WO2014136857A1 - Composition d'enrobage, préparation enrobée et son procédé de production - Google Patents

Composition d'enrobage, préparation enrobée et son procédé de production Download PDF

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Publication number
WO2014136857A1
WO2014136857A1 PCT/JP2014/055707 JP2014055707W WO2014136857A1 WO 2014136857 A1 WO2014136857 A1 WO 2014136857A1 JP 2014055707 W JP2014055707 W JP 2014055707W WO 2014136857 A1 WO2014136857 A1 WO 2014136857A1
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Prior art keywords
coating
coating composition
alginate
composition according
mass
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PCT/JP2014/055707
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English (en)
Japanese (ja)
Inventor
千晶 高橋
木津　典生
あゆみ 松野
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ライオン株式会社
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Application filed by ライオン株式会社 filed Critical ライオン株式会社
Priority to JP2015504372A priority Critical patent/JP6304234B2/ja
Priority to CN201480012829.1A priority patent/CN105007949B/zh
Priority to KR1020157024322A priority patent/KR102201077B1/ko
Publication of WO2014136857A1 publication Critical patent/WO2014136857A1/fr
Priority to HK16102684.9A priority patent/HK1214753A1/zh

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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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin

Definitions

  • the present invention relates to a coating composition used for coating foods, pharmaceuticals, etc., a coating preparation and a method for producing the same.
  • ingredients that do not dissolve under the pH conditions (acidic) in the stomach but dissolve under the pH conditions (neutral to alkaline) of the small intestine such as methacrylic acid polymers Compounds, shellac, zein and the like are common.
  • methacrylic acid polymer compounds are limited to pharmaceutical use and cannot be used for food.
  • shellac and zein are also used for food applications, but spraying using an organic solvent is common.
  • the use of a water-soluble film agent capable of coating with water in consideration of the environment for food applications is also desired.
  • the present invention does not dissolve in the stomach, dissolves in the intestine, and allows the coated material to be coated such as the active ingredient to reach the intestine.
  • An object of the present invention is to provide a coating preparation coated with a coating composition and a method for producing the same.
  • the inventors of the present invention have a coating composition containing an alginate and a plasticizer that dissolves in the intestine without dissolving in the stomach, and allows an object to be coated such as an active ingredient to reach the intestine and has excellent coating properties. This has led to the present invention.
  • a coating composition comprising (A) an alginate and (B) a plasticizer. [2].
  • the component (A) is an alginate (A-1) in which the viscosity at 20 ° C.
  • [1] A coating preparation having a coating film formed from the coating composition according to any one of [8]. [10].
  • a coating composition that dissolves in the intestine without dissolving in the stomach and allows the coated active ingredient to reach the intestine and has excellent coating properties, and a coating coated with this coating composition A preparation and a method for producing the same can be provided.
  • the coating composition of the present invention contains (A) an alginate and (B) a plasticizer.
  • Alginic acid salt As the alginic acid salt, monovalent alginate such as sodium salt, potassium salt and ammonium salt, and alginic acid water-soluble salt are preferable.
  • alginate As the alginate, (A-1) a 1% by mass aqueous solution having a viscosity at 20 ° C. of more than 50 mPa ⁇ s, (A-2) a 1% by mass aqueous solution having a viscosity at 20 ° C. of 50 mPa ⁇ s or less. Can be used alone or in combination of two or more.
  • A-1 As the viscosity of a 1% by mass aqueous solution at 20 ° C. exceeding 50 mPa ⁇ s, a viscosity exceeding 50 mPa ⁇ s and preferably 600 mPa ⁇ s or less is preferable and exceeding 50 mPa ⁇ s to 400 mPa ⁇ s or less Is more preferable.
  • the alginate having a viscosity of 50 mPa ⁇ s or less at 20 ° C. in a 1% by mass aqueous solution is preferably 5 to 50 mPa ⁇ s, more preferably 10 to 50 mPa ⁇ s.
  • the blending amount of the component (A) is 5 to 85% by mass with respect to the coating composition (in the case where the solid content is described as the solid content below) Are the same.).
  • the range of 10 to 80% by mass (solid content) is more preferable, the range of 10 to 70% by mass (solid content) is more preferable, and the range of 10 to 60% by mass (solid content) is more preferable.
  • the blending amount is preferably 5 to 85% by mass (solid content), more preferably 10 to 60% by mass (solid content), more preferably 20 to 50%, based on the coating composition.
  • the range of mass% (solid content) is more preferable.
  • the blending amount is preferably 85% by mass (solid content) or less, more preferably 5 to 50% by mass (solid content), more preferably 10 to 40%, based on the coating composition.
  • the range of mass% (solid content) is more preferable. By setting it as the said range or more, enteric property improves and coating property becomes favorable.
  • (A-1) alginate as (A) alginate.
  • the coating property is good and high acid resistance can be imparted to the formed coating film.
  • the coating performance can be further improved while maintaining enteric properties.
  • the use of two types of alginate having different viscosities such as the above (A-1) alginate and (A-2) alginate is not just adjustment of the viscosity of the coating solution, but enteric and coating properties. From the viewpoint of the above, two types of alginate are selected.
  • the mass ratio of (A-1) :( A-2) ((A-1) / (A-2)) is preferably 1: 5 to 10: 1 (0.2 to 10), and 1: 3 to 5: 1 (0.33-5) is more preferred, and 1: 1.8-3: 1 (0.56-3) is even more preferred.
  • the viscosity of the alginate is measured using a rotary viscometer (BM type). Viscosity with a viscosity of less than 200 mPa ⁇ s 1 and a viscosity of 200 mPa ⁇ s or more and less than 1,000 mPa ⁇ s is rotor No. 2 is used to measure a 1% by mass aqueous solution under the conditions of 20 ° C. and 30 rpm, and the value after 60 seconds is taken as the measurement value.
  • BM type rotary viscometer
  • the viscosity of alginate is almost proportional to the molecular weight of alginate.
  • the weight average molecular weight (Mw) of (A-1) is 800,000 or more, preferably from 80 to less than 3 million, and more preferably from 800 to 1.9 million.
  • the weight average molecular weight (Mw) of (A-2) is from 200,000 to less than 800,000, preferably from 300,000 to less than 800,000.
  • the measuring method of the gel chromatography of the weight average molecular weight (Mw) of the alginate of this invention is shown below.
  • Plasticizer Plasticizers include surfactants such as sucrose fatty acid esters, glycerin fatty acid esters, monoglycerin fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyhydric alcohols such as glycerin, propylene glycol, and polyethylene glycol, and glucose.
  • Sugars such as fructose, glucose liquid sugar, sucrose, sugar alcohols such as sorbitol, maltitol, mannitol, erythritol, xylitol, dodecanol, tridecanol, tetradecanol, pentadecanol, hexadecanol, heptadecanol, octadecanol Oils such as higher alcohols such as hexadecyl alcohol, isostearyl alcohol, 2-octyldodecanol (preferably having 6 to 22 carbon atoms) and medium chain fatty acid esters (preferably having 6 to 12 carbon atoms). I can get lost.
  • sugar alcohols such as sorbitol, maltitol, mannitol, erythritol, xylitol, dodecanol, tridecanol, tetradecanol, pentadecanol, hexa
  • glycerin is preferable from the viewpoint of the plastic effect of the coating film
  • a surfactant is preferable from the viewpoint of enteric properties
  • glycerin and / or sucrose fatty acid ester is more preferable.
  • the blending amount of the component (B) is preferably 0.1 to 70% by mass (solid content), more preferably 2 to 50% by mass (solid content) with respect to the coating composition.
  • the mass ratio represented by (B) / (A) is preferably in the range of 0.05 to 3.0, more preferably 0.1 to 2.0, still more preferably 0.15 to 1.5, and 15 to 1.1 is particularly preferred.
  • membrane performance in acidification becomes higher, and coating property becomes more favorable by setting it as an upper limit or less.
  • the coating composition of the present invention may contain a film-forming component other than (A).
  • (C) Gelatin, pectin, curdlan, pullulan, gum arabic, xanthan gum, gellan gum, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, agar, chitosan, tamarind seed gum, locust bean gum, polyvinyl Alcohol, ethylcellulose aqueous dispersion, etc. are mentioned. These can be used individually by 1 type or in combination of 2 or more types.
  • components selected from gelatin, pectin, curdlan, pullulan, gum arabic, xanthan gum, gellan gum, hydroxypropylmethylcellulose, sodium carboxymethylcellulose and hydroxypropylcellulose are from the viewpoint of coating properties and combination with component (A). preferable.
  • the mass ratio represented by (A) :( C) ((A) / (C)) is preferably 1:10 to 20: 1 (0.1 to 20), and preferably 1: 5 to 20 : 1 (0.2 to 20) is more preferable, and 1: 1 to 10: 1 (1 to 10) is more preferable.
  • coat performance especially in an acidic condition is higher can be obtained.
  • the amount of component (C) is preferably 1 to 90% by mass (solid content), more preferably 5 to 80% by mass (solid content), and more preferably 10 to 80% by mass (solid content) with respect to the coating composition. Further preferred. By setting it as the said range or more, the effect of (C) component mixing
  • Fine particles may be blended in the coating composition. By blending the fine particles, it is possible to prevent peeling of the coating film due to adhesion between tablets during the coating process.
  • the component (D) include talc, calcium stearate, silicon dioxide, titanium oxide, and the like, which can be used alone or in combination of two or more.
  • the particle diameter of the fine particles is 0.01 to 50 ⁇ m, preferably 0.1 to 20 ⁇ m. The particle size is measured with a laser diffraction particle size distribution measuring device (dry measurement).
  • the blending amount of component (D) is preferably 1 to 80% by mass (solid content), more preferably 3 to 60% by mass (solid content), and more preferably 5 to 40% by mass (solid content) with respect to the coating composition. Further preferred. When the content is within the above range, the effect of blending the component (D) can be further obtained. When the content exceeds the above range, the film formability may be affected.
  • the coating composition preferably does not contain divalent metal ions such as copper ions, barium ions, and calcium ions. This is because the alginate is cross-linked and gelled, and the coating property is deteriorated. In other words, when monovalent alginate is reacted with a divalent cation to crosslink, the dried membrane is insoluble in water, but the viscosity becomes too high due to gelation, so a fine liquid spray and on the tablet It becomes difficult to spread. As a result, it is difficult to form a uniform film, the appearance is deteriorated, and the elution property may vary.
  • the allowable range of the divalent metal ion is preferably 0.25 mol or less, more preferably 0.1 mol or less, per 1 mol of the alginate monomer.
  • the coating composition of the present invention may contain one or more components that are usually used in coating compositions in an appropriate amount.
  • optional components include antifoaming agents and coloring agents.
  • antifoaming agent examples include glycerin fatty acid ester, dimethylpolysiloxane, dimethylpolysiloxane / silicon dioxide mixture, hydrous silicon dioxide, silicon dioxide and the like, and these may be used alone or in combination of two or more. it can.
  • Examples of the colorant include asen yak tannin powder, turmeric extract, yellow ferric oxide, orange essence, brown iron oxide, carbon black, caramel, carmine, carotene solution, ⁇ -carotene, licorice extract, gold leaf, black iron oxide , Light anhydrous silicic acid, titanium oxide, iron sesquioxide, edible blue No. 1, edible yellow No. 4, edible yellow No. 4 aluminum lake, edible yellow No. 5, edible red No. 2, edible red No. 3, edible red No. 102, Examples include sodium hydroxide, copper chlorofin sodium, copper chlorophyll, green leaf extract, medicinal charcoal, riboflavin butyrate, riboflavin, green tea powder, and sodium riboflavin phosphate.
  • the coating composition of the present invention can contain an organic solvent such as water and ethanol as long as the effects of the present invention are not impaired.
  • the amount of the solvent in the coating composition is appropriately selected in the range of 1 to 98% by mass, preferably 50 to 98% by mass, and more preferably 70 to 96% by mass with respect to the entire coating composition.
  • the coating film formed from the coating composition of the present invention contains the above-mentioned component (A), but an aqueous alginic acid solution is directly dried to form a water-soluble film as described later.
  • This water-soluble film has the property that, under acidic conditions, monovalent cations are replaced with hydrogen ions to form alginic acid to form an insoluble film, which is further neutral to alkaline.
  • the coating composition of the present invention and the coating film formed from the coating composition have the property of being enteric, that is, “does not dissolve in the stomach but dissolves in the intestine and allows the article to be coated to reach the intestine”. Is. An enteric coating preparation in which the coating film is enteric is obtained.
  • enteric means an agent that delivers a functional ingredient to the intestine.
  • the test was conducted according to the method of dissolution test method of Japanese Pharmacy Method, and dissolution rate was less than 50% (preferably 30% or less) in 2 hours in dissolution test solution (pH 1.2) corresponding to gastric juice. Dissolution rate of 70% or more in 2 hours with dissolution test solution (pH 6.8).
  • the shape and dosage form of the object to be coated are not particularly limited, and there are no particular limitations on tablets, powders, fine granules, granules and the like.
  • the tablet may be a single layer or two or more layers. Among these, it is preferable to set it as a tablet from the point which exhibits enteric property more.
  • the size of the tablet is not particularly limited, and the tablet diameter is preferably 5 to 14 mm ⁇ and more preferably 7 to 12 mm ⁇ from the viewpoint of easy handling and swallowability.
  • the tablet mass per tablet is suitably about 150 to 700 mg.
  • the thickness of the coating film is not particularly limited, but is preferably 5 ⁇ m to 1 mm, more preferably 10 to 500 ⁇ m.
  • the coating film is preferably 0.5 to 20% by mass, more preferably 1 to 15% by mass, based on the coating preparation.
  • the content is preferably 10 to 60% by mass, more preferably 15 to 50% by mass.
  • content (solid content) of each said component in a coating film is the same as the said coating composition.
  • the coating material is not particularly limited, and examples thereof include active ingredients such as foods and pharmaceuticals. Examples include lactic acid bacteria, cysteine, iron, proteins such as antibodies and lactoferrin, peptides, ATP-2Na, and the like, and these can be used alone or in combination of two or more. Among them, it is suitable for high molecular weight components such as proteins and water insoluble components.
  • a coating composition can be obtained by mixing the above-mentioned essential components, and the coating preparation is sprayed on the coating composition as it is or with a coating solution added with water, By drying, it can be obtained by forming a coating film on the surface of the object to be coated. Since the coating composition of the present invention is aqueous, coating with water is possible, and a water-soluble film is formed.
  • the coating solution contains a coating composition and water, and the water content of the coating solution is preferably 50 to 98% by mass, more preferably 70 to 96% by mass. Moreover, you may mix
  • the coating machine is not particularly limited, and a pan coating machine, a fluidized bed coating machine, a rolling coating, etc. can be used.
  • the coating method is not particularly limited, and examples thereof include a method of forming a film on the surface of the coating by spraying a coating solution on the coating and drying by heating.
  • the coating solution can be appropriately heated, and the temperature is preferably 30 to 80 ° C. and the drying temperature is preferably 40 to 80 ° C.
  • the addition rate of the coating solution is preferably 1 to 5 g / min with respect to a dry air volume of 1 m 3 / min.
  • it is also possible to adopt a dip coating method in which an object to be coated is immersed in a coating solution and dried. The drying is preferably performed until the water content in the coating preparation is 0.1 to 20% by mass.
  • Examples 1 to 78, Comparative Examples 1 to 4 The following uncoated tablets were prepared, coating solutions having the compositions shown in Tables 1 to 22 below were prepared, and the uncoated tablets were coated by the following method to prepare coated tablets.
  • Uncoated tablet The following raw materials were mixed and compressed into tablets (300 mg, ⁇ 9.0 mm, thickness 5 mm) using a tableting machine. ⁇ Uncoated tablet composition> Lactoferrin: 1,156g Hihatsu extract powder: 500g Lactose: 492.5g Crystalline cellulose: 731.5 g Sodium carboxymethylcellulose: 60g Sucrose fatty acid ester: 30 g Fine silicon dioxide: 30g
  • the coating property was evaluated based on the following evaluation criteria.
  • Example 75 0.014 mol
  • Example 76 0.027 mol
  • Example 77 0.041 mol
  • Example 78 0.054 mol
  • Example 1 Six coated tablets prepared in Example 38, Example 53, and Comparative Examples 1 and 2 were placed in a solution of pH 1.2 (Japanese Pharmacopoeia 1 solution + pepsin dissolution test solution) at 37 ° C. and 100 mL, and shaken. Stir for 2 hours. Then, in order to inactivate pepsin, it processed at 100 degreeC for 20 minutes. After cooling to 37 ° C., 110 mL of a pH 8.5 aqueous sodium hydrogen carbonate solution at 37 ° C. was added to adjust to about pH 6.0, and the mixture was further shaken and stirred for 2 hours. This solution was filtered with a 0.45 ⁇ m filter to obtain an evaluation sample.
  • pH 1.2 Japanese Pharmacopoeia 1 solution + pepsin dissolution test solution
  • Human preadipocytes were seeded on a 24-well plate in a visceral adipocyte differentiation medium (Primary Cell Company Limited, Tokyo, Japan) so as to be 3.0 ⁇ 10 5 CELL / cm 2 , for 6 days at 5% concentration
  • the cells were cultured at 37 ° C. in a CO 2 environment. Thereafter, 1 mL of a solution obtained by diluting the evaluation sample 10-fold with a medium is added and cultured for 24 hours. Thereafter, the glycerol concentration in the culture supernatant was measured.
  • the concentration of glycerol generated by the promotion of fat degradation by lactoferrin was increased, and it was confirmed that the coated tablet of the Example was enteric. The results are shown in FIG.

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Abstract

L'invention concerne une composition d'enrobage, qui contient (A) un sel d'acide alginique et (B) un plastifiant, et qui est apte à administrer une matière enrobée, telle qu'un principe actif enrobé, dans l'intestin, étant donné que la composition d'enrobage ne se dissout pas dans l'estomac mais se dissout dans l'intestin. Cette composition d'enrobage a d'excellentes propriétés d'enrobage et est apte à fournir un enrobage uniforme sans écaillage ni pelage. L'invention concerne également une préparation enrobée, qui est enrobée de cette composition d'enrobage.
PCT/JP2014/055707 2013-03-08 2014-03-06 Composition d'enrobage, préparation enrobée et son procédé de production WO2014136857A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2015504372A JP6304234B2 (ja) 2013-03-08 2014-03-06 コーティング組成物、コーティング製剤及びその製造方法
CN201480012829.1A CN105007949B (zh) 2013-03-08 2014-03-06 包衣组合物、包衣制剂及其制造方法
KR1020157024322A KR102201077B1 (ko) 2013-03-08 2014-03-06 코팅 조성물, 코팅 제제 및 그 제조 방법
HK16102684.9A HK1214753A1 (zh) 2013-03-08 2016-03-09 包衣組合物、包衣製劑及其製造方法

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JP2013046697 2013-03-08
JP2013-046697 2013-03-08

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WO2014136857A1 true WO2014136857A1 (fr) 2014-09-12

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JP (1) JP6304234B2 (fr)
KR (1) KR102201077B1 (fr)
CN (1) CN105007949B (fr)
HK (1) HK1214753A1 (fr)
WO (1) WO2014136857A1 (fr)

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CN104857520A (zh) * 2015-04-29 2015-08-26 南京圣诺生物科技实业有限公司 一种海藻酸钠包衣液组合物及包衣方法
CN107106501A (zh) * 2014-12-23 2017-08-29 Fmc有限公司 肠溶膜包衣组合物、包覆方法以及包覆的制剂
JP2017165701A (ja) * 2016-03-18 2017-09-21 日油株式会社 ｐＨ応答溶出性被覆造粒物および食品
CN108740371A (zh) * 2018-04-04 2018-11-06 广州智特奇生物科技股份有限公司 肠溶包被材料、采用该包被材料包被的氧化锌及其制备方法
WO2019031550A1 (fr) * 2017-08-09 2019-02-14 ライオン株式会社 Composition de revêtement, film de revêtement et préparation de revêtement et son procédé de production
JP2020011994A (ja) * 2014-09-03 2020-01-23 ライオン株式会社 コーティング製剤及びその製造方法
WO2021263230A1 (fr) * 2020-06-26 2021-12-30 Sensient Colors Llc Composition d'enrobage entérique et procédé pour la produire et l'utiliser

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GB201607548D0 (en) * 2016-04-29 2016-06-15 Univ Central Lancashire Solid dosage form
CN108543072A (zh) * 2018-04-09 2018-09-18 鲍引健 一种包衣用组合物及其相关用途
KR102031515B1 (ko) * 2019-04-09 2019-10-11 나누리영농조합법인 계란의 표면코팅 조성물 및 그 제조방법

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WO2005025609A1 (fr) * 2003-09-10 2005-03-24 Nrl Pharma, Inc. Composition d'un produit a la lactoferrine
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JP2020011994A (ja) * 2014-09-03 2020-01-23 ライオン株式会社 コーティング製剤及びその製造方法
EP3236954A4 (fr) * 2014-12-23 2018-08-01 FMC Corporation Composition de pelliculage entérique, procédé d'enrobage, et formes enrobées
CN107106501A (zh) * 2014-12-23 2017-08-29 Fmc有限公司 肠溶膜包衣组合物、包覆方法以及包覆的制剂
CN107106501B (zh) * 2014-12-23 2021-07-06 杜邦营养美国有限公司 肠溶膜包衣组合物、包覆方法以及包覆的制剂
EP3236954B1 (fr) 2014-12-23 2022-03-23 DuPont Nutrition USA, Inc. Composition de pelliculage entérique, procédé d'enrobage, et formes enrobées
CN104857520A (zh) * 2015-04-29 2015-08-26 南京圣诺生物科技实业有限公司 一种海藻酸钠包衣液组合物及包衣方法
JP2017165701A (ja) * 2016-03-18 2017-09-21 日油株式会社 ｐＨ応答溶出性被覆造粒物および食品
WO2019031550A1 (fr) * 2017-08-09 2019-02-14 ライオン株式会社 Composition de revêtement, film de revêtement et préparation de revêtement et son procédé de production
JPWO2019031550A1 (ja) * 2017-08-09 2020-09-03 ライオン株式会社 コーティング組成物、コーティング膜、コーティング製剤及びその製造方法
JP7111104B2 (ja) 2017-08-09 2022-08-02 ライオン株式会社 コーティング組成物、コーティング膜、コーティング製剤及びその製造方法
CN108740371A (zh) * 2018-04-04 2018-11-06 广州智特奇生物科技股份有限公司 肠溶包被材料、采用该包被材料包被的氧化锌及其制备方法
CN108740371B (zh) * 2018-04-04 2021-07-30 广州智特奇生物科技股份有限公司 肠溶包被材料、采用该包被材料包被的氧化锌及其制备方法
WO2021263230A1 (fr) * 2020-06-26 2021-12-30 Sensient Colors Llc Composition d'enrobage entérique et procédé pour la produire et l'utiliser

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