JP2022023152A - 外用薬 - Google Patents
外用薬 Download PDFInfo
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- JP2022023152A JP2022023152A JP2021171779A JP2021171779A JP2022023152A JP 2022023152 A JP2022023152 A JP 2022023152A JP 2021171779 A JP2021171779 A JP 2021171779A JP 2021171779 A JP2021171779 A JP 2021171779A JP 2022023152 A JP2022023152 A JP 2022023152A
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- 239000000203 mixture Substances 0.000 claims abstract description 111
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- 150000002576 ketones Chemical class 0.000 claims abstract description 12
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- 230000015572 biosynthetic process Effects 0.000 claims description 12
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Abstract
Description
一方、特許文献4に記載の静電スプレーによる被覆を形成する方法は、形成される被膜が繊維の堆積物であるため、一枚膜として取り扱うことができ、使用後に剥がし易くなる。しかし、静電スプレーによって形成された被膜と基板との密着性が十分でなく、摩擦等の外力に起因して被膜が損傷したり剥離したりすることがある。更に、特許文献4には、繊維の堆積物からなる被膜を皮膚に密着性よく被覆すること、被膜透明化し皮膚を自然な状態で被覆すること、薬剤の放出や経皮吸収速度を高めることに関して、何ら記載されていない。また、特許文献5に記載の薬物含有超極細ファイバーは、貼付剤を製造する方法に関するものであり、皮膚上で被膜を形成する方法ではない。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
本発明により、薬効成分が難溶性物質であった場合でも、溶解性の高い非晶状態で繊維中に担持されることから、経皮投与可能な薬効成分が幅広く利用できるという利点もある。
HLB=(Σ無機性値/Σ有機性値)×10
成分(d)は、成分(b)のポリマーの被膜形成対象物への密着性をより向上する観点から、20℃において液体の油を含有することが好ましく、極性を有し、成分(b)のポリマーの被膜対象物へ密着性をより良好にする観点から、好ましくはエステル油、及び高級アルコールから選ばれる1種又は2種以上を含有することが好ましく、エステル油から選ばれる1種又は2種以上を含有することが好ましい。
これらの中では、静電噴霧された被膜を皮膚に密着させる観点及び皮膚に塗布した際の感触を向上させる観点から、イソステアリン酸ポリグリセリル、ジイソステアリン酸ポリグリセリル、トリイソステアリン酸ポリグリセリル、ステアリン酸ポリグリセリル、オレイン酸ポリグリセリル、セスキカプリン酸ポリグリセリルが好ましく、ジイソステアリン酸ポリグリセリルがより好ましい。
25℃におけるシリコーン油の動粘度は、静電噴霧された被膜を皮膚等に密着させる観点から、好ましくは3mm2/s以上であり、より好ましくは4mm2/s以上であり、更に好ましくは5mm2/s以上であり、好ましくは30mm2/s以下であり、より好ましくは20mm2/s以下であり、更に好ましくは10mm2/s以下である。これらの中では静電噴霧された被膜を密着させる観点から、シリコーン油はジメチルポリシロキサンを含むことが好ましい。
(皮膚に対して紡糸し、30秒後の繊維径)>(金属板に対して紡糸し、30秒後の繊維径)・・・(1)
溶液状態にて液体クロマトグラフ(HPLC)による分離同定や、赤外分光光度計(IR)にて同定する方法がある。液体クロマトグラフでは、分子量の大きい成分から溶出するため、分子量の予測や、成分の溶出位置によって組成を同定することもできる。IR分析では個々の吸収体より官能基を帰属し同定することも可能であり、一般的には市販添加剤の標準チャートと成分のIRチャートを比較することで同定することが可能である。
被膜を溶解可能な溶媒の探索を行い、溶媒に被膜を溶解後、液体クロマトグラフ(HPLC)による分離同定や、赤外分光光度計(IR)にて同定する。
<1>成分(a)、成分(b)及び成分(c)を含有する外用薬であって、成分(a)、成分(b)及び成分(c)を含有する組成物を皮膚に直接静電スプレーして皮膚上に被膜を形成して使用することを特徴とする外用薬。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
<3>前記静電スプレーする工程が、静電スプレー装置を用いて皮膚に前記組成物を静電スプレーして繊維の堆積物からなる被膜を形成する工程であり、
前記静電スプレー装置が、前記組成物を収容する容器と、前記組成物を吐出するノズルと、前記容器中に収容されている前記組成物を前記ノズルに供給する供給装置と、前記ノズルに電圧を印加する電源とを備える前記<1>又は<2>に記載の外用薬。
<5>前記成分(a)の揮発性物質のうち、アルコールとしては、一価の鎖式脂肪族アルコールや、一価の環式脂肪族アルコールや、一価の芳香族アルコールを用い、前記アルコールとしては、エタノール、イソプロピルアルコール、ブチルアルコール、フェニルエチルアルコール、プロパノール、ペンタノールなどを用い、これらのアルコールは、これらから選ばれる1種又は2種以上を用いる、前記<1>ないし<4>のいずれかに記載の外用薬。
<6>前記成分(a)の揮発性物質のうち、ケトンとしては、アセトン、メチルエチルケトン、メチルイソブチルケトンなどを用い、これらのケトンは1種を単独で、又は2種以上を組み合わせて用いる、前記<1>ないし<5>のいずれかに記載の外用薬。
<7>前記成分(a)の揮発性物質は、エタノール、イソプロピルアルコール、ブチルアルコール、及び水から選ばれる1種又は2種以上であり、好ましくはエタノール、及びブチルアルコールから選ばれる1種又は2種以上であり、最も好ましくはエタノールである、前記<1>ないし<6>のいずれかに記載の外用薬。
前記水溶性である被膜形成能を有するポリマーは、プルラン、ヒアルロン酸、コンドロイチン硫酸、ポリ-γ-グルタミン酸、変性コーンスターチ、β-グルカン、グルコオリゴ糖、ヘパリン、ケラト硫酸等のムコ多糖、セルロース、ペクチン、キシラン、リグニン、グルコマンナン、ガラクツロン酸、サイリウムシードガム、タマリンド種子ガム、アラビアガム、トラガントガム、大豆水溶性多糖、アルギン酸、カラギーナン、ラミナラン、寒天(アガロース)、フコイダン、メチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース等の天然高分子、部分鹸化ポリビニルアルコール(架橋剤と併用しない場合)、低鹸化ポリビニルアルコール、ポリビニルピロリドン(PVP)、ポリエチレンオキサイド、ポリアクリル酸ナトリウム等の合成高分子であり、これらの水溶性ポリマーは単独で又は2種以上を組み合わせて用いる、前記<1>ないし<7>のいずれかに記載の外用薬。
<9>被膜形成能を有するポリマーは水不溶性であり、
前記水不溶性である被膜形成能を有するポリマーは、被膜形成後に不溶化処理できる完全鹸化ポリビニルアルコール、架橋剤と併用することで被膜形成後に架橋処理できる部分鹸化ポリビニルアルコール、ポリ(N-プロパノイルエチレンイミン)グラフト-ジメチルシロキサン/γ-アミノプロピルメチルシロキサン共重合体等のオキサゾリン変性シリコーン、ポリビニルアセタールジエチルアミノアセテート、ツエイン(とうもろこし蛋白質の主要成分)、ポリエステル、ポリ乳酸(PLA)、ポリアクリロニトリル樹脂、ポリメタクリル酸樹脂等のアクリル樹脂、ポリスチレン樹脂、ポリビニルブチラール樹脂、ポリエチレンテレフタレート樹脂、ポリブチレンテレフタレート樹脂、ポリウレタン樹脂、ポリアミド樹脂、ポリイミド樹脂、ポリアミドイミド樹脂であり、これらの水不溶性ポリマーは単独で又は2種以上を組み合わせて用いる、前記<1>ないし<7>のいずれかに記載の外用薬。
<10>成分(c)が、αアドレナリン受容体遮断薬、アドレナリン受容体刺激薬、アンジオテンシンII受容体拮抗薬、アンジオテンシン変換酵素阻害薬、カルシウム拮抗薬、ステロイド系抗炎症・消炎鎮痛剤、パーキンソン病治療薬、ビタミン関連薬、ホルモン薬、みずむし・たむし用薬(抗真菌薬)、解熱鎮痛薬、外用痔疾用薬、冠血管拡張薬、気管支拡張・鎮咳剤、強心薬、狭心症治療薬、局所麻酔薬、血糖降下薬、口腔咽喉薬、向精神薬、抗アレルギー薬、抗ヒスタミン薬、抗菌薬、抗虫・駆虫・殺虫薬、抗不整脈薬、抗嘔吐薬、高脂血症治療薬、殺菌薬、止血薬、女性用薬、消毒薬、睡眠薬、組織呼吸賦活剤、鎮痒消炎薬、等張液、皮膚疾患治療剤、非ステロイド系抗炎症・消炎鎮痛剤、保湿剤、勃起不全治療薬、麻酔薬、末梢血管拡張薬、免疫抑制剤、毛髪用薬、利尿薬、浣腸剤及び禁煙補助剤から選ばれる少なくとも1種であり、好ましくは、アドレナリン受容体刺激薬、ステロイド系抗炎症・消炎鎮痛剤、ビタミン関連薬、外用痔疾用薬、気管支拡張・鎮咳剤、口腔咽喉薬、向精神薬、抗アレルギー薬、抗ヒスタミン薬、抗菌薬、抗虫・駆虫・殺虫薬、殺菌薬、止血薬、女性用薬、消毒薬、組織呼吸賦活剤、鎮痒消炎薬、等張液、皮膚疾患治療剤、非ステロイド系抗炎症・消炎鎮痛剤、保湿剤、免疫抑制剤及び毛髪用薬から選ばれる少なくとも1種である前記<1>~<9>のいずれかに記載の外用薬。
<11>成分(c)が、好ましくは非ステロイド系抗炎症・消炎鎮痛剤であり、より好ましくはフェルビナク、ジクロフェナク又はその塩、ロキソプロフェン及びフルルビプロフェンから選ばれる1種又は2種以上である前記<1>~<10>のいずれかに記載の外用薬。
<12>前記組成物における前記成分(a)の含有量は、50質量%以上、好ましくは55質量%以上、更に好ましくは60質量%以上であり、また98質量%以下、好ましくは96質量%以下、更に好ましくは94質量%以下であり、50質量%以上98質量%以下、好ましくは55質量%以上96質量%以下、更に好ましくは60質量%以上94質量%以下である、前記<1>ないし<11>のいずれかに記載の外用薬。
<13>前記組成物における前記成分(b)の含有量は、2質量%以上、好ましくは4質量%以上、更に好ましくは6質量%以上であり、また50質量%以下、好ましくは45質量%以下、更に好ましくは40質量%以下であり、2質量%以上50質量%以下、好ましくは4質量%以上45質量%以下、更に好ましくは6質量%以上40質量%以下である、前記<1>ないし<12>のいずれかに記載の外用薬。
<15>前記組成物は、その粘度が、25℃において、1mPa・s以上、好ましくは10mPa・s以上、更に好ましくは50mPa・s以上であり、また、25℃において、5000mPa・s以下、好ましくは2000mPa・s以下、更に好ましくは1500mPa・s以下であり、1mPa・s以上5000mPa・s以下、好ましくは10mPa・s以上2000mPa・s以下、更に好ましくは50mPa・s以上1500mPa・s以下である、前記<1>ないし<14>のいずれかに記載の外用薬。
<16>前記組成物が、さらに成分(d)20℃で液体の油及びポリオールから選ばれる1種又は2種以上を含有する<1>~<15>のいずれかに記載の外用薬。
<17>前記被膜は、構成する前記繊維の表面側に、前記成分(c)又は成分(c)及び成分(d)が存在する薬効成分担持被膜を有している、前記<1>~<16>のいずれかに記載の外用薬。
<18>前記被膜あるいは噴霧用組成物における、前記成分(c)に対する前記成分(b)の質量比((c)/(b))の値が、0.01以上20以下、好ましくは0.1以上10以下、より好ましくは0.6以上6以下、さらに好ましくは0.6以上4.5以下である、前記<1>~<17>のいずれかに記載の外用薬。
<19>前記被膜あるいは噴霧用組成物における、前記成分(d)に対する前記成分(b)の質量比((d)/(b))の値が、0.01以上10以下、好ましくは0.05以上5以下、より好ましくは0.1以上4以下である、前記<1>~<18>のいずれかに記載の外用薬。
<20>前記成分(d)が、炭化水素油、エステル油、シリコーン油、高級アルコール、及びポリオールから選択される1種又は2種以上の物質である、前記<16>ないし<19>のいずれかに記載の外用薬。
<21>前記成分(d)である20℃で液体の油は、20℃において液状の炭化水素油、エステル油、シリコーン油、高級アルコールであり、これらから選ばれる液体油を1種又は2種以上を組み合わせて用いられ、
前記エステル油は、植物油に含まれるトリグリセライド等の油以外に、HLB値が10以下のエステル構造を有する化合物を含み、
前記成分(c)である20℃で液体の油は、好ましくはエステル油、及び高級アルコールから選ばれる1種又は2種以上を含有し、より好ましくはエステル油から選ばれる1種又は2種以上を含有する、前記<16>ないし<20>のいずれかに記載の外用薬。
<22>前記成分(d)である20℃で液体の炭化水素油は、流動パラフィン、スクワラン、スクワレン、n-オクタン、n-ヘプタン、シクロヘキサン、軽質イソパラフィン、流動イソパラフィンであり、好ましくは流動パラフィン、スクワランである、前記<21>に記載の外用薬。
<23>前記炭化水素油の30℃における粘度は、10mPa・s以上、好ましくは30mPa・s以上である、前記<21>又は<22>に記載の外用薬。
<25>前記成分(d)である20℃で液体のエステル油は、HLB値が10以下のエステル化合物であり、脂肪酸エステル、脂肪酸アルコールエステル、多価アルコールエステル、グリセリン脂肪酸エステル、ポリグリセリン脂肪酸エステル、ソルビタン脂肪酸エステルであり、これらから選ばれる1種又は2種以上を用いる、前記<20>又は<21>に記載の外用薬。
<26>前記成分(d)である20℃で液体のエステル油は、ミリスチン酸イソプロピル、オクタン酸セチル、ミリスチン酸オクチルドデシル、パルミチン酸イソプロピル、ステアリン酸ブチル、ラウリン酸ヘキシル、ミリスチン酸ミリスチル、オレイン酸デシル、ジメチルオクタン酸ヘキシルデシル、乳酸セチル、乳酸ミリスチル、酢酸ラノリン、ステアリン酸イソセチル、イソステアリン酸イソセチル、12-ヒドロキシステアリル酸コレステリル、ジ2-エチルヘキサン酸エチレングリコール、ジペンタエリスリトール脂肪酸エステル、モノイソステアリン酸N-アルキルグリコール、ジカプリン酸ネオペンチルグリコール、リンゴ酸ジイソステアリル、ジ2-ヘプチルウンデカン酸グリセリン、トリ2-エチルヘキサン酸トリメチロールプロパン、トリイソステアリン酸トリメチロールプロパン、テトラ2-エチルヘキサン酸ペンタエリスリット、トリ2-エチルヘキサン酸グリセリル、トリイソステアリン酸トリメチロールプロパン、セチル2-エチルヘキサノエート、2エチルヘキシルパルミテート、ナフタレンジカルボン酸ジエチルヘキシル、安息香酸(炭素数12~15)アルキル、セテアリルイソノナノエート、トリ(カプリル酸・カプリン酸)グリセリン、(ジカプリル酸/カプリン酸)ブチレングリコール、トリラウリン酸グリセリル、トリミリスチン酸グリセリル、トリパルミチン酸グリセリル、トリイソステアリン酸グリセリル、トリ2-ヘプチルウンデカン酸グリセリル、トリベヘン酸グリセリル、トリヤシ油脂肪酸グリセリル、トリオレイン酸グリセリル、トリリノール酸グリセリル、ヒマシ油脂肪酸メチルエステル、オレイン酸オレイル、パルミチン酸2-ヘプチルウンデシル、アジピン酸ジイソブチル、N-ラウロイル-L-グルタミン酸-2-オクチルドデシルエステル、アジピン酸ジ2-ヘプチルウンデシル、エチルラウレート、アジピン酸イソブチル、セバシン酸ジエチル、セバシン酸ジ2-エチルヘキシル、ミリスチン酸2ヘキシルデシル、パルミチン酸2-ヘキシルデシル、アジピン酸2-ヘキシルデシル、セバシン酸ジイソプロピル、コハク酸ジ2-エチルヘキシル、クエン酸トリエチル、パラメトキシケイ皮酸2-エチルヘキシル、ジピバリン酸トリプロピレングリコールである、前記<20>、<21>又は<25>に記載の外用薬。
<27>前記成分(d)である20℃で液体のエステル油は、ミリスチン酸オクチルドデシル、ミリスチン酸ミリスチル、ステアリン酸イソセチル、イソステアリン酸イソセチル、セテアリルイソノナノエート、アジピン酸イソブチル、セバシン酸ジエチル、セバシン酸ジ2-エチルヘキシル、ミリスチン酸イソプロピル、パルミチン酸イソプロピル、リンゴ酸ジイソステアリル、ジカプリン酸ネオペンチルグリコール、安息香酸(炭素数12~15)アルキル、トリ(カプリル酸・カプリン酸)グリセリン、及びトリオレイン酸グリセリル、トリステアリン酸グリセリル、トリパルミチン酸グリセリル等のトリグリセライドから選ばれる少なくとも1種が好ましく、ミリスチン酸イソプロピル、パルミチン酸イソプロピル、リンゴ酸ジイソステアリル、セバシン酸ジエチル、ジカプリン酸ネオペンチルグリコール、安息香酸(炭素数12~15)アルキル、トリ(カプリル酸・カプリン酸)グリセリン、及びトリグリセライドから選ばれる1種又は2種以上である、前記<20>、<21>、<25>又は<26>に記載の外用薬。
<28>前記成分(d)である20℃で液体のエステル油はポリグリセリン脂肪酸エステルであり、
前記ポリグリセリン脂肪酸エステルは、HLB値が10以下である、イソステアリン酸ポリグリセリル、ジイソステアリン酸ポリグリセリル、トリイソステアリン酸ポリグリセリル、ステアリン酸ポリグリセリル、オレイン酸ポリグリセリル、セスキカプリン酸ポリグリセリルである、前記<21>に記載の外用薬。
<30>前記成分(d)である20℃で液体のエステル油は、イソステアリン酸ポリグリセリル、ジイソステアリン酸ポリグリセリル、トリイソステアリン酸ポリグリセリル、ステアリン酸ポリグリセリル、オレイン酸ポリグリセリル、セスキカプリン酸ポリグリセリルであり、好ましくはジイソステアリン酸ポリグリセリルである、前記<21>に記載の外用薬。
<31>前記成分(d)である20℃で液体のシリコーン油は、ジメチルポリシロキサン、ジメチルシクロポリシロキサン、メチルフェニルポリシロキサン、メチルハイドロジェンポリシロキサン、高級アルコール変性オルガノポリシロキサンである、前記<21>に記載の外用薬。
<32>前記シリコーン油の組成物中の含有量は、10質量%以下、好ましくは5質量%以下、更に好ましくは1質量%以下、より更に好ましくは0.1質量%以下であり、
25℃における前記シリコーン油の動粘度は、3mm2/s以上、好ましくは4mm2/s以上、更に好ましくは5mm2/s以上であり、30mm2/s以下、好ましくは20mm2/s以下、更に好ましくは10mm2/s以下であり、
前記シリコーン油はジメチルポリシロキサンを含む、前記<20>、<21>、<31>に記載の外用薬。
<33>前記成分(d)である20℃で液体の高級アルコールは、炭素数12~20の液状の高級アルコールであり、
前記高級アルコールは、分岐脂肪酸あるいは不飽和脂肪酸の高級アルコールであり、好ましくはイソステアリルアルコール、オレイルアルコールである、前記<20>又は<21>に記載の外用薬。
前記ポリオールは、エチレングリコール、プロピレングリコール、1,3-プロパンジオール、1,3-ブタンジオール等のアルキレングリコール;ジエチレングリコール、ジプロピレングリコール、数平均分子量が1000以下のポリエチレングリコール、ポリプロピレングリコール等のポリアルキレングリコール;グリセリン、ジグリセリン、トリグリセリン等のグリセリン又はポリグリセリルであり、好ましくはエチレングリコール、プロピレングリコール、1,3-ブタンジオール、ジプロピレングリコール、ポリエチレングリコール、グリセリン、ジグリセリンであり、より好ましくはプロピレングリコール、1,3-ブタンジオール、グリセリンであり、
前記ポリエチレングリコールは、その数平均分子量が、600以下、好ましくは400以下である、前記<20>ないし<33>のいずれかに記載の外用薬。
<35>前記成分(d)の20℃で液体の油及びポリオールは、炭化水素油、エステル油、シリコーン油、及び高級アルコールから選ばれる20℃で液体の油、並びにアルキレングリコール、ポリアルキレングリコール、グリセリン及びトリグリセリンから選ばれるポリオールから選択される1種又は2種以上の物質である、前記<20>ないし<34>のいずれかに記載の外用薬。
<36>経皮投与による疾患の治療方法であって、成分(a)、成分(b)及び成分(c)を含有する組成物を皮膚に直接静電スプレーして皮膚上に被膜を形成することを特徴とする方法。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
<37>成分(a)、成分(b)及び成分(c)の組み合わせであって、成分(a)、成分(b)及び成分(c)を含有する組成物を皮膚に直接静電スプレーして皮膚上に被膜を形成して使用することを特徴とする組み合わせ。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
<38>外用薬製造のための使用であって、成分(a)、成分(b)及び成分(c)を含有する組成物を皮膚に直接静電スプレーして皮膚上に被膜を形成して使用することを特徴とする外用薬製造のための使用。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質、
(b)被膜形成能を有するポリマー、
(c)経皮投与可能な薬効成分。
(1)噴霧用組成物の調製 噴霧用組成物の成分(a)としてエタノール(和光純薬工業社製:商品名エタノール(99.5))を用いた。噴霧用組成物の成分(b)としてポリビニルブチラール(PVB、積水化学工業社製:商品名S-LEC B BM-1)を用いた。噴霧用組成物の成分(c)としてフェルビナク(純正化学社製)用いた。噴霧用組成物における配合割合は、表1に示すとおりである。なお、表1に示すエタノールの量は、有効量であり水を含まない。
(2)静電スプレー工程
図1に示す構成を有し、図2に示す外観を有する静電スプレー装置10を用い、皮膚モデル(人工皮革、プロテインレザー PBZ13001BK、出光テクノファイン社製)に向けて静電スプレー法を180秒間行った。静電スプレー法の条件は以下に示すとおりとした。
・印加電圧:30kV
・ノズルと皮膚との距離:150mm
・噴霧用組成物の吐出量:3mL/h
・環境:25℃、30%RH
この静電スプレーによって、皮膚モデルの表面に繊維の堆積物からなる一枚の膜の形態である被膜が形成された。被膜は直径約4cmの円であり、質量は約3.8mgであった。上述した方法で測定された繊維の太さは660nmであった。
噴霧用組成物における成分(a)、(b)、(c)及び(d)を、以下の表1に示す条件とした以外は実施例1と同様にして、静電スプレー工程を行い、繊維の堆積物からなる被膜を得た。成分(c)は以下の材料を用いた。ジクロフェナク(東京化成工業社製)、ロキソプロフェン(純正化学社製)、フルルビプロフェン(東京化成工業社製)。
噴霧用組成物における成分(d)としてグリセリン(和光純薬工業社製)を用いた以外は、実施例1と同様にして、静電スプレー工程を行い、繊維の堆積物からなる被膜を得た。噴霧用組成物における配合割合は、表2に示すとおりである。なお、表2に示すエタノール、グリセリン、およびジプロピレングリコールの量は、有効分量である。
噴霧用組成物における成分(a)、(b)、(c)及び(d)を、以下の表2に示す条件とした以外は実施例13と同様にして、静電スプレー工程を行い、繊維の堆積物からなる被膜を得た。成分(d)は以下の材料を用いた。ジプロピレングリコール(DPG、和光純薬工業社製)。
実施例2と同様の噴霧用組成物を用い、被膜形成対象を皮膚モデルに代えてアルミ箔を用いた以外は実施例2と同様にして繊維の堆積物からなる一枚の膜を得た。この膜を25℃、50%RH環境下で3日間保持した後、この膜をアルミ箔から剥離し、皮膚モデルに貼付することで皮膚モデル上に被膜を形成した。
実施例5、8、11と同様の噴霧用組成物を用い、噴霧対象を皮膚モデルに代えてアルミ箔を用いた以外は実施例2と同様にして繊維の堆積物からなる一枚の膜を得た。比較例1と同様に、アルミ箔から剥離し、皮膚モデル上に被膜を形成した。
実施例及び比較例で形成された被膜について、成分(c)の結晶状態、皮膚との密着性、皮膚上での耐久性を、以下の基準で評価した。その結果を表1及び表2に示す。
各被膜について、広角X線回折法(XRD)により成分の結晶状態を確認した。具体的には、広角X線回折において、Bragg角=15~25°付近に薬効成分由来の鋭い回折ピークが、少なくとも1本現れる被膜は結晶性、それ以外は非晶性と評価した。測定条件は、X線源Cu/Kα-radiation、管電圧40kV、管電流15mA、回折角5-60°、X線スキャンスピード10°/minで測定(測定装置:RIGAKU社製 MiniFlex600)。なお実施例、比較例ともに皮膚モデルに被膜を形成してから、24時間以内に測定を行った。
被膜を形成した皮膚モデルの屈曲試験により密着性を評価した。被膜を外側にし、180度の屈曲を5回繰り返し、被膜と皮膚モデルの付着状態から、以下の基準で密着性を評価した。
A:皮膚モデルと膜の間に浮き、膜剥がれが全くない
B:屈曲部から周囲10mm以内でのみ膜の浮きが発生するが、膜剥がれはない
C:屈曲部から周囲10mm超に渡り膜の浮きが発生するが、膜剥がれはない
D:膜が完全に剥離する
被膜の擦過試験により耐久性を評価した。皮膚モデルを固定し、被膜を上面から人差し指で約50gfの荷重をかけながら、2cmの距離を1方向に5回擦過した。その後の被膜と皮膚モデルの付着状態と人差し指への付着性から、以下の基準で耐久性を評価した。
A:膜の剥離、破れ、人差し指への付着が全くない
B:被膜表面の破れはあるが、人差し指への付着はない
C:被膜表面の破れがあり、人差し指への付着もある
D:膜が破れ、完全に剥離する
ブタ皮膚を用いたin vitro皮膚透過試験を行った。具体的には、ブタ皮膚を垂直型拡散セルに装着させて成分(c)の皮膚透過量を測定した。すなわち、豚耳皮(東京芝浦臓器株式会社より購入)より摘出した皮膚を垂直型拡散セルのレセプター層側に装着し、その内側を生理食塩水で満たした後、各外用薬を摘出皮膚の表面に適用して被膜形成を行った。適用24時間後にレセプター液を回収し、高速液体クロマトグラフィーにて有効成分の薬剤透過量(μg/cm2)を測定した。結果を表3に示す。
11 低電圧電源
12 高電圧電源
13 補助的電気回路
14 マイクロギヤポンプ
15 容器
16 ノズル
17 管路
18 フレキシブル管路
19 電流制限抵抗
20 筐体
Claims (9)
- 成分(a)、成分(b)及び成分(c)を含有する繊維形成用の外用薬であって、成分(a)、成分(b)及び成分(c)を含有する組成物を皮膚に直接静電スプレーして皮膚上に繊維の堆積物からなる被膜を形成して使用することを特徴とする外用薬。
(a)水、アルコール及びケトンから選ばれる1種又は2種以上の揮発性物質 50質量%以上98質量%以下、
(b)被膜形成能を有する水不溶性ポリマー 1質量%以上40質量%以下、
(c)経皮投与可能な薬効成分。 - 前記組成物における前記成分(b)の含有量が4質量%以上40質量%以下であり、
前記成分(a)の含有量が50質量%以上94質量%以下である請求項1に記載の外用薬。 - 前記繊維の太さが円相当直径で10nm以上3000nm以下である請求項1又は2に記載の外用薬。
- 前記成分(b)に対する前記成分(c)の質量比((c)/(b))が0.01以上20以下である請求項1~3のいずれか1項に記載の外用薬。
- 成分(a)、成分(b)及び成分(c)を含有する繊維形成用の外用薬であって、成分(a)、成分(b)及び成分(c)を含有る組成物を皮膚に直接静電スプレーして皮膚上に繊維の堆積物からなる被膜を形成して使用することを特徴とする外用薬。
(a)エタノール、イソプロピルアルコール、及びブチルアルコールから選ばれる1種又は2種以上の揮発性物質 50質量%以上98質量%以下、
(b)被膜形成能を有する水不溶性ポリマー 1質量%以上40質量%以下、
(c)経皮投与可能な薬効成分。 - 前記組成物において前記成分(b)が前記成分(a)に溶解又は分散して含有されている請求項5に記載の外用薬。
- 前記組成物がさらに水を含有する請求項5又は6に記載の外用薬。
- 前記静電スプレーする工程が、静電スプレー装置を用いて皮膚に前記組成物を静電スプレーして繊維の堆積物からなる被膜を形成する工程であり、
前記静電スプレー装置が、前記組成物を収容する容器と、前記組成物を吐出するノズルと、前記容器中に収容されている前記組成物を前記ノズルに供給する供給装置と、前記ノズルに電圧を印加する電源とを備える請求項1~7のいずれか1項に記載の外用薬。 - 請求項1~8のいずれか1項に記載の外用薬を静電スプレーして、繊維の堆積物からなる被膜を形成する被膜の製造方法。
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