JPS595122A - Film coating composition for medicine - Google Patents
Film coating composition for medicineInfo
- Publication number
- JPS595122A JPS595122A JP11326782A JP11326782A JPS595122A JP S595122 A JPS595122 A JP S595122A JP 11326782 A JP11326782 A JP 11326782A JP 11326782 A JP11326782 A JP 11326782A JP S595122 A JPS595122 A JP S595122A
- Authority
- JP
- Japan
- Prior art keywords
- film
- composition
- molecular weight
- coating
- hpc
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 24
- 239000007888 film coating Substances 0.000 title abstract description 8
- 238000009501 film coating Methods 0.000 title abstract description 8
- 239000003814 drug Substances 0.000 title abstract description 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 13
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 13
- 229920000609 methyl cellulose Polymers 0.000 claims abstract description 6
- 239000001923 methylcellulose Substances 0.000 claims abstract description 6
- 235000010981 methylcellulose Nutrition 0.000 claims abstract description 6
- -1 polyoxyethylene lauryl ether Polymers 0.000 claims abstract description 6
- 229920000259 polyoxyethylene lauryl ether Polymers 0.000 claims abstract description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 5
- 239000012232 pharmaceutical film coating Substances 0.000 claims description 8
- 239000011248 coating agent Substances 0.000 abstract description 17
- 238000000576 coating method Methods 0.000 abstract description 17
- 239000007787 solid Substances 0.000 abstract description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 6
- 239000002904 solvent Substances 0.000 abstract description 4
- 238000002156 mixing Methods 0.000 abstract description 3
- 230000000704 physical effect Effects 0.000 abstract description 3
- 229940079593 drug Drugs 0.000 abstract description 2
- 229920000642 polymer Polymers 0.000 abstract 2
- 230000000903 blocking effect Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 6
- 238000002360 preparation method Methods 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 229920001800 Shellac Polymers 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 239000004208 shellac Substances 0.000 description 2
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 2
- 229940113147 shellac Drugs 0.000 description 2
- 235000013874 shellac Nutrition 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 229920003169 water-soluble polymer Polymers 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 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
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 239000003125 aqueous solvent Substances 0.000 description 1
- 239000012752 auxiliary agent Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229920003086 cellulose ether Polymers 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- LQZZUXJYWNFBMV-UHFFFAOYSA-N dodecan-1-ol Chemical compound CCCCCCCCCCCCO LQZZUXJYWNFBMV-UHFFFAOYSA-N 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 239000000576 food coloring agent Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229930014626 natural product Natural products 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 239000000123 paper Substances 0.000 description 1
- 239000011087 paperboard Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000002798 polar solvent Substances 0.000 description 1
- 235000003441 saturated fatty acids Nutrition 0.000 description 1
- 150000004671 saturated fatty acids Chemical class 0.000 description 1
- DVQHRBFGRZHMSR-UHFFFAOYSA-N sodium methyl 2,2-dimethyl-4,6-dioxo-5-(N-prop-2-enoxy-C-propylcarbonimidoyl)cyclohexane-1-carboxylate Chemical compound [Na+].C=CCON=C(CCC)[C-]1C(=O)CC(C)(C)C(C(=O)OC)C1=O DVQHRBFGRZHMSR-UHFFFAOYSA-N 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
本発明は医薬用フィルムコーティング組成物に係り、さ
らに詳しくはヒドロキシプロピルセルロースを主成分と
する水溶媒系医薬用フィルムコーティング組成物に関す
る。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a pharmaceutical film coating composition, and more particularly to a water-based pharmaceutical film coating composition containing hydroxypropyl cellulose as a main component.
医薬用の錠剤、九剤、顆粒剤、カプセル剤等の固形製剤
には服用し島くする目的および／または、吸湿、酸化、
粘着等を防止し、貯蔵安定性を付与する目的のためフィ
ルムがコーティングされている。このフィルム基材とし
て水溶性高分子中でもセルロースエーテル類が広く採用
されている。セルロースのグルコース残基１個当り２．
０〜４．２モルのプロピレンオキサイドを付加したヒド
ロキリプロピルセルロース（以下「ＨＰ ＣＪと称す。Solid preparations such as pharmaceutical tablets, tablets, granules, and capsules have the purpose of making them easier to take and/or absorb moisture, oxidation,
Films are coated to prevent sticking and provide storage stability. Among water-soluble polymers, cellulose ethers are widely used as the base material for this film. 2 per glucose residue in cellulose.
Hydroxylypropyl cellulose to which 0 to 4.2 moles of propylene oxide have been added (hereinafter referred to as "HP CJ").
）は水およびエタノール、イソプロパツール、アセトン
等の極性溶媒に再溶であり、これらの溶液から橋めて柔
軟性に富んだフィルムが得られるため固形製剤コーティ
ング用のフィルム基材としての使用が期待されるが、防
湿性、耐粘着性の面で満足のいくフィルムが得られない
欠点がある。この欠点を改良するものとしてＮＰＣにシ
ェラツクおよび長鎖飽和脂肪酸を配合したフィルムコー
ティング組成物の発明（特公昭４５−１２７５８号、同
４６−８７１９号、同４７−６４３５号参照）について
本出願人は先に特許を受けた。しかしながらこれらの発
明においては品質の一定しない天然物であるシェラツク
を使用するため一定の性状のコーティングフィルムを得
るための配合設計が面倒であり、かつ、コーティング作
業に際してメタノール、エタノール、エチルセロソルブ
等の有機溶剤に溶解して使用しなければならない。特に
労働安全衛生面および省資源の面から有機溶剤に替えて
水を溶媒とするフィルムコーティング組成物が強く要望
されている。) can be redissolved in water and polar solvents such as ethanol, isopropanol, and acetone, and can be crosslinked from these solutions to obtain highly flexible films, making it suitable for use as a film base for coating solid drug preparations. Although this method is promising, it has the disadvantage that it is not possible to obtain a film that is satisfactory in terms of moisture resistance and adhesion resistance. In order to improve this drawback, the present applicant has proposed an invention for a film coating composition in which NPC is blended with shellac and long-chain saturated fatty acids (see Japanese Patent Publications Nos. 45-12758, 46-8719, and 47-6435). Received a patent first. However, these inventions use shellac, a natural product with variable quality, which makes it difficult to design a formulation to obtain a coating film with consistent properties. Must be used by dissolving it in a solvent. In particular, from the standpoints of occupational safety and health and resource conservation, there is a strong demand for film coating compositions that use water as a solvent instead of organic solvents.
本発明は、成膜性および得られたフィルムの柔軟性等の
ＨＰＣの特長を損うことなく、防湿性および耐粘着性に
優れたＨＰＣを主成分とする水溶媒系医薬用フィルムコ
ーティング組成物を提供することを目的とする。The present invention provides an aqueous solvent-based pharmaceutical film coating composition containing HPC as a main component, which has excellent moisture resistance and adhesion resistance without impairing the characteristics of HPC such as film formability and flexibility of the obtained film. The purpose is to provide
本発明者等は、１紀目的、特にＲＰＣフィルムの吸湿性
、および粘着性を改良すべく鋭意研究の結果、ＨＰＣに
ある種の合成水溶性高分子物質を配合した組成物の水溶
液を用いて錠剤のフィルムコーティングを行ったところ
極めて防湿性および耐粘着性に優れたコーティングフィ
ルムが得られることを見出し本発明を完成した。As a result of intensive research aimed at improving the hygroscopicity and adhesion of RPC films, the present inventors have developed a method using an aqueous solution of a composition containing HPC and a certain synthetic water-soluble polymer substance. When tablets were coated with a film, it was discovered that a coating film with extremely excellent moisture resistance and adhesion resistance could be obtained, and the present invention was completed.
本発明は、メチルセルロース、ポリエチレングリコール
、およびポリオキシエチレンラウリルエーテルの単独ま
たは２種以上をヒドロキシプロピルセルロースに配合し
て成ることを特徴とする医薬フィルムコーティング組成
物である。The present invention is a pharmaceutical film coating composition comprising hydroxypropyl cellulose mixed with methyl cellulose, polyethylene glycol, and polyoxyethylene lauryl ether alone or in combination with two or more of them.
本発明において、分子１１１０ρ００〜１５０ρ００
好ましくは、１０，０００〜２０，０００のメチルセル
ロース、分子量１００〜ｉｏ、ｏｏｏ好ましくは３ρ０
０〜８Ｘ）００のポリエチレングリコール、およびラウ
リルア、ルコール１モルに対し酸化エチレン２〜３０モ
ル好マしくは９〜２５モルを付加したポリオキシエチレ
ンラウリルエーテルの単独または２種以上がＨＰＣに配
合される。In the present invention, molecules 1110ρ00 to 150ρ00
Preferably methylcellulose of 10,000-20,000, molecular weight 100-io, ooo preferably 3ρ0
0 to 8X) 00 polyethylene glycol, and polyoxyethylene lauryl ether, in which 2 to 30 moles of ethylene oxide, preferably 9 to 25 moles, is added to 1 mole of lauryl alcohol are blended into HPC. Ru.
本発明において、医薬用フィルムコーティング組成物は
、ＮＰＣ１００重量部に対し前記メチルセルロース、ポ
リエチレングリコールおよびポリオキシエチレンラウリ
ルエーテルの単独または２種以上の混合物を１０〜２０
０重置部配合して得られる。In the present invention, the pharmaceutical film coating composition contains 10 to 20 parts of methyl cellulose, polyethylene glycol, and polyoxyethylene lauryl ether alone or in a mixture of two or more of them, per 100 parts by weight of NPC.
Obtained by blending 0 overlapping parts.
また、所望により着色料、香料、矯味料等を助剤として
、該組成物に添加することができる。Furthermore, if desired, coloring agents, fragrances, flavoring agents, and the like can be added to the composition as auxiliary agents.
本発明のフィルムコーティング組成物を用いる固形製剤
のコーティング方法として、パンコーティング装置、フ
ローコーティング装置またはドラムタイプコーディング
装置たとえばハイコーター■（フロイント産業■製）、
アクセラコーター■（ＭＡＮＥＳ１’Ｙ社製）等の装置
を用い該組成物の水溶液を固形製剤にスプレーコーティ
ングする方法が採用できる。As a method for coating solid preparations using the film coating composition of the present invention, pan coating equipment, flow coating equipment, or drum type coding equipment such as Hi-Coater (manufactured by Freund Sangyo),
A method of spray coating a solid preparation with an aqueous solution of the composition using a device such as Accela Coater (manufactured by MANES 1'Y) can be adopted.
本発明の医薬用フィルムコーティング組成物はその組成
成分のいずれもが合成高分子物質であるため各成分の分
子量、配合比等を調節することによ０コーテイング液の
性状、得られるフィルムの物性等を任意に調節すること
ができる。また、各成分が水可溶性物質であるため水を
溶媒として使用することができる。さらに得られたコー
ティングフィルムの粘着性が低下し、固形製剤相互間の
粘着が防止されるため、フィルムコーティング作業ニ際
し、コーテイング液の最大供給速度をＲＰＣの単独使用
に比較し大巾に増加することができ作業性が改善される
。Since all of the components of the pharmaceutical film coating composition of the present invention are synthetic polymer substances, the properties of the coating liquid and the physical properties of the resulting film can be adjusted by adjusting the molecular weight, blending ratio, etc. of each component. can be adjusted arbitrarily. Moreover, since each component is a water-soluble substance, water can be used as a solvent. Furthermore, the tackiness of the resulting coating film is reduced and adhesion between solid preparations is prevented, so the maximum supply rate of the coating liquid during film coating operations is greatly increased compared to when RPC is used alone. This improves workability.
本発明は防湿性、および耐粘着性の改良されたＲＰＣを
主成分とする水溶媒系医薬用フィルムコーティング組成
物を提供するものでありその産業的意義は極めて大きい
。The present invention provides an aqueous pharmaceutical film coating composition containing RPC as a main component which has improved moisture resistance and adhesion resistance, and has extremely great industrial significance.
以下、実施例により本発明をさらに詳細に説明する。た
だし本発明は下記実施例に限定されるもものではない。Hereinafter, the present invention will be explained in more detail with reference to Examples. However, the present invention is not limited to the following examples.
なお、実施例中で部数とあるのは全て重量部を表す。In addition, all parts indicated in the examples represent parts by weight.
実施例１〜７
コーテイング液の調整
フィルムコーティング組成物 ８ 部水
９２ 部食用色素（黄
色４号）０．２部
からなる水溶液を調整した。第１表中にフィルムコーテ
ィング組成物の各成分の組成をＨＰＣ１００部に対する
部数で示す。Examples 1 to 7 Adjustment of coating liquid Film coating composition 8 parts water
An aqueous solution consisting of 92 parts and 0.2 parts of food coloring (yellow No. 4) was prepared. Table 1 shows the composition of each component of the film coating composition in parts per 100 parts of HPC.
コーティング操作
乳糖Ｇを直打した錠剤（直径８１１１、重量ｉｓｏ ｑ
硬度２．５ Ｋｐ、フロイント産業■製） ３００ ＃
をハイコーターＨＣＴミニ（フロイント産業■製）に仕
込み上記コーテイング液を用いスプレーコーティングを
行い、パン回転数３６ ｒ、ｐｍ、パン温度４０℃、ス
プレー空気圧１．５１’ｌ／ｃｄの条件でコーティング
時に錠剤の相互粘着をおこさないコーテイング液の最大
供給速度を求めた。結果を第１表中に示す。Coated lactose G tablets (diameter 8111, weight iso q
Hardness 2.5 Kp, manufactured by Freund Sangyo ■) 300#
was placed in Hi-Coater HCT Mini (manufactured by Freund Sangyo ■) and spray-coated using the above coating liquid, and during coating the pan rotation speed was 36 r, pm, the pan temperature was 40°C, and the spray air pressure was 1.51'l/cd. The maximum feed rate of the coating liquid that would not cause the tablets to stick together was determined. The results are shown in Table 1.
第 １ 表
１）ＨＰＣ：ＨＰＣ−８Ｌ（日本曹達■製品）２）メチ
ルセルロース：メトローズ５Ｍ−１５（信越化学■製品
）
３）ポリオキシエチレンラウリルエーテル：ニラコール
ＢＬ９ＥＸ（日光ケミカルズ■製品）
また、調整したコーテイング液から得られたフィルムに
ついて各種物性を測定した。結果を第２表中に示す。Table 1 1) HPC: HPC-8L (Nippon Soda product) 2) Methylcellulose: Metrose 5M-15 (Shin-Etsu Chemical product) 3) Polyoxyethylene lauryl ether: Niracol BL9EX (Nikko Chemicals product) Various physical properties of the film obtained from the coating liquid were measured. The results are shown in Table 2.
第２表
１ ） Ｔ Ｉ ５Ｋ６７３２ 農業用塩化ビニルフィ
ルム試験方法準拠
２ ） Ｊ Ｉ ５Ｐ８１１５ 紙及び板紙の耐折強
さ試験方法準拠
３ ） Ｊ Ｉ ５ＺＯ２０８防湿包装材料の透湿度試
験方法準拠（膜厚０，０５鰭）Table 2 1) Based on T I 5K6732 Test method for agricultural vinyl chloride film 2) Based on J I 5P8115 Test method for folding strength of paper and paperboard 3) Based on J I 5ZO208 Moisture permeability test method for moisture-proof packaging materials (film thickness 0 ,05 fin)
Claims (1)
ポリオキシ工ｔレンラウリルエーテルの単独または２種
以上をヒドロキシプロピルセルロースに配合して成るこ
とを特徴とする医薬フィルムコーティング組成物。1. A pharmaceutical film coating composition comprising hydroxypropyl cellulose mixed with one or more of methyl cellulose, polyethylene glycol, and polyoxyethylene lauryl ether.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11326782A JPS595122A (en) | 1982-06-30 | 1982-06-30 | Film coating composition for medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP11326782A JPS595122A (en) | 1982-06-30 | 1982-06-30 | Film coating composition for medicine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS595122A true JPS595122A (en) | 1984-01-12 |
Family
ID=14607833
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP11326782A Pending JPS595122A (en) | 1982-06-30 | 1982-06-30 | Film coating composition for medicine |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS595122A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH02174931A (en) * | 1988-09-27 | 1990-07-06 | Takeda Chem Ind Ltd | Nucleate granule and its preparation |
| KR100493449B1 (en) * | 2002-05-28 | 2005-06-07 | 한국화학연구원 | A surface coating method of nanoparticle for cosmetic material |
-
1982
- 1982-06-30 JP JP11326782A patent/JPS595122A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH02174931A (en) * | 1988-09-27 | 1990-07-06 | Takeda Chem Ind Ltd | Nucleate granule and its preparation |
| KR100493449B1 (en) * | 2002-05-28 | 2005-06-07 | 한국화학연구원 | A surface coating method of nanoparticle for cosmetic material |
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