JP5614826B2 - 退色を抑制した製剤 - Google Patents
退色を抑制した製剤 Download PDFInfo
- Publication number
- JP5614826B2 JP5614826B2 JP2005204241A JP2005204241A JP5614826B2 JP 5614826 B2 JP5614826 B2 JP 5614826B2 JP 2005204241 A JP2005204241 A JP 2005204241A JP 2005204241 A JP2005204241 A JP 2005204241A JP 5614826 B2 JP5614826 B2 JP 5614826B2
- Authority
- JP
- Japan
- Prior art keywords
- polyvinyl alcohol
- tablet
- alcohol copolymer
- pigment
- chromatic
- 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.)
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- 238000005562 fading Methods 0.000 title description 9
- 238000009472 formulation Methods 0.000 title description 3
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- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 100
- 239000003826 tablet Substances 0.000 claims description 72
- 239000000049 pigment Substances 0.000 claims description 41
- 238000000034 method Methods 0.000 claims description 27
- 238000006116 polymerization reaction Methods 0.000 claims description 25
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 20
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 18
- 239000011248 coating agent Substances 0.000 claims description 13
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 10
- 239000011247 coating layer Substances 0.000 claims description 10
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
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- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 10
- 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 10
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- SGHZXLIDFTYFHQ-UHFFFAOYSA-L Brilliant Blue Chemical compound [Na+].[Na+].C=1C=C(C(=C2C=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C=2C(=CC=CC=2)S([O-])(=O)=O)C=CC=1N(CC)CC1=CC=CC(S([O-])(=O)=O)=C1 SGHZXLIDFTYFHQ-UHFFFAOYSA-L 0.000 description 8
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
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- WDQMWEYDKDCEHT-UHFFFAOYSA-N 2-ethylhexyl 2-methylprop-2-enoate Chemical compound CCCCC(CC)COC(=O)C(C)=C WDQMWEYDKDCEHT-UHFFFAOYSA-N 0.000 description 2
- RUMACXVDVNRZJZ-UHFFFAOYSA-N 2-methylpropyl 2-methylprop-2-enoate Chemical compound CC(C)COC(=O)C(C)=C RUMACXVDVNRZJZ-UHFFFAOYSA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
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- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 description 2
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
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- KFSLWBXXFJQRDL-UHFFFAOYSA-N Peracetic acid Chemical compound CC(=O)OO KFSLWBXXFJQRDL-UHFFFAOYSA-N 0.000 description 2
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 description 2
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Description
しかしながら、平成9年より公定法が変更となり、屋外の昼光色の光に類似した光を製剤に照射し、製剤の色の変化を観察する必要が生じた。この試験によって、多くの色素、特に、厚生省令で定められた医薬品に使用できるタール色素や医薬品添加物事典に収載されている有彩色(黒、白、灰色以外のすべての色)の色素、たとえば、レーキ化したタール色素、水溶性のタール色素や天然色素の多くは、公定法によって退色することが明らかとなり、製剤を有彩色で着色することは困難となった。
(1)錠剤または顆粒剤の表面に、有彩色の色素およびポリビニルアルコール共重合体を含む被覆層を設けたことを特徴とする錠剤または顆粒剤。
(2)有彩色の色素を含有した錠剤または顆粒剤の表面に、ポリビニルアルコール共重合体を含む被覆層を設けたことを特徴とする錠剤または顆粒剤。
(3)当該有彩色の色素が光によって退色しやすい色素である、上記(1)または(2)に記載の錠剤または顆粒剤。
(4)当該有彩色の色素がレーキ化したタール色素である、上記(3)記載の錠剤または顆粒剤。
(5)当該有彩色の色素が水溶性タール色素である、上記(3)記載の錠剤または顆粒剤。
(6)当該有彩色の色素が天然色素である、上記(3)記載の錠剤または顆粒剤。
(7)当該ポリビニルアルコール共重合体が平均重合度100〜2000のポリビニルアルコールと少なくとも1以上の重合性ビニル単量体とを重量比6:4〜9:1の割合で共重合させて得られる共重合体であり、当該共重合体の溶液の粘度が10〜300mPa・sである上記(1)から(6)のいずれかに記載の錠剤または顆粒剤。
(8)当該ポリビニルアルコール共重合体が平均重合度150〜1000のポリビニルアルコールと少なくとも1以上の重合性ビニル単量体とを重量比6:4〜9:1の割合で共重合させて得られる共重合体であり、当該共重合体の溶液の粘度が10〜200mPa・sである上記(7)記載の錠剤または顆粒剤。
(9)当該ポリビニルアルコールが部分けん化ポリビニルアルコールである上記(7)または(8)に記載の錠剤または顆粒剤。
(10)当該重合性ビニル単量体が、不飽和カルボン酸類、不飽和カルボン酸類のエステル類及びそれらの塩から選択される1または2以上である上記(7)から(9)のいずれかに記載の錠剤または顆粒剤。
(11)当該重合性ビニル単量体が、アクリル酸又はその塩及びメチルメタクリレートであり、共重合する際におけるアクリル酸又はその塩とメチルメタクリレートの重量比が3:7〜0.5:9.5である上記(10)記載の錠剤または顆粒剤。
(12)平均重合度100〜2000の部分けん化ポリビニルアルコール、メチルメタクリレートおよびアクリル酸を共重合する際における重量比が60〜90:7〜38:0.5〜12であり、当該共重合体の溶液の粘度が10〜300mPa・sである上記(7)記載の錠剤または顆粒剤。
(13)公定法において、累積照射量が120万ルクス・時間の光を照射した場合、錠剤または顆粒剤の変色度(ΔE)が5以下である上記(1)から(12)のいずれかに記載の錠剤または顆粒剤。
(14)上記(1)から(13)のいずれかに記載の錠剤または顆粒剤を製造することを目的とした、有彩色の色素およびポリビニルアルコール共重合体を含有することを特徴とするコーティング剤。
(15)ポリビニルアルコール共重合体で被覆することを特徴とする、退色を防止する方法。
(16)錠剤または顆粒剤にポリビニルアルコール共重合体で被覆することを特徴とする、錠剤または顆粒剤の退色を防止する方法。
(17)有彩色の色素の退色を防止するためのポリビニルアルコール共重合体の使用。
実施例
部分けん化ポリビニルアルコール[平均重合度500、けん化度88%]にアクリル酸およびメチルメタクリレートを共重合させたポリビニルアルコール共重合体(重量比 部分けん化ポリビニルアルコール:メチルメタクリレート:アクリル酸=80:17.5:2.5)70gを精製水900gに溶解した。この溶液に酸化チタン20g、タルク10g、青色1号アルミニュームレーキ色素(三栄源エフ・エフ・アイ社製)1gを3000回転、10分間の条件でホモジナイザーを用いて混合分散し、フィルムコーティング用液を調製した。調製したフィルムコーティング用液を直径9mm、重量290mgの白色錠剤に自動コーティング装置(ハイコーターHTC48 フロイント産業)を用いて、12mg/錠の被覆を行い、濃い青色のフィルムコーティング錠を得た。自動コーティング装置における被覆条件は、下記のとおりである。
給気温度:65℃
給気風量:3m3/min
液供給量:8g/min
排気温度:40℃
得られたフィルムコーティング錠を未包装の状態でISO10977(公定法)に規定されている、屋外の昼光の標準である光源を備えた光安定性試験装置(ナガノ科学機械製作所 型式LTL400−D50)中で最大累積積算量が30万ルクス・時間(3000ルクス×100時間)、60万ルクス・時間(3000ルクス×200時間)、120万ルクス・時間(3000ルクス×400時間)光照射をおこなった。得られた試料の変色度(ΔE)を分光色差計(日本電色製 型式SE−2000)をもちいて測定し、未照射品に対しての変色度を算出した。
錠剤の外観は、変色の度合いを3段階にスコアー化し、これを集計して順序化する方法によっておこなった。すなわち、未照射錠剤と光照射錠剤の外観を蛍光燈下および室内散光下に並べて観察を行った。照射後の錠剤の外観を「変化なし」、「ごく僅かに変色」、「退色」の3段階にわけた。
比較例1
ポリビニルアルコール共重合体をヒドロキシプロピルメチルセルロース(TC−5R、信越化学株式会社)に変更したこと以外は、実施例1と同様である。
青色1号アルミニュームレーキ色素を赤色3号アルミニュームレーキ色素(三栄源エフ・エフ・アイ社製)に変更した以外は、実施例1と同様である。
比較例2
青色1号アルミニュームレーキ色素を赤色3号アルミニュームレーキ色素(三栄源エフ・エフ・アイ社製)に変更し、ポリビニルアルコール共重合体をヒドロキシプロピルメチルセルロース(TC−5R、信越化学株式会社)に変更したこと以外は、実施例1と同様である
実施例1で用いたフィルムコーティング液中の青色1号アルミニュームレーキ色素を青色1号水溶性色素(三栄源エフ・エフ・アイ社製)0.15gに変更した以外は、実施例1と同様である。
Claims (8)
- 錠剤の表面に、光によって退色しやすい有彩色の色素、ならびに平均重合度100〜2000の部分けん化ポリビニルアルコール、メチルメタクリレートおよびアクリル酸を共重合する際における重量比が60〜90:7〜38:0.5〜12であるポリビニルアルコール共重合体を含み、白糖を含まない被覆層を設けたことを特徴とするフィルムコーティング錠剤。
- 光によって退色しやすい有彩色の色素を含有した錠剤の表面に、平均重合度100〜2000の部分けん化ポリビニルアルコール、メチルメタクリレートおよびアクリル酸を共重合する際における重量比が60〜90:7〜38:0.5〜12であるポリビニルアルコール共重合体を含み、白糖を含まない被覆層を設けたことを特徴とするフィルムコーティング錠剤。
- 当該有彩色の色素がレーキ化したタール色素である、請求項1または2記載の錠剤。
- 当該有彩色の色素が水溶性タール色素である、請求項1または2記載の錠剤。
- 当該有彩色の色素が天然色素である、請求項1または2記載の錠剤。
- ポリビニルアルコール共重合体の2重量%溶液の粘度が、20℃で10〜300mPa・sであるポリビニルアルコール共重合体である、請求項1または2記載の錠剤。
- 公定法において、累積照射量が120万ルクス・時間の光を照射した場合、錠剤の変色度(Δ E)が5以下である請求項1または2記載の錠剤。
- 請求項1〜7のいずれかに記載の錠剤を製造することを目的とした、有彩色の色素およびポリビニルアルコール共重合体を含有することを特徴とするコーティング剤。
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