JP2022501372A - 審美的皮膚状態を治療する為の鉄キレート化合物 - Google Patents
審美的皮膚状態を治療する為の鉄キレート化合物 Download PDFInfo
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- JP2022501372A JP2022501372A JP2021515532A JP2021515532A JP2022501372A JP 2022501372 A JP2022501372 A JP 2022501372A JP 2021515532 A JP2021515532 A JP 2021515532A JP 2021515532 A JP2021515532 A JP 2021515532A JP 2022501372 A JP2022501372 A JP 2022501372A
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- skin
- iron chelator
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- compound
- chelator compound
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
Description
本出願は、2018年9月20日出願の米国仮特許出願第62/734,164号の利益を主張するものであり、この仮特許出願の開示は参照によりその全体が本明細書に組み込まれる。
本明細書において言及される全ての刊行物及び特許出願は、その全体が、各個々の刊行物若しくは特許出願が具体的に及び独立に参照により組み込まれることが示されるのと同様の程度まで、参照により本明細書に組み込まれる。
本明細書において、用語「治療すること」及び「治療」等は一般的に、(1)その疾患を阻止すること、例えば、審美的皮膚疾患、状態、若しくは障害の病態若しくは総体症状を経験している若しくは提示している個人において、その疾患、状態、若しくは障害を阻止すること(即ち、その病態及び/若しくは総体症状の更なる発達を阻むこと)、及び(2)その審美的皮膚疾患若しくは状態を寛解させること、例えば、審美的皮膚疾患、状態、若しくは障害の病態若しくは総体症状を経験している若しくは提示している個人において、その皮膚疾患、状態、若しくは障害を寛解させること(即ち、その病態及び/若しくは総体症状を反転させること)、例えば、疾患の重篤度を低下させること、のうちの1つ以上を意味する為に使用される。本開示の前記化合物及び/若しくは組成物及び/若しくはデバイス並びに方法は、本明細書で言及される前記審美的皮膚疾患のいずれかを発症させるリスクを予防する若しくは低減すること、例えば、審美的皮膚疾患、状態、若しくは障害に罹る傾向を有し得るがその疾患の病態若しくは総体症状を未だ経験若しくは提示していない個人において、その審美的皮膚疾患、状態、若しくは障害を発症させるリスクを予防する、改善する、若しくは低減すること、において有用である。故に、「治療すること」は審美的皮膚状態を予防することを包含する。
皮膚は身体の複雑な器官であり、その構造によって、本開示の組成物を用いて皮膚状態を予防する若しくは寛解させる為の介入のポイントを知ることができる。表皮は皮膚の最も外側の耐水保護層であり、感染に対する障壁を提供する。表皮は血管を含有せず、及びその最深層における細胞は、殆どは外気から拡散された酸素によって、そして多少は真皮の外側層へと延びる毛細血管によって、栄養分を与えられる。表皮は、以下に示す層(strata)に更に細かく分けることができる(最外層を発端として):角質層、透明層(手掌及び足裏のみ)、顆粒層、有棘層、及び基底層。表皮を構成する細胞の主なタイプは、ケラチノサイト(前記層の全体に渡って位置する、主に基底細胞層内に位置するメルケル細胞及びメラノサイト)、及びランゲルハンス細胞(前記層の全体に渡って位置する)である。最内層において新しい細胞が形成され、及び娘細胞が外側の層に向かって移動し、それらが血液源からの分離に起因して死ぬときに形状及び組成を変化させる。核の構造及び細胞質小器官が消失し、細胞質が放出され、細胞質の放出と共にケラチンタンパク質が産生され、保持され、及び重合されてケラチンフィラメントとなる。それらは最終的に角質に到達して剥がれ落ちる。皮膚のこの角質化された層は、身体中の水分を維持する為及び皮膚を感染及び異物に対する天然の障壁とする為に貢献している。表皮の最外層は25〜30層の死細胞の層を含む。
幾つかの実施形態では、前記薬剤組成物は、経口消費に好適な液体薬剤組成物であってよい。経口投与に好適な薬剤組成物は、それぞれが、粉末として若しくは顆粒、水性若しくは非水性液体中の溶液若しくは懸濁液、水中油エマルション、又は油中水液体エマルション中に、予め決められた量の有効成分を含有する、カプセル、カシェ剤、若しくは錠剤等の離散型の剤型、又は液体若しくはエアロゾルスプレーとして提供することができる。かかる剤型は、薬学の方法のいずれかによって調製することができるが、全ての方法は、前記有効成分を、1以上の必要な成分を構成する前記担体と結びつける工程を含む。一般に、前記組成物は、前記有効成分を液体担体若しくは微粉化した固体担体又は両方と均一に及び密接に混和させ、及びその後、必要に応じて、その生成物を所望の体裁に成形することによって調製される。例えば錠剤は、任意で1以上のアクセサリ成分と共に、圧縮若しくは成型することによって調製することができる。圧縮錠剤は、任意で結合剤、潤滑剤、不活性希釈剤、及び/又は界面活性若しくは分散剤等が挙げられるが限定されない賦形剤と混合された、粉末若しくは顆粒等の自由流動形態の前記有効成分を、好適な機械中で圧縮することによって、調製することができる。成型錠剤は、水分を含ませた粉末化化合物の不活性液体希釈剤との混合物を好適な機械中で成型することによって作製することができる。
デフェロキサミン、デフェリプロン、若しくはデフェラシロクス等の前記鉄キレーター分子のいずれかを、パッチ、薄膜、ゲル、若しくはローションに処方してよい。幾つかの変形形態では、前記鉄キレーターはデフェロキサミンであってよく、パッチとして処方されてよい。幾つかの変形形態では、前記鉄キレーターはデフェロキサミンであってよく、薄膜として処方されてよい。幾つかの変形形態では、前記鉄キレーターはデフェロキサミンであってよく、ゲル若しくはローションとして処方されてよい。幾つかの変形形態では、デフェロキサミン、デフェリプロン、若しくはデフェラシロクス等の前記鉄キレーター分子は、少なくとも約1%、約2%、約3%、約5%、約7.5%、約12%、約15%、約18%、且つ約35%以下、約50%以下、約75%以下、約20%以下、約15%以下、約12.5%w/w以下、又は前記列挙された濃度の間の任意の数値の濃度で存在してよい。幾つかの変形形態では、前記鉄キレーター分子は、ローション、ゲル、フィルム、若しくはパッチ内の鉄キレーター分子:製剤成分の重量/重量%として約15%の濃度で存在してよい。使用される具体的な鉄キレーターに依存して、鉄キレーターの濃度は、異なる鉄キレーターが1:1、1:2、1:3、若しくは3:1、2:1のキレーター:鉄部分の比率で鉄をキレートするような効果的な鉄キレート化の為により高く若しくはより低くてもよい。
局所的なデフェロキサミン(デスフェリオキサミン、デスフェロキサアミン、DFOとしても知られる)は、実験条件に応じて幾つかの濃度で使用される。更に、デフェリプロン、デフェラシロクス等の、本明細書に記載されるような複数の他の鉄キレーターも用いられる。
DFO製剤:フィルム。本発明に使用される製剤のうちの幾つかを表1に挙げる。
(1)1600mgのエチルセルロースを24mlのエタノールに溶解する(一晩撹拌、白濁溶液)。
(2)セチルアルコール、PVP、プルロールオレイーク(Plurol Oleique)、及び16mlのエタノールを合わせて、撹拌する。
(3)400mgのDFOを秤量し、それを約400μlの水で湿らせ、(2)から得られた溶液を添加し、撹拌する(懸濁液となる)。
(4)(1)と(3)とを合わせて、撹拌する。
(5)37℃の温度で8ウェルトレイを水平面上に設置する。
(6)4mlの(4)を各ウェルに分注し、ティッシュ/ペーパータオルで被覆する。一晩乾燥させる。
(7)スパチュラを用いてトレイからパッチを取り出す。気密な容器中に室温で保管する。
(1)1600mgのエチルセルロースを24mlのギ酸エチルに溶解する(一晩撹拌、白濁溶液)。
(2)セチルアルコール、PVP、プルロールオレイーク(Plurol Oleique)、及び16mlのギ酸エチルを合わせて、撹拌する。
(3)400mgのDFOを秤量し、それを約600μlの水で湿らせ、(2)から得られた溶液600μlを添加する。(2)の残りを加えて撹拌する(透明な溶液となる)。
(4)(1)と(3)とを合わせて、撹拌する(濁るが沈降はしない)。
(5)37℃の温度で8ウェルトレイを水平面上に設置する。
(6)4mlの(4)を各ウェルに分注し、ティッシュ/ペーパータオルで被覆する。一晩乾燥させる。
(7)スパチュラを用いてトレイからパッチを取り出す。気密な容器中に室温で保管する。
(1)1600mgのエチルセルロースを24mlのエチルアルコールに溶解する(一晩撹拌、白濁溶液)。
(2)CTAB、PVP、及び16mlのエチルアルコールを合わせて、撹拌する。
(3)400mgのDFOを秤量し、それを約600μlの水で湿らせ、(2)から得られた溶液600μlを添加する。(2)の残りを加えて攪拌する(白濁溶液となり振盪すると渦が見える)。
(4)1.2mlの水を加えて、一晩撹拌する。更に1mlの水を加える。
(5)(1)と(4)とを合わせて、撹拌する(濁るが沈降はしない)。
(6)37℃の温度で8ウェルトレイを水平面上に設置する。
(7)4mlの(5)を各ウェルに分注し、ティッシュ/ペーパータオルで被覆する。一晩乾燥させる。
(8)スパチュラを用いてトレイからパッチを取り出す。気密な容器中に室温で保管する。
(1)1600mgのエチルセルロースを24mlのギ酸エチルに溶解する(一晩撹拌、白濁溶液)。
(2)CTAB、PVP、及び16mlのギ酸エチルを合わせて、撹拌する(溶解されない)。500μl×3(1.5ml)の水を加える(白濁溶液となる)
(3)400mgのDFOを秤量し、それを約600μlの水で湿らせ、(2)から得られた溶液600μlを添加する。(2)の残りを加えて攪拌する(白濁溶液となり、浸透すると渦が見える)。
(4)1.2mlの水を加えて、一晩撹拌する。更に1mlの水を加える。
(5)(1)と(4)とを合わせて、撹拌する(濁るが沈降はしない)。
(6)37℃の温度で8ウェルトレイを水平面上に設置する。
(7)4mlの(5)を各ウェルに分注し、ティッシュ/ペーパータオルで被覆する。一晩乾燥させる。
(8)スパチュラを用いてトレイからパッチを取り出す。気密な容器中に室温で保管する。
DFO製剤:ローション若しくはクリーム。表3に、クリーム若しくはローションとして使用され得る製剤の幾つかを列挙する。
(1)100uLの水を100mgのDFOに加える。
(2)0.9mLのエタノールを2段階添加で加える。0.4mLを加え、成分を混合し、次いで残りの0.5mLを加える。
(3)1mLのエタノール中に溶解された選択された量のポリビニルピロリドン(PVP)を加える。
(4)1mLのエタノール中の選択された量のセチルアルコールを加える。
(5)1mLのエタノール中の選択された量のプルロールオレイーク(Plurol Oleique)を加える。
(6)合わせた混合物((2)、(3)、(4)、及び(5)から を超音波を用いて10分間混合する。
(7)別の容器中で、400mgのワセリン(Vaseline)を、容器を温浴中に入れた状態で磁性撹拌機上で温めることにより溶融する。
(8)(6)から得られたDFO含有混合物を前記溶融されたワセリン(Vaseline)に撹拌しながらゆっくりと加える。
(9)30分間若しくはエタノールが蒸発するまで撹拌する。
(10)混合物を撹拌しながら冷まして、均質なクリームを得る。
Claims (41)
- 被験者の皮膚における審美的皮膚状態を治療する方法であって、
それを必要とする前記被験者の皮膚を、有効量の鉄キレーター化合物若しくはその薬剤的に許容可能な塩又は鉄キレーター化合物若しくはその薬剤的に許容可能な塩を含む組成物と、接触させることを含み、その際に前記審美的皮膚状態が予防される若しくは治療される、方法。 - 前記鉄キレーター化合物は、デフェロキサミン、デフェリプロン、デフェラシロクス、N,N’−ジ(2−ヒドロキシベンジル)エチレンジアミン−N,N’−二酢酸一塩酸塩(HBED)、ピリドキサールイソニコチノイルヒドラジン(PIH)、デスフェリチオシン、及びデフェリトリンから選択される、請求項1に記載の方法。
- 前記鉄キレーター化合物はデフェロキサミンである、請求項1に記載の方法。
- 前記審美的皮膚状態は、低下した毛髪密度、痩せた皮膚、皺、皮膚上の細線、乾燥した、鱗状の、若しくは痒みを伴う皮膚、脱毛症、老化、皮膚変色、日焼け染み、加齢染み、目元の隈、外傷若しくは手術後の打撲傷、肝斑、傷痕、くも状静脈、又は酒さである、請求項1に記載の方法。
- 前記有効量の鉄キレーター化合物若しくはその薬剤的に許容可能な塩又は鉄キレーター化合物若しくはその薬剤的に許容可能な塩を含む組成物は、局所的に投与される、請求項1に記載の方法。
- 前記鉄キレーター化合物は、少なくとも1つの界面活性剤を用いて逆ミセル構造中に封入される、請求項1〜5のいずれか1項に記載の方法。
- 被験者の皮膚を前記鉄キレーター化合物を含む組成物と接触させることは、治療期間に渡り前記鉄キレーター化合物を前記組成物から放出させることと、前記鉄キレーター化合物を治療を必要とする前記皮膚に浸透させることと、を更に含む、請求項6に記載の方法。
- 前記鉄キレーター化合物を放出させることは、前記鉄キレーター化合物を前記組成物のマトリックス内から放出させることを更に含む、請求項7に記載の方法。
- 前記マトリックスはエチルセルロースを含む、請求項8に記載の方法。
- 前記組成物はポリビニルピロリドン(PVP)を更に含む、請求項1に記載の方法。
- 前記鉄キレーター化合物は、前記組成物の重量/重量パーセントとして少なくとも約0.1%且つ約40%以下の濃度を有する、請求項1に記載の方法。
- 前記組成物は、クリーム若しくはローションである、請求項1に記載の方法。
- 前記組成物はフィルムである、請求項1に記載の方法。
- 適用することは、皮膚に前記組成物を含有する経皮パッチを適用することを含む、請求項13に記載の方法。
- 前記有効量の鉄キレーター化合物若しくはその薬剤的に許容可能な塩又は鉄キレーター化合物若しくはその薬剤的に許容可能な塩を含む組成物は、局所的に投与される、請求項1に記載の方法。
- 経皮的な審美的皮膚治療の為に処方されたクリーム、ローション、若しくはフィルム組成物中に鉄キレーター化合物若しくはその薬剤的に許容可能な塩を含む、製剤。
- 前記鉄キレーター化合物は前記クリーム、ローション、若しくはフィルム組成物中で安定化される、請求項16に記載の製剤。
- 前記鉄キレーター化合物は逆ミセル構造中に封入される、請求項16に記載の製剤。
- 前記鉄キレーター化合物若しくはその薬剤的に許容可能な塩は、前記逆ミセル内に少なくとも1つの界面活性剤を用いて封入される、請求項18に記載の製剤。
- 前記少なくとも1つの界面活性剤は、トウィーン(TWEEN)85(登録商標)(ポリオキシエチレン(20)ソルビタントリオレエート(Polyoxyethylene (20) Sorbitan Trioleate))、リン脂質類、脂肪酸エステル類、トリトン(TRITON)X−100(登録商標)(オクチルフェノールエチレンオキシド凝縮物(Octylphenol ethylene oxide condensate))、AOT(ジオクチルスルホスクシネート)−トウィーン(TWEEN)80(登録商標)(ポリソルベート(Polysorbate)80)、スパン(Span)20(ソルビタンモノラウレート)、AOT−DOLPA(ジオレイルリン酸)、AOT−OPE4(p,t−オクチルフェノキシエトキシエタノール)、CTAB(セチルトリメチルアンモニウムブロミド)−TRPO(混合トリアルキルホスフィンオキシド類)、脂肪アルコール類、及びCTAB(セチルトリメチルアンモニウムブロミド)のうちの1つ以上を含む、請求項19に記載の製剤。
- 前記少なくとも1つの界面活性剤は、ポリソルベート(Polysorbate)80及びソルビタンモノラウレート(スパン(Span)20)の少なくとも1つを含む、請求項19に記載の製剤。
- 前記少なくとも1つの界面活性剤は1%w/w〜25%w/wの濃度で存在する、請求項19に記載の製剤。
- 前記逆ミセルはポリビニルピロリドンを更に含む、請求項18に記載の製剤。
- 前記ポリビニルピロリドンは0.1%〜25%w/wの濃度で存在する、請求項23に記載の製剤。
- 前記鉄キレート化合物は、前記製剤内に1%〜35%w/wの濃度で存在する、請求項16〜24のいずれか1項に記載の製剤。
- 前記鉄キレート化合物は、前記製剤内に15%w/wの濃度で存在する、請求項25に記載の製剤。
- 前記製剤はローション若しくはゲルである、請求項16に記載の製剤。
- マトリックスを更に含む、請求項18に記載の製剤。
- 前記マトリックスは生分解性ポリマーである、28に記載の製剤。
- 前記生分解性ポリマーはエチルセルロースを含む、請求項29に記載の製剤。
- 前記エチルセルロースは25%w/w〜75%w/wの濃度で存在する、請求項30に記載の製剤。
- 前記鉄キレート化合物の前記製剤はフィルム若しくはパッチである、請求項16に記載の製剤。
- 前記製剤は被験者の顔の皮膚若しくは頭皮と適合可能となるように構成される、請求項16に記載の製剤。
- 皮膚細胞の酸化に伴う皮膚状態を治療する方法であって、それを必要とする皮膚に鉄キレーター化合物若しくはその薬剤的に許容可能な塩又は鉄キレーター化合物若しくはその薬剤的に許容可能な塩を含む組成物を局所的に適用することを含み、その際に前記化合物、塩、又は組成物の局所適用が皮膚細胞の酸化を治療する、方法。
- 適用することが、前記皮膚に前記組成物を含有する経皮パッチを適用することを含む、請求項34に記載の方法。
- 前記鉄キレーター化合物は、デフェロキサミン、デフェリプロン、デフェラシロクス、N,N’−ジ(2−ヒドロキシベンジル)エチレンジアミン−N,N’−二酢酸一塩酸塩(HBED)、ピリドキサールイソニコチノイルヒドラジン(PIH)、デスフェリチオシン、及びデフェリトリンから選択される、請求項34に記載の方法。
- 前記鉄キレーター化合物はDFOである、請求項34に記載の方法。
- 前記鉄キレーター化合物は界面活性剤を用いて逆ミセル構造中に封入される、請求項34〜37のいずれか1項に記載の方法。
- 前記鉄キレーター化合物はマトリックス内で前記逆ミセル構造内に封入される、請求項38に記載の方法。
- 前記マトリックスは生分解性ポリマーを含む、請求項39に記載の方法。
- 前記組成物はポリビニルピロリドン(PVP)を更に含む、請求項34に記載の方法。
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JPH10182407A (ja) * | 1996-12-24 | 1998-07-07 | Kose Corp | 皮膚外用剤 |
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IL281405A (en) | 2021-04-29 |
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