KR101801064B1 - Three-layered tablet for treating stomach and intestines disease - Google Patents
Three-layered tablet for treating stomach and intestines disease Download PDFInfo
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- KR101801064B1 KR101801064B1 KR1020150102230A KR20150102230A KR101801064B1 KR 101801064 B1 KR101801064 B1 KR 101801064B1 KR 1020150102230 A KR1020150102230 A KR 1020150102230A KR 20150102230 A KR20150102230 A KR 20150102230A KR 101801064 B1 KR101801064 B1 KR 101801064B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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Abstract
The present invention relates to a triple-layer tablet for the treatment of gastrointestinal diseases. More specifically, it comprises an upper layer, an intermediate layer and a lower layer adjacent to each other, wherein the intermediate layer contains ranitidine hydrochloride as an active ingredient, Which comprises potassium citrate and sucralate hydrate as an active ingredient. The present invention also relates to a triple layer tablet for treating gastrointestinal diseases.
Description
The present invention relates to a triple-layer tablet for the treatment of gastrointestinal diseases. More specifically, it comprises an upper layer, an intermediate layer and a lower layer adjacent to each other, wherein the intermediate layer contains ranitidine hydrochloride as an active ingredient, Which comprises potassium citrate and sucralate hydrate as an active ingredient. The present invention also relates to a triple layer tablet for treating gastrointestinal diseases.
As is well known, Ranitidine hydrochloride is an H 2 receptor blocker that inhibits gastric acid secretion and has the effect of treating or preventing gastric ulcer or reflux esophagitis caused by attack factors such as gastric acid, A large number of products are commercially available.
And Tripotassium Bismuth Dicitrate is a drug widely used for the protection of stomach or duodenal ulcer sites and in particular for the destruction of Helicobacter pylori.
In addition, Sucralfate protects the gastric wall by changing into a viscous substance in the gastric region, that is, in acidic condition of stomach fluid, and further promotes mucous secretion, saccharification, promotion of regeneration of mucous cells, prostagladin, The secretory stimulation of the stomach ulcers and has the effect of treating.
As such, the above three drugs have complementary pharmacological efficacy and clinically sufficient stability is secured, so that various products containing each ingredient are commercially available, and a complex agent system in which these three drugs are mixed has already been developed.
However, in the combined preparation in which the three drugs are simply mixed, potassium bismuth citrate changes the physical properties of the lanitidine hydrochloride, and since the sucralate is changed into a viscous substance and applied to the gastric wall, There is a problem of lowering.
In order to solve such a problem, Korean Patent No. 10-119031 (July 26, 1997) discloses a pharmaceutical composition comprising 50 to 150 mg of ranitidine as granules, which is prepared as a core, 100 to 200 mg of bismuth subcitrate and 300 to 600 mg of sucralfate Coated tablets for the treatment of gastrointestinal diseases.
The double coated tablet is prepared by first preparing tablets containing ranitidine hydrochloride to prepare coated tablets, separately preparing granules in which potassium bismuth citrate and sucralfate are mixed, preparing coated tablets using the coated tablets as a core layer, After preparing the double-coated tablets coated with the granules, the double tablets should be coated again.
Therefore, the double coated tablet has a complicated production process, must use an expensive tablet press machine, requires a long working time, and thus has a problem of increased production cost. In addition, there is a high possibility that the active ingredients may not have a uniform drug release pattern because the double-coated tablets have a complicated structure such as tableting and coating of tablets, and dual definition tableting and coating.
Accordingly, it is an object of the present invention to provide a pharmaceutical composition containing, as an active ingredient, ranitidine hydrochloride, potassium bismuth citrate and sucralate, wherein the sucralate does not change the physical properties of ranitidine or lower the water absorption rate, The present invention also provides a triple-layered tablet for gastrointestinal diseases, which has a novel structure capable of remarkably reducing the production cost as well as being easy to mass-produce in addition to a simple and rapid manufacturing process.
The triple-layered tablet for the treatment of gastrointestinal diseases according to the present invention has a structure in which an upper layer and a lower layer are laminated on both sides with an intermediate layer interposed therebetween. The intermediate layer is composed of ranitidine hydrochloride, excipient, binder, Wherein the upper layer and the lower layer each comprise tripotassium bismuth dicitrate and sucralfate hydrate, an excipient, a binder, a disintegrant, and a glidant.
And the intermediate layer comprises 12 to 13% by weight of ranitidine hydrochloride based on the weight of the whole tablet; 8 to 10% by weight of an excipient selected from deminitol, lactose, microcrystalline cellulose and silicon dioxide; 0.7 to 2.5% by weight of a binder selected from heptamelose, hydroxypropylcellulose, povidone, methylcellulose and gelatin; 1 to 2% by weight of a disintegrant selected from croscarmellose sodium, crospovidone, sodium starch glycolate; 0.2 to 0.5% by weight of a lubricant selected from light anhydrous silicic acid, talc, magnesium stearate and glyceryl behenate.
The upper layer and the lower layer are composed of 13 to 16% by weight of potassium bismuth citrate by combining the two layers based on the weight of the whole tablet; 43 to 45% by weight of sucralate hydrate; 6 to 10% by weight of an excipient selected from deminitol, lactose, microcrystalline cellulose and silicon dioxide; 1 to 3% by weight of a binder selected from heptammelose, hydroxypropylcellulose, povidone, methylcellulose and gelatin; 2 to 7% by weight of a disintegrant selected from croscarmellose sodium, crospovidone, sodium starch glycolate; 0.5 to 0.7% by weight of a lubricant selected from light anhydrous silicic acid, talc, magnesium stearate and glyceryl behenate.
The triple-layered tablet according to the present invention includes ranitidine hydrochloride, potassium bismuth citrate and sucralate, which have complementary pharmacological effects, and in particular, the active ingredients can form a uniform drug release pattern without causing side effects due to interaction It has an effect of effectively treating or preventing acute chronic gastrointestinal disease which is high in safety and is solid.
Also, since the entire manufacturing process is very simple and quick, and mass production is possible, the production cost can be greatly reduced.
1 to 3 are graphs comparing the elution pattern of the three active ingredients for the triple-layer tablet according to the present invention and the commercial product,
4 is a graph showing the effect of the particle size of sucralate on the dissolution rate of ranitidine,
FIG. 5 and FIG. 6 are graphs showing the dissolution test results of the triple-layer tablets prepared according to the respective examples of the present invention.
The triple layer tablet for treating gastrointestinal diseases according to the present invention has a three-layer structure of an upper layer, an intermediate layer and a lower layer. That is, the upper layer is laminated on one surface of the intermediate layer, the lower layer is laminated on the other surface, and the rim portion of the intermediate layer is exposed between the upper layer and the lower layer.
In the present invention, the upper layer and the lower layer are names given arbitrarily to indicate that they are two independent components, and it is not necessarily used that the upper layer is located above the middle layer or the lower layer is located below the middle layer . Therefore, the upper layer and the lower layer may be called opposite to each other. For convenience, upper and lower layers may be collectively referred to as " upper and lower layers ".
A feature of the present invention is that the intermediate layer contains ranitidine hydrochloride as an active ingredient, and the upper layer and the lower layer contain potassium bismuth citrate and sucralfate hydrate as an active ingredient, respectively. At this time, it is preferable that the contents of all components are distributed in the ratio of 1: 1 in the upper layer and the lower layer. This is because the disintegration speeds of the upper and lower layers are the same so that the exposure of the intermediate layer containing the ranitidine hydrochloride can proceed simultaneously in the upper and lower layers.
In the triple-layer tablet, the upper and lower layers of the gastrointestinal tract first come into contact with the body fluids, thereby releasing bismuth citrate potassium and sucralfate hydrates contained therein to protect the ulcer site and kill Helicobacter pylori. At the same time, Accelerate and perform the action of the divide action. Thus, once the upper and lower layers are substantially dissolved, the release of ranitidine in the middle layer results in the inhibition of gastric acid production and the treatment and prevention of gastric ulcer and reflux esophagitis.
As described above, the triple-layered tablet is prepared by dissolving the active ingredient, lanitidine hydrochloride, which is an active ingredient contained in the middle layer, in a time lag after first eluting the active ingredient bismuth citrate potassium and sucralfate hydrate contained in the upper and lower layers Therefore, side effects due to the interaction between the two active ingredients can be prevented.
According to an embodiment of the present invention, the intermediate layer comprises 12 to 13% by weight of active ingredient, ranitidine hydrochloride, 8 to 10% by weight of excipient, 0.7 to 2.5% by weight of binder, 1 to 2% by weight of disintegrant, And 0.2 to 0.5% by weight of a lubricant, wherein the upper layer and the lower layer are composed of 13 to 16% by weight of potassium bismuth citrate, 43 to 45% by weight of sucralfate hydrate, 6 to 10% by weight of an excipient, 1 to 3% by weight of a binder, 2 to 7% by weight of a disintegrant, and 0.5 to 0.7% by weight of a lubricant.
At this time, any one or more selected from the group consisting of deminitol, lactose, microcrystalline cellulose and silicon dioxide can be used as the excipient. Hypromellose, hydroxypropylcellulose, povidone, methylcellulose and gelatin can be used as the binding agent . The disintegrant may be croscarmellose sodium, crospovidone or sodium starch glycolate. The lubricant may be selected from the group consisting of light anhydrous silicic acid, talc, magnesium stearate and glyceryl behenate. You can use more than one.
Preferably, in the case of the intermediate layer, microcrystalline cellulose as an excipient, hydroxypropylcellulose as a binder, croscarmellose sodium as a disintegrant and magnesium stearate as a lubricant are used. In the upper and lower layers, microcrystalline cellulose, silicon dioxide, Hydroxypropylcellulose, sodium croscarmellose sodium as a disintegrant, and magnesium stearate as a lubricant.
It is preferable that the excipient used for the upper and lower layers includes 2 to 4% by weight of silicon dioxide together with microcrystalline cellulose. If the content is less than 2% by weight, the surface of the tablets may be worn during the coating process. In contrast, if the content exceeds 4% by weight , The hardness of the tablet becomes low, and the tablet may break.
According to a preferred embodiment of the present invention, the triple-layered tablet has a tablet weight of 650 to 1400 mg, a content of ranitidine hydrochloride as an active ingredient of 84 to 168 mg per tablet, and a content of bismuth citrate potassium per tablet of 100 to 200 mg , And the content of sucralate hydrate is 300 to 600 mg per one unit.
The triple-layered tablet for treating gastrointestinal diseases according to the present invention can be prepared by a conventional tableting method for oral tablets, but it is preferably prepared by a wet method. That is, the upper and lower layer compositions constituting the upper and lower layers and the intermediate layer composition constituting the intermediate layer are each granulated, dried and sized, and then tableted in the form of a tablet of a three-layer structure using a tablet machine.
At this time, since the particles of the dried material are very weak in the upper and lower layer composition, it is preferable to use an oscilater sizer when granulating the granules. When a general sizing machine is used, granules are small in size every week, dust is generated a lot, and flowability and flowability are poor, so that there is a possibility that a normal tableting process may not be performed.
The sucralate hydrate is preferably a raw material having a particle size of not less than 20 탆 in an amount of not less than 90% by weight through a finely divided process. The present inventors have found that the use of sucralfate hydrate not subjected to the pulverization process results in a change in the sucralate hydrate to a viscous substance in the gastrointestinal tract as described above, and the adverse effects of inhibiting the elution and absorption of ranitidine hydrochloride are more strongly exhibited do.
Hereinafter, the present invention will be described in more detail by way of examples. However, the scope of the present invention is not limited by these embodiments.
[Examples 1 to 8]
The upper and lower layer compositions and the intermediate layer composition were prepared by the composition and composition ratios as shown in the following Tables 1 and 2, respectively. Each of the above compositions was granulated, tableted by a conventional wet method, tableted in a three-layer structure in which an upper layer, an intermediate layer and a lower layer were laminated side by side, and then a conventional film coating machine was coated thereon.
At this time, the sucralfate hydrate was subjected to the undifferentiated raw material as shown in Table 3 below. The upper and lower layer compositions were granulated by using an oscillator (Oscilater), and the weight of the upper layer and the lower layer was divided by half. The weight of the triple-layer tablet thus prepared was 1,356 mg.
In the following Tables 1 to 2, numerals (1) to (6) indicate an active ingredient, (2) an excipient, (3) a binder, (4) a disintegrant, and (5) a lubricant.
The following Table 3 shows the particle size test results for subcultured sucralfate hydrate and conventional sucralate hydrate not subjected to an undifferentiation process according to the present invention. At this time, SYMPATEC, HELOS & RODOS, R1 were used as the particle size analyzer.
[Example 9]
A triple-layered tablet was prepared in the same manner as in Example 1, except that the normal sucralate hydrate not subjected to the micronization step in Table 3 was used.
[Comparative Example]
We used Daewoong 's' Albis' tablets, which are currently on the market, as a control sample. The above-mentioned " Albis " is a double-coated tablet prepared according to the Korean Patent No. 10-119031 previously described in the background art.
[Dissolution test]
The elution test was carried out using the triple-layered tablet prepared according to the above example and the double-coated tablet as the comparative example as the respective samples, and the results are shown in the attached FIGS. 1 to 6. At this time, the comparative dissolution test was performed under the condition of rotating the paddle at 50 rpm in the pH 1.2 eluate according to the comparative dissolution test standard of the drug equivalency standard. The results were as follows: ranitidine hydrochloride, potassium in bismuth citrate potassium, Sucrose octasulfate ester in the hydrate was analyzed and summarized.
As can be seen from the dissolution test results of FIGS. 1 to 2, the triple-layered tablet of the present invention (Example 1) and the commercially available product "Alvis tablet" (comparative example) were totally similar to ranitidine hydrochloride and sucralfate Emission pattern. However, as shown in Fig. 3, the initial release rate of potassium bismuth citrate was about four times higher than that of the commercially available product (Comparative Example) of the triple-layer tablet of the present invention (Example 1).
4 shows the comparison between the case of using sucralate hydrate after micronization (Example 1) and the case of using ordinary sucralate hydrate without micronization (Example 9) It can be confirmed that when sucralate hydrate is used (Example 1), the dissolution rate of sucralate is better.
[Effects of Silicon Dioxide]
The following Table 4 shows the results of measuring the hardness and the degree of abrasion of the upper and lower layers in the case of using silicon dioxide as the excipient (Example 1) and the case of not using the silicon dioxide (Examples 2 and 3) The hardness and the degree of abrasion are greatly improved.
Claims (7)
Wherein the intermediate layer comprises 12 to 13% by weight of ranitidine hydrochloride, 8 to 10% by weight of microcrystalline cellulose, 0.7 to 2.5% by weight of hydroxypropylcellulose, 1 to 2% by weight of croscarmellose sodium, By weight and magnesium stearate in an amount of 0.2 to 0.5% by weight,
The upper layer and the lower layer are formed by combining the two layers based on the weight of the whole tablets, wherein 13 to 16% by weight of potassium bismuth citrate, 43 to 45% by weight of sucralate hydrate, 4 to 6% by weight of microcrystalline cellulose, To 4% by weight of hydroxypropyl cellulose, 1 to 3% by weight of hydroxypropyl cellulose, 2 to 7% by weight of croscarmellose sodium and 0.5 to 0.7% by weight of magnesium stearate,
Wherein the sucralfate hydrate is micronized to have a particle size of at least 90% by weight of not more than 20 탆.
Wherein the amount of said ranitidine hydrochloride is from 84 to 168 mg per tablet, the content of potassium bismuth citrate is from 100 to 200 mg per tablet, and the content of sucralfate hydrates is from 300 to 600 mg per tablet.
Wherein the content of all components in the upper layer and the lower layer is distributed in a ratio of 1: 1.
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| KR1020150102230A KR101801064B1 (en) | 2015-07-20 | 2015-07-20 | Three-layered tablet for treating stomach and intestines disease |
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| KR1020150102230A KR101801064B1 (en) | 2015-07-20 | 2015-07-20 | Three-layered tablet for treating stomach and intestines disease |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20230156474A (en) | 2022-05-06 | 2023-11-14 | 에니솔루션 주식회사 | Composite tablet for treating stomach and intestines disease |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114129532B (en) * | 2021-12-10 | 2023-09-19 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100453179B1 (en) | 1999-06-21 | 2004-10-15 | 주식회사 대웅 | Orally Administrable Pharmaceutical Preparation Having Therapeutic Effect on Gastrointestinal Disorders Comprising Coated Ranitidine, Bismuth Subcitrate and Sucralfate |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100453179B1 (en) | 1999-06-21 | 2004-10-15 | 주식회사 대웅 | Orally Administrable Pharmaceutical Preparation Having Therapeutic Effect on Gastrointestinal Disorders Comprising Coated Ranitidine, Bismuth Subcitrate and Sucralfate |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20230156474A (en) | 2022-05-06 | 2023-11-14 | 에니솔루션 주식회사 | Composite tablet for treating stomach and intestines disease |
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