JP2022120120A - 眼科用水性組成物及びプロスタグランジンF2α誘導体の含量の低下を抑制する方法 - Google Patents
眼科用水性組成物及びプロスタグランジンF2α誘導体の含量の低下を抑制する方法 Download PDFInfo
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- JP2022120120A JP2022120120A JP2022095194A JP2022095194A JP2022120120A JP 2022120120 A JP2022120120 A JP 2022120120A JP 2022095194 A JP2022095194 A JP 2022095194A JP 2022095194 A JP2022095194 A JP 2022095194A JP 2022120120 A JP2022120120 A JP 2022120120A
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- aqueous composition
- ophthalmic
- prostaglandin
- derivative
- ophthalmic aqueous
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- Medicinal Preparation (AREA)
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Abstract
Description
タフルプロスト(3mg)、ポリオキシエチレン硬化ヒマシ油40(1g)、リン酸二水素ナトリウム水和物(NaH2PO4・2H2O、400mg)、塩化ナトリウム(1.6g)、及びベンザルコニウム塩化物(2mg)を、精製水に溶解させ、塩酸/水酸化ナトリウムを用いてpHを6.0に調整することにより、200mLの点眼液を調製した。
実施例1と同様の方法で、表1~4に示す組成の点眼液を調製した。また、実施例1と同様に、得られた点眼液の含量安定性試験を行った。
実施例1と同様の方法で、表1,3~4に示す組成の点眼液を調製した。また、実施例1と同様に、得られた点眼液の含量安定性試験を行った。
タフルプロスト(3mg)、ポリオキシエチレン硬化ヒマシ油40(100mg)、リン酸二水素ナトリウム水和物(400mg)、プロピレングリコール(3.46g)、塩化ナトリウム(100mg)、及びベンザルコニウム塩化物(2mg)を、精製水に溶解させ、塩酸/水酸化ナトリウムを用いてpHを6.0に調整することにより、200mLの点眼液を調製し、そのうち3mLをポリエチレン(PE)容器に充填する。
製剤例1と同様の方法で、表5~13に示す組成の点眼液を調製する。ただし、製剤例2~72においては塩酸/水酸化ナトリウムを用いてpHを6.0に調整する一方で、製剤例73~108では塩酸/水酸化ナトリウムを用いてpHを6.9に調整する。調製した点眼液のうち3mLをポリエチレン(PE)容器に充填する。
点眼液をポリプロピレン(PP)容器に充填することを除き、製剤例1~108と同様に製剤を作製する。
点眼液を環状オレフィンポリマー(COP)容器に充填することを除き、製剤例1~108と同様に製剤を作製する。
点眼液を環状オレフィンコポリマー(COC)容器に充填することを除き、製剤例1~108と同様に製剤を作製する。
Claims (11)
- プロスタグランジンF2α誘導体を有効成分とする眼科用水性組成物であって、非イオン性界面活性剤と等張化剤とを含み、グリセリンを実質的に含有しない、眼科用水性組成物。
- 前記有効成分としてタフルプロストを含む、請求項1に記載の眼科用水性組成物。
- 前記非イオン性界面活性剤として、ポリオキシエチレン硬化ヒマシ油及びポリソルベートからなる群から選択される1つ以上を含む、請求項1に記載の眼科用水性組成物。
- 前記非イオン性界面活性剤の濃度が0.5mg/mL以上25mg/mL以下である、請求項1に記載の眼科用水性組成物。
- 前記等張化剤として、プロピレングリコール及び塩化ナトリウムからなる群から選択される1つ以上を含む、請求項1に記載の眼科用水性組成物。
- 浸透圧比が0.5以上2.0以下である、請求項1に記載の眼科用水性組成物。
- 樹脂製容器に充填されている、請求項1から6のいずれか1項に記載の眼科用水性組成物。
- タフルプロストを有効成分とする眼科用水性組成物であって、ポリオキシエチレン硬化ヒマシ油及びポリソルベートからなる群から選択される1つ以上の添加剤と、プロピレングリコール及び塩化ナトリウムからなる群から選択される1つ以上の添加剤と、を含み、グリセリンを実質的に含有しない、眼科用水性組成物。
- 浸透圧比が0.8以上1.2以下である、請求項8に記載の眼科用水性組成物。
- 樹脂製容器に充填されている、請求項8又は9に記載の眼科用水性組成物。
- プロスタグランジンF2α誘導体を有効成分とする眼科用水性組成物におけるプロスタグランジンF2α誘導体の含量の低下を抑制する方法であって、グリセリンを実質的に添加することなく、非イオン性界面活性剤及び等張化剤を添加する工程を含む、方法。
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