JP5513111B2 - フィルム送達リンス - Google Patents
フィルム送達リンス Download PDFInfo
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- JP5513111B2 JP5513111B2 JP2009521013A JP2009521013A JP5513111B2 JP 5513111 B2 JP5513111 B2 JP 5513111B2 JP 2009521013 A JP2009521013 A JP 2009521013A JP 2009521013 A JP2009521013 A JP 2009521013A JP 5513111 B2 JP5513111 B2 JP 5513111B2
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- rinse
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- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
Description
(i) 1以上のセイヨウニワトコ、ツボクサ又はエキナセアの活性物質を含む、有効量の適切な草本生理活性物質成分及び(ii) 前記組織を被覆し、前記抽出物を封入するのに有効なポリマー又はポリマー混合物; セイヨウニワトコの活性物質を含む草本生理活性物質を含む適切な植物抽出物成分を含む経粘膜伝達リンスを含む、フィルム、パッチ又は粘着性固体製剤を含む前記キットを提供する。
装置における使用のために適切な植物抽出物組成物にはセイヨウニワトコ (SN)の抽出物及び/又はニンニク(Allium sativum:AS)、キンセンカ(Calendula officinalis: CO)、チャノキ(Camellia sinensis:CS)、ツボクサ (CA、Gotu Kolaとしても知られる)、ミルラ(Commiphora molmol:CM)、エキナセア (EP)、ウィンターグリーン(Gaultheria procumbens:GP)、セントジョーンズワート(Hypericum perforatum:HP)、ラタニア(Krameria triandra:KT)、オシャ(Ligusticum porterii-osha:LP)、ジャーマンカモミール(Matricaria recutita)、レモンバーム(Melissa officinalis)、セイヨウシロヤナギ(Salix alba)、コモンタイム(Thymus vulgaris)、キャッツクロー(Uncaria tomentosa)、苔癬(Usnea barbata)又はコケモモ(Vaccinium myrtillus)の植物抽出物を含む。抽出成分としては、例えば、セイヨウニワトコの抽出物を、次の文に記載される下限(質量%)から、90、95、96、97、98、99又は100%の量まで含むことができる。これらの下限は50、55、60、65、70、75、80、85、90又は95%である。もし第2又は第3の抽出物が存在するのであれば、例えば以下の文に記載する下限の内の1つから上限の内の1つまでの量で含んでもよい。第2又は第3の抽出物の下限は例えば、0.5、1、2、5、10又は20%である。上限は例えば、1、2、5、10、20、30、40又は50%でありうる。これらの範囲、およびこの出願において記載されたいかなる他の範囲も、1又は両方の端を含むこともでき、含まないこともできる。
熱抽出法は、より一般的には樹皮や、木の枝や、より大きい根などのようにより固く、頑丈な植物の部位に適用される。いくつかの場合、連続抽出は、1以上の溶剤、および異なった温度で実行する必要がある。植物抽出液の標準的な製造方法(熱抽出、冷抽出及び他の方法)は「Medicinal plants: a field guide to the medicinal plants of the Land of Israel」 (ヘブライ語)、著者: N. Krispil, Har Gilo, Israel, 1986及び「Making plant medicine」、著者: R. Cech, pub. by Horizon Herbs, 2000を含む多くの文献に記載されている。
本発明のリンスはある実施態様において、粘膜組織上にフィルムを形成し一定量の草本抽出物を封入するために選択されたポリマーを含む。適切な粘膜組織を被覆する任意のポリマーを使用することができる。いくつかの例示的に実施例には架橋ポリアクリル酸-部分-含有ポリマー (エステル化可能) (例えば、Carbopol(登録商標))、カルボキシメチルセルロース塩 (例えばNa-CMC)、ヒドロキシプロピルメチルセルロース (Methocel(登録商標))、ヒアルロン酸、アルギン酸ガム、キトサン、ペクチン、イナゴマメガム(locust bean gum)、キサンタンガム、アラビアゴム、架橋した前記のもの等が含まれる。ポリマーは水分膨張性又は水分散性であっても良い。US 4,615,697に記載されるような他のポリアニオン性ポリマーを使用することができる。又は、ポリカチオン性ポリマー (キトサンのような)を使用することができる。
ある実施態様において、粘膜接着性のフィルムを提供するためにポリマー、相対量及び濃度が選択される。本明細書で使用される粘膜接着性という用語はin-vivo及び/又はin-vitroにおいて粘膜組織に接着する材料を意味する。前記接着は粘膜上に製剤を付着して局在化し、ある実施態様においては、接着性材料を粘膜から分離するのに少なくとも約50 dynes/cm2の力の適用が要求される。
ある実施態様においてポリマーには35℃近くでは可逆性のゲルであるが、約25℃以下の温度で水分散性であるポリマーを含む。従ってより多くの液体のリンスを適用ことができ、組織のより暖かい表面又はその近隣においてゲルの形成が強調される場合、粘膜表面におけるフィルム形成を増加させることができる。
ある実施態様において、リンスは1以上のセイヨウニワトコ、ツボクサ又はエキナセアの活性物質を含む、有効量の適切な草本生理活性物質成分及び抗菌的に有効な量の界面活性な四級アンモニウム化合物を含む。
ある実施態様において、リンスは1以上の歯肉炎関連細菌の成長を減少させる量の抗菌剤を含む。抗菌剤は界面活性四級アンモニウム化合物、クロルヘキシジン、亜鉛塩(例えば、塩化物)、フッ化塩(例えば、フッ化Na/Sn)、トリクロサン、ベンジダミン、クロロブタノール、クロロチモール、チモール、サリチル酸メチル、メントール、アルキル硫酸塩(例えば、ラウリル硫酸ナトリウム)、過酸化物(例えば、過酸化水素)等であっても良い。
リンスには可塑剤、浸透促進剤、香料、保存料、着色剤、界面活性剤等を含むことができる。可塑剤は一般的にフィルムの触感、柔らかさ、柔軟性を改変する。いくつかの場合、浸透促進剤は可塑剤として機能してもよい。可塑剤の例としてはグリセロール、プロピレングリコール、ソルビトール、脂肪酸エステル(オレイン酸グリセリルのような)等が挙げられるが、これらに制限されない。浸透促進剤の例としては脂肪酸エステル、脂肪アルコールエーテル、PEG-[C10-C30]アルキル、N-ラウロイルザルコシン、ソルビタンモノラウレート、ステアリルメタクリレート、N-ドデシルアザシクロヘプタン-2-オン、N-ドデシル-2-ピロリジノン、N-ドデシル-2-ピペリジノン、2-(1-ノニル)-1,3-ジオキソラン、N-(2-メトキシメチル) ドデシルアミン、N-ドデシルエタノールアミン、N-ドデシル-N-(2-メトキシメチル)アセトアミド、1-N-ドデシル-2-ピロリドン-5-カルボン酸、2-ペンチル-2-オキソ-ピロリジン酢酸、2-ドデシル-2-オキソ-1-ピロリジン酢酸、2-ドデシル-2-オキソ-1-ピロリジン酢酸、1-アザシクロヘプタン-2-オン-ドデシル酢酸等が挙げられるがこれらに限定されない。
特定の実施態様において、リンスは殺菌剤に有効な量のプロピル又はエチルアルコールを含まない。
本発明の方法及び装置によって治療される適応症には、植物抽出物及び/又は記載された抗菌剤で治療可能な粘膜組織又は粘膜組織に十分近接している組織の任意の適用症が含まれる。例えば、口内の適応症及び微生物性の適用症(微生物性病変など)が方法及び装置を用いて治療することができる。
ある実施態様においてリンスは他の投与形態、例えばフィルム、パッチ又は粘膜接着性固体製剤と組み合わせて投与される。この固体製剤はリンスの投与の前、同時、後に投与されてもよい。固体製剤は、より重篤に発症している組織又は機械的によりアクセスしやすい組織への薬物送達を補助することができ、一方リンスは薬物をほかの場所に送達する。 固体製剤中の薬物はリンス中のものと同じであっても異なっても良い。しかしながら、上記草本抽出物及び抽出物混合物が通常採用される。同様に、四級アミン界面活性剤が通常採用される。例えば、WO 02/094300及びPCT/US05/42348に記載されている製剤を採用することができる。又は、2007年6月20日に出願された「Anti-Inflammatory Dissolvable Film」という表題の出願番号11/765,587の特許出願に記載されているフィルムを採用することができる。
ある実施態様において、リンスはさらにステロイド性又は非ステロイド性抗炎症剤のような抗炎症剤を含む。ステロイド性抗炎症剤としては、ヒドロコーチゾン、ヒドロキシトリアムシノロン、α-メチルデキサメサゾン、リン酸デキサメタゾン、ベクロメタゾンジプロピオン酸エステル、吉草酸クロベタゾール、デソニド、デソキシメタゾン、デゾオキシコルチコステロン酢酸塩、デキサメサゾン、ジクロリゾン、酢酸ジフロラゾン、吉草酸ジフルコルトロン、フルアドレノロン、フルクロロロンアセトニド、フルドロコルチゾン、ピバル酸フルメタゾン、フルオシノロンアセトニド、フルオシノニド、フルコルチンブチルエステル、フルオコルトロン、フルプレドニデン(フルプレドニリデン)酢酸塩、フルランドレノロン、ハルシノニド; 酢酸ヒドロコルチゾン、酪酸ヒドロコルチゾン、メチルプレドニソロン、トリアムシノロンアセトニド、コーチゾン、コルトドキソン、フルセトニド、フルドロコルチゾン、酢酸ジフルオロゾン(difluorosone diacetate)、フルラドレノロン(fluradrenolone)、フルドロコルチゾン、酢酸ジフルオロゾン(difluorosone diacetate)、フルラドレナロンアセトニド(fluradrenalone acetonide)、メドリゾン、アムシアフェル(amciafel)、アムシナファイド(amcinafide)、ベタメタゾン及びそのエステルの平衡(balance)、酢酸クロルプレドニゾン、クロコルテロン(clocortelone)、クレスシノロン(clescinolone)、ジクロリゾン、ジフルルプレドネート、フルクロロニド、フルニソリド、フルオトメタロン、フルペロロン、フルプレドニゾロン、吉草酸ヒドロコルチゾン、ヒドロコルチゾンシクロペンチルプロピオネート、ヒドロコルタメート、メプレドニゾン、パラメタゾン、プレドニゾロン、プレドニゾン、ジプロピオン酸ベクロメタゾン、トリアムシノロン及びそれらの混合物のような副腎皮質ステロイドが含まれるが、これらに限られない。
以下の用語は、本出願の目的のためにそれぞれ以下に示す意味を有する。
Claims (1)
- (1)リンス中における植物抽出物固体の重量によって規定される抗炎症有効量のセイヨウニワトコ、ツボクサ及びエキナセアの抽出物からなる植物抽出物であって、セイヨウニワトコの抽出物が植物抽出物固体の70〜90質量%を構成し、ツボクサの抽出物が植物抽出物固体の5〜20質量%を構成し、エキナセアの抽出物が植物抽出物固体の2〜10質量%を構成する前記植物抽出物、
(2)リンスの15〜35質量%を構成するプロピレングリコール、及び
(3)抗菌的有効量のセチルピリジニウム塩である界面活性剤であって、リンスの0.03〜0.25質量%を構成する前記界面活性剤、
を含み、
殺菌剤に有効な量のエチル又はプロピルアルコールを含まない、歯肉炎を治療又は寛解するための経粘膜伝達リンス。
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IL153124A (en) * | 2002-11-27 | 2010-06-30 | Herbal Synthesis Corp | Solid composition that can be glued to the lining |
US20050100601A1 (en) * | 2003-11-07 | 2005-05-12 | Viratox, L.L.C. | Virucidal activities of cetylpyridinium chloride |
DE102005003387A1 (de) * | 2004-09-01 | 2006-03-02 | LABTEC Gesellschaft für technologische Forschung und Entwicklung mbH | Atrium Patch |
ES2747729T3 (es) * | 2004-11-22 | 2020-03-11 | Izun Pharmaceuticals Corp | Dispositivo de administración oral a través de la mucosa |
US8021696B2 (en) | 2006-06-20 | 2011-09-20 | Izun Pharmaceuticals Corporation | Anti-inflammatory dissolvable film |
JP5513111B2 (ja) | 2006-07-20 | 2014-06-04 | イズン ファーマシューティカルズ コーポレイション | フィルム送達リンス |
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Also Published As
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ES2605794T3 (es) | 2017-03-16 |
EP2594278A1 (en) | 2013-05-22 |
JP2009544624A (ja) | 2009-12-17 |
US20130122124A1 (en) | 2013-05-16 |
US8852652B2 (en) | 2014-10-07 |
US20120082738A1 (en) | 2012-04-05 |
IL196521A0 (en) | 2009-11-18 |
IL196521A (en) | 2014-12-31 |
US20080020027A1 (en) | 2008-01-24 |
KR101474809B1 (ko) | 2014-12-19 |
CA2660894A1 (en) | 2008-01-24 |
US8075924B2 (en) | 2011-12-13 |
US8383170B2 (en) | 2013-02-26 |
AU2007275217B2 (en) | 2013-02-07 |
WO2008011556A3 (en) | 2008-12-24 |
ES2539114T3 (es) | 2015-06-26 |
WO2008011556A2 (en) | 2008-01-24 |
EP2594278B1 (en) | 2016-09-07 |
KR101531185B1 (ko) | 2015-06-25 |
AU2007275217A1 (en) | 2008-01-24 |
KR20140121836A (ko) | 2014-10-16 |
EP2068900A2 (en) | 2009-06-17 |
EP2068900A4 (en) | 2011-11-23 |
KR20090031617A (ko) | 2009-03-26 |
CA2660894C (en) | 2018-12-04 |
EP2068900B1 (en) | 2015-04-15 |
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