JP6267394B1 - 水溶性粘稠化剤を含有する医薬組成物 - Google Patents
水溶性粘稠化剤を含有する医薬組成物 Download PDFInfo
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- JP6267394B1 JP6267394B1 JP2017171850A JP2017171850A JP6267394B1 JP 6267394 B1 JP6267394 B1 JP 6267394B1 JP 2017171850 A JP2017171850 A JP 2017171850A JP 2017171850 A JP2017171850 A JP 2017171850A JP 6267394 B1 JP6267394 B1 JP 6267394B1
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Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
(2)水溶性粘稠化剤が、セルロース系高分子、ポリビニルピロリドン、カルボキシビニルポリマー及び多価アルコールよりなる群から選択される1又は複数の水溶性粘稠化剤である、(1)に記載の医薬組成物。
(3)セルロース系高分子が、ヒドロキシエチルセルロース、ヒドロキシメチルセルロース及びヒドロキシプロピルメチルセルロースよりなる群から選択される1又は複数のセルロース系高分子である、(2)に記載の医薬組成物。
(4)水溶性粘稠化剤の含有量が0.001〜10%(w/v)である、(1)〜(3)のいずれかに記載の医薬組成物。
(5)容器が樹脂製容器である、(1)〜(4)のいずれかに記載の医薬組成物。
(6)樹脂製容器がポリエチレン製、ポリプロピレン製、またはポリエチレンテレフタレート製である、(5)に記載の医薬組成物。
(7)水溶性粘稠化剤としてセルロース系高分子を含有する医薬組成物であって、エチレンオキサイドガス滅菌樹脂製容器に収容された、医薬組成物。
(8)水性点眼剤である、(1)〜(7)のいずれかに記載の医薬組成物。
(9)緑内障治療剤である、(1)〜(8)のいずれかに記載の医薬組成物。
(10)有効成分としてドルゾラミド又はその塩を含有する、(1)〜(9)のいずれかに記載の医薬組成物。
(11)有効成分としてドルゾラミド又はその塩及びチモロール又はその塩、水溶性粘稠化剤としてヒドロキシエチルセルロースを含有する医薬組成物であって、エチレンオキサイドガス滅菌樹脂製容器に収容された、医薬組成物。
(12)水溶性粘稠化剤を含有する医薬組成物を、エチレンオキサイドガス滅菌容器に収容することによって、医薬組成物の粘度低下を抑制する方法。
(13)水溶性粘稠化剤を含有する医薬組成物を、エチレンオキサイドガス滅菌容器に収容することによって、医薬組成物の安定性を向上する方法。
以下に本発明の代表的な製剤例を示す。なお、下記製剤例において各成分の配合量は製剤1mL中の含量である。
ドルゾラミド塩酸塩 10mg
チモロールマレイン酸塩 5mg
ヒドロキシエチルセルロース 5mg
クエン酸ナトリウム水和物 5mg
希塩酸 適量
水酸化ナトリウム 適量
精製水 適量
pH 6.5
(1)被験製剤の調製
ドルゾラミド塩酸塩(19.759g)、チモロールマレイン酸塩(12.127g)、クエン酸ナトリウム水和物(5.219g)、エデト酸二ナトリウム(0.178g)、ポリソルベート80(1.78g)を精製水に溶解し、全量を710gとなるように精製水を添加した。この水溶液の一部(412.8g)を取り出して0.8%ヒドロキシエチルセルロース溶液(612.75g)と混合し、pH調節剤(塩酸および/または水酸化ナトリウム)によりpHを5.60〜5.70に調整した。全量を1042gとなるように精製水を添加して、被験製剤とした。
エチレンオキサイドガス滅菌処理(エチレンオキサイド濃度:480mg/L、温度:40℃、相対湿度:45%、処理時間:3時間)が施されたポリエチレン製容器に(1)で調製した被験製剤を充填した。このエチレンオキサイドガス滅菌容器に収容された被験製剤(実施例1)を、温度40℃または60℃で最長3か月間保存した。充填直後及び保存開始後経時的に被験製剤の粘度を測定した。なお、粘度の測定にはマイクロオストワルド(SI Analytics GmbH社製、Type No.51623)を使用し、25℃±0.1℃における被験製剤の粘度を測定した。
Claims (5)
- ドルゾラミド又はその塩、チモロール又はその塩、及びヒドロキシエチルセルロースを含有する医薬組成物であって、エチレンオキサイドガス滅菌容器に収容された、医薬組成物。
- さらに緩衝剤、pH調節剤を含む、請求項1に記載の医薬組成物。
- ヒドロキシエチルセルロースの含有量が0.001〜10%(w/v)である、請求項1又は2に記載の医薬組成物。
- 容器が点眼用の樹脂製容器である、請求項1〜3のいずれか一項に記載の医薬組成物。
- 水性点眼剤である、請求項1〜4のいずれか一項に記載の医薬組成物。
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