogenized at 3,000 rpm using a homogenizer (IKA? T25 digital UTRA-TURRAX) Homogenized. In the case of the base layer 10, 5% concentration of a red ginseng extract solution diluted with water as a pharmacologically active agent was added to the outer layer layer 20 and Comparative Example 1, And the heat-treated lactic acid bacterium cells (trade name: EF-2001) powder thus prepared were added.

The oral dissolution film of Comparative Example 1 is composed of a single layer and has a thickness of 475 占 퐉.

The tensile strength of the oral dissolvable film samples of Example 1 and Comparative Example 1 was measured by a method of measuring the strength when the oral disintegration film was torn by descending at a constant speed with a tensile strength tester. To estimate the rate of disintegration in the mouth after taking the pet, 5 mL of distilled water was poured into a Petri dish and the oral disintegration film was placed thereon to measure the time taken for the film to disintegrate (Garsuch, V., et al., 2009, Eur. J. Pharm. Biopharm., 73, 195-201). The results of the tensile strength measurement and the disintegration rate measurement test are shown in Table 2 below.

division Tensile strength (N / cm2) Disintegration rate (sec) Example 1 1.82 67 Comparative Example 1 1.43 62

As shown in Table 2 above, it was confirmed that the tensile strength of Example 1 was remarkably larger than that of Comparative Example 1. Also, the disintegration rate of Example 1 was slightly slower than that of Comparative Example 1, but it was confirmed that the disintegration rate of Example 1 and Comparative Example 1 was about 1 minute, so that they had a good disintegration rate.

As described above, the oral dissolution film according to the present invention has a multi-layered structure in which the base layer 10 and the outer skin layer 20 are laminated and has a high tensile strength. The oral dissolution film according to the present invention can be used in combination with a pharmacologically active agent (for example, It is possible to take the lactic acid bacteria at the same time, so that the difficulty of the pet to separately take the pharmacologically active agent and the lactic acid bacteria or the lactic acid bacteria is remarkably reduced.

In addition, since the base layer 10 containing a relatively bitter taste pharmacologically active agent is coated on the outer layer 20 containing lactic acid bacteria or lactic acid bacteria, the release of the pharmacologically active agent is minimized, Since the skin layer 20 is dissolved and consumed from the fragrant and tasty skin layer 20, the pet having excellent olfactory nourishment does not have a great resistance to ingestion.

In addition, once the oral dissolution film is put into the oral cavity of a pet such as a dog or a cat, it sticks to the tongue or the mucous membrane of the mouth of the mouth and does not fall off and dissolves quickly, so that the pet can not spit out the film again, and a certain amount of pharmacologically active agent and lactic acid bacterium Lactic acid bacteria can be taken.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention as defined by the appended claims. And it is to be understood that such modified embodiments belong to the scope of protection of the present invention defined by the appended claims.

10: base layer 11: micro slit
12: chitosan fiber powder 20: outer shell layer

Claims (4)

As a disintegrant, at least one selected from carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch, a plasticizer, an emulsifier, a sweetener, titanium dioxide, poly-γ- PGA), a base layer comprising a pharmacologically active agent for the treatment of a pet's disease or a health aid;
Wherein the base layer is laminated on the surface of the base layer and at least one selected from the group consisting of carboxymethylcellulose sodium (CMC-Na), pullulan and modified starch, plasticizers, emulsifiers, sweeteners, titanium dioxide, polygamma glutamic acid poly-γ-glutamic acid, γ-PGA), heat-treated lactic acid bacterium cells or Lactobacillus lacta bacteria isolated from kimchi;
/ RTI >
Wherein the base layer further comprises a rod-shaped chitosan fiber powder having a width-to-length ratio of 1: 3 to 1: 5 and a length of 20 to 50 m, 3% by weight,
Wherein the base layer has a plurality of micro slits formed by uniaxial stretching or biaxial stretching to a length of 10 to 300 mu m and the encapsulation layer is filled in the micro slit in the course of laminating the encapsulation layer to the base layer Oral lining film for pets. delete delete The oral dissolution film for a pet according to claim 1, wherein the outer layer further comprises polyvinylpyrrolidone.

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