JPH0138091B2 - - Google Patents
Info
- Publication number
- JPH0138091B2 JPH0138091B2 JP55008430A JP843080A JPH0138091B2 JP H0138091 B2 JPH0138091 B2 JP H0138091B2 JP 55008430 A JP55008430 A JP 55008430A JP 843080 A JP843080 A JP 843080A JP H0138091 B2 JPH0138091 B2 JP H0138091B2
- Authority
- JP
- Japan
- Prior art keywords
- coating
- enteric
- coated
- liquid
- water
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 239000003814 drug Substances 0.000 claims description 16
- 239000007787 solid Substances 0.000 claims description 16
- 229940079593 drug Drugs 0.000 claims description 15
- 238000009505 enteric coating Methods 0.000 claims description 14
- 239000002702 enteric coating Substances 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 14
- 239000002245 particle Substances 0.000 claims description 11
- 239000004014 plasticizer Substances 0.000 claims description 9
- 239000011253 protective coating Substances 0.000 claims description 9
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 4
- 239000012736 aqueous medium Substances 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 description 74
- 238000000576 coating method Methods 0.000 description 73
- 239000007788 liquid Substances 0.000 description 34
- 238000002360 preparation method Methods 0.000 description 17
- 239000000843 powder Substances 0.000 description 15
- 239000003826 tablet Substances 0.000 description 12
- -1 fatty acid esters Chemical class 0.000 description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
- 238000000034 method Methods 0.000 description 9
- 239000007921 spray Substances 0.000 description 9
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 description 8
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 description 8
- 239000006185 dispersion Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 235000014113 dietary fatty acids Nutrition 0.000 description 5
- 239000000194 fatty acid Substances 0.000 description 5
- 229930195729 fatty acid Natural products 0.000 description 5
- 239000012530 fluid Substances 0.000 description 5
- 239000008187 granular material Substances 0.000 description 5
- 239000003960 organic solvent Substances 0.000 description 5
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 4
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 description 4
- 239000012669 liquid formulation Substances 0.000 description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 4
- 229920000053 polysorbate 80 Polymers 0.000 description 4
- 229920001214 Polysorbate 60 Polymers 0.000 description 3
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 239000007931 coated granule Substances 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 230000002496 gastric effect Effects 0.000 description 3
- 210000004051 gastric juice Anatomy 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- LDVVTQMJQSCDMK-UHFFFAOYSA-N 1,3-dihydroxypropan-2-yl formate Chemical compound OCC(CO)OC=O LDVVTQMJQSCDMK-UHFFFAOYSA-N 0.000 description 2
- ZNQVEEAIQZEUHB-UHFFFAOYSA-N 2-ethoxyethanol Chemical compound CCOCCO ZNQVEEAIQZEUHB-UHFFFAOYSA-N 0.000 description 2
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 2
- NIQCNGHVCWTJSM-UHFFFAOYSA-N Dimethyl phthalate Chemical compound COC(=O)C1=CC=CC=C1C(=O)OC NIQCNGHVCWTJSM-UHFFFAOYSA-N 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 description 2
- UYXTWWCETRIEDR-UHFFFAOYSA-N Tributyrin Chemical compound CCCC(=O)OCC(OC(=O)CCC)COC(=O)CCC UYXTWWCETRIEDR-UHFFFAOYSA-N 0.000 description 2
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- YSAVZVORKRDODB-WDSKDSINSA-N diethyl tartrate Chemical compound CCOC(=O)[C@@H](O)[C@H](O)C(=O)OCC YSAVZVORKRDODB-WDSKDSINSA-N 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 2
- 239000002075 main ingredient Substances 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 125000002730 succinyl group Chemical group C(CCC(=O)*)(=O)* 0.000 description 2
- QZCLKYGREBVARF-UHFFFAOYSA-N Acetyl tributyl citrate Chemical compound CCCCOC(=O)CC(C(=O)OCCCC)(OC(C)=O)CC(=O)OCCCC QZCLKYGREBVARF-UHFFFAOYSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- GOJCZVPJCKEBQV-UHFFFAOYSA-N Butyl phthalyl butylglycolate Chemical compound CCCCOC(=O)COC(=O)C1=CC=CC=C1C(=O)OCCCC GOJCZVPJCKEBQV-UHFFFAOYSA-N 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 108010019160 Pancreatin Proteins 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 125000005907 alkyl ester group Chemical group 0.000 description 1
- 150000005215 alkyl ethers Chemical class 0.000 description 1
- 239000012298 atmosphere Substances 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical class OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- FBSAITBEAPNWJG-UHFFFAOYSA-N dimethyl phthalate Natural products CC(=O)OC1=CC=CC=C1OC(C)=O FBSAITBEAPNWJG-UHFFFAOYSA-N 0.000 description 1
- 229960001826 dimethylphthalate Drugs 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 238000004880 explosion Methods 0.000 description 1
- 239000003925 fat Substances 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 230000005802 health problem Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 125000005395 methacrylic acid group Chemical group 0.000 description 1
- 229920003146 methacrylic ester copolymer Polymers 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 229940055695 pancreatin Drugs 0.000 description 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000012254 powdered material Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- WEAPVABOECTMGR-UHFFFAOYSA-N triethyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCOC(=O)CC(C(=O)OCC)(OC(C)=O)CC(=O)OCC WEAPVABOECTMGR-UHFFFAOYSA-N 0.000 description 1
- FRDNONBEXWDRDM-UHFFFAOYSA-N tris(2-ethylhexyl) 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCCCC(CC)COC(=O)CC(C(=O)OCC(CC)CCCC)(OC(C)=O)CC(=O)OCC(CC)CCCC FRDNONBEXWDRDM-UHFFFAOYSA-N 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Description
【発明の詳細な説明】
本発明は、改良された固形薬剤用腸溶性保護コ
ーテイング剤組成物に関する。DETAILED DESCRIPTION OF THE INVENTION This invention relates to improved enteric protective coating compositions for solid pharmaceuticals.
従来、腸溶性被覆製剤を製造する方法として
は、錠剤、顆粒あるいはカプセル剤に腸溶性被覆
基剤を有機溶媒に溶かした被覆液を用いて被覆す
る方法が公知とされている。しかし、この場合多
量の有機溶媒が使用されるため、火炎、爆発の危
検性、作業員の安全衛生上の問題、さらにはこの
有機溶媒の大気中への逸散による環環汚染の問題
があるほか、コスト的にも不利であるという欠点
がある。 Conventionally, a known method for producing enteric coated preparations is a method in which tablets, granules, or capsules are coated with a coating solution in which an enteric coating base is dissolved in an organic solvent. However, since a large amount of organic solvent is used in this case, there is a risk of flames, explosion, safety and health problems for workers, and furthermore, there is a problem of environmental pollution due to the dissipation of this organic solvent into the atmosphere. In addition, it has the disadvantage of being disadvantageous in terms of cost.
このため、有機溶媒を使用しないで腸溶性被覆
製剤を製造する技術の開発が望まれており、たと
えば皮膜形成補助剤を溶解した水溶液に水不溶性
の微粉状皮膜剤を添加して得られる懸濁液を用い
る薬剤のコーテイング方法が提案されている（特
開昭54−84020号公報参照）。 For this reason, it is desired to develop a technology for manufacturing enteric coated preparations without using organic solvents. A drug coating method using a liquid has been proposed (see Japanese Patent Application Laid-open No. 84020/1983).
しかし、この方法には、水不溶性の微粉状皮膜
剤に対して皮膜形成補助剤を著しく高い比率で使
用することが必要とされ、この比率が低いと皮膜
剤の固形製剤上に付着する歩留りが悪く、皮膜剤
の大部分が粉末のままで拝気中に移行したり、ま
た形成された被覆膜が均一でなく、白化した状態
になつたりあるいはもろいなどの欠点がある。 However, this method requires the use of a significantly high ratio of film-forming adjuvant to the water-insoluble fine powder coating agent, and if this ratio is low, the yield of the coating agent deposited on the solid formulation is reduced. Unfortunately, most of the coating agent is transferred into the air as a powder, and the coating film formed is not uniform and becomes white or brittle.
またこの方法では皮膜形成補助剤として、ポリ
エチレングリコール、プロピレングリコール、エ
チルセロソルブ、ポリオキシエチレンソルビタン
脂肪酸エステル類などいずれも水に溶けやすい物
質が使用されるが、これが前記水溶性の微粉状皮
膜剤と高割合で一体となつて被覆膜を形成するの
で、腸溶性保護コーテイング製剤（錠剤等）を製
造した場合、このものが胃液と接触すると、該反
膜形成補助剤が溶け出し、被膜液の強度が低下し
て製剤自体が胃液中で崩壊するにいたつたり、崩
壊しないまでも胃液が製剤中に多量に侵透し、医
薬成分が溶け出たり、あるいは医薬成分が酸に弱
い場合には分解してしまうといつた問題がある。 In addition, in this method, substances that are easily soluble in water, such as polyethylene glycol, propylene glycol, ethyl cellosolve, and polyoxyethylene sorbitan fatty acid esters, are used as film-forming aids, and these are the same as the water-soluble fine powder film forming agent. A high proportion of these agents combine to form a coating film, so when enteric protective coating preparations (tablets, etc.) come into contact with gastric fluid, the antifilm-forming adjuvant dissolves out and forms a coating fluid. If the strength decreases and the preparation itself disintegrates in gastric juice, or even if it does not disintegrate, a large amount of gastric juice penetrates into the preparation and the medicinal ingredient dissolves out, or if the medicinal ingredient is sensitive to acid. There is a problem with disassembling it.
さらにまた、前記した皮膜形成補助剤中エチル
セロソルプあるいはプロピレングリコールなどは
揮発生があり、被覆操作中にそれが排気中に移行
するおそれがあるという問題点もある。 Furthermore, there is a problem that ethyl cellosolp or propylene glycol among the above-mentioned film forming aids is volatile, and there is a possibility that it may be transferred to the exhaust gas during the coating operation.
本発明者らは水を媒体とする被覆液を用いる、
腸溶性被覆製剤の製造におけるかかる問題点を改
善すべく鋭意研究を重ねた結果、全く新しいタイ
プの腸溶性保護コーテイング剤組成物を開発し
た。 The present inventors use a coating liquid using water as a medium.
As a result of intensive research to improve these problems in the production of enteric-coated preparations, we have developed a completely new type of enteric-coated protective coating agent composition.
すなわち、本発明は平均粒子径100μｍ以下の
粉末状腸溶性被覆基剤を、これに対して５〜100
重量％の水に溶けにくい、またはそれ以下の溶解
性を有す可塑剤、および５重量％以下の界面活性
剤を含む水媒体中に分散させてなる固形薬剤用腸
溶性保護コーテイング剤組成物に関するものであ
る。 That is, the present invention uses a powdered enteric coating base with an average particle size of 100 μm or less, and
An enteric protective coating composition for solid drugs, which is dispersed in an aqueous medium containing 5% by weight or less of a plasticizer having a solubility in water or less, and a surfactant of 5% by weight or less. It is something.
この組成物は、一種の懸濁状水性液であり、こ
れを用いて錠剤等の固形薬剤に対する被覆操作を
行うことにより、きわめて容易に腸溶性被覆膜を
形成することができ、この被覆膜は耐胃液性にす
ぐれ、腸液ですみやかに崩壊し、また被覆製剤は
貯蔵安定性にすぐれているという利点が与えられ
る。 This composition is a kind of suspended aqueous liquid, and by coating a solid drug such as a tablet with it, an enteric coating film can be formed very easily. The membrane has the advantage of being highly resistant to gastric juices, rapidly disintegrating in intestinal fluids, and the coated formulation having good storage stability.
以下本発明の詳細に説明する。 The present invention will be explained in detail below.
本発明に使用される腸溶性被覆基剤としては、
従来公知のものが使用でき、これにはヒドロキシ
プロピルメチルセルロースフタレート
（HPMCP）、ヒドロキシプロピルメチルセルロー
スの酸性サクシニルおよびアセチル混式エステル
（HPMCAS）、酢酸フタル酸セルロース（CAP）、
カルボキシメチルエチルセルロース（CMEC）、
メタアクリル酸−メタアクリル酸エステル共重合
体等が例示されるが、これらは必要に応じふるい
分けあるいは公知の方法で粉砕するなどにより平
均粒子径100μｍ以下の粉末状であることが必要
とされる。平均粒子径の大きいあらい粉粒状のも
のを用いると、水中へ分散させるにあたつて安定
した分散液が得難いほか、そのような分散液は固
形薬剤の被覆に応用するにあたつて一般に使用さ
れるスプレーガンのノルズを閉塞する原因ともな
り、また目的の被覆膜形成が困難になる。したが
つて特には50μｍ以下の粉末状物であることが望
ましい。 The enteric coating base used in the present invention includes:
Conventionally known materials can be used, including hydroxypropyl methylcellulose phthalate (HPMCP), acidic succinyl and acetyl mixed ester of hydroxypropyl methylcellulose (HPMCAS), cellulose acetate phthalate (CAP),
carboxymethylethylcellulose (CMEC),
Examples include methacrylic acid-methacrylic ester copolymers, which are required to be in powder form with an average particle size of 100 μm or less by sieving or pulverizing by a known method, if necessary. If rough powder particles with a large average particle size are used, it is difficult to obtain a stable dispersion when dispersing in water, and such dispersions are generally not used for coating solid drugs. This may cause the nozzle of the spray gun to become clogged, making it difficult to form the desired coating film. Therefore, it is particularly desirable to use a powdered material with a diameter of 50 μm or less.
可塑剤としては、その水に対する溶解性がおお
むね20±５℃においてその１mlを溶かすに要する
水の量が100ml以上になるような、水に溶けにく
いものが望ましく、これにはアセチルトリエチル
シトレート、トリブチルシトレート、アセチルト
リブチルシトレート、アセチルトリ−２−エチル
ヘキシルシトレートなどのクエン酸エステル類、
オリーブ油、ヒマシ油等の食用油脂類、フタル酸
ジメチル、フタル酸ジエチル、フタル酸ジプチ
ル、フタル酸ジ−２−エチルヘキシル、ブチルフ
タリルブチルグリコレートなどのマタル酸エステ
ル類、その他トリブチリン、アセチル化モノグリ
セライド、モノグリセライド、酒石酸ジエチルな
どが例示される。 As a plasticizer, it is desirable to use one that is difficult to dissolve in water, such that the amount of water required to dissolve 1 ml at approximately 20±5°C is 100 ml or more, and examples include acetyl triethyl citrate, Citric acid esters such as tributyl citrate, acetyl tributyl citrate, acetyl tri-2-ethylhexyl citrate,
Edible fats and oils such as olive oil and castor oil, matal acid esters such as dimethyl phthalate, diethyl phthalate, diptyl phthalate, di-2-ethylhexyl phthalate, butylphthalyl butyl glycolate, other tributyrin, acetylated monoglyceride, Examples include monoglyceride and diethyl tartrate.
これらの可塑剤の水に対する溶解性は日本薬局
方の通則における溶解性の表記方法によれば、溶
けにくい、またはそれ以下の溶解性を有するもの
であり、すなわち、これら可塑剤１mlを溶かすに
要する水の量が20±５℃において100ml以上にな
るものである。また、これらの可塑剤の使用量は
腸溶性被覆基剤に対して通常５〜100重量％、望
ましくは10〜80重量％の範囲が適当である。 The solubility of these plasticizers in water is that according to the solubility notation method in the general rules of the Japanese Pharmacopoeia, they are difficult to dissolve or have a lower solubility. The amount of water is 100ml or more at 20±5℃. The appropriate amount of these plasticizers to be used is usually 5 to 100% by weight, preferably 10 to 80% by weight, based on the enteric coating base.
このような水に溶けにくい、またはそれ以下の
溶解性を有する可塑剤を用いることによつて前記
した従来の不利を解決することができる。 The above-mentioned conventional disadvantages can be overcome by using such a plasticizer that is poorly soluble in water or has a lower solubility.
本発明の腸溶性保護コーテイング剤組成物はつ
ぎのようにして調製することができる。すなわち
前記可塑剤は水に溶けにくいものであるので、あ
らかじめ用いる水に加えた後単なるかくはんある
いはホモジナイザー、コロイドミル等を用いるな
どして均一に分散あるいは乳化させることが必要
である。この分散あるいは乳化を促進させるた
め、適当な分散補助剤あるいは乳化剤としての界
面活性剤を加えるのが望ましく、これにはポリオ
キシエチレンソルビタン脂肪酸エステル（ツイー
ン80など）、ソルビタン脂肪酸エステル（スパル
80など）、ポリオキシエチレンアルキルエーテル、
ポリオキシエチレンアルキルエステル、ラウリル
硫酸ナトリウム等が例示される。 The enteric protective coating composition of the present invention can be prepared as follows. That is, since the plasticizer is difficult to dissolve in water, it is necessary to add it to the water used in advance and then uniformly disperse or emulsify it by simple stirring or using a homogenizer, colloid mill, etc. In order to promote this dispersion or emulsification, it is desirable to add a surfactant as a suitable dispersion aid or emulsifier, such as polyoxyethylene sorbitan fatty acid ester (Tween 80, etc.), sorbitan fatty acid ester (Spar
80), polyoxyethylene alkyl ether,
Examples include polyoxyethylene alkyl ester and sodium lauryl sulfate.
これら界面活性剤の使用量は腸溶性被覆基剤に
対して５重量％以下が適当である。 The appropriate amount of these surfactants to be used is 5% by weight or less based on the enteric coating base.
腸溶性被覆基剤の粉末は、あらかじめ可塑剤を
加えた水中に加えて分散させるのが適当である
が、各成分の加える順序に関しては特に制限はな
い。 It is appropriate to add and disperse the enteric coating base powder in water to which a plasticizer has been added in advance, but there is no particular restriction on the order in which each component is added.
このようにして調製した腸溶性保護コーテイン
グ剤組成物（被覆液）は温度が高いと腸溶性被覆
基剤の粒子が凝集する傾向があり、被覆液は調製
時あるいは被覆操作時、貯臓タンク中において30
℃以下に保つことが、分散液を均一に保つ目的の
ために望ましい、また被覆操作時、被覆液をスプ
レーガンへ供給する経路で著しく加熱されること
も、凝集を促進し、配管あるいはスプレーガンの
ノズルを閉塞させるおそれがあるので注意を要す
る。 In the enteric protective coating agent composition (coating liquid) prepared in this way, the particles of the enteric coating base tend to aggregate when the temperature is high, and the coating liquid is stored in the storage tank during preparation or coating operation. at 30
It is desirable to keep the dispersion below ℃ for the purpose of keeping the dispersion uniform.Also, during the coating operation, significant heating in the route that supplies the coating liquid to the spray gun will promote agglomeration and cause damage to piping or the spray gun. Please be careful as there is a risk of clogging the nozzle.
腸溶性被覆基剤の被覆液中における濃度は３〜
20重量％望ましくは５〜15重量％となるようにす
るのが適当で、この下限以下では所望の厚さの被
覆膜を得る被覆操作に長時間を要するようになり
経済的に好ましくなく、また、上限以上では表面
の滑らかな被覆膜を得ることが困難となる。 The concentration of the enteric coating base in the coating solution is 3 to 3.
It is appropriate to set the amount to 20% by weight, preferably 5 to 15% by weight; below this lower limit, the coating operation to obtain a coating film of the desired thickness will require a long time, which is economically undesirable; Moreover, if it exceeds the upper limit, it becomes difficult to obtain a coating film with a smooth surface.
こうして得られた被覆液に必要に応じて着色
剤、きよう味きよう臭剤あるいは少量の水溶性ま
たは水分性高分子物質を加えることは自由であ
る。目的とする腸溶性被覆基剤は上記被覆液を用
いて錠剤、顆粒あるいはカプセル剤等の固形薬剤
を被覆することにより得られるが、この被覆操作
は従来公知の手段たとえば、パンコーテイング装
置、ドラムタイプコーテイング装置、流動法コー
テイング装置等を用いる方法によればよい。また
被覆装置に付帯するスプレー装置としてはエアー
スプレー、エアーレススプレー等いずれも用いる
ことができる。 If necessary, a coloring agent, a flavoring agent, or a small amount of a water-soluble or water-based polymeric substance may be added to the coating liquid thus obtained. The desired enteric coating base can be obtained by coating solid drugs such as tablets, granules, or capsules with the above-mentioned coating liquid. A method using a coating device, a flow method coating device, etc. may be used. Further, as the spray device attached to the coating device, either an air spray or an airless spray can be used.
なお、この被覆工程において被覆液はそれに分
散含有される腸溶性被覆基剤の粉末、その他必要
に応じ加えられた着色剤等の固形成分が沈降する
おそれがあるので、被覆操作を行つている間、か
くはんを続けることが望ましい。 In addition, during this coating process, there is a risk that solid components such as enteric coating base powder dispersed in the coating liquid and other coloring agents added as necessary may settle. , it is desirable to continue stirring.
本発明の腸溶性保護コーテイング剤組成物を用
いて、錠剤、顆粒剤あるいはカプセル剤などの固
形薬剤に被覆することにより、外観的にも腸溶性
製剤としての性能あるいは長期保存安定性の点で
もほとんど問題がないすぐれた製剤が得られる
が、有機溶媒を用いないですむという点に関して
大巾な改善が図られるものである。 By coating solid drugs such as tablets, granules, or capsules with the enteric-coated protective coating composition of the present invention, it is possible to improve the appearance, performance, and long-term storage stability of enteric-coated preparations. Although an excellent formulation is obtained without any problems, it is a significant improvement in that it does not require the use of organic solvents.
なお被覆量は固形薬剤の種類によつても異なる
が固形分で固形薬剤の重量に対しおおむね３〜50
重量％とすればよい。 The amount of coating varies depending on the type of solid drug, but the solid content is approximately 3 to 50% of the weight of the solid drug.
It may be expressed as weight %.
本発明の腸溶性保護コーテイング剤組成物を適
用することにより、固形薬剤上に良好な被覆がな
され、またその被覆製剤は腸溶性製剤としてすぐ
れた性能を示すことに関しては、必ずしもその理
由は明らかではないが、これは被覆液が、熱風下
で乾燥するに際して、まず腸溶性被覆基剤の粉末
が凝集し、ついで水の蒸発と共に可塑剤がその凝
集体中に拡散し、熱の助けで該凝集体が融着し、
最終的に被膜となる過程を経ることによるものと
考えられる。 The reason why the enteric-coated protective coating agent composition of the present invention provides good coating on solid drugs and the coated preparation exhibits excellent performance as an enteric-coated preparation is not necessarily clear. However, this is because when the coating liquid dries under hot air, the powder of the enteric coating base first aggregates, and then as the water evaporates, the plasticizer diffuses into the aggregates, and the coagulation occurs with the help of heat. The aggregates fuse,
This is thought to be due to the process of finally forming a film.
なお、固形薬剤を被覆する場合に、それに先立
つて固形薬剤を別の被覆基剤、たとえばヒドロキ
シプロピルメチルセルロースなどの胃溶性被覆基
剤の水溶液を用いて被覆してもよく、これによれ
ば衝撃により摩損しやすい固形薬剤に対してもそ
の被覆が容易になり、より少ない被覆量で、耐胃
液性にすぐれた腸溶性被覆基剤を得ることができ
る。 In addition, when coating a solid drug, the solid drug may be coated with another coating base, for example, an aqueous solution of a gastric soluble coating base such as hydroxypropyl methyl cellulose. It becomes easier to coat even solid drugs that are easily abraded, and an enteric coated base with excellent gastric fluid resistance can be obtained with a smaller amount of coating.
また、被覆操操作終了後は常法による乾燥、単
に熱にかける熱処理、公知の方法によるつや出し
操作、糖衣がけ、さらには他の被覆基剤を用いる
被覆等を適宜行つてよい。 Further, after the coating operation is completed, drying by a conventional method, heat treatment by simply applying heat, polishing operation by a known method, sugar coating, coating using another coating base, etc. may be carried out as appropriate.
つぎに、本発明の実施例をあげる。実施例中単
に部あるいは％とあるのはいずれもそれぞれ重量
部あるいは重量％を示したものである。 Next, examples of the present invention will be given. In the examples, parts or percentages indicate parts by weight or percentages by weight, respectively.
実施例 １
アスピリンを主薬成分として含む直径9.5mm、
１錠当り重量300mgの錠剤につぎに示す条件で被
覆操作を行い腸溶性被覆基剤を得た。Example 1 Diameter 9.5 mm containing aspirin as the main drug ingredient,
Tablets each weighing 300 mg were coated under the following conditions to obtain an enteric coated base.
被覆液処方：
HPMCP〔（HP−55：信越化学工業社製、商品名）
粉末をさらに微粉砕して得た平均粒子径10μｍの
微粉状物〕 ……10部
フタル酸ジブチル ……５部
ツイーン80（ポリオキシエチレンソルビタン脂肪
酸エステル） 0.3部
水 ……84.7部
水の中にツイーン80を溶解し、これにフタル酸
ジブチルを加えてかくはん機を用いてかくはん
し、充分に乳化させ、ついでこれにHPMCPの粉
末を加え、かくはんして均一に分散させた。この
ようにして得た被覆液は以降被覆操作中ゆるやか
にかくはんを続けた。Coating liquid formulation: HPMCP [(HP-55: manufactured by Shin-Etsu Chemical Co., Ltd., trade name)
A fine powder with an average particle size of 10 μm obtained by further pulverizing the powder] ...10 parts dibutyl phthalate ...5 parts Tween 80 (polyoxyethylene sorbitan fatty acid ester) 0.3 parts water ...84.7 parts in water Tween 80 was dissolved, dibutyl phthalate was added thereto, and the mixture was stirred using a stirrer to thoroughly emulsify it, and then HPMCP powder was added thereto and stirred to uniformly disperse it. The coating liquid thus obtained was then gently stirred during the coating operation.
被覆条件：
被覆装置：英国マネステイー社製、24インチアク
セラコータ
スプレーガン：ノルズ径1.2mmのエアースプレー
型
液送ポンプ：チユーブ式ポンプ
被覆液温度：25℃
錠剤仕込量：10Kg
被覆液供給速度：70ｇ／分
スプレ空気流量：120／分
乾燥空気温度：70℃
被覆操作中錠剤温度：38℃
被覆操作時間：115分
被覆液使用量：８Kg
被覆基剤（HPMCP）使用量：800ｇ（対錠剤８
％））
このようにして被覆することにより、１錠当り
約33mgの被覆が施された腸溶性被覆錠剤を得た。Coating conditions: Coating equipment: 24-inch Axela Coater, manufactured by British Manestee Co., Ltd. Spray gun: Air spray type with nose diameter of 1.2 mm Liquid feed pump: Tube type pump Coating liquid temperature: 25℃ Tablet loading amount: 10Kg Coating liquid supply rate: 70g /min Spray air flow rate: 120/min Drying air temperature: 70℃ Tablet temperature during coating operation: 38℃ Coating operation time: 115 minutes Amount of coating liquid used: 8Kg Amount of coating base (HPMCP) used: 800g (for 8 tablets)
%)) By coating in this manner, enteric coated tablets were obtained in which each tablet was coated in an amount of about 33 mg.
この被覆錠剤を日本薬局方による腸溶性製剤に
関する崩壊試験法にしたがつて試験を行なつたと
ころ、第１液による試験では変化はなく、第２液
による試験では11〜13分で崩壊し、腸溶性製剤と
しての特性を満足した。 When this coated tablet was tested according to the disintegration test method for enteric-coated preparations according to the Japanese Pharmacopoeia, there was no change in the test with the first liquid, and it disintegrated in 11 to 13 minutes in the test with the second liquid. The characteristics as an enteric-coated preparation were satisfied.
実施例 ２
パンクレアチンを主薬成分として含む球形造粒
した顆粒を分級してふるい番号で12〜32号
（1410μ〜500μ）の部分をとり、その５Kgをグラ
ツト流動コーテイング装置WSLD−３（大川原製
作所製）に仕込み、前記実施例１と同一被覆液を
用いて、以下の条件で被覆操作を行つた。Example 2 Spherical granules containing pancreatin as the main ingredient were classified, and the sieve number 12 to 32 (1410μ to 500μ) was taken, and 5 kg of the granules were placed in a gratified fluid coating device WSLD-3 (manufactured by Okawara Manufacturing Co., Ltd.). ), and using the same coating solution as in Example 1, a coating operation was performed under the following conditions.
被覆操作条件：
被覆液温度 ……25℃
被覆液供給速度 60ｇ／分
流動空気温度……80℃
排気温度 ……32〜35℃
被覆液使用量 ……15Kg
被覆基剤使用量 ……1.5Kg（対頼粒30％）
操作時間 ……250分
被覆顆粒について、日本薬局方、腸溶性顆粒剤
の崩壊試験法を適用したところ、第１液による試
験には適合し、第２液による試験では４〜５分で
完全に崩壊し、腸溶性顆粒剤としての性能を満足
した。Coating operation conditions: Coating liquid temperature: 25℃ Coating liquid supply rate: 60g/min Flowing air temperature: 80℃ Exhaust temperature: 32~35℃ Coating liquid usage: 15Kg Coating base usage: 1.5Kg ( Operating time: 250 minutes When the Japanese Pharmacopoeia's disintegration test method for enteric-coated granules was applied to the coated granules, it passed the test with the first liquid, and the test with the second liquid showed a rating of 4. It completely disintegrated in ~5 minutes, satisfying the performance as an enteric-coated granule.
実施例 ３
HPMCAS（ヒドロキシプロポキシル基、M.S.
＝0.27、メトキシル基D.S.＝1.85、アセチル基D.
S.＝0.51、サクシニル基D.S.＝0.28）を粉砕して
平均粒子径10μｍ（最大粒子径30μｍ）としたも
のを用い、つぎの被覆液を調製し、実施例１に準
じた被覆操作を行つた。Example 3 HPMCAS (hydroxypropoxyl group, MS
= 0.27, methoxyl group DS = 1.85, acetyl group D.
S. = 0.51, succinyl group DS = 0.28) was pulverized to an average particle size of 10 μm (maximum particle size of 30 μm), the following coating solution was prepared, and the coating operation was performed in accordance with Example 1. .
被覆液処方：
HPMCAS ……10部
フタル酸ジエチル ……５部
ツイーン80 ……0.3部
水 ……84.7部
被覆錠剤について、同様に崩壊試験法にしたが
つて試験を行つたところ、第１液による試験では
変化はなく、第２液による試験では11〜13分で崩
壊した。Coating liquid formulation: HPMCAS...10 parts Diethyl phthalate...5 parts Tween 80...0.3 parts Water...84.7 parts When the coated tablets were tested in the same manner according to the disintegration test method, it was found that the first liquid In the test, there was no change, and in the test with the second liquid, it disintegrated in 11 to 13 minutes.
実施例 ４
本発明のコーテイング液組成物（被覆液）を用
いた場合、および対照として皮膜形成補助剤とし
て水溶性の物質を溶解した水溶液に腸溶性被覆基
剤の微粉末を添加分散させて得た懸濁液（被覆
液）を使用した場合の結果を示す。Example 4 When the coating liquid composition (coating liquid) of the present invention was used, and as a control, a fine powder of an enteric coating base was added and dispersed in an aqueous solution in which a water-soluble substance was dissolved as a film forming aid. The results are shown when a suspension (coating liquid) was used.
被覆液処方（本発明被覆液）：
HPMCP〔（HP−50：信越化学工業製商品名）粉
末をさらに微粉砕して平均粒子径10μｍ（最大粒
子径30μｍ）の微粉状物〕 ……10部
酒石酸ジエチル ……３部
スパン80（ソルビタン脂肪酸エステル） ……0.3部
水 ……86.7部
被覆液処方（対照被覆液）
上記本発明被覆液で使用したと同じ
HPMCPの微粉状物 ……６部
プロピレングリコール ……12部
エチレングリコールモノエチルエーテル 3.6部
タルク ……３部
水 ……75.4部
乳糖およびコーンスターチを主成分とする直径
９mm、１錠当り270mgの錠剤に実施例１に準じた
条件で上記被覆液を用いて被覆を行つた。被覆基
剤はいずれもHPMCPとして錠剤重量当り８重量
％を用いた。Coating liquid formulation (coating liquid of the present invention): HPMCP [(HP-50: Shin-Etsu Chemical Co., Ltd. trade name) powder is further finely pulverized to form a fine powder with an average particle size of 10 μm (maximum particle size of 30 μm)] ...10 parts Diethyl tartrate...3 parts Span 80 (Sorbitan fatty acid ester)...0.3 parts Water...86.7 parts Coating liquid formulation (control coating liquid) Fine powder of HPMCP, the same as used in the coating liquid of the present invention above...6 parts Propylene Glycol: 12 parts Ethylene glycol monoethyl ether 3.6 parts Talc: 3 parts Water: 75.4 parts Tablets with a diameter of 9 mm and 270 mg each containing lactose and corn starch as main ingredients were coated under the same conditions as in Example 1. Coating was carried out using a liquid. The coating base used was HPMCP in an amount of 8% by weight based on the weight of the tablet.
この結果得られた被覆製剤はいずれも外観的に
は表面もなめらかで特に問題のないものであつ
た。これらについて日本薬局方、腸溶性製剤に関
する崩壊試験を行つたところ、本発明の被覆液を
用いた被覆製剤は第１液による試験では変化がな
く、第２液による試験では９〜10分で崩壊した。
これに対し対照被覆液を用いた被覆製剤は第１液
による試験で25〜45分で全て崩壊してしまい、腸
溶性製剤として不満足な結果を示した。 All of the coated preparations obtained as a result had smooth surfaces and no particular problems in appearance. When disintegration tests were conducted on these enteric-coated preparations using the Japanese Pharmacopoeia, the coated preparations using the coating liquid of the present invention showed no change in the test with the first liquid, and disintegrated in 9 to 10 minutes in the test with the second liquid. did.
On the other hand, the coated preparation using the control coating solution completely disintegrated in 25 to 45 minutes in the test with the first solution, showing unsatisfactory results as an enteric-coated preparation.
Claims (1)
基剤を、これに対して５〜100重量％の水に溶け
にくい、またはそれ以下の溶解性を有する可塑
剤、および５重量％以下の界面活性剤を含む水媒
体中に分散させてなる固形薬剤用腸溶性保護コー
テイング剤組成物。1 Powdered enteric coating base with an average particle size of 100 μm or less, 5 to 100% by weight of a plasticizer that is poorly soluble in water or less soluble, and 5% by weight or less of a surfactant. An enteric protective coating agent composition for a solid drug, which is dispersed in an aqueous medium containing a drug.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP843080A JPS56104823A (en) | 1980-01-28 | 1980-01-28 | Enteric coating composition for solid preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP843080A JPS56104823A (en) | 1980-01-28 | 1980-01-28 | Enteric coating composition for solid preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS56104823A JPS56104823A (en) | 1981-08-20 |
| JPH0138091B2 true JPH0138091B2 (en) | 1989-08-11 |
Family
ID=11692899
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP843080A Granted JPS56104823A (en) | 1980-01-28 | 1980-01-28 | Enteric coating composition for solid preparation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS56104823A (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS58157726A (en) * | 1982-03-11 | 1983-09-19 | Shin Etsu Chem Co Ltd | Enteric coating composition for solid preparation |
| JPS5973529A (en) * | 1982-10-12 | 1984-04-25 | Sankyo Co Ltd | Preparation of coated solid drug |
| US4518433A (en) * | 1982-11-08 | 1985-05-21 | Fmc Corporation | Enteric coating for pharmaceutical dosage forms |
| JPS59155325A (en) * | 1983-02-25 | 1984-09-04 | Kohjin Co Ltd | Preparation of water-based enteric coating agent |
| JPS59193831A (en) * | 1983-04-18 | 1984-11-02 | Sankyo Co Ltd | Preparation of enteric drug |
| JPS6216432A (en) * | 1985-07-05 | 1987-01-24 | Shin Etsu Chem Co Ltd | Enteric coating composition |
| JPH0774166B2 (en) * | 1987-02-06 | 1995-08-09 | 信越化学工業株式会社 | Method for producing sustained-release coated drug |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2887440A (en) * | 1957-08-12 | 1959-05-19 | Dow Chemical Co | Enteric coating |
| US3353971A (en) * | 1963-01-11 | 1967-11-21 | Dow Chemical Co | Ethylcellulose latex polish composition |
| JPS50129729A (en) * | 1974-04-05 | 1975-10-14 | ||
| JPS517112A (en) * | 1974-07-04 | 1976-01-21 | Meiji Seika Co | Hifukuyakuzaino seizohoho |
| JPS5484020A (en) * | 1977-11-21 | 1979-07-04 | Dai Ichi Seiyaku Co Ltd | Composition for coating medicine and method for coating the same |
| JPS6141325A (en) * | 1985-04-22 | 1986-02-27 | Fuji Standard Res Kk | Manufacture of carbon fiber |
-
1980
- 1980-01-28 JP JP843080A patent/JPS56104823A/en active Granted
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2887440A (en) * | 1957-08-12 | 1959-05-19 | Dow Chemical Co | Enteric coating |
| US3353971A (en) * | 1963-01-11 | 1967-11-21 | Dow Chemical Co | Ethylcellulose latex polish composition |
| JPS50129729A (en) * | 1974-04-05 | 1975-10-14 | ||
| JPS517112A (en) * | 1974-07-04 | 1976-01-21 | Meiji Seika Co | Hifukuyakuzaino seizohoho |
| JPS5484020A (en) * | 1977-11-21 | 1979-07-04 | Dai Ichi Seiyaku Co Ltd | Composition for coating medicine and method for coating the same |
| JPS6141325A (en) * | 1985-04-22 | 1986-02-27 | Fuji Standard Res Kk | Manufacture of carbon fiber |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS56104823A (en) | 1981-08-20 |
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