JP6252475B2 - 外用剤組成物 - Google Patents
外用剤組成物 Download PDFInfo
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- JP6252475B2 JP6252475B2 JP2014526989A JP2014526989A JP6252475B2 JP 6252475 B2 JP6252475 B2 JP 6252475B2 JP 2014526989 A JP2014526989 A JP 2014526989A JP 2014526989 A JP2014526989 A JP 2014526989A JP 6252475 B2 JP6252475 B2 JP 6252475B2
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- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
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- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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Description
ローションタイプの製剤では、使用時に液だれが起こることが懸念される。そのため、液だれのないミノキシジル含有外用剤組成物が望まれていたが、ミノキシジルの液だれが十分に抑えられた製品は、未だに提供されていないというのが実状であった。なお、ここで「液だれ」とは、頭皮等の患部に外用剤組成物を施用した場合に、薬液が施用部から流れ落ちてしまうことをいい、使用感を損なう一因となる。
すなわち本発明は、
(1)(a)ミノキシジル、(b)ヒドロキシプロピルセルロース及びヒプロメロース、(c)エタノール、並びに(d)水を含有することを特徴とする、外用剤組成物、
(2)ヒドロキシプロピルセルロースの含有量が、0.05〜2.5w/v%である(1)に記載の外用剤組成物、
(3)ヒドロキシプロピルセルロースの含有量が、0.1〜2w/v%である(1)又は(2)に記載の外用剤組成物、
(4)25℃における粘度が30〜250mPa・sである(1)〜(3)の何れかに記載の外用剤組成物、
(5)さらに酸を含有する(4)に記載の外用剤組成物、
(6)酸が、クエン酸、塩酸、乳酸、リン酸、酒石酸、及びグルコン酸からなる群から選ばれる少なくとも1種である(1)〜(5)の何れかに記載の外用剤組成物、
(7)pHが5.0〜8.5である(1)〜(6)の何れかに記載の外用剤組成物、
(8)pHが5.5〜7.0である(1)〜(7)の何れかに記載の外用剤組成物、
(9)エタノールの含有量が、25〜70w/v%である(1)〜(8)の何れかに記載の外用剤組成物、
(10)エタノールの含有量が、50〜70w/v%である(1)〜(9)の何れかに記載の外用剤組成物、
(11)ミノキシジルの含有量が、1〜10w/v%である(1)〜(10)の何れかに記載の外用剤組成物、
(12)さらに多価アルコールを含有する、(1)〜(11)の何れかに記載の外用剤組成物、
(13)多価アルコールが、1,3−ブチレングリコール、プロピレングリコール、グリセリン、ジプロピレングリコール、マクロゴール400、及びマクロゴール600からなる群から選ばれる少なくとも1種である(12)に記載の外用組成物、
(14)多価アルコールが、1,3−ブチレングリコールである(12)に記載の外用剤組成物、
(15)剤形が、ゲル剤、ローション剤、又は液剤である(1)〜(14)に記載の外用剤組成物、
である。
本発明において用いるミノキシジルは、通常医薬品に用いられる品質のものを適宜使用することができる。ミノキシジルの配合量は、外用剤組成物中1〜10w/v%であり、好ましくは3〜8w/v%、更に好ましくは5〜8w/v%である。
ヒドロキシプロピルセルロースは、その2w/v%水溶液の20℃における粘度(第十四改正日本薬局法に記載の第2法(回転粘度計)により測定)が150mPa・sより大きく、4000mPa・s以下であるものが望ましい。用いるヒドロキシプロピルセルロースは、通常医薬品に用いられる品質のものを適宜使用することができる。ヒドロキシプロピルセルロースは市販品を利用でき、例えばNISSO HPC−H(日本曹達株式会社)、NISSO HPC−M(日本曹達株式会社)等を使用することができる。また、ヒドロキシプロピルセルロースの配合量は、本発明の外用剤組成物中0.05〜2.5w/v%が好ましく、0.1〜2w/v%がさらに好ましい。
かくして得られる本発明の外用剤組成物は、頭髪用剤、皮膚適用製剤等として使用することができる。
以下表1に示す処方に従い、各成分を秤量し、粘稠剤を水、エタノールまたは1,3−ブチレングリコールに分散、膨潤させた後、ジブチルヒドロキシトルエン、ミノキシジル、リン酸を添加し、さらに残りのエタノール及び精製水を加えて全量100mLの製剤を調製し、参考例1〜11とした。これらの調製後の製剤の外観を目視により、下記判定基準に従い評価した。その結果を表2に示した。
〔判定基準〕
外観
○:沈殿の生成や濁り、分離が認められなかった。
×:沈殿の生成や濁り、分離が認められた。
アルコール試験用紙を20°の角度で平板に設置し、アルコール試験用紙に対して90°の角度で実施例1〜6、11及び比較例1〜10の製剤を100μLずつ吐出し、30秒後にアルコール試験用紙上の液だれ距離を測定し、下記評価基準に従って評価した。
〔評価基準〕
○:30秒後の液だれ距離が50mm以下
×:30秒後の液だれ距離が50mmよりも大きい
製剤の使用感試験を専門パネラー3名により評価を行った。実施例1〜6、11及び比較例1〜10の製剤を、専門パネラー3名の上腕内側に塗布し、「べたつき感」「よれ」「のび」の3項目について、各パネラーに評価させる評点法による官能評価試験を行った。なお、ここで「よれ」とは、頭皮に外用剤組成物を施用時あるいは施用後に、外用剤組成物が白い粉状の固まりとなって現れる現象である。評価方法としては、各評価項目につき1から5までの5段階のレベルを設定し、1から5のいずれかで回答させる方法をとり、下記評価基準に従って評価した。
〔評価項目〕
1)べたつき感
べたつきを感じない :スコア5
べたつきを少し感じる :スコア4
べたつきを感じる :スコア3
べたつきをやや強く感じる:スコア2
べたつきを十分に感じる :スコア1
2)よれ
よれがない :スコア5
よれがある(わずかにある):スコア4
よれがある(少しある) :スコア3
よれがある(やや多くある):スコア2
よれがある(多くある) :スコア1
3)のび
のびが良い(かなり良い):スコア5
のびが良い(良い) :スコア4
のびが良い(やや良い) :スコア3
のびが悪い(やや悪い) :スコア2
のびが悪い(かなり悪い):スコア1
〔評価基準〕
○:各評価項目における平均点が3.5点以上
×:各評価項目における平均点が3.5点未満
実施例1〜6、11、比較例1〜10の液だれ試験の結果、使用感試験による結果、及びこれらの総合評価を表5に示す。
Claims (12)
- (a)1〜10w/v%のミノキシジル、(b)ヒドロキシプロピルセルロース及びヒプロメロース、(c)25〜70w/v%のエタノール、並びに(d)水を含有し、25℃における粘度が30〜250mPa・sであることを特徴とする、外用剤組成物。
- ヒドロキシプロピルセルロースの含有量が、0.05〜2.5w/v%である請求項1に記載の外用剤組成物。
- ヒドロキシプロピルセルロースの含有量が、0.1〜2w/v%である請求項1又は2に記載の外用剤組成物。
- さらに酸を含有する請求項1〜3の何れかに記載の外用剤組成物。
- 酸が、クエン酸、塩酸、乳酸、リン酸、酒石酸、及びグルコン酸からなる群から選ばれる少なくとも1種である請求項4に記載の外用剤組成物。
- pHが5.0〜8.5である請求項1〜5の何れかに記載の外用剤組成物。
- pHが5.5〜7.0である請求項1〜6の何れかに記載の外用剤組成物。
- エタノールの含有量が、50〜70w/v%である請求項1〜7の何れかに記載の外用剤組成物。
- さらに多価アルコールを含有する、請求項1〜8の何れかに記載の外用剤組成物。
- 多価アルコールが、1,3−ブチレングリコール、プロピレングリコール、グリセリン、ジプロピレングリコール、マクロゴール400、及びマクロゴール600からなる群から選ばれる少なくとも1種である請求項9に記載の外用組成物。
- 多価アルコールが、1,3−ブチレングリコールである請求項9に記載の外用剤組成物。
- 剤形が、ゲル剤、ローション剤、又は液剤である請求項1〜11に記載の外用剤組成物。
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US10738175B2 (en) * | 2017-08-15 | 2020-08-11 | Sanford, L.P. | Glue slime activator and associated methods and kits |
WO2019035874A1 (en) * | 2017-08-15 | 2019-02-21 | Sanford L.P. | STICK SLUDGE ACTIVATOR AND METHODS AND KITS THEREOF |
JP2020023467A (ja) * | 2018-01-19 | 2020-02-13 | ロート製薬株式会社 | 外用製剤、液切れ性を改善する方法、および、液切れ性改善剤 |
JP7379094B2 (ja) * | 2019-11-01 | 2023-11-14 | 富士化学工業株式会社 | 外用液剤 |
JP7361004B2 (ja) * | 2020-09-08 | 2023-10-13 | 信越化学工業株式会社 | アルコール組成物の製造方法 |
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US4139619A (en) | 1976-05-24 | 1979-02-13 | The Upjohn Company | 6-Amino-4-(substituted amino)-1,2-dihydro-1-hydroxy-2-iminopyrimidine, topical compositions and process for hair growth |
JP2733980B2 (ja) * | 1988-08-26 | 1998-03-30 | 大正製薬株式会社 | 養毛組成物 |
JPH0977640A (ja) * | 1995-09-14 | 1997-03-25 | Lion Corp | 発毛・育毛料 |
JPH1192378A (ja) * | 1997-09-19 | 1999-04-06 | Taisho Pharmaceut Co Ltd | 外用育毛液剤 |
WO2000059477A1 (en) * | 1999-03-31 | 2000-10-12 | Janssen Pharmaceutica N.V. | Pregelatinized starch in a controlled release formulation |
HUP0300417A2 (hu) * | 2000-04-07 | 2003-08-28 | Taisho Pharmaceutical Co., Ltd. | Hajnövesztő kompozíciók és eljárás azok stabilizálására a kristálykiválás gátlásával |
US7442369B1 (en) * | 2000-08-09 | 2008-10-28 | Mcneil Ab | Compositions of minoxidil |
JP2002308737A (ja) * | 2001-04-05 | 2002-10-23 | Taisho Pharmaceut Co Ltd | 育毛組成物 |
JP2005119996A (ja) * | 2003-10-15 | 2005-05-12 | Sato Pharmaceutical Co Ltd | 育毛剤 |
JP4688579B2 (ja) * | 2005-06-08 | 2011-05-25 | 株式会社マンダム | 頭皮用組成物 |
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TW201406376A (zh) | 2014-02-16 |
PH12015500138A1 (en) | 2015-03-02 |
RU2015106686A (ru) | 2016-09-20 |
EP2883538A1 (en) | 2015-06-17 |
US20150196476A1 (en) | 2015-07-16 |
HK1206976A1 (en) | 2016-01-22 |
SG11201500544SA (en) | 2015-04-29 |
WO2014017573A1 (ja) | 2014-01-30 |
IN2015DN00560A (ja) | 2015-06-26 |
KR20150037867A (ko) | 2015-04-08 |
CN104487048A (zh) | 2015-04-01 |
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