JP2018504439A - 粘膜炎の治療のための組成物及び方法 - Google Patents
粘膜炎の治療のための組成物及び方法 Download PDFInfo
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- JP2018504439A JP2018504439A JP2017541347A JP2017541347A JP2018504439A JP 2018504439 A JP2018504439 A JP 2018504439A JP 2017541347 A JP2017541347 A JP 2017541347A JP 2017541347 A JP2017541347 A JP 2017541347A JP 2018504439 A JP2018504439 A JP 2018504439A
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- 201000010927 Mucositis Diseases 0.000 title claims abstract description 23
- 239000000203 mixture Substances 0.000 title abstract description 162
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- 238000002347 injection Methods 0.000 claims abstract description 9
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- 229940100688 oral solution Drugs 0.000 claims abstract description 6
- 208000003265 stomatitis Diseases 0.000 claims abstract description 6
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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Abstract
Description
本出願は、2015年2月9日出願のインド仮特許出願第622/CHE/2015号の利益を主張するものであり、その開示全体があらゆる目的に依拠し、引用することにより本出願の一部をなす。
並びにその薬学的に許容可能な水和物、溶媒和物、鏡像異性体及び立体異性体。
RHは、独立して、
的に許容可能な賦形剤とを含む医薬組成物を提供する。
Xは、独立して、
Xは、独立して、
マロン酸、マンデル酸(dl)、メタンスルホン酸、ナフタレン−1,5−ジスルホン酸、ナフタレン−2−スルホン酸、ニコチン酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸(−l)、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸(+l)、チオシアン酸、トルエンスルホン酸(p)、ウンデシレン酸、n−アセチルシステイン(nac)、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。
Xは、独立して、
酸(d)、グルクロン酸(d)、グルタミン酸、グルタル酸、グリセロリン酸、グリコール酸、馬尿酸、臭化水素酸、イソ酪酸、乳酸(dl)、ラクトビオン酸、ラウリン酸、マレイン酸、リンゴ酸(−l)、マロン酸、マンデル酸(dl)、メタンスルホン酸、ナフタレン−1,5−ジスルホン酸、カプロン酸、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、ミリストレイン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、エライジン酸、リノール酸、リノレン酸、リノールエライジン酸、アラキドン酸、ナフタレン−2−スルホン酸、ニコチン酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸(−l)、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸(+l)、チオシアン酸、トルエンスルホン酸(p)、ウンデシレン酸、n−アセチルシステイン(nac)、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。
RHは、独立して、
カン酸)、カプロン酸(ヘキサン酸)、カプリル酸(オクタン酸)、炭酸、ケイ皮酸、クエン酸、シクラミン酸、カプロン酸、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、ミリストレイン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、エライジン酸、リノール酸、リノレン酸、リノールエライジン酸、アラキドン酸、ドデシル硫酸、エタン−1,2−ジスルホン酸、エタンスルホン酸、ギ酸、フマル酸、ガラクタル酸、ゲンチシン酸、グルコヘプトン酸(d)、グルコン酸(d)、グルクロン酸(d)、グルタミン酸、グルタル酸、グリセロリン酸、グリコール酸、馬尿酸、臭化水素酸、塩酸、イソ酪酸、乳酸(dl)、ラクトビオン酸、ラウリン酸、マレイン酸、リンゴ酸(−l)、マロン酸、マンデル酸(dl)、メタンスルホン酸、ナフタレン−1,5−ジスルホン酸、ナフタレン−2−スルホン酸、ニコチン酸、R−リポ酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸(−l)、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸(+l)、チオシアン酸、トルエンスルホン酸(p)、ウンデシレン酸、n−アセチルシステイン(nac)、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。
Xは、独立して、
Xは、独立して、
Xは、独立して、
タレン−1,5−ジスルホン酸、カプロン酸、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、ミリストレイン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、エライジン酸、リノール酸、リノレン酸、リノールエライジン酸、アラキドン酸、ナフタレン−2−スルホン酸、ニコチン酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸(−l)、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸(+l)、チオシアン酸、トルエンスルホン酸(p)、ウンデシレン酸、n−アセチルシステイン(nac)、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。
本明細書において使用される以下の用語及び語句は、以下に記載の意味を有するものとする。他に定義されない限り、本明細書において使用される全ての技術用語及び科学用語は、当業者により通常理解されるものと同じ意味を有する。
体と比較して、被験体における医学的状態の症状の頻度を減らすか、又は該症状の発症を遅延させる組成物の投与が含まれる。
特定の実施形態において、この用語は、任意の医学的処置に適用可能な合理的なベネフィット/リスク比にて或る程度の所望の効果を得る、本明細書に開示の溶媒和物又は水和物又は組成物の量を指す。或る特定の実施形態において、この用語は、医学的症状を一定期間にわたり排除又は低減させるのに必要な又は十分な量を指す。有効量は、治療対象の疾患又は病態、投与する特定の標的構築物、被験体の大きさ、又は疾患若しくは病態の重症度等の因子に応じて変化し得る。当業者であれば、過度の実験を必要とせずに、特定の組成物の有効量を経験的に決定することができる。
々の剤形においての投与が容易である。これらの医薬組成物は、所望の場合、風味料、結合剤、賦形剤等の追加の成分を含有することができる。したがって、経口投与において、L−アルギニン、クエン酸ナトリウム、炭酸カルシウム、及びリン酸カルシウム等の種々の賦形剤を含有する錠剤を、デンプン、アルギン酸、及び或る特定の複合ケイ酸塩等の種々の崩壊物と、ポリビニルピロリドン、スクロース、ゼラチン、及びアラビアゴム等の結合剤とを合わせて使用することができる。さらに、ステアリン酸マグネシウム、ラウリル硫酸ナトリウム、及びタルク等の潤沢剤は多くの場合、打錠用に有用である。類似の種類の固形組成物を軟質及び硬質の充填ゼラチンカプセルの充填剤として使用することもできる。これに適した物質には、ラクトース又は乳糖及び高分子量ポリエチレングリコールが挙げられる。懸濁水溶液又はエリキシル剤が経口投与において望ましいとき、その中の必須活性成分を、種々の甘味料又は風味剤、着色物質又は染料と組み合わせることができ、所望の場合、乳化剤又は懸濁剤を、水、エタノール、プロピレングリコール、グリセリン等の希釈剤、及びそれらの組合せと組み合わせることができる。式I、式II、式III、式IV、式V、式VI、式VII又は式VIIIの化合物はまた、製薬分野においてよく知られている経腸被覆を含む(enterically coated comprising)種々の賦形剤を構成することができる。
、膣内、経直腸、又は眼内に対する局部使用において、組成物の約0.01% w/w〜約50% w/wの濃度、好ましくは組成物の約1% w/w〜約20% w/w、及び非経口使用において、組成物の約0.05% w/v〜約50% w/vの濃度及び好ましくは約5% w/v〜約20% w/vの濃度で存在することができる。
ザン、ズーグラン、メチラン、キチン、シクロデキストリン、キトサン、ポリビニルピロリドン、セルロース系、スクロース、及びデンプン等の親水コロイドを含む水溶性ポリマー;並びにそれらの混合物が挙げられるが、これらに限定されない。適切な崩壊剤には、デンプングリコール酸ナトリウム、架橋ポリビニルピロリドン、架橋カルボキシメチルセルロース、デンプン、微結晶セルロース、及びそれらの混合物が挙げられるが、これらに限定されない。
施形態において、それらの部分は錠剤の中心軸で互いに接触する。1つの実施形態において、第1の部分は第1の薬学的に活性な薬剤を含み、第2の部分は第2の薬学的に活性な薬剤を含む。
、対象の組成物を、1つ以上の薬学的に許容可能な担体及び/又は以下のいずれかと混合する:(1)充填剤又は増量剤、例えばデンプン、ラクトース、スクロース、グルコース、マンニトール、及び/又はケイ酸;(2)結合剤、例えばカルボキシメチルセルロース、アルギン酸塩、ゼラチン、ポリビニルピロリドン、スクロース、及び/又はアラビアゴム等;(3)保湿剤、例えばグリセロール;(4)崩壊剤、例えば粉寒天、炭酸カルシウム、ジャガイモデンプン、又はタピオカデンプン、アルギン酸、或る特定のケイ酸塩、及び炭酸ナトリウム;(5)難溶媒、例えばパラフィン;(6)吸収促進剤、例えば第四級アンモニウム化合物;(7)湿潤剤、例えばアセチルアルコール及びモノステアリン酸グリセロール等;(8)吸収剤、例えばカオリン及びベントナイトクレイ;(9)滑沢剤、例えばタルク、ステアリン酸カルシウム、ステアリン酸マグネシウム、ポリエチレングリコール固体、ラウリル硫酸ナトリウム、及びそれらの混合物;並びに(10)着色剤。カプセル、錠剤、及び丸剤の場合において、医薬組成物は、緩衝剤も含むことができる。同様の種類の固形組成物を、ラクトース又は乳糖、及び高分子量ポリエチレングリコール等を用いた軟質及び硬質の充填ゼラチンカプセルの充填剤としても使用することができる。
ウム、及びポリアミド粉末、又はこのような物質の混合物を含有することができる。噴霧剤は、常用の噴射剤、例えばクロロフルオロ炭化水素(chlorofluorohydrocarbons:フロン)及び揮発性非置換炭化水素、例えばブタン及びプロパンを更に含有することができる。
装業界ではよく知られており、医薬単位剤形(錠剤、カプセル等)の包装に広く用いられている。ブリスターパックは一般に、透明の場合もあるプラスチック材料製の箔で覆われた比較的剛性の材質のシートからなる。
の化合物、並びにその薬学的に許容可能な水和物、溶媒和物、鏡像異性体及び立体異性体を投与することを含む、粘膜炎を治療する方法を提供する。
RHは、独立して、
Xは、独立して、
Xは、独立して、
Xは、独立して、
RHは、独立して、
Xは、独立して、
Xは、独立して、
Xは、独立して、
本開示は、特に神経疾患及びその合併症を治療するための組成物及び方法を提供する。本開示の特定の実施形態について詳述したが、上記の明細書は例示的なものであり、制限するものではない。本明細書の系及び方法の多くの変形例について、本明細書を検討すれば当業者には明らかとなるであろう。特許請求した系及び方法の全範囲は、特許請求の範囲とその等価物の全範囲、及び明細書とそのような変形例を参照して決定するものとする。
上記に挙げたものを含む本明細書で言及した全ての刊行物及び特許は、各々の刊行物又は特許が詳細にかつ個々に参照により引用されると示されているかのように、その内容全体を引用することにより本明細書の一部をなす。矛盾する場合、本明細書における任意の定義を含む本出願に従うものとする。
Claims (8)
- 式I:
(式中、
RHは、独立して、1−ヒドロキシ−2−ナフトエ酸、2,2−ジクロロ酢酸、2−ヒドロキシエタンスルホン酸、2−オキソグルタル酸、4−アセトアミド安息香酸、4−アミノサリチル酸、酢酸、アジピン酸、アスコルビン酸、アスパラギン酸、ベンゼンスルホン酸、安息香酸、ショウノウ酸、カンファー−10−スルホン酸、カプリン酸(デカン酸)、カプロン酸(ヘキサン酸)、カプリル酸(オクタン酸)、炭酸、ケイ皮酸、クエン酸、シクラミン酸、カプロン酸、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、ミリストレイン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、エライジン酸、リノール酸、リノレン酸、リノールエライジン酸、アラキドン酸、ドデシル硫酸、エタン−1,2−ジスルホン酸、エタンスルホン酸、ギ酸、フマル酸、ガラクタル酸、ゲンチシン酸、グルコヘプトン酸、グルコン酸、グルクロン酸、グルタミン酸、グルタル酸、グリセロリン酸、グリコール酸、馬尿酸、臭化水素酸、塩酸、イソ酪酸、乳酸、ラクトビオン酸、ラウリン酸、マレイン酸、リンゴ酸、マロン酸、マンデル酸、メタンスルホン酸、ナフタレン−1,5−ジスルホン酸、ナフタレン−2−スルホン酸、ニコチン酸、R−リポ酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸、チオシアン酸、トルエンスルホン酸、ウンデシレン酸、n−アセチルシステイン、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。)
の化合物又はその薬学的に許容可能な水和物、溶媒和物、鏡像異性体若しくは立体異性体。 - 式V:
(式中、
RHは、独立して、1−ヒドロキシ−2−ナフトエ酸、2,2−ジクロロ酢酸、2−ヒドロキシエタンスルホン酸、2−オキソグルタル酸、4−アセトアミド安息香酸、4−アミノサリチル酸、酢酸、アジピン酸、アスコルビン酸、アスパラギン酸、ベンゼンスルホン酸、安息香酸、ショウノウ酸、カンファー−10−スルホン酸、カプリン酸(デカン酸)、カプロン酸(ヘキサン酸)、カプリル酸(オクタン酸)、炭酸、ケイ皮酸、クエン酸、シクラミン酸、カプロン酸、カプリル酸、カプリン酸、ラウリン酸、ミリスチン酸、ミリストレイン酸、パルミチン酸、パルミトレイン酸、ステアリン酸、オレイン酸、エライジン酸、リノール酸、リノレン酸、リノールエライジン酸、アラキドン酸、ドデシル硫酸、エタン−1,2−ジスルホン酸、エタンスルホン酸、ギ酸、フマル酸、ガラクタル酸、ゲンチシン酸、グルコヘプトン酸、グルコン酸、グルクロン酸、グルタミン酸、グルタル酸、グリセロリン酸、グリコール酸、馬尿酸、臭化水素酸、塩酸、イソ酪酸、乳酸、ラクトビオン酸、ラウリン酸、マレイン酸、リンゴ酸、マロン酸、マンデル酸、メタンスルホン酸、ナフタレン−1,5−ジスルホン酸、ナフタレン−2−スルホン酸、ニコチン酸、R−リポ酸、硝酸、オレイン酸、シュウ酸、パルミチン酸、パモ酸、リン酸、プロピオン酸、ピログルタミン酸、サリチル酸、セバシン酸、ステアリン酸、コハク酸、硫酸、酒石酸、チオシアン酸、トルエンスルホン酸、ウンデシレン酸、n−アセチルシステイン、フロエート、メチルフロエート、エチルフロエート又はアミノカプロン酸を表す。)
の化合物又はその薬学的に許容可能な水和物、溶媒和物、鏡像異性体若しくは立体異性体。 - 請求項1に記載の化合物と薬学的に許容可能な担体とを含む医薬組成物。
- 請求項2に記載の化合物と薬学的に許容可能な担体とを含む医薬組成物。
- 疼痛、粘膜炎、歯口腔学的状態:歯肉炎、口内炎、舌炎、アフタ性潰瘍、歯科手術、口腔内潰瘍、咽頭炎、扁桃炎、扁桃摘出術後粘膜炎、放射性粘膜炎又は挿管粘膜炎の治療方法であって、治療を必要とする患者に、治療的有効量の請求項3に記載の医薬組成物を投与することを含み、かつ前記医薬組成物は、前記治療を必要とする患者に、経口投与、遅延放出若しくは徐放、経粘膜投与、シロップ、粘膜付着剤、スプレー、口腔用製剤、粘膜付着性錠剤、局所投与、非経口投与、注射、皮下投与、経口溶液、経直腸投与、頬内投与又は経皮投与によって投与される、方法。
- 粘膜炎、疼痛、口腔内粘膜炎に伴う疼痛、鬱病、不安障害、掻痒症、不眠症、慢性突発性蕁麻疹、アトピー性皮膚炎、慢性単純性苔癬及び神経障害の治療方法であって、治療を必要とする患者に、治療的有効量の請求項4に記載の医薬組成物を投与することを含み、かつ前記医薬組成物は、前記治療を必要とする患者に、経口投与、遅延放出若しくは徐放
、経粘膜投与、シロップ、粘膜付着剤、スプレー、口腔用製剤、粘膜付着性錠剤、局所投与、非経口投与、注射、皮下投与、経口溶液、経直腸投与、頬内投与又は経皮投与によって投与される、方法。
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EP3256459A1 (en) | 2017-12-20 |
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SG10201906474QA (en) | 2019-09-27 |
SG11201706369PA (en) | 2017-09-28 |
JP6698669B2 (ja) | 2020-05-27 |
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CA2976187A1 (en) | 2016-08-18 |
CN107873024A (zh) | 2018-04-03 |
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