JP2020523406A - 眼科用組成物および使用方法 - Google Patents
眼科用組成物および使用方法 Download PDFInfo
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- JP2020523406A JP2020523406A JP2020514657A JP2020514657A JP2020523406A JP 2020523406 A JP2020523406 A JP 2020523406A JP 2020514657 A JP2020514657 A JP 2020514657A JP 2020514657 A JP2020514657 A JP 2020514657A JP 2020523406 A JP2020523406 A JP 2020523406A
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- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
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- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
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- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
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Abstract
Description
1.油相の混合:均一になるまで、適切な量のヒマシ油とポリソルベート80を混合する。
2.水相の混合:均一になるまで、必要な量のペムレン、水、グリセリンを混合する。
3.工程1および2からの油と水相の混合物の一次混合を実行する。
4.工程3の混合物の高せん断混合と均質化を実行する。
5.進行中の試験で点眼液の特性を確認する。
1.油相:均一になるまで適切な量のヒマシ油とポリソルベート80を混合
2.水相:均一になるまで必要な量のペムレン、水、およびグリセリンを混合
3.工程1および2からの油相と水相の混合物の一次混合を実行
4.高せん断混合を実行し、工程3から不均一な溶液を形成
5.工程内試験による不均一な溶液の特性の確認
1.油相:均一になるまで適切な量のヒマシ油とポリソルベート80を混合
水相:均一になるまで必要な量のペムレン、水、およびグリセリンを混合
3.工程1および2からの油相と水相の混合物の一次混合を実行
4.高せん断混合を実行し、工程3から不均一な溶液を形成
5.他の賦形剤およびAPIの混合
6.工程内試験による不均一な溶液/エマルジョン/懸濁液の特性の確認
1(a). X/4 Vの水中のカルボキシメチルセルロース−Naを混合する
1(b). X/2 Vの水中のポリソルベート、API(酒石酸ブリモニジンおよびリフィテグラスト)、および安定剤(トレハロース/マンニトール)を混合する
2. 均一または不均一な溶液が形成されるまで、1(a)と1(b)の混合物を混ぜる。
3. 工程2の最終混合物に緩衝液の10 Xストック(X/10 V)を加える。
4. 工程3の混合物にNaClストックを加えて、浸透圧を調整する。
5. 工程4の混合物にHCl/NaOHを加えてpHを調整する。
6. 工程5の混合物に水を加えて、Vを最終体積とする。
7. フィルター滅菌を行う。
8. 充填(BFS)。
Untreated:未処理
Combination of APIs: APIの組み合わせ
Cyclosporine:シクロスポリン
Lifitegrast:リフィテグラスト
Fluorescein score:フルオレセインスコア
% of total:全体の%
Scores:スコア
Claims (21)
- 第1の眼科用化合物、および前記第1の眼科用化合物とは異なる第2の眼科用化合物を含む、眼科用組成物であって、前記第1の眼科用化合物は、アルファ2アドレナリンアゴニスト、および副腎皮質ステロイドからなる群から選択され、ならびに、前記第2の眼科用化合物は、(i)アルファ2アドレナリンアゴニスト、(ii)副腎皮質ステロイド、(iii)リンパ球機能関連抗原アンタゴニスト、(iv)ナトリウムチャネル遮断薬、(v)非ステロイド性抗炎症薬、(vi)抗生物質、および(vii)これらの2つ以上の組み合わせからなる群から選択される、眼科用組成物。
- 前記第1の眼科用化合物は、ブリモニジン、その薬学的に許容される塩、またはその組み合わせからなる群から選択されるアルファ2アドレナリンアゴニストである、請求項1に記載の組成物。
- 前記第1の眼科用化合物は、ロテプレドノールエタボン酸エステル、ジフルプレドナート、酢酸プレドニゾン、リン酸プレドニゾロンナトリウム、トリアムシノロン、フルオシノロン、フルオロメトロン、ベタメタゾン、メドリゾンまたはそれらの組み合わせからなる群から選択される副腎皮質ステロイドである、請求項1に記載の組成物。
- 前記第1の眼科用化合物は、ブリモニジン、その薬学的に許容される塩、またはその組み合わせであり、かつ前記第2の眼科用化合物は、ロテプレドノール、その薬学的に許容される塩、またはその組み合わせである、請求項1に記載の組成物。
- 薬学的に許容される賦形剤をさらに含む、請求項4に記載の組成物。
- 前記第1の眼科用化合物は、全組成物の約0.01%から約0.5%w/wを含む、請求項5に記載の組成物。
- 前記第2の眼科用化合物は、全組成物の約0.01%から約0.5%w/wを含む、請求項5に記載の組成物。
- 前記副腎皮質ステロイドは、ロテプレドノールエタボン酸エステル、ジフルプレドナート、酢酸プレドニゾン、リン酸プレドニゾロンナトリウム、トリアムシノロン、フルオシノロン、フルオロメトロン、ベタメタゾン、メドリゾンまたはそれらの組み合わせを含む、請求項1に記載の組成物。
- 前記組成物は不均一な水溶液である、請求項5に記載の組成物。
- 不均一な水溶液は、エマルジョン、懸濁液、またはそれらの組み合わせを含む、請求項10に記載の組成物。
- 前記エマルジョンがナノエマルジョンである、請求項10に記載の組成物。
- 不均一な水溶液が、エマルジョン、ゲル、またはその組み合わせを含む、請求項10に記載の組成物。
- 前記組成物が不均一な水溶液として製剤化されている、請求項5に記載の組成物。
- 前記薬学的に許容される賦形剤は、エマルジョン安定化ポリマー、水溶性ポリマー、界面活性剤、張性調整剤、粘度調整剤、安定剤、またはそれらの組み合わせを含む、請求項5に記載の組成物。
- 前記リンパ球機能関連抗原アンタゴニストは、N-{[2-(1-ベンゾフラン-6-イルカルボニル)-5,7-ジクロロ-1,2,3,4-テトラヒドロ-6-イソキノリニル]カルボニル}-3-(メチルスルホニル)-L-フェニルアラニン、すなわち、リフィテグラストを含む、請求項1に記載の組成物。
- 前記ナトリウムチャネル遮断薬は、アミロライド、アミロライド類縁体/誘導体、ベンザミル、ベンザミル類縁体/誘導体、フェナミル、フェナミル類縁体/誘導体、ピラジノイルグアニジン類縁体/誘導体を含む、請求項1に記載の組成物。
- 眼の障害を治療するための方法であって、前記方法は請求項1〜16のいずれか1項に記載の組成部の治療有効量をそのような治療を必要とする対象に投与することを含む、方法。
- 前記眼の障害は、ドライアイ症候群、眼移植片対宿主病、眼性酒さ、アレルギー性結膜炎、自己免疫性眼表面疾患、タイゲソン点状表層角膜症、帯状疱疹角膜炎、スティーブンス・ジョンソン症候群、角膜炎、結膜炎、眼瞼炎、眼瞼皮膚弛緩症、結膜弛緩症、眼瞼結膜炎、眼瞼角結膜炎、手術後の炎症または眼科手術による痛み、強膜炎、上強膜炎、前部ぶどう膜炎、虹彩炎、毛様体炎、眼表面血管障害、潰瘍性角膜炎、光線角膜炎、涙嚢炎、まぶたの障害、先天性アラクリマ、眼球乾燥症、涙腺炎、春季角結膜炎、瞼裂斑、および化学熱傷、熱傷、または眼表面への物理的損傷によって誘発される眼表面障害からなる群から選択される、請求項17に記載の方法。
- ドライアイ症候群は、シェーグレン症候群、マイボーム腺障害および角結膜炎からなる群から選択される、請求項18に記載の方法。
- 前記まぶたの障害は、まぶたの炎症、疼痛、および/または浮腫を含む、請求項18に記載の方法。
- 前記組成物は前記対象の眼に局所投与される、請求項18に記載の方法。
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US20220071945A1 (en) * | 2018-12-27 | 2022-03-10 | Surface Ophthalmics, Inc. | Ophthalmic pharmaceutical compositions and methods for treating ocular surface disease |
EP3705114A1 (en) * | 2019-03-06 | 2020-09-09 | Avizorex Pharma, S.L. | Ophthalmic composition for treating dry eye and symptoms thereof |
RU2705392C1 (ru) * | 2019-07-19 | 2019-11-07 | федеральное государственное бюджетное образовательное учреждение высшего образования "Башкирский государственный медицинский университет" Министерства здравоохранения Российской Федерации | Глазная мазь на основе 6-метил-3-(тиетан-3-ил)урацила с ранозаживляющим эффектом |
WO2021191273A1 (en) | 2020-03-24 | 2021-09-30 | Hovione Scientia Limited | Compositions for use in treating meibomian gland dysfunction |
US11672798B2 (en) * | 2021-06-03 | 2023-06-13 | Laboratorios Salvat, S.A. | Ciprofloxacin ophthalmic topical composition for treating ocular disease |
KR102391198B1 (ko) * | 2021-08-27 | 2022-04-27 | 한림제약(주) | 리피테그라스트 또는 이의 약제학적으로 허용가능한 염을 포함하는 수용액 형태의 점안액 조성물 |
WO2023152644A1 (en) * | 2022-02-08 | 2023-08-17 | Orbicular Pharmaceutical Technologies Pvt. Ltd | Pharmaceutical composition of lifitegrast and loteprednol etabonate |
WO2024028815A1 (en) * | 2022-08-04 | 2024-02-08 | Bausch + Lomb Ireland Limited | Ophthalmic composition comprising an anti-allergen and a redness reduction agent |
WO2024028816A1 (en) * | 2022-08-04 | 2024-02-08 | Bausch + Lomb Ireland Limited | Ophthalmic composition comprising pilocarpine and a redness reduction agent |
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WO2018212955A1 (en) | 2018-11-22 |
US10555947B2 (en) | 2020-02-11 |
EP3624773A1 (en) | 2020-03-25 |
EP3624773A4 (en) | 2021-04-07 |
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