JP2017526663A - 食物アレルゲン組成物 - Google Patents
食物アレルゲン組成物 Download PDFInfo
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- JP2017526663A JP2017526663A JP2017506411A JP2017506411A JP2017526663A JP 2017526663 A JP2017526663 A JP 2017526663A JP 2017506411 A JP2017506411 A JP 2017506411A JP 2017506411 A JP2017506411 A JP 2017506411A JP 2017526663 A JP2017526663 A JP 2017526663A
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- food
- product
- allergen
- allergens
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Abstract
Description
(2)乾燥食物等の加工食物を用いると、関連のあるアレルゲンを破壊する場合がある。
(3)患者が、大きな又は複数のカプセルを飲み込むことが困難な場合がある。
(4)消化に対するカプセルの耐性が大きい場合があり、その結果、遅延吸収となる(特に、通常は口中で、アレルギー性反応の一部が起こるかもしれない)。そして、30〜60分間といった長い服用間隔が必要になり、2時間を超える長い観察期間が必要になる。
(i)食物を供給すること、
(ii)任意に、アレルゲンを強化又は精製して該食物を処理すること、
(iii)任意に、(i)又は(ii)の食物もしくはアレルゲンを加熱すること、及び
(iv)食物又はアレルゲンを、マトリクスと混合するか、もしくはマトリクスでコーティングすることにより、粒子を形成すること
からなる。
以下に示すように、本発明は特に、特定の分解/溶解特性を伴う食物アレルゲンの新規処方の開発に係り、これらの処方は、アレルギーを示す患者における、耐性の誘発又は食物アレルゲンへの反応性の試験に特に有利である。
(i)層で被覆された顆粒又は中性コア等のコア。該コアは、食物アレルゲンと、任意に、1種又は数種の賦形剤とを含む。
(ii)任意に、胃易動性コーティング。
(iii)任意に、賦形剤、添加剤、及び/又はコントロールされた量の食物アレルゲンを含む外層。
アレルゲン 30〜35%、
Povidone K30(結合剤) 15〜20%、
コア(糖類)粒子(250〜355μm) 45〜50%、及び
香料及び/又は着色料 0.1〜1%
アレルゲン 50〜60%、
粉糖 37〜43%、
Povidone K29−32 1〜5%、及び
香料及び/又は着色料 0.0〜1%
アレルゲン 0.1〜70%、
粉糖 35〜60%、
Povidone K29−32 0〜3%、
Avicel PH101 0〜45%、
着色料1 0.1〜2%、
乳白剤 0.5〜20%、
香料1 0〜0.5%
好ましくは0.1〜0.5%、
ヒドロキシエチルセルロース 0〜2%
好ましくは1〜2%、及び
コロイド状二酸化ケイ素 0〜0.5%
好ましくは0.1〜0.5%
(i)食物アレルゲンを供給すること、
(ii)任意に、食物アレルゲンを処理及び/又は加熱すること、
(iii)任意に、食物アレルゲンを、1つもしくはそれ以上の賦形剤又は添加剤と組み合わせること、
(iv)平均サイズが10μmから1mmの間の粒子として食物アレルゲンを処方すること、
(v)任意に、(iv)の粒子を胃易動性コートでコーティングすること、並びに
(vi)任意に、(iii)又は(iv)の粒子に、賦形剤及び/又は添加剤及び/又はコントロールされた量の食物アレルゲンを含む外層を加えること
からなる。
(i)1つ又はそれ以上の賦形剤を供給すること、
(ii)平均サイズが10μmから1mmの間の粒子として賦形剤を処方すること、
(iii)任意に、(ii)の粒子を胃易動性コートでコーティングすること、及び
(iv)任意に、(ii)又は(iii)の粒子に、賦形剤及び/又は添加剤を含む外層を加えること
からなる。
本発明のさらなる目的は、1つ又はそれ以上の前記のごとき製品もしくは組成物と、コンテナー又はリーフレット又は取扱説明書とからなるキットを提供することである。該キットは、さらに、ブリスター、ボトル、容積測定スプーンセット、ボックス等の梱包手段を備えることができる。
本発明は、限定がないが、落花生、ピーナッツ、ミルク、卵、木の実及び種(限定がないが、例えば、ヘーゼルナッツ、カシューナッツ、クルミ、ピーカンナッツ、ブラジルナッツ、マカダミアナッツ、クリ、ピスタチオ、ココナッツ、アーモンド、セサミ、マスタード)、魚、貝、甲殻類、穀草(限定がないが、例えば、小麦、コーン、オート麦、大麦、ライ麦、米、モロコシ、スペルト小麦)、マメ科植物(限定がないが、例えば、豆、インゲン豆、黒豆、三度豆、ひよこ豆、エンドウ豆、カウピー豆、レンズ豆、ハウチワ豆)、又はこれらの混合物等の、食物もしくは食物アレルゲンにて用いることができる。
本発明の別の局面は、食物アレルゲンに対する対象の反応性の試験、アレルギーの診断/検出、もしくは、食物アレルギーを、又は食物アレルギーを処置するための日常の臨床措置を処置する臨床研究のフレームワークにおける、対象の反応性の試験についての、本発明の製品又は組成物の使用に関する。
本発明の別の局面は、食物に対してアレルギーを示す患者に耐性を誘発するための(又は、脱感作のための)、本発明の製品又は組成物の使用に関する。アレルギー性の対象を、経口ルートにて食物に曝露させる(経口免疫療法、OIT)ことによって、耐性を誘発することに関する多数のレポートが公開されてきている。しかしながら、先に説明したように、多くの患者が好酸球性食道炎及び/又は経口反応を生じるので、これらのアプローチは、臨床診療に適していない。本発明により、従来技術の欠点が克服され、経口投与による効果的な脱感作が可能になる。
本発明にしたがった特定製品は以下のとおりである。
ラクトースコア 1g
ピーナッツアレルゲン 1g
HPMC 150mg
サッカロースコア 1g
ピーナッツアレルゲン 1g
HPMC/メタクリレート 150mg
ピーナッツアレルゲン 2g
HPMC 200mg
処方Aの組成を以下の表に示す。
注入口温度:60℃
製品温度:37℃
空気体積:80m3/h
噴霧圧力:2.5bar
噴霧速度:11g/min
処方Bの組成を以下の表に示す。
注入口温度:36℃
製品温度:31℃
空気体積:90m3/h
噴霧圧力:2.5bar
噴霧速度:12g/min
処方D及びEの組成を、各々以下の表に示す。
処方F、G、及びHの組成を、各々以下の表に示す。
現在の米国及びヨーロッパ薬局方に記載の標準溶解装置(装置2、回転100rpm)にて、異なる溶解媒体中、37℃に加熱して溶解試験を行った。処方(1g粉末の等価)を、中性pHの溶液(インキュベーションA、750ml)及び酸性溶液(インキュベーションB、pH=1.2、2、3又は4、750ml)に溶解させ、穏やかに撹拌して懸濁状態を保持する。各時間(0、15、30、60、90及び120分)にサンプルを回収し、遠心分離して、溶解物(上清)から非溶解物(ペレット)を分離する。
Claims (27)
- 食物アレルゲン及びマトリクスの粒子からなり、
前記粒子のサイズ又は平均サイズが、1μm〜10mmであり、
胃においてアレルゲンを放出する、経口投与に適した医薬製品。 - 前記粒子が、前記食物アレルゲンからなる第1層で包囲された中性コアを含む、請求項1に記載の製品。
- 前記粒子が、中性pHで安定な胃易動性コーティングをさらに含む、請求項2に記載の製品。
- 前記粒子が、外層をさらに含み、
前記外層が、製品における食物アレルゲンの総量に対して0.5重量%〜15重量%の食物アレルゲンを含み、かつ、前記第1層が、製品における食物アレルゲンの総量に対して99.5重量%〜85重量%の食物アレルゲンを含む、請求項2又は3に記載の製品。 - 前記第1層、及び、存在するのならば前記外層が、香料、着色料、及び/又は乳白剤から好適に選ばれた1つもしくはそれ以上の添加剤を含む、請求項2〜4のいずれか1つに記載の製品。
- 前記食物アレルゲンが、前記マトリクス中に埋め込まれている、請求項1に記載の製品。
- 前記マトリクスでの前記食物アレルゲンの直接造粒物である、請求項6に記載の製品。
- 外層をさらに含む、請求項6又は7に記載の製品。
- 前記マトリクス、及び、存在するのならば前記外層が、香料、着色料、甘味料、テクスチャー化剤、及び/又は乳白剤から好適に選ばれた1つもしくはそれ以上の添加剤を含む、請求項6〜8のいずれか1つに記載の製品。
- 前記粒子のサイズ又は平均サイズが、10μm〜1.5mm、好適には50μm〜1000μmである、請求項1〜9のいずれか1つに記載の製品。
- 前記粒子が、本質的に球形である、請求項1〜10のいずれか1つに記載の製品。
- 前記粒子の少なくとも50%、好適には少なくとも60%が、pH=1で、5分間で溶解する、請求項1に記載の製品。
- 前記粒子が、口腔で溶解しない、請求項3に記載の製品。
- 前記粒子が、口腔で、特に口中で溶解し、アレルゲンを放出する、請求項1に記載の製品。
- 前記マトリクスが、好適には、糖類;セルロース、(メタ)アクリレート、アルギネート、マルトデキストリン、シクロデキストリン、ゼラチン、ポビドン、ポリエチレングリコール(PEG)、及び/又はキサンタンガム由来の(コ)ポリマーから選ばれた1種又は数種の医薬として適合し得る(コ)ポリマーからなる、請求項1〜14のいずれか1つに記載の製品。
- 前記マトリクスが、セルロース、エチルセルロース、メチルセルロース、カルボキシメチルセルロース(CMC)、又はヒドロキシプロピルセルロース(HPMC)からなる、請求項15に記載の製品。
- 前記マトリクスが、例えばCMC又はHPMCである水溶性ポリマーと、例えばメタクリレートポリマーである非水溶性ポリマーとからなる、請求項15に記載の製品。
- 前記中性コアが、本質的に、直径約90μm〜1000μmの球形で、好適にはポリヒドロキシル化された化合物又は糖類からなり、
前記第1層が、製品における食物アレルゲンの総量の70重量%〜100重量%と、任意に、1つ又はそれ以上の添加剤及び賦形剤とを含み、
前記層が、好適には均質で、前記コアの表面全体を被覆しており、
コーティングが、前記第1層の表面全体を被覆し、中性pHでは安定で、酸性pHでは溶解する、請求項2に記載の製品。 - 前記食物アレルゲンが、食物抽出物、単離もしくは精製された食物アレルゲン、又はこれらの混合物である、請求項1〜18のいずれか1つに記載の製品。
- 前記食物アレルゲンが、熱処理、好適には100℃〜130℃の温度で熱処理した食物アレルゲンである、請求項1〜19のいずれか1つに記載の製品。
- 前記食物アレルゲンが、低脂肪のアレルゲン調剤である、請求項1〜19のいずれか1つに記載の製品。
- 前記食物が、落花生、ピーナッツ、ミルク、卵、木の実及び種、魚、貝、甲殻類、穀草、マメ科植物、又はこれらの組み合わせから選ばれ、好適にはピーナッツである、請求項1〜21のいずれか1つに記載の製品。
- 前記食物アレルゲンが、ピーナッツ粉調剤である、請求項22に記載の製品。
- 請求項1〜23のいずれか1つに記載の製品からなる、医薬組成物。
- 食物アレルゲンを、経口投与によって対象へ供給するのに使用するための、請求項1〜23のいずれか1つに記載の製品。
- 食物アレルゲンに対する対象の反応性を判定するのに使用するための、請求項1〜23のいずれか1つに記載の製品。
- 食物アレルゲンに対してアレルギー性を示す対象において、該食物アレルゲンに対する耐性を誘導するのに使用するための、請求項1〜23のいずれか1つに記載の製品。
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US11452774B2 (en) | 2015-02-20 | 2022-09-27 | The Board Of Trustees Of The Leland Stanford Junior University | Mixed allergen compositions and methods for using the same |
US10143742B2 (en) | 2015-02-20 | 2018-12-04 | The Board Of Trustees Of The Leland Stanford Junior University | Mixed allergen compositions and methods for using the same |
US10149904B2 (en) | 2015-02-20 | 2018-12-11 | The Board Of Trusteees Of The Leland Stanford Junior University | Mixed allergen compositions and methods for using the same |
US10166286B2 (en) | 2015-02-20 | 2019-01-01 | The Board Of Trustees Of The Leland Stanford Junior University | Mixed allergen compositions and methods for using the same |
WO2018094390A1 (en) * | 2016-11-21 | 2018-05-24 | Before Brands, Inc. | Liquid allergen compositions and methods for making the same |
US11439342B2 (en) | 2016-12-05 | 2022-09-13 | Reacta Biotech Limited | Oral food challenge meal formulations |
SG11202000419QA (en) | 2017-07-18 | 2020-02-27 | Before Brands Inc | Methods for making mixed allergen compositions |
WO2019076477A1 (en) * | 2017-10-18 | 2019-04-25 | Luxembourg Institute Of Health (Lih) | INDUCTION OF ALLERGEN-SPECIFIC TREGS PRIOR TO ORAL OR SUBLINGUAL IMMUNOTHERAPY OF FOOD ALLERGY |
GB201718342D0 (en) * | 2017-11-06 | 2017-12-20 | Cambridge Allergy Ltd | Allergenic protein formulations for immunotherapy |
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