JP5258315B2 - フルニソリド含有粘膜適用組成物 - Google Patents
フルニソリド含有粘膜適用組成物 Download PDFInfo
- Publication number
- JP5258315B2 JP5258315B2 JP2008023476A JP2008023476A JP5258315B2 JP 5258315 B2 JP5258315 B2 JP 5258315B2 JP 2008023476 A JP2008023476 A JP 2008023476A JP 2008023476 A JP2008023476 A JP 2008023476A JP 5258315 B2 JP5258315 B2 JP 5258315B2
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- JP
- Japan
- Prior art keywords
- composition
- mucosa
- acid
- component
- flunisolide
- Prior art date
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- 210000004877 mucosa Anatomy 0.000 title claims description 58
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- XFLNVMPCPRLYBE-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate;tetrahydrate Chemical compound O.O.O.O.[Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O XFLNVMPCPRLYBE-UHFFFAOYSA-J 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- FYZXEMANQYHCFX-UHFFFAOYSA-K tripotassium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [K+].[K+].[K+].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O FYZXEMANQYHCFX-UHFFFAOYSA-K 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- 229960000281 trometamol Drugs 0.000 description 1
- 229950010121 ufenamate Drugs 0.000 description 1
- 208000001319 vasomotor rhinitis Diseases 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- 235000014692 zinc oxide Nutrition 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 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
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
項1. (A)フルニソリド、(B)血管収縮剤、及び(C)キレート剤を含有することを特徴とする、粘膜適用組成物。
項2. (B)成分が、ナファゾリン、テトラヒドロゾリン、エピネフリン、エフェドリン、メチルエフェドリン、オキシメタゾリン、キシロメタゾリン、トラマゾリン、チマゾリン、メチゾリン、フェニレフリン及びこれらの塩よりなる群から選択される少なくとも1種である、項1記載の粘膜適用組成物。
項3. (C)成分が、エチレンジアミン四酢酸、アスコルビン酸、クエン酸、コハク酸、トリヒドロキシメチルアミノメタン、ニトリロトリ酢酸、1-ヒドロキシエタン-1,1-ジホスホン酸、ヘキサメタリン酸、ポリリン酸、メタリン酸及びこれらの塩よりなる群から選択される少なくとも1種である、項1記載の粘膜適用組成物。
項4. 更に、モノテルペンを含有する、項1乃至3のいずれかに記載の粘膜適用組成物。
項5. モノテルペンがl-メントールである、項4に記載の粘膜適用組成物。
項6. 点鼻剤である、項1乃至4のいずれかに記載の粘膜適用組成物。
項7. 花粉症の予防乃至治療用である、項1乃至6のいずれかに記載の粘膜適用組成物。
項8.(A)フルニソリド、(B)血管収縮剤、及び(C)キレート剤を含有する保存剤組成物。
項9. (B)成分が、ナファゾリン、テトラヒドロゾリン、エピネフリン、エフェドリン、メチルエフェドリン、オキシメタゾリン、キシロメタゾリン、トラマゾリン、チマゾリン、メチゾリン、フェニレフリン及びこれらの塩よりなる群から選択される少なくとも1種である、項8記載の保存剤組成物。
項10. (C)成分が、エチレンジアミン四酢酸、アスコルビン酸、クエン酸、コハク酸、トリヒドロキシメチルアミノメタン、ニトリロトリ酢酸、1-ヒドロキシエタン-1,1-ジホスホン酸、ヘキサメタリン酸、ポリリン酸、メタリン酸及びこれらの塩よりなる群から選択される少なくとも1種である、項8記載の保存剤組成物。
項11. Burkholderia cepaciaに対する殺菌又は増殖抑制用である、項8乃至10のいずれかに記載の保存剤組成物。
項12. (A)フルニソリドを含有する粘膜適用組成物に保存効力を付与する方法であって、該粘膜適用組成物に(B)血管収縮剤、及び(C)キレート剤を配合することを特徴とする、保存効力の付与方法。
項13. (B)成分が、ナファゾリン、テトラヒドロゾリン、エピネフリン、エフェドリン、メチルエフェドリン、オキシメタゾリン、キシロメタゾリン、トラマゾリン、チマゾリン、メチゾリン、フェニレフリン及びこれらの塩よりなる群から選択される少なくとも1種である、項12記載の方法。
項14. (C)成分が、エチレンジアミン四酢酸、アスコルビン酸、クエン酸、コハク酸、トリヒドロキシメチルアミノメタン、ニトリロトリ酢酸、1-ヒドロキシエタン-1,1-ジホスホン酸、ヘキサメタリン酸、ポリリン酸、メタリン酸及びこれらの塩よりなる群から選択される少なくとも1種である、項12記載の方法。
項15. 粘膜適用組成物が点鼻剤である、項12乃至14のいずれかに記載の方法。
項16. (A)フルニソリド、(B)血管収縮剤、及び(C)キレート剤を含有する粘膜適用組成物に、モノテルペンを配合することを特徴とする、該粘膜適用組成物の光安定性の改善方法。
項17. (B)成分が、ナファゾリン、テトラヒドロゾリン、エピネフリン、エフェドリン、メチルエフェドリン、オキシメタゾリン、キシロメタゾリン、トラマゾリン、チマゾリン、メチゾリン、フェニレフリン及びこれらの塩よりなる群から選択される少なくとも1種である、項16記載の方法。
項18. (C)成分が、エチレンジアミン四酢酸、アスコルビン酸、クエン酸、コハク酸、トリヒドロキシメチルアミノメタン、ニトリロトリ酢酸、1-ヒドロキシエタン-1,1-ジホスホン酸、ヘキサメタリン酸、ポリリン酸、メタリン酸及びこれらの塩よりなる群から選択される少なくとも1種である、項16記載の方法。
項19. モノテルペンがl-メントールである、項16記載の方法。
本発明の粘膜適用組成物は、フルニソリド(以下、単に(A)成分と表記することもある)を含有する。フルニソリドは、6α−フルオロ−11β,16α,17,21−テトラヒドロキシ−1,4−プレグナジエン−3,20−ジオン−16,17−アセトニドとも称される合成副腎皮質ホルモンである。本発明において、フルニソリドは1/2水和物等の水和物の形態のものを使用することもできる。
フルニソリドは、公知の方法により合成してもよく市販品として入手することもできる。
抗ヒスタミン剤:例えば、イプロヘプチン、ジフェンヒドラミン、クロルフェニラミン等。
殺菌剤:例えば、アクリノール、セチルピリジニウム、ベンザルコニウム、ベンゼトニウム、クロルヘキシジン等。
消炎剤:例えば、グリチルレチン酸、グリチルリチン酸、サリチル酸メチル、サリチル酸グリコール、アラントイン、アズレン、アズレンスルホン酸、グアイアズレン、トラネキサム酸、ε−アミノカプロン酸、ベルベリン、リゾチーム、甘草等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
その他:例えば、インドメタシン、イブプロフェン、イブプロフェンピコノール、ブフェキサマク、フルフェナム酸ブチル、ベンダザック、ピロキシカム、ケトプロフェン、フェルビナク、紫根、セイヨウトチノキ、及びこれらの塩等。
担体:例えば、水、含水エタノール等の水性溶媒。
増粘剤:例えば、カルボキシビニルポリマー、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、アルギン酸、ポリビニルアルコール(完全、又は部分ケン化物)、ポリビニルピロリドン、マクロゴール、コンドロイチン硫酸ナトリウム等。
糖類:例えば、グルコース、シクロデキストリン等。
糖アルコール類:例えば、キシリトール、ソルビトール、マンニトールなど。これらはd体、l体又はdl体のいずれでもよい。
界面活性剤:例えば、ポリオキシエチレン(以下、POEと略す)−ポリオキシプロピレン(以下、POPと略す)ブロックコポリマー(具体的には、ポロクサマー407等)、エチレンジアミンのPOE-POPブロックコポリマー付加物(具体的には、ポロキサミン等)、モノオレイン酸POEソルビタン、POE硬化ヒマシ油(具体的には、POE(60)硬化ヒマシ油等)、ステアリン酸ポリオキシル等の非イオン性界面活性剤;アルキルジアミノエチルグリシン等のグリシン型両性界面活性剤;アルキル4級アンモニウム塩(具体的には、塩化ベンザルコニウム、塩化ベンゼトニウム等の陽イオン界面活性剤等。なお、括弧内の数字は付加モル数を示す。
防腐剤、殺菌剤又は抗菌剤:例えば、塩酸アルキルジアミノエチルグリシン、安息香酸ナトリウム、エタノール、塩化ベンザルコニウム、塩化ベンゼトニウム、グルコン酸クロルヘキシジン、クロロブタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール、ビグアニド化合物(具体的には、ポリヘキサメチレンビグアニド等)、グローキル(ローディア社製 商品名)等。
pH調節剤:例えば、塩酸、ホウ酸、アミノエチルスルホン酸、イプシロン−アミノカプロン酸、クエン酸、酢酸、水酸化ナトリウム、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム、炭酸水素ナトリウム、炭酸ナトリウム、ホウ砂、トリエタノールアミン、モノエタノールアミン、ジイソプロパノールアミン、硫酸、リン酸、ポリリン酸、プロピオン酸、シュウ酸、グルコン酸、フマル酸、乳酸、酒石酸、リンゴ酸、コハク酸、グルコノラクトン、酢酸アンモニウム等。
等張化剤:例えば、亜硫酸水素ナトリウム、亜硫酸ナトリウム、塩化カリウム、塩化カルシウム、塩化ナトリウム、塩化マグネシウム、酢酸カリウム、酢酸ナトリウム、炭酸水素ナトリウム、炭酸ナトリウム、チオ硫酸ナトリウム、硫酸マグネシウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、リン酸二水素カリウム、グリセリン、プロピレングリコール等。
安定化剤:ジブチルヒドロキシトルエン、トロメタモール、ナトリウムホルムアルデヒドスルホキシレート(ロンガリット)、トコフェロール、ピロ亜硫酸ナトリウム、モノエタノールアミン、モノステアリン酸アルミニウム、モノステアリン酸グリセリン等。
基剤:オクチルドデカノール、オリーブ油、ゴマ油、酸化チタン、臭化カリウム、ダイズ油、ツバキ油、トウモロコシ油、ナタネ油、綿実油、パラフィン、ヒマシ油、プラスチベース、ラッカセイ油、ラノリン、ワセリン、プロピレングリコール等。
前述するように、上記(A)〜(C)成分を組み合わせて含有させることにより、Burkholderia cepacia等の雑菌の繁殖を防止して優れた保存効力を示すので、本発明は、更に他の観点から、(A)フルニソリド、(B)血管収縮剤、及び(C)キレート剤を含有する保存剤組成物を提供する。ここで、保存剤組成物とは、保存剤(防腐剤)として、例えば、医薬組成物等の防腐対象となる組成物(以下、保存対象組成物と表記する)に配合して使用される添加剤のことを意味する。当該保存剤組成物において、上記(A)〜(C)成分の種類、及びこれら両成分の比率については、上記「(I)粘膜適用組成物」の項に記載する内容と同様である。
前述するように、粘膜適用組成物中で、上記(A)〜(C)成分を共存させることにより、Burkholderiacepacia等の雑菌の繁殖を防止して優れた保存効力を示す。従って、本発明は、更に(A)フルニソリドを含有する粘膜適用組成物に保存効力を付与する方法であって、該粘膜適用組成物に(B)血管収縮剤、及び(C)キレート剤を配合することを特徴とする、保存効力の付与方法を提供する。当該保存効力の付与方法は、フルニソリドを含有する粘膜適用組成物を防腐する方法と言い換えることもできる。
前述するように、上記(A)〜(C)成分を含む粘膜適用組成物において、更にモノテルペンを配合することによって、光曝露によって生じる粘膜適用組成物の着色化を抑制して、光安定性を改善することができる。従って、本発明は、更に(A)フルニソリド、(B)血管収縮剤、及び(C)キレート剤を含有する粘膜適用組成物に、モノテルペンを配合することを特徴とする、該粘膜適用組成物の光安定性の改善方法を提供する。
表1に示す組成の粘膜適用組成物(実施例1−2及び比較例1−8)を調製し、これらの粘膜適用組成物を用いて、日本薬局方(第15改正)に定める方法に準じて保存効力試験(防腐試験)を行い、各粘膜適用組成物の防腐性を評価した。
表2に示す組成の粘膜適用組成物(実施例3及び比較例9−15)を調製し、これらの粘膜適用組成物のスギ花粉の破裂抑制効果について、以下の試験を行い評価した。
表3に示す組成の粘膜適用組成物(実施例4及び5)を調製し、これらの粘膜適用組成物の光暴露時の着色性について、以下の試験を行い評価した。
表4−6に記載の処方で、粘膜適用組成物(実施例6−20)が製造される。
Claims (11)
- (A)フルニソリド、(B)ナファゾリン及びその塩よりなる群から選択される少なくとも1種、及び(C)エチレンジアミン四酢酸及びその塩よりなる群から選択される少なくとも1種を含有することを特徴とする、粘膜適用組成物。
- (B)成分が、塩酸ナファゾリン及び硝酸ナファゾリンから選択される少なくとも1種である、請求項1記載の粘膜適用組成物。
- (C)成分が、エチレンジアミン四酢酸、エチレンジアミン四酢酸二ナトリウム及びエチレンジアミン四酢酸四ナトリウムよりなる群から選択される少なくとも1種である、請求項1記載の粘膜適用組成物。
- 更に、モノテルペンを含有する、請求項1乃至3のいずれかに記載の粘膜適用組成物。
- モノテルペンがl−メントールである、請求項4に記載の粘膜適用組成物。
- 点鼻剤である、請求項1乃至5のいずれかに記載の粘膜適用組成物。
- (A)成分を0.003〜0.03重量%、(B)成分を0.001〜0.1重量%、(C)成分を0.005〜1重量%含有し、(A)成分100重量部あたり、(B)成分が20〜1000重量部、且つ(C)成分が20〜1000重量部である、請求項1乃至6のいずれかに記載の粘膜適用組成物。
- 花粉症の予防乃至治療用である、請求項1乃至7のいずれかに記載の粘膜適用組成物。
- (A)フルニソリドを含有する粘膜適用組成物に保存効力を付与する方法であって、該粘膜適用組成物に(B)ナファゾリン及びその塩よりなる群から選択される少なくとも1種、及び(C)エチレンジアミン四酢酸及びその塩よりなる群から選択される少なくとも1種を配合することを特徴とする、保存効力の付与方法。
- (A)フルニソリド、(B)ナファゾリン及びその塩よりなる群から選択される少なくとも1種、及び(C)エチレンジアミン四酢酸及びその塩よりなる群から選択される少なくとも1種を含有する粘膜適用組成物に、モノテルペンを配合することを特徴とする、粘膜適用組成物の光安定性の改善方法。
- モノテルペンがl−メントールである、請求項10に記載の方法。
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