JP7209425B2 - 口腔粘膜にアレルゲンを供給するための練り歯磨き - Google Patents
口腔粘膜にアレルゲンを供給するための練り歯磨き Download PDFInfo
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Description
[0001]本出願は、2013年9月19日に出願された米国特許仮出願61/879779号及び2013年9月19日に出願された米国特許仮出願61/879779号に対する、米国特許法119条下の優先権を主張するものであり、これらの全ての開示は、その全てが参考文献として援用される。
剤は、消費者にとってなじみの深い非OMIT練り歯磨きと、可能な限り類似でなければならない。一般的に、OMIT練り歯磨きは、次の特性:(1)練り歯磨き中のアレルゲンの均一な分布、(2)練り歯磨きの製品寿命の期待値と妥当に釣り合った時間枠にわたって保存されるアレルゲンの免疫学的特性、及び(3)既知の製品と類似であり、そして毎日の使用を励ます、外観、芳香、稠度、質感、及び口内感触の、消費者の現象学的経験特性を持たなければならない。然しながら、アレルゲン又はアレルゲン抽出物を伴う適した練り歯磨きを処方する最初の試みは、稠度、外観、及び質感の、即時の又は2-3日内の重度の分解を経験した。従って、OMIT治療様式により各種のアレルゲンを効果的に提供するために適した、消費者が受容可能なOMIT練り歯磨き製剤に対する必要性が残ったままである。
一部であるが、然しながら、アレルゲン又はアレルゲン抽出物を含んでなる第2の部分を伴うプロ-練り歯磨きの混合物に適合するために、一つ又はそれより多い典型的な成分が、除去、置換、又は減少されている。例えば、典型的なベヒクルは、保水剤及び水を含んでなることができる。特定の特定の態様によれば、プロ-練り歯磨き組成物を処方することは、典型的な練り歯磨き組成物中の結合剤、表面活性剤、及び研磨剤の量を保持するが、一方、ベヒクル(水及び/又は保水剤)の合計パーセントを、プロ-OMIT練り歯磨きに加えられるアレルゲンの所定の体積に対応する量、プロ-練歯磨きが濃縮されるように減少することを含んでなる。一つの例示的な例において、水溶液又は50容量/容量%のグリセリン溶液中に懸濁されたアレルゲンが、練り歯磨きが、例えば、臨床医、薬剤師又は消費者によって、完成品のアレルゲン含有OMIT練り歯磨き製品として使用可能な形態に再構成することができるようにプロ-練り歯磨きと混合される。
(1)結合剤は、約10%-22%(重量/重量)を構成し、
(2)表面活性剤は、約1.0%-2.0%(重量/重量)を構成し、
(3)研磨剤は、約5%-10%(重量/重量)を構成し、
(4)保水剤は、約40%-55%(重量/重量)を構成し、
(5)水は、約18%-25%(重量/重量)を構成し、
そしてこれは、甘味剤;保存剤;芳香剤;乳白剤及び/又は着色剤、並びに抗カリエス剤を所望により含んでなり;ここにおいて
(6)甘味剤は、約0.2%-0.4%(重量/重量)を構成し、
(7)保存剤は、約1.5%-3%(重量/重量)を構成し、
(8)芳香剤は、約0.5%-1.5%(重量/重量)を構成し、
(9)乳白剤及び/又は着色剤は、約0.1%-0.2%(重量/重量)を構成し、
(10)抗カリエス剤は、約0.2%-0.5%(重量/重量)を構成する。
(1)結合剤は、約0.35%-0.45%(重量/重量)のカルボマー940TM又は類似の結合剤;約0.75%-1.0%(重量/重量)のカルボキシメチルセルロースナトリウム(CMC)又は類似の結合剤;及び約10%-20%(重量/重量)のゼオデント153TM又は類似のシリカ増粘剤を含んでなり、
(2)表面活性剤は、約1.0%-2.0%(重量/重量)のラウリル硫酸ナトリウム(SLS)又は他の類似の薬剤を含んでなり、
(3)研磨剤は、約5.0%-10.0%(重量/重量)ゼオデント113TM又は他の類似の研磨剤を含んでなり、
(4)保水剤は、約40%-55%(重量/重量)のポリオール、例えばグリセリン又はソルビトール(70重量/容量%の溶液)、又は他の保水剤を含んでなり、
(5)水は、約18%-25%(重量/重量)を構成し、
(6)甘味剤は、約0.2%-0.4%(重量/重量)のサッカリンナトリウム又は他の類似の甘味剤を含んでなり、
(7)保存剤は、約1.0%-2.0%(重量/重量)の三塩基性リン酸ナトリウム(Na3PO4)、及び約0.5%-1.0%(重量/重量)の一塩基性リン酸ナトリウム(NaH2PO4)、又は他の類似の保存剤を含んでなり、
(8)芳香剤は、約0.1%-1.5%(重量/重量)の天然のペパーミント油又は他の類似の芳香剤を含んでなり、
(9)乳白剤及び/又は着色剤は、約0.1%-0.2%(重量/重量)の二酸化チタン及び/又は他の乳白剤又は着色剤を含んでなり、そして
(10)虫歯予防剤は、約0.2%-0.5%(重量/重量)のフッ化ナトリウム(NaF)又は他の類似の虫歯予防剤を含んでなる。
(1)結合剤は、約0.43%(重量/重量)のカルボマー940TM;約0.935%(重量/重量)のカルボキシメチルセルロースナトリウム(CMC);及び約12.3%(重量/重量)のゼオデント153TMを含んでなり、
(2)表面活性剤は、約1.41%(重量/重量)のラウリル硫酸ナトリウム(SLS)又は他の類似の薬剤を含んでなり、
(3)研磨剤は、約6.15%(重量/重量)ゼオデント113TM又は他の類似の研磨剤を含んでなり、
(4)保水剤は、約53.1%(重量/重量)のグリセリンを含んでなり、
(5)水は、約22.9%(重量/重量)を構成し、
(6)甘味剤は、約0.246%(重量/重量)のサッカリンナトリウムを含んでなり、
(7)保存剤は、約1.23%(重量/重量)の三塩基性リン酸ナトリウム(Na3PO4)及び約0.614%(重量/重量)の一塩基性リン酸ナトリウム(NaH2PO4
)を含んでなり、
(8)芳香剤は、約0.254%(重量/重量)の天然のペパーミント油を含んでなり、
(9)乳白剤は、約0.123%(重量/重量)の二酸化チタンを含んでなり、そして
(10)虫歯予防剤は、約0.254%(重量/重量)のフッ化ナトリウム(NaF)を含んでなる。
プフルーツ、キンカン、タンジェリン及びオレンジの油を含む。好ましい芳香性油、例えばペパーミント油は、天然の供給源から抽出することができ、そして精製するか、又は合成することができる。
p、又はPhi pタンパク質を含んでなることができる。
ルゲンは、普通にスギ又はニホンスギと呼ばれる、Cryptomeria japonica(ヒノキ科スギ亜科)からの花粉である。
いし6ヶ月における食物タンパク質への曝露に対する重要な“発育の機会”が存在することを示唆する。
推奨される練り歯磨きの処方は、年齢に基づくことを、当業者は容易に認識するものである。
サイト、http://www.greerlabs.com/files/catalogs/HumanAllergyCatalog.pdfで、現時点でオンラインで入手可能な“Human Allergy Products and Services”と題する小冊子を刊行している。GREERは、更に、会社のウェブサイト、http://www.greerlabs.com/files/catalogs/SourceMaterialsCatalog.pdfで、現時点でオンラインで入手可能な“Source Materials Products and Services”と題する小冊子を刊行し、これは、アレルゲン抽出物又は更に高度に精製されたアレルゲンタンパク質製剤の製造のための原料物質として使用することができる、入手可能なアレルゲンを詳述している。両方の刊行物は、参考文献として本明細書中に援用される。アレルゲン及び/又はアレルゲン抽出物の他の商業的な供給業者は、ALK Abello,Inc.、Allermed Labs、及びHollisterStierを含む。アレルゲン抽出物は、典型的には、複数のタンパク質、例えばアレルゲンの天然の形態で存在する複数のアレルゲン性タンパク質を含有する。抽出物は、例えば、花粉(例えば、樹木、灌木、牧草、他の植物、例えばしばしば“草”と呼ばれるものの)、動物の上皮、羽毛、真菌の菌糸体又はカビ、胞子、黒カビ、ダニ、昆虫、昆虫の毒液、食物、チリ、等から調製することができる。
or-Dogs.pdfで入手可能であり、そして本明細書中に参考文献として援用される。更に、特異的に処方されたSCIT及びSLIT製品、例えばALLERCEPT製品(Heska,Inc.,Loveland CO)は、動物のアレルギー及びアトピー性疾患のAIT治療のために入手可能であり、これは、ここ、http://www.heska.com/Products/ALLERCEPT/ALLERCEPT.aspxで精査可能であり、本明細書中に参考文献として援用される。従って、本明細書中で考察される態様から利益を享受することができる患者は、非ヒトの動物を含む。
非限定的に、本発明は以下の態様を含む。
[態様1] 糖アルコールを含んでなる溶液中に懸濁されたアレルゲン又はアレルゲン抽出物と混合可能であるように処方されたプロ-練り歯磨きであって、前記懸濁溶液中に存在する糖アルコールに対応するように選択された糖アルコール及び粘度調整剤を含んでなる、前記プロ-練り歯磨き。
[態様2] 前記糖アルコールが、グリセロールを含んでなり、そして前記粘度調整剤が、シリカ基剤粘度調整剤を、約15%ないし約30重量%間の量で含んでなる、態様1に記載のプロ-練り歯磨き。
[態様3] 前記組成物が、約40%ないし約60容量%間のグリセロールを含んでなる、態様2に記載のプロ-練り歯磨き。
[態様4] 前記組成物が、約50容量%のグリセロール及び約20重量%のシリカ基剤粘度調整剤を含んでなる、態様3に記載のプロ-練り歯磨き。
[態様5] 態様1に記載のプロ-練り歯磨きを、糖アルコールを含んでなる溶液中に懸濁されたアレルゲン又はアレルゲン抽出物と混合することによって処方される練り歯磨き組成物であって、約25%ないし約75容量%間の糖アルコール及び約20重量%のシリカ基剤粘度調整剤を含んでなる、前記練り歯磨き組成物。
[態様6] 前記糖アルコールが、グリセロールを含んでなる、態様5に記載の練り歯磨き組成物。
[態様7] 約50容量%のグリセロールを含んでなる、態様6に記載の練り歯磨き組成物。
[態様8] 一つ又はそれより多い練り歯磨き、チュートイ又は食品により動物の口腔粘膜に、抗アレルギー治療の利益を供給するために適合された、アレルゲン及び/又はアレルゲン抽出物と共に処方される、グリセリン基剤組成物。
[態様9] 態様1に記載のプロ-練り歯磨きの少なくとも一つのバイアル、及び少なくとも一つのアレルゲン又はアレルゲン抽出物を含んでなる溶液の少なくとも一つのバイアルを含んでなる口腔粘膜療法キット。
[態様10] 前記少なくとも一つのアレルゲン又はアレルゲン抽出物が、動物、植物、又は真菌/カビアレルゲンを含んでなる、態様9に記載の口腔粘膜療法キット。
[態様11] 前記少なくとも一つのアレルゲン又はアレルゲン抽出物が、食物導入技術の治療計画(food introduction technology regimen)に適合するように選択される、態様9に記載の口腔粘膜療法キット。
[態様12] 前記少なくとも一つのアレルゲン又はアレルゲン抽出物が、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルギー性タンパク質を含んでなる、態様11に記載の口腔粘膜療法キット。
[態様13] それぞれのアレルゲン/抽出物が、別個のバイアル内に含有され、そしてアレルゲン/抽出物のバイアルの数に対応する数のプロ-練り歯磨きのバイアルを含んでなる、態様12に記載の口腔粘膜療法キット。
[態様14] 口腔粘膜療法のために適した練り歯磨きを処方する方法であって、アレルゲン又はアレルゲン抽出物及び一定濃度の糖アルコールを含んでなる溶液の第1の体積を用意し;慣用的な練り歯磨きと比較した場合、減少したベヒクルの濃度及び増粘剤の増加した濃度を含んでなるプロ-練り歯磨きの第2の体積を処方し、前記ベヒクルは、第1の体積の糖アルコールに対応する糖アルコールを、第1の体積の糖アルコールの濃度に実質的に対応する濃度で含んでなり、第1及び第2の体積は、混合した体積中の糖アルコールの濃度が約45%ないし55容量%間であるような比で混合可能であり、そして第1の体積及び第2の体積をその比で混合することを含んでなる、前記方法。
[態様15] 前記糖アルコールがグリセロールである、態様14に記載の方法。
[態様16] 前記増粘剤が、カルボマー及びシリカ基剤増粘剤から選択される、態様14に記載の方法。
[態様17] 前記アレルゲンが、植物アレルゲン、動物アレルゲン、真菌/カビアレルゲン、及びこれらの組合せから選択される、態様14に記載の方法。
[態様18] 混合した体積中のグリセロールの濃度が、約50容量%である、態様15に記載の方法。
[態様19] 前記アレルゲンが、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルギー性タンパク質を含んでなる、態様14に記載の方法。
[態様20] 患者のアレルゲンに対する免疫反応を軽減するための方法であって、態様5に記載の練り歯磨き製剤と口腔粘膜の標的領域を接触させることによって、患者の口腔粘膜の標的領域に一定量の一つ又はそれより多いアレルゲンを、少なくとも毎日一回供給することを含んでなる、前記方法。
[態様21] 前記口腔粘膜の標的領域が、前庭頬側領域を含んでなる、態様20に記載の方法。
[態様22] 毎日の口腔手入れ計画が、前記歯磨き製剤で、少なくとも毎日2回歯磨きすることを含んでなる、態様20に記載の方法。
[態様23] 前記アレルゲンが、動物アレルゲン、植物アレルゲン、真菌/カビアレルゲン又はこれらの組合せから選択される、態様20に記載の方法。
[態様24] 前記アレルゲンが、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルゲンタンパク質を含んでなる、態様20に記載の方法。
[態様25] 前記患者が4ヶ月ないし6歳間の年齢のヒトである、食物導入技術の治療計画を含んでなる態様24に記載の方法。
[態様26] それぞれのアレルゲンタンパク質に対して独特な練り歯磨き製剤を含んでなる、態様25に記載の方法であって、更に、それぞれの独特な練り歯磨き製剤を、時間枠の重複しない順序で一定の時間枠間、標的領域に接触させることを含んでなる、前記方法。
[態様27] 前記練り歯磨き製剤が、それぞれの食物製品からの一つのアレルゲンタンパク質を含んでなる、態様24に記載の方法。
[態様28] 前記患者が非ヒトの動物である、態様20に記載の方法。
[態様29] 前記アレルゲン及び/又はアレルゲン抽出物が、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルゲンタンパク質を含んでなる、態様5に記載の練り歯磨き。
[態様30] 4ヶ月ないし6歳間の年齢のヒトにおける食物アレルギーを発症する傾向を診断するための方法であって、(a)一つの食物製品からのアレルゲンタンパク質を含めるように、態様29に記載の練り歯磨きを処方し、そして(b)ヒトの口腔粘膜の領域を、工程(a)で処方した練り歯磨きと毎日の治療計画の一定の時間枠で接触させ;(c)時間枠中又はその後、口腔粘膜の免疫反応の症状をモニターし;(d)それぞれの独立の食物製品に対して一つの、少なくとも2種の練り歯磨き製剤で実行するまで、工程(a)、(b)及び(c)を繰返し、そして(c)において免疫反応の症状が観察された食物製品に対するアレルギーを発症する傾向を診断する、ことを含んでなる、前記方法。
以下の実施例は、慣用的な練り歯磨き製剤が、最終製品の特性を重度に損なうことなくアレルゲン抽出物溶液と混合することができないことを例示し、そして更に予備的な処方のガイダンスを得るために行った予備的な混合及び安定性を例示する。慣用的活性な処方を伴うが、しかしベヒクル及び水のパーセントが異なる幾つかの市販の練り歯磨きを、ホワイトオークのアレルゲン抽出物(Antigen Laboratories,Inc,Liberty,MO)と混合し、そして得られた混合物を、練り歯磨きとしての質感及び有用性を観察した。
次の列挙される成分:精製水、ソルビトール、ポリエチレングリコール、グリセリン、セルロースガム、ポロキサマー407、芳香料、シメチコン、メチルパラベン、ソルビン酸カリウム、サッカリンナトリウム、プロピルパラベン、及びクエン酸を含んでいた。最初に、アレルゲンを製品1中に混合したが、組合せは、本来の製品1の質感及び稠度を喪失し、最終的に更にその色も喪失し、そして1週間で透明なシロップとなった。記載したようにアレルゲンと混合した製品1は、練り歯磨きとして不満足であった。
PT-5の処方
25.0% 蒸留水
0.33% サッカリンナトリウム
0.58% カルボマー940
41.7% ソルビトール(70重量/容量%の溶液中)
0.83% カルボキシメチルセルロースナトリウム
1.67% 三塩基性リン酸ナトリウム
0.41% フッ化ナトリウム
0.83% 一塩基性リン酸ナトリウム
16.7% ゼオデント(登録商標)153
8.3% ゼオデント(登録商標)113
0.17% 二酸化チタン
1.92% ラウリル硫酸ナトリウム。
注記:パーセントは、実験助手の実験ノートに基づき、そして合計は、98.44合計%である;PT-5に香料は加えなかった。
PT-7の処方
18.2% 蒸留水
0.36% サッカリンナトリウム
0.64% カルボマーTM940
45.5% ソルビトール(70重量/容量%の溶液中)
0.91% カルボキシメチルセルロースナトリウム
1.82% 三塩基性リン酸ナトリウム
0.44% フッ化ナトリウム
0.91% 一塩基性リン酸ナトリウム
18.2% ゼオデント(登録商標)153
9.09% ゼオデント(登録商標)113
0.18% 二酸化チタン
2.09% ラウリル硫酸ナトリウム
0.2% ペパーミント油香料。
PT-16の処方
22.9% 蒸留水
0.25% サッカリンナトリウム
0.43% カルボマーTM940
53.1% グリセリン
0.94% カルボキシメチルセルロースナトリウム
1.23% 三塩基性リン酸ナトリウム
0.25% フッ化ナトリウム
0.61% 一塩基性リン酸ナトリウム
12.3% ゼオデント(登録商標)153
6.15% ゼオデント(登録商標)113
0.12% 二酸化チタン
1.41% ラウリル硫酸ナトリウム
0.25% ペパーミント油香料。
以下の実施例は、アレルゲン抽出物の懸濁液の糖アルコール側面(グリセロール)に対応していない糖アルコール(ソルビトール、例えば実施例3、PT-7を参照)を含んで
なるプロ-練り歯磨きと処方された練り歯磨きは、アレルゲン抽出物の懸濁液中に存在する糖アルコールに対応する糖アルコールを含んでなるプロ-練り歯磨きと処方された練り歯磨き(実施例4、PT-16)と比較した場合、1ヶ月の時間枠後の検出可能なアレルゲンに関して、不安定であったことを証明する。例示的なアレルゲン抽出物は、ウマダニ抽出物、Der f 1、及びネコ鱗屑抽出物、Fel d 1であった。それぞれ四つのアリコートのPT-7及びPT-16を、アレルゲン抽出物又はグリセリンと1:4の比(2mlのプレ-練り歯磨き中の0.5mlのアレルゲン抽出物)で混合した。予備的初期干渉試験の結果は、最良の分析法が、Multiplex Array for Indoor Allergens(MARIA(登録商標))であることを決定した。MARIA(登録商標)は、モノクローナル抗体とカップリングした蛍光微小球に基づくアレルゲン検出技術であり、これは、単一の試験で複数のアレルゲンの同時検出を可能にする。先に記載した抽出法の後、それぞれの試料を、Der f 1、Fel d 1及びPhl p 5含有量に対してMARIA(登録商標)を使用して測定した。全ての7種の試料を、1/10、1/100及び1/10,000の希釈でプレートに付加した。PT-16処方中の1ヶ月後のアレルゲン濃度の実質的な保持に対するPT-7中の1ヶ月後のアレルゲンの濃度の実質的減少を示す結果を、以下の表1及び2に示す。
以下の実施例は、本発明の態様によるアレルゲンと共に処方された練り歯磨きが、180日目まで安定なままであり、安定性がSLIT適用のために設計されたような単独のアレルゲン懸濁溶液(50容量/容量%グリセロール溶液中に処方された抽出されたアレルゲン)の安定性と釣り合っていることを例示する。アレルゲン濃度を測定し、そして実施例5に記載したような基本的プロトコルに従った。Der f 1と4:1で処方されたPT-16及びFel d 1と4:1で処方されたPT-16は、試験処方検体を提供
し、そして単独の抽出物安定性と比較された。結果を図1及び図2に示す。統計的な差は、本発明の側面によって処方された場合、SLIT適用のために使用可能なグリセロール中のアレルゲン抽出物の懸濁液中に存在する場合に対して、365日にわたるアレルゲンの安定性において観察されなかった。
リンゴ又は生野菜を食した場合の通年性の口腔のかゆみと共に、春のくしゃみ、鼻のかゆみ、及び鼻漏の症状の特性を伴う25年のアレルギー性鼻炎の病歴を持つ42歳の女性の症例報告#1。
くしゃみ、鼻鬱血、鼻漏、並びに鼻及び目のかゆみをもたらす季節的悪化を伴う通年性のARの生まれてからの病歴を持つ39歳の女性の症例報告#2。
性は不変のままであった。
鼻鬱血、鼻漏及び目のかゆみを伴う季節性ARの病歴を持つ37歳の男性の症例報告#3。
Claims (14)
- 口腔粘膜療法練り歯磨きを処方するためのキットであって、当該キットは、
(a)約50容量%のグリセロール;
アクリル酸のポリマー、セルロース誘導体、およびシリカ基剤粘度調整剤を含む、約10%-22%(重量/重量)間の量の結合剤;
約1.0%-2.0%(重量/重量)の表面活性剤;
約5%-10%(重量/重量)の研磨剤;
約0.2%-0.4%(重量/重量)の甘味剤:
約1.5%-3%(重量/重量)の保存剤;
約0.1%-1.5%(重量/重量)の芳香剤;
約0.1%-0.2%(重量/重量)の乳白剤;
約0.2%-0.5%(重量/重量)の抗カリエス剤;および
約18%-25%(重量/重量)の水、
を含むプロ-練り歯磨きの少なくとも一つのバイアル、並びに、
(b)約50容量%のグリセロールを含む溶液中に懸濁されている少なくとも一つのアレルゲン又はアレルゲン抽出物を含む溶液の少なくとも1つの別個のバイアル、ここにおいて、前記少なくとも一つのアレルゲン又はアレルゲン抽出物は、植物アレルゲン、動物アレルゲン、真菌アレルゲン、昆虫の毒液アレルゲン、食物アレルゲン、およびこれらの組合せからなる群から選択される、
を含み、
ここにおいて、前記アレルゲン又はアレルゲン抽出物の懸濁溶液中のグリセロールの濃度は、プロ-練り歯磨き中のグリセロールの濃度と実質的に同じになるように選択される、
前記キット。 - 前記プロ-練り歯磨きが、約20%(重量/重量)のシリカ基剤粘度調整剤を含んでなる、請求項1に記載のキット。
- 少なくとも一つのアレルゲン又はアレルゲン抽出物が、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルギー性タンパク質を含んでなり、そして、アレルゲン又はアレルゲン抽出物のバイアルの数に対応する数のプロ-練り歯磨きのバイアルを含む、請求項1に記載のキット。
- 口腔粘膜療法のために適した練り歯磨き組成物を処方する方法であって、請求項1に記載の、前記プロ-練り歯磨きと、前記アレルゲン又はアレルゲン抽出物の懸濁溶液とを混合することを含む、前記方法。
- 前記アレルゲンが、植物アレルゲン、動物アレルゲン、真菌アレルゲン、及びこれらの組合せから選択される、請求項4に記載の方法。
- 前記アレルゲンが、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルギー性タンパク質を含んでなる、請求項4に記載の方法。
- 前記練り歯磨き組成物と口腔粘膜の標的領域を接触させることによって、患者の口腔粘膜の標的領域に一定量の一つ又はそれより多いアレルゲンを、少なくとも毎日一回供給することを含んでなる、患者のアレルゲンに対する免疫反応を軽減するための方法、に使用するための練り歯磨き組成物の処方における使用のための、請求項1に記載のキット。
- 前記口腔粘膜の標的領域が、前庭領域及び/又は頬側領域を含んでなる、請求項7に記載のキット。
- 少なくとも毎日一回前記練り歯磨き組成物と口腔粘膜の標的領域を接触させることが、前記練り歯磨き組成物で、少なくとも毎日2回歯磨きすることを含む、請求項7に記載のキット。
- 前記患者が非ヒトの動物である、請求項7に記載のキット。
- 前記アレルゲンが、動物アレルゲン、植物アレルゲン、真菌アレルゲン又はこれらの組合せから選択される、請求項7に記載のキット。
- 前記アレルゲンが、ミルク、タマゴ、ダイズ、コムギ、ピーナッツ、木の実、魚類、甲殻類、及びこれらの組合せからなる食物製品の群から選択されるアレルゲンタンパク質を含んでなり、そして、所望により、前記練り歯磨き組成物は、それぞれの食物製品からの一つのアレルゲンタンパク質を含んでなる、請求項7に記載のキット。
- 患者のアレルゲンに対する免疫反応を軽減するための方法が、前記患者が4ヶ月ないし6歳間の年齢のヒトであり、そして、更に、前記練り歯磨き組成物を毎日、一定の時間枠間、標的領域に接触させる、ことを含む、食物導入治療計画を含む、請求項12に記載のキット。
- (a)一つの食物製品からのアレルゲンタンパク質を含めるように、前記キットから練り歯磨きを処方し;
b)ヒトの口腔粘膜の領域を、前記練り歯磨きと毎日の治療計画の一定の時間枠で接触させ;
(c)時間枠中又はその後、口腔粘膜の免疫反応の症状をモニターし;
(d)それぞれの独立の食物製品に対して一つの、少なくとも2種の練り歯磨き組成物で実行するまで、工程(a)、(b)及び(c)を繰返し、そして(c)において免疫反応の症状が観察された食物製品に対するアレルギーを発症する傾向をモニターする、ことを含んでなる、4ヶ月ないし6歳間の年齢のヒトにおける食物アレルギーを発症する傾向をモニターするための方法、
における使用のための、請求項1に記載のキット。
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BR112016006064A8 (pt) | 2018-02-06 |
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WO2015042402A1 (en) | 2015-03-26 |
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