WO2018190659A1 - 수산화알루미늄과 수산화마그네슘을 포함하는 현탁액 및 그 제조방법 - Google Patents
수산화알루미늄과 수산화마그네슘을 포함하는 현탁액 및 그 제조방법 Download PDFInfo
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- WO2018190659A1 WO2018190659A1 PCT/KR2018/004305 KR2018004305W WO2018190659A1 WO 2018190659 A1 WO2018190659 A1 WO 2018190659A1 KR 2018004305 W KR2018004305 W KR 2018004305W WO 2018190659 A1 WO2018190659 A1 WO 2018190659A1
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- aqueous suspension
- aqueous
- suspension composition
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- cellulose
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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
- A61K9/10—Dispersions; Emulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
-
- 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
-
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Definitions
- the present invention relates to a suspension comprising aluminum hydroxide and magnesium hydroxide and a method for producing the same.
- the combination of aluminum hydroxide and magnesium hydroxide is not only good at antacids, but also has no interaction between the two components and does not induce secretory acid recoil or metabolic alkalosis without interaction with food, alcohol and other antacids. As it is not used, it is widely used all over the world.
- Suspensions are generally preferred over tablets or powders because the liquid suspensions dissolve more quickly and effectively and have a superior ability to react with and neutralize gastric acid.
- suspending agent it is necessary to use a large amount of suspending agent to stabilize the suspension dispersed in the solution, unless it is prepared and taken immediately. However, if a large amount of the suspending agent is used, the bioavailability and the like can be varied, so it is desirable to reduce the amount of the suspending agent.
- Patent Document 1 Korean Patent No. 10-0726690 discloses that suspending agents tend to undergo thermal gelation in the temperature range used in the pasteurization process and are available.
- the choice of suspending agents is already limited to not interacting with metal ions, and hydroxypropyl methylcellulose (HPMC) is most commonly used and its miscibility with antacids (metal ions) and low temperatures at mild temperatures of 60 to 70 ° C.
- HPMC hydroxypropyl methylcellulose
- metal ions antacids
- Low temperatures 60 to 70 ° C.
- the use of hydroxyethyl cellulose as suspending agent can be easily sterilized by pasteurization without fear of condensation of the suspending agent.
- Patent Document 1 prior documents including Patent Document 1 have not reported that the use of a specific combination of suspending agents can improve problems such as sedimentation rate, texture of the suspending agent.
- the present invention is to provide a suspension containing aluminum hydroxide and magnesium hydroxide that can improve the problems such as sedimentation rate, texture, viscosity of the suspending agent and a method for producing the same.
- Cellulose-based suspending agents such as hydroxypropyl methylcellulose (HPMC) have been used as suspending agents usually used in aqueous suspending agent compositions comprising aluminum hydroxide and magnesium hydroxide, and usually single suspending agents have been used.
- HPMC hydroxypropyl methylcellulose
- the present invention finds that a single suspending agent exhibits problems such as sedimentation rate and texture of the suspending agent, and by using a specific combination of suspending agents in order to solve such a problem, It is characterized by improving problems such as texture.
- the mixed suspending agent provides an aqueous suspending agent composition that is a mixture of hydroxypropylmethyl cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, and carrageenan.
- an aqueous solution comprising hydroxypropylmethyl cellulose (comparative example 1), carrageenan (comparative example 2), microcrystalline cellulose and carboxymethyl cellulose sodium (comparative example 3) each as a single suspending agent Compared with the suspending agent composition, it was confirmed that the aqueous suspending agent composition using hydroxypropylmethyl cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose and carrageenan as a mixed suspending agent in terms of sedimentation rate and texture.
- Aqueous suspension compositions comprising aluminum hydroxide and magnesium hydroxide are used for the treatment or amelioration of hyperacid, heartburn, discomfort, gastric bloating, planting (gastrointestinal), nausea, vomiting, stomach pain, sintrim and the like.
- aluminum hydroxide and magnesium hydroxide are included as antacids.
- the content of aluminum hydroxide and magnesium hydroxide relative to the aqueous suspension composition may be 3 to 5% (w / v), respectively.
- the content of aluminum hydroxide and magnesium hydroxide relative to the aqueous suspension composition may be 3.5 to 4.5% (w / v), for example, 3.9 to 4.1% (w / v).
- aluminum hydroxide it can be expressed as a value corresponding to about 1.5 to 2.5% (w / v), that is 1/2 of the content calculated by Al 2 O 3 .
- the aqueous suspending agent composition according to the invention comprises a mixture of hydroxypropylmethyl cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose and carrageenan as mixed suspending agents.
- the content of hydroxypropylmethyl cellulose relative to the aqueous suspension composition may be 0.4 to 0.9% (w / v).
- the content of hydroxypropylmethyl cellulose relative to the aqueous suspending agent composition may be, for example, 0.45 to 0.9% (w / v), 0.5 to 0.85% (w / v), 0.55 to 0.8% (w / v), 0.55 to 0.75% (w / v), 0.6 to 0.7% (w / v).
- microcrystalline cellulose and carboxymethyl cellulose sodium used as a mixed suspending agent may be used in the form of an excipient containing two components together, such as Avicel RC-581, or each may be used as a single component. have.
- the content of the mixture of microcrystalline cellulose and sodium carboxymethyl cellulose relative to the aqueous suspension composition may be 0.1 to 0.5% (w / v).
- the content of the mixture of microcrystalline cellulose and carboxymethyl cellulose sodium relative to the aqueous suspending agent composition is 0.1 to 0.4% (w / v), for example 0.1 to 0.3% (w / v), 0.1 to 0.25% (w / v), from 0.1 to 0.2% (w / v).
- the content ratio of the microcrystalline cellulose and carboxymethyl cellulose sodium may be 7: 1 to 9: 1.
- the content ratio of the microcrystalline cellulose and the carboxy methyl cellulose sodium may be 7.5: 1 to 8.5: 1.
- the content of carrageenan relative to the aqueous suspension composition may be 0.1 to 0.3% (w / v).
- the content of carrageenan relative to the aqueous suspension composition may be, for example, 0.1 to 0.25% (w / v), 0.1 to 0.2% (w / v).
- the content of the aluminum hydroxide (calculated by AL 2 O 3 ) is preferably 0.02 g / mL, the content of the magnesium hydroxide is preferably 0.04 g / mL.
- the aqueous suspension composition according to the present invention may contain, in addition to the above components, an antifoaming component.
- a simethicone and a silicone resin can be used as an antifoamer.
- the content of simethicone in comparison to the aqueous suspension composition is 0.01 to 0.05% (w / v), for example, 0.02 to 0.04% (w / v), and the content of silicone resin is 0.2 to 0.8% ( w / v), for example, 0.3 to 0.6% (w / v).
- Simethicone may be included in the suspending agent in the form of a simethicone emulsion, for example, the content of the simethicone 30% emulsion relative to the aqueous suspending agent composition may be 0.05 to 0.15%.
- the aqueous suspension composition according to the invention may further comprise other additives which may be included in the suspension composition.
- other additives which may be included in the suspension composition.
- sweeteners preservatives, correctors, flavoring agents and coloring agents are not particularly limited and may be appropriately selected and used by those skilled in the art.
- the sweetener may be stevioside
- the preservative may be chlorhexidine acetate
- the corrective agent may be sorbitol
- the flavoring agent may be orange flavor essence.
- aqueous suspending agent composition according to the present invention provides a good settling rate by using the complex suspending agent of the specific composition described above.
- the sedimentation rate of the aqueous suspension composition according to the present invention is 0.97 to 1, which satisfies the needs of the pharmacopeias.
- the sedimentation rate in the above range means that a uniform dispersion system can be obtained together with the physical stability of the suspending agent.
- a suspending agent having a homogeneous dispersion system can ensure the reproducibility or effectiveness of the bioavailability of the drug.
- aqueous suspending agent compositions according to the invention also provide an excellent texture by using mixed suspending agents in specific composition ratios.
- composition ratio of the mixed suspending agent according to the embodiment of the present invention described above relates to the texture of the composition of the aqueous suspending agent.
- Oral suspension compositions such as the aqueous suspension composition according to the present invention, because they contain powder particles of insoluble drugs, can cause a bad texture, in this case can cause a feeling of rejection in patients. Therefore, the texture may be a very important factor in increasing patient compliance.
- composition ratio of the mixed suspending agent according to the embodiment of the present invention significantly improves the texture of the aqueous suspending agent composition.
- step d) the third aqueous solution is added to the homogeneous solution obtained in step c) and stirred;
- step d) providing a method for preparing an aqueous suspension composition according to the present invention, comprising adding and stirring additives to the solution obtained in step d) and quantifying by adding purified water:
- aqueous suspension composition according to the present invention can be prepared by the following method.
- Solution 1 Preparation: A calibrator was added to purified water and stirred for 5 to 10 minutes, hydroxypropylmethyl cellulose was added and stirred for 5 to 10 minutes, microcrystalline cellulose and carboxymethyl cellulose sodium were added, and then 30 to Stir for 60 minutes to confirm complete dispersion and swell;
- Primary Homogenizer Homogenize the primary pressure to 130 ⁇ 150bar, the secondary pressure to 26 ⁇ 30bar, and wash the homogenizer tube with purified water.
- Secondary Homogenizer Homogenize the primary pressure to 140-160bar and the secondary pressure to 28-32bar, and wash the homogenizer tube with purified water.
- Third Homogenizer Homogenize the primary pressure to 160 ⁇ 180bar, the secondary pressure to 38 ⁇ 42bar, and wash the homogenizer tube with purified water.
- the manufacturing method is specifically as follows.
- Solution 1 Preparation: Add sorbitol solution to purified water, stir for 5 minutes, add hydroxypropylmethyl cellulose, stir for 5 minutes, add microcrystalline cellulose and carboxymethyl cellulose, and stir for 40 minutes to confirm complete dispersion. And swell;
- Primary Homogenizer Homogenize the primary pressure to 140bar and the secondary pressure to 28bar, and wash the homogenizer tube with purified water.
- Secondary Homogenizer Homogenize by setting the primary pressure to 150bar and the secondary pressure to 30bar, and wash the inside of the homogenizer tube with purified water.
- 3rd Homogenizer Homogenize with the 1st pressure set at 170bar and the 2nd pressure set at 40bar and wash the inside of the homogenizer tube with purified water.
- the aqueous suspension composition according to the present invention ensures excellent sedimentation rate by using a mixed suspending agent of a specific composition, so that insoluble aluminum hydroxide and magnesium hydroxide do not easily settle, do not form a cake, and redispersion Make it easy
- the aqueous suspending agent composition having an excellent sedimentation rate not only has physical stability but also forms a uniform dispersion system, thereby ensuring reproducibility or effectiveness of bioavailability.
- the aqueous suspension composition according to the present invention provides an excellent texture, increasing patient compliance with the medication.
- Viscosity values were obtained at room temperature (20-25 ° C.) using a LV 2 (62) spindle with a Brookfield viscometer (BROOKFIELD LVDV-I Prime; serial number 8570291).
- the sample was placed in a 50 ml mass cylinder at room temperature, shaken vigorously for 1 minute, mixed to indicate the height of the contents, which was referred to as H 0 . .
- the panel consisted of 10 male and female adults, and the scores of each panel were summed based on 10 points out of 10 for each sample.
- the present invention satisfies the requirements of the pharmacopeia by increasing the sedimentation rate of the aluminum magnesium suspension by using a mixed suspending agent, and at the same time, the texture of the suspension is softer and easier to take.
- Examples 6 to 20 were prepared by varying the composition ratio of the mixed suspending agent to the following composition.
- Example 6 Example 7 Example 8 Example 9 Example 10
- Example 12 Example 13 Al (OH) 3 (g) 39.98 39.98 39.98 39.98 39.98 39.98 39.98 Mg (OH) 2 (g) 40 40 40 40 40 40 40 g Shimethicone Emulsion 30% (g) 0.84 0.84 0.84 0.84 0.84 0.84 0.84 0.84 0.84 0.84 0.84 0.84 H.P.M.C.
- Example 14 Example 15 Example 16 Example 17 Example 18 Example 19 Example 20 Al (OH) 3 (g) 39.98 39.98 39.98 39.98 39.98 Mg (OH) 2 (g) 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40
- the aqueous suspension composition of Examples 6 to 20 all exhibited a settling ratio of 0.99 to 1, all showing an excellent settling ratio regardless of the composition ratio of the components constituting the mixed suspending agent.
- Table 3 the aqueous suspension composition of Examples 6 to 20 all exhibited a settling ratio of 0.99 to 1, all showing an excellent settling ratio regardless of the composition ratio of the components constituting the mixed suspending agent.
- the aqueous suspending agent composition having an excellent sedimentation rate not only has physical stability but also forms a uniform dispersion system, thereby ensuring reproducibility or effectiveness of bioavailability.
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Abstract
Description
실시예 6 | 실시예 7 | 실시예 8 | 실시예 9 | 실시예 10 | 실시예 11 | 실시예 12 | 실시예 13 | |
Al(OH)3(g) | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 |
Mg(OH)2(g) | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40g |
시메치콘 에멀젼30% (g) | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 |
H.P.M.C. 2208(4000cps) (g) | 4.5 | 4.5 | 4.5 | 4.5 | 4.5 | 6.5 | 6.5 | 6.5 |
카라기난(CST#7632)(g) | 0.5 | 1 | 1.5 | 2 | 2.5 | 0.5 | 1 | 1.5 |
Avicel RC-581 (g) | 0.5 | 1 | 2 | 3 | 4 | 0.5 | 1 | 2 |
D-솔비톨70% (g) | 250 | 250 | 250 | 250 | 250 | 250 | 250 | 250 |
스테비오사이드 (g) | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
실리콘수지(30%)(g) | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
클로르헥시딘 아세테이트 (g) | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 |
오렌지향 (g) | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
정제수를 적량 가한 총부피 | 1L | 1L | 1L | 1L | 1L | 1L | 1L | 1L |
실시예 14 | 실시예 15 | 실시예 16 | 실시예 17 | 실시예 18 | 실시예 19 | 실시예 20 | |
Al(OH)3(g) | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 | 39.98 |
Mg(OH)2(g) | 40 | 40 | 40 | 40 | 40 | 40 | 40 |
시메치콘 에멀젼 30%(g) | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 | 0.84 |
H.P.M.C. 2208(4000cps)(g) | 6.5 | 6.5 | 8.5 | 8.5 | 8.5 | 8.5 | 8.5 |
카라기난(CST#7632)(g) | 2 | 2.5 | 0.5 | 1 | 1.5 | 2 | 2.5 |
Avicel RC-581(g) | 3 | 4 | 0.5 | 1 | 2 | 3 | 4 |
D-솔비톨 70%(g) | 250 | 250 | 250 | 250 | 250 | 250 | 250 |
스테비오사이드(g) | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
실리콘수지(30%)(g) | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
클로르헥시딘 아세테이트(g) | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 |
오렌지향(g) | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
정제수를 적량 가한 총부피 | 1L | 1L | 1L | 1L | 1L | 1L | 1L |
실시예 | 식감(1~ 10점) | 침강률 |
실시예 6 | 1 | 1 |
실시예 7 | 3 | 0.99 |
실시예 8 | 8 | 1 |
실시예 9 | 9 | 1 |
실시예 10 | 7 | 0.99 |
실시예 11 | 2 | 0.99 |
실시예 12 | 8 | 1 |
실시예 13 | 10 | 1 |
실시예 14 | 9 | 0.99 |
실시예 15 | 7 | 0.99 |
실시예 16 | 8 | 1 |
실시예 17 | 8 | 1 |
실시예 18 | 7 | 0.99 |
실시예 19 | 7 | 1 |
실시예 20 | 6 | 1 |
Claims (12)
- 수산화알루미늄, 수산화마그네슘, 혼합 현탁화제 및 소포제를 포함하며;상기 혼합 현탁화제는 하이드록시프로필메틸 셀룰로오스, 미결정 셀룰로오스, 카르복시메틸 셀룰로오스나트륨 및 카라기난의 혼합물인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비 수산화알루미늄 및 수산화마그네슘의 함량은 각각 3 내지 5%(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비 하이드록시프로필메틸 셀룰로오스의 함량은 0.4 내지 0.9 %(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비 미결정 셀룰로오스 및 카르복시메틸 셀룰로오스나트륨의 혼합물의 함량은 0.1 내지 0.5 %(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 미결정셀룰로오스와 카르복실 메틸셀룰로오스 나트륨의 함량비는 7:1 내지 9:1인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비 카라기난의 함량은 0.1 내지 0.3 %(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비수산화알루미늄 및 수산화마그네슘의 함량은 각각 3 내지 5%(w/v)이고,하이드록시프로필메틸 셀룰로오스의 함량은 0.4 내지 0.9 %(w/v)이며,미결정 셀룰로오스 및 카르복시메틸 셀룰로오스나트륨의 혼합물의 함량은 0.1 내지 0.5 %(w/v)이고,카라기난의 함량은 0.1 내지 0.3 %(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비수산화알루미늄 및 수산화마그네슘의 함량은 각각 3.5 내지 4.5%(w/v)이고,하이드록시프로필메틸 셀룰로오스의 함량은 0.45 내지 0.85 %(w/v)이며,미결정 셀룰로오스 및 카르복시메틸 셀룰로오스나트륨의 혼합물의 함량은 0.1 내지 0.4 %(w/v)이고,카라기난의 함량은 0.1 내지 0.25 %(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,상기 소포제는 시메치콘 및 실리콘 수지인 수성 현탁제 조성물.
- 제1항에 있어서,상기 수성 현탁제 조성물 대비 시메치콘의 함량은 0.01 내지 0.05%(w/v)이고, 실리콘 수지의 함량은 0.2 내지 0.8%(w/v)인 수성 현탁제 조성물.
- 제1항에 있어서,감미제, 방부제, 교정제, 및 착색제 중 하나 이상을 추가로 포함하는 수성 현탁제 조성물.
- a) 하이드록시프로필메틸 셀룰로오스, 미결정 셀룰로오스 및 카르복시메틸 셀룰로오스 나트륨을 포함하는 제1수용액, 소포제를 포함하는 제2수용액, 및 카라기난을 포함하는 제3수용액을 준비하고,b) 제1수용액과 제2수용액을 혼합하여 교반한 혼합 용액에 수산화알루미늄 및 수산화마그네슘을 가하여 교반하고,c) 단계 b)에서 얻은 용액을 균질화하고,d) 단계 c)에서 얻은 균질된 용액에 상기 제3수용액을 투입하여 교반하고,e) 단계 d)에서 얻은 용액에 첨가제를 투입하여 교반하고 정제수를 투입하여 정량하는 단계를 포함하는제1항의 수성 현탁제 조성물의 제조방법.
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BR112019021477-1A BR112019021477A2 (pt) | 2017-04-13 | 2018-04-12 | Composição de suspensão aquosa, e, método para preparar a composição de suspensão aquosa |
ES18783778T ES2908336T3 (es) | 2017-04-13 | 2018-04-12 | Suspensión que comprende hidróxido de aluminio e hidróxido de magnesio y procedimiento de preparación de la misma |
AU2018251519A AU2018251519B2 (en) | 2017-04-13 | 2018-04-12 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
EP18783778.6A EP3610857B1 (en) | 2017-04-13 | 2018-04-12 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
PL18783778T PL3610857T3 (pl) | 2017-04-13 | 2018-04-12 | Zawiesina zawierająca wodorotlenek glinu i wodorotlenek magnezu oraz sposób ich otrzymywania |
JP2019555963A JP7090641B2 (ja) | 2017-04-13 | 2018-04-12 | 水酸化アルミニウムと水酸化マグネシウムを含む懸濁液及びその製造方法 |
CA3059031A CA3059031C (en) | 2017-04-13 | 2018-04-12 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
US16/604,167 US11135165B2 (en) | 2017-04-13 | 2018-04-12 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
KR1020197029219A KR102396359B1 (ko) | 2017-04-13 | 2018-04-12 | 수산화알루미늄과 수산화마그네슘을 포함하는 현탁액 및 그 제조방법 |
MX2019012084A MX2019012084A (es) | 2017-04-13 | 2018-04-12 | Suspensión que comprende hidróxido de aluminio e hidróxido de magnesio y método de preparación de la misma. |
CN201880001603.XA CN109414406B (zh) | 2017-04-13 | 2018-04-12 | 含有氢氧化铝和氢氧化镁的悬浮液及其制造方法 |
RU2019131244A RU2795006C2 (ru) | 2017-04-13 | 2018-04-12 | Суспензия, содержащая гидроксид алюминия и гидроксид магния, и способ ее получения |
ZA2019/06662A ZA201906662B (en) | 2017-04-13 | 2019-10-09 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
PH12019502323A PH12019502323B1 (en) | 2017-04-13 | 2019-10-10 | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
CONC2019/0012413A CO2019012413A2 (es) | 2017-04-13 | 2019-11-05 | Suspensión que comprende hidróxido de aluminio e hidróxido de magnesio y método de preparación de la misma |
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CN201710240597.0A CN108721213A (zh) | 2017-04-13 | 2017-04-13 | 铝镁混悬液及其制备方法 |
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EP (1) | EP3610857B1 (ko) |
JP (1) | JP7090641B2 (ko) |
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CN (2) | CN108721213A (ko) |
AU (1) | AU2018251519B2 (ko) |
BR (1) | BR112019021477A2 (ko) |
CA (1) | CA3059031C (ko) |
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US11135165B2 (en) | 2017-04-13 | 2021-10-05 | Daewoong Pharmaceutical Co., Ltd. | Suspension comprising aluminum hydroxide and magnesium hydroxide and preparation method therefor |
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CN114028331B (zh) * | 2021-11-03 | 2022-11-18 | 北京鑫开元医药科技有限公司 | 镁加铝混悬液及其制备工艺 |
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RU2019131244A3 (ko) | 2021-06-30 |
KR102396359B1 (ko) | 2022-05-10 |
CN108721213A (zh) | 2018-11-02 |
EP3610857B1 (en) | 2022-02-09 |
BR112019021477A2 (pt) | 2020-05-12 |
CN109414406B (zh) | 2019-12-13 |
EP3610857A1 (en) | 2020-02-19 |
MX2019012084A (es) | 2020-01-20 |
ZA201906662B (en) | 2021-06-30 |
JP2020516660A (ja) | 2020-06-11 |
ES2908336T3 (es) | 2022-04-28 |
PH12019502323A1 (en) | 2020-07-06 |
AU2018251519B2 (en) | 2023-06-15 |
AU2018251519A1 (en) | 2019-11-14 |
EP3610857A4 (en) | 2020-09-16 |
CN109414406A (zh) | 2019-03-01 |
CO2019012413A2 (es) | 2020-01-17 |
CA3059031C (en) | 2022-08-16 |
RU2019131244A (ru) | 2021-04-05 |
US20200113826A1 (en) | 2020-04-16 |
US11135165B2 (en) | 2021-10-05 |
PH12019502323B1 (en) | 2020-07-06 |
KR20190130590A (ko) | 2019-11-22 |
CA3059031A1 (en) | 2018-10-18 |
PL3610857T3 (pl) | 2022-06-20 |
JP7090641B2 (ja) | 2022-06-24 |
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