JP2014529622A - 抗炎症補助のための製品 - Google Patents
抗炎症補助のための製品 Download PDFInfo
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- JP2014529622A JP2014529622A JP2014528385A JP2014528385A JP2014529622A JP 2014529622 A JP2014529622 A JP 2014529622A JP 2014528385 A JP2014528385 A JP 2014528385A JP 2014528385 A JP2014528385 A JP 2014528385A JP 2014529622 A JP2014529622 A JP 2014529622A
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- Prior art keywords
- anatabine
- product
- vitamin
- acid
- product according
- Prior art date
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- SOPPBXUYQGUQHE-JTQLQIEISA-N Anatabine Chemical compound C1C=CCN[C@@H]1C1=CC=CN=C1 SOPPBXUYQGUQHE-JTQLQIEISA-N 0.000 claims description 59
- 229910052799 carbon Inorganic materials 0.000 claims description 25
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Abstract
Description
下記の式Iの化合物(例えば、アナタビン)及びビタミンを含む製品は、抗炎症補助のために有用である。本明細書中で使用される「抗炎症補助」なる用語は、身体に過剰な炎症が起こるのを避けるのを助け、身体が低レベルの炎症を維持するのを助け、身体がC反応性タンパク質の健康的なレベルを維持するのを助けること等を含む。本明細書で記載される製品は、例えば、薬学的組成物または栄養補助食品であり得る。本明細書で用いられる「栄養補助食品」は、米国で、1994年の栄養補助食品健康教育法(DSHEA)に「栄養補助食品(dietary supplement)」として規定されたタイプの製品及び、世界の他の地域で、例えば、「栄養補助食品(food supplements)」、「機能性食品(nutraceuticals)」、「機能性食品(functional foods)」、または、単純に「食品」なる用語で規定されるタイプの製品を含む。
を含み、該式Iの化合物は、薬学的に許容される塩または食品用の塩として提供されうる。式中、
Rは、水素またはC1〜C5アルキルであり、
R'は、水素またはC1〜C7アルキルであり、
Xは、ハロゲンまたはC1〜C7アルキルである。
Rは、水素またはC1〜C3アルキルであり、
R'は、水素またはC1〜C4アルキルであり、
Xは、ハロゲンまたはC1〜C3アルキルである。
本明細書に開示される製品(例えば、薬学的組成物、栄養補助食品)は、また、ビタミンA(レチノール)、ビタミンB1(チアミン)、ビタミンC(アスコルビン酸)、ビタミンD(カルシフェロール)、ビタミンD2(エルゴカルシフェロール)、ビタミンD3(コレカルシフェロール)、ビタミンB2(リボフラビン)、ビタミンE(トコフェロール)、ビタミンB12(コバラミン)、ビタミンK1(フィロキノン)、ビタミンB5(パントテン酸)、ビタミンB7(ビオチン)、ビタミンB6(ピリドキシン)、ビタミンB3(ナイアシン)、ビタミンB9(葉酸)等の、一つ以上のビタミンも含む。ビタミンを合成する方法は公知であり、ビタミンは、信頼の置ける商業的供給源から得られうる。いくつかの態様において、製品(例えば、薬学的組成物、栄養補助食品)は、合成のまたは天然のアナタビン(または、式Iの他の化合物)及びビタミンAを含む。いくつかの態様では、製品(例えば、薬学的組成物、栄養補助食品)は、ビタミンD3を含む。いくつかの態様では、製品(例えば、薬学的組成物、栄養補助食品)は、ビタミンA及びビタミンD3を含む。
追加の成分は、製品(例えば、薬学的組成物、栄養補助食品)に、味や安定性を向上させるために添加されてもよい。任意で、甘味料や香味料のような他の成分が添加されうる。追加の成分は、これに限られないが、甘味料、天然風味料、人工風味料、着色料、抗酸化剤、保存料、キレート剤、粘性調整剤、等張剤、着臭剤、乳白剤、懸濁剤、結合剤、増粘剤、及びそれらの混合物を含み、これに限られないが、キサンタンガム、カルボキシメチルセルロース、カルボキシエチルセルロース、ヒドロキシプロピルセルロース、メチルセルロール、結晶セルロース、デンプン、デキストリン、発酵乳清、豆腐、マルトデキストリン、ポリオール(ソルビトールまたはマンニトールのような、糖アルコールを含む)、炭水化物(例えば、乳糖)、アルギン酸プロピレングリコールエステル、ジェランガム、グアーガム、ペクチン、トラガカントゴム、アカシアゴム、ローカストビーンガム、アラビアゴム、ゼラチン、マンニトール、天然及び/または合成のミント風味、スクラロース、二酸化ケイ素、ステアリン酸、ヒドロキシプロピルメチルセルロース、ステアリン酸マグネシウム、二酸化チタン、自然釉、メチルパラベン、プロピルパラベン、クエン酸トリエチル、クエン酸、ブチルヒドロキシトルエン(BHT)、モノグリセリド及びジグリセリド、ポリソルベート80等を含む。
本明細書で開示される製品(例えば、薬学的組成物、栄養補助食品)は、多くの形態であり得、丸剤、錠剤、カプセル、軟質ゲル、ジェルキャップ、液体、シロップ、懸濁液、粉末、チューズ、トローチ剤、ガム、バー等経口で摂取される形態、または、他の経路、例えば吸入スプレーによるような非経口的に、埋め込み式リザーバーを介して局所的に、等による投与であり得る。本製品は、食品または飲料内に調製され投与され得る。本製品は、使用前に、水または他の好適な媒体(例えば、牛乳、フルーツジュース、等)を用いて再構成される、乾燥または粉末状製品として供給され得る。
本明細書に開示される製品(例えば、薬学的組成物、栄養補助食品)は、抗炎症補助用の使用のために、調製され、包装され、かつ、ラベル付され得る。
本明細書で開示される製品(例えば、薬学的組成物、栄養補助食品)は、本明細書で開示されたように、任意の好適な技術によって調製されてもよく、いかなる特定の製造方法にも限定されない。例えば、アナタビン(または式Iの別の化合物)及びビタミンは、賦形剤及び結合剤と組み合わせ、その後顆粒化され得る。顆粒は、任意の残りの成分と乾式混合され得、錠剤のような固体に圧縮され得る。
NFκB媒介転写アッセイ;細胞毒性試験
アナタビン、ニコチン、無煙タバコの粗抽出物、及び無煙タバコのアルカロイド抽出物のある範囲の服用量の効果は、NFκBルシフェラーゼアッセイ(TNFα誘導性NFκB活性の阻害)で試験した。これらの実験で使用される無煙タバコは、地元の販売店で購入した味付けされていない長葉のコペンハーゲンタバコであった。粗抽出物は、メタノール及び水を用いて抽出され、遠心分離及び濾過によって浄化された。アルカロイド抽出物は、水酸化ナトリウム及びメタノール抽出物、有機相分離及び精製から調製された。すべての処理試料は、重量(μg/ml)の関数として調製し、すべての試料は、DMSOで希釈した。希釈は、細胞培養処理の前に速やかに行い、すべての場合において、DMSOの最終量が、細胞培養培地において1%を超えないようにした。
アナタビン、セレブレックス(登録商標)、及びアスピリンのヒト白血球細胞におけるLPS誘導性NFκB活性に対する効果
末梢血単核球は、フィコールプラーク法を用いて、製造元の指示に従って単離した。細胞を10μg/mlのLPSで活性化し、1.25mMのアナタビン、セレコキシブ(セレブレックス(登録商標))、またはアスピリンで処理した。その後細胞を37℃、5%CO2で、終夜(18時間)、20mg/mlのPHA、1%のペニシリン/ストレプトマイシン、及び1%のグルタマックスを補充されたRPMI培地でインキュベートし、アッセイでNFκB活性を調べた。結果は、図7に示されている。
ヒト血液細胞からのIL-1β放出に関する、アナタビン濃度の増加の効果
LPSを用いたヒト血液細胞の刺激は、インターロイキン1β(IL-1β)の放出を起こす。アナタビンは、図8に示されるように、濃度に依存して、この放出を阻害する。図9は、この抑制を時間経過に従って示すグラフである。
アナタビン、アスピリン、イブプロフェン、セレコキシブ、及びジクロフェナクの、LPSを用いたヒト全血の処理後のIL-1βの蓄積に関する効果
LPS(IL-1β生産を刺激するため)、及び、アナタビン、アスピリン、イブプロフェン、セレコキシブ、またはジクロフェナクのいずれかを用いて、ヒト全血を処理した。16時間後、IL-1β放出が測定された。結果が図10に示されており、他の抗炎症剤を用いて処理された血液に比べ、アナタビンで処理された血液中のIL-1βの蓄積が減少していることを示している。
栄養補助食品製剤
以下の表2に挙げられた成分を組み合わせることにより栄養補助食品を調製し、1mgのアナタビン、417IUのビタミンA(レチニル酢酸エステルとして)、及び33IUのビタミンD3(カルシフェロールとして)を含む、160mg錠剤を形成した。同時係属中の出願第12/729,346の実施例1〜3に記載されたように、クエン酸アナタビンは合成によって調製され、この出願はその全体が参照により本明細書に組み入れられる。顆粒は、1.003mgの遊離塩基アナタビン(ダボス/Anthem)、1.003mgのクエン酸無水物(Spectrum Chemical Mfg.Corp.)、0.090mgのBHT(Spectrum Chemical Mfg.Corp.)、及び17.958mgのマンニトール(Roquette)を含んで作製され、かつ表2の成分と組み合わせられた。
式Iの化合物:
またはその薬学的に許容される塩と、(b)ビタミンとを含む製品であって:
式中、
Rは、水素またはC 1 〜C 5 アルキルであり;
R'は、水素またはC 1 〜C 7 アルキルであり;
Xは、ハロゲンまたはC 1 〜C 7 アルキルであり;かつ
ピペリジン環B内の点線は、炭素/炭素二重結合若しくは炭素/窒素二重結合、または、炭素/窒素二重結合及び炭素/炭素二重結合から独立して選択される二つの共役した二重結合を表し、
炭素/窒素二重結合が存在するとき、Rが存在せず、かつ
以下:
(i)"a"が1〜4の整数であり、かつ"b"が0〜8の整数である;または、
(ii)"a"が0〜4の整数であり、かつ"b"が1〜8の整数である
のいずれかであり、
炭素/窒素二重結合が存在しないとき、Rが存在し、
"a"が0〜4の整数であり、かつ"b"が0〜8の整数である、製品。
[本発明1002]
Rが、水素またはC 1 〜C 3 アルキルである、本発明1001の製品。
[本発明1003]
R'が、水素またはC 1 〜C 4 アルキルである、本発明1001または1002の製品。
[本発明1004]
Xが、ハロゲンまたはC 1 〜C 3 アルキルである、本発明1001、1002、または1003の製品。
[本発明1005]
化合物がアナタビンである、本発明1001の製品。
[本発明1006]
化合物が、S-(-)-アナタビンである、本発明1005の製品。
[本発明1007]
化合物が、R-(+)-アナタビンである、本発明1005の製品。
[本発明1008]
ビタミンが、ビタミンAである、本発明1001〜1007のいずれかの製品。
[本発明1009]
ビタミンが、ビタミンD3である、本発明1001〜1007のいずれかの製品。
[本発明1010]
ビタミンD3をさらに含む、本発明1001〜1007のいずれかの製品。
[本発明1011]
アナタビンが、合成アナタビンである、本発明1005〜1010のいずれかの製品。
[本発明1012]
アナタビンが、植物からの抽出物の形態で提供される、本発明1005〜1010のいずれかの製品。
[本発明1013]
アナタビンを約1mgの量で含む、本発明1005〜1012のいずれかの製品。
[本発明1014]
ビタミンAを約417IUの量で含む、本発明1001〜1013のいずれかの製品。
[本発明1015]
ビタミンD3を約33IUの量で含む、本発明1001〜1013のいずれかの製品。
[本発明1016]
マンニトール、天然及び/または合成のミント風味、スクラロース、二酸化ケイ素、ステアリン酸、ヒドロキシプロピルメチルセルロース、ステアリン酸マグネシウム、二酸化チタン、自然釉、メチルパラベン、プロピルパラベン、クエン酸トリエチル、クエン酸、BHT、モノグリセリド及びジグリセリド、ならびにポリソルベート80からなる群より選択される、一つ以上の追加の成分をさらに含む、本発明1001〜1015のいずれかの製品。
[本発明1017]
栄養補助食品である、本発明1001〜1016のいずれかの製品。
[本発明1018]
薬学的組成物である、本発明1001〜1016のいずれかの製品。
[本発明1019]
本発明1001〜1018のいずれかの製品を、それを必要とする個体に投与する段階を含む、抗炎症補助を提供する方法。
[本発明1020]
個体が人である、本発明1019の方法。
Claims (20)
- 式Iの化合物:
またはその薬学的に許容される塩と、(b)ビタミンとを含む製品であって:
式中、
Rは、水素またはC1〜C5アルキルであり;
R'は、水素またはC1〜C7アルキルであり;
Xは、ハロゲンまたはC1〜C7アルキルであり;かつ
ピペリジン環B内の点線は、炭素/炭素二重結合若しくは炭素/窒素二重結合、または、炭素/窒素二重結合及び炭素/炭素二重結合から独立して選択される二つの共役した二重結合を表し、
炭素/窒素二重結合が存在するとき、Rが存在せず、かつ
以下:
(i)"a"が1〜4の整数であり、かつ"b"が0〜8の整数である;または、
(ii)"a"が0〜4の整数であり、かつ"b"が1〜8の整数である
のいずれかであり、
炭素/窒素二重結合が存在しないとき、Rが存在し、
"a"が0〜4の整数であり、かつ"b"が0〜8の整数である、製品。 - Rが、水素またはC1〜C3アルキルである、請求項1に記載の製品。
- R'が、水素またはC1〜C4アルキルである、請求項1または2に記載の製品。
- Xが、ハロゲンまたはC1〜C3アルキルである、請求項1、2、または3に記載の製品。
- 化合物がアナタビンである、請求項1に記載の製品。
- 化合物が、S-(-)-アナタビンである、請求項5に記載の製品。
- 化合物が、R-(+)-アナタビンである、請求項5に記載の製品。
- ビタミンが、ビタミンAである、請求項1〜7のいずれか一項に記載の製品。
- ビタミンが、ビタミンD3である、請求項1〜7のいずれか一項に記載の製品。
- ビタミンD3をさらに含む、請求項1〜7のいずれか一項に記載の製品。
- アナタビンが、合成アナタビンである、請求項5〜10のいずれか一項に記載の製品。
- アナタビンが、植物からの抽出物の形態で提供される、請求項5〜10のいずれか一項に記載の製品。
- アナタビンを約1mgの量で含む、請求項5〜12のいずれか一項に記載の製品。
- ビタミンAを約417IUの量で含む、請求項1〜13のいずれか一項に記載の製品。
- ビタミンD3を約33IUの量で含む、請求項1〜13のいずれか一項に記載の製品。
- マンニトール、天然及び/または合成のミント風味、スクラロース、二酸化ケイ素、ステアリン酸、ヒドロキシプロピルメチルセルロース、ステアリン酸マグネシウム、二酸化チタン、自然釉、メチルパラベン、プロピルパラベン、クエン酸トリエチル、クエン酸、BHT、モノグリセリド及びジグリセリド、ならびにポリソルベート80からなる群より選択される、一つ以上の追加の成分をさらに含む、請求項1〜15のいずれか一項に記載の製品。
- 栄養補助食品である、請求項1〜16のいずれか一項に記載の製品。
- 薬学的組成物である、請求項1〜16のいずれか一項に記載の製品。
- 請求項1〜18のいずれか一項に記載の製品を、それを必要とする個体に投与する段階を含む、抗炎症補助を提供する方法。
- 個体が人である、請求項19に記載の方法。
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GB2612481A (en) * | 2020-06-09 | 2023-05-03 | Fadly Abd El Ghany Elkazaz Mohamed | A novel medicament for immune modulation and treating chronic or hyper inflammation |
KR20230024889A (ko) | 2020-06-15 | 2023-02-21 | 필립모리스 프로덕츠 에스.에이. | 아나타빈 분말 조성물 |
CN116171149A (zh) | 2020-09-03 | 2023-05-26 | 菲利普莫里斯生产公司 | 喷雾干燥的低吸湿性活性粉末组合物 |
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CN116033891A (zh) | 2020-09-03 | 2023-04-28 | 菲利普莫里斯生产公司 | 冷冻干燥的低吸湿性活性粉末组合物 |
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AU2012302257A1 (en) | 2014-03-13 |
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WO2013032558A3 (en) | 2013-09-26 |
KR20140124354A (ko) | 2014-10-24 |
EP2751091A2 (en) | 2014-07-09 |
AU2018202701A1 (en) | 2018-07-05 |
CN104169269A (zh) | 2014-11-26 |
US20140206656A1 (en) | 2014-07-24 |
US20130053355A1 (en) | 2013-02-28 |
JP5934796B2 (ja) | 2016-06-15 |
EP2751091A4 (en) | 2015-03-11 |
CA2847199A1 (en) | 2013-03-07 |
CN108578405A (zh) | 2018-09-28 |
HK1199733A1 (en) | 2015-07-17 |
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