JP2020516695A - 改善された安定性を備えた注射器中に局所麻酔薬、緩衝液、およびグルコサミノグリカンを含む製品 - Google Patents
改善された安定性を備えた注射器中に局所麻酔薬、緩衝液、およびグルコサミノグリカンを含む製品 Download PDFInfo
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Abstract
Description
本出願は、Dan Vickery博士らによる“Article of Manufacture Comprising Local Anesthetic,Buffer,and Glycosaminoglycan in Plastic Syringe with Improved Stability”と題し、そして2017年4月12日に出願された米国仮出願番号62/484,477号の利益を主張しており、その内容は、本参照によりその全体が本明細書中に援用される。
本発明は、注射器またはバイアル中に局所麻酔薬、緩衝液、およびグリコサミノグリカンを含む、改善された安定性を有する製品であって、典型的には製品の最終滅菌と組み合わされている、製品を対象とする。
しばしば膀胱痛症候群または過敏性膀胱症候群としても知られる間質性膀胱炎(IC)は、尿意切迫および頻数、ならびに/または骨盤痛を引き起こす下部尿路の慢性進行性障害である。アメリカ泌尿器科学会は、IC/BPSを「感染症または他の同定可能な原因の非存在下における、6週間超の持続期間の下部尿路症状を伴う、膀胱に関連すると知覚される不愉快な感覚(疼痛、圧迫感、不快感)」と定義している。長年の間、泌尿器科医は、IC/BPSを、広く有効な処置を有しない珍しい疾患と見なしていた。実際には、その状態は極めて一般的である。1999年、米国における有病数は750,000例と推定された(Curhanら、J Urol161巻(2号):549〜552頁(1999年))。しかしながら、RAND間質性膀胱炎疫学(RICE)研究による現在の推定では、IC/BPSの真の有病率は2.7%から6.53%(18歳またはそれよりも上の年齢の米国女性およそ330万から790万人)および2.9%から4.2%(18歳またはそれよりも上の年齢の米国男性およそ200万から460万人)と推定されるということが示唆されているBerry SHら、J Urol2011年、186巻、540頁。およびSuskind AMら、J Urol2013年、189巻、141頁(。加えて、有効な療法がない、切迫、頻数、失禁、および/または骨盤痛という膀胱症状をも結果としてもたらす過活動膀胱、尿道症候群、前立腺炎、および婦人科慢性骨盤痛症候群は、数百万の患者を含み、これらの症候群は全て、伝統的に診断されたICと同様の症状およびおそらくは共通の病態生理を共有している(Parsons、CL Int Br J Urol2010年12月)が、これらの状態に対する広く有効な処置は存在しない。
しかしながら、グリコサミノグリカン、緩衝液、および局所麻酔薬の混合を含む、組成物の形成に関するリドカインの即座の沈殿を防ぐ方法で組成物を調製したとしても、組成物の保存および輸送は、長期安定性を必要とする。リドカインの安定性の喪失とそれによる組成物からのリドカインの喪失との1つの要因は、アルカリ化リドカインと注射器成分との相互作用である。リドカインは、滅菌後、注射器に付くようになる。そのような長期安定性の非存在下では、患者に対し、所望の臨床効果を有し得ない投薬量の組成物の1つまたは複数の成分を投与し得るという重大な危険がある。したがって、組成物を含み、安定で、すぐに患者に投与できる形態で輸送および保存することができる製造の組成物に対する特定の必要性がある。加えて、安定性の重大な減少なしに滅菌に耐え得るような物質の組成物に対する必要性がある。
ガラスおよび高密度プラスチックポリマーから選択される材料から構築されている注射器またはバイアルに包装された、グリコサミノグリカン、局所麻酔薬、および緩衝液を含む組成物を含む製品。典型的には、高密度プラスチックポリマーは、環状オレフィンポリマー、環状オレフィンコポリマー、高密度ポリエチレン、および高密度無核ポリプロピレンからなる群から選択され、これらの必要性を満たし、間質性膀胱炎(膀胱痛症候群もしくは過敏性膀胱症候群)または別の尿路疾患もしくは障害に罹患している患者の尿路への投与に好適であるような容器中の組成物の改善された安定性を実現する、プラスチックである。
一般に、本発明は、ガラスまたは高密度プラスチックポリマーから構築されている注射器またはバイアルに包装された、グリコサミノグリカン、局所麻酔薬、および緩衝液を含む組成物を含む製品に関する。典型的には、高密度プラスチックポリマーは、環状オレフィンポリマー、環状オレフィンコポリマー、高密度ポリエチレン、および高密度無核ポリプロピレンからなる群から選択される。
(1)ヒト細胞および血液と適合性の等張またはほぼ等張の溶液を提供する浸透圧成分、
(2)下部尿路障害を処置、回復、または予防するに十分な量の、膀胱上皮の表面に対する前記組成物の存続を可能にする化合物、
(3)下部尿路障害を処置、回復、または予防するに十分な量の抗菌剤、
(4)下部尿路障害を処置、回復、または予防するに十分な量の抗真菌剤、
(5)下部尿路障害を処置、回復、または予防するに十分な量の血管収縮剤、
(6)保存剤、ならびに
(7)抗炎症剤
からなる群から選択される追加の成分を含む。
(1)16.67g/Lのヘパリンナトリウム、
(2)13.33g/Lのリドカイン塩酸塩、
(3)0.028Mの濃度を得るための、10.03g/LのNa2HPO4・12H2O、および
(4)必要に応じて、pHを調製するための、0.02N NaOH。
一般に、本発明は、ガラス、または環状オレフィンポリマー、環状オレフィンコポリマー、高密度ポリエチレン、および高密度無核ポリプロピレンからなる群から選択されるプラスチックから構築されている注射器またはバイアルに包装された、グリコサミノグリカン、局所麻酔薬、および緩衝液を含む組成物を含む製品を含む。典型的には、以下に詳述するように、グリコサミノグリカンはヘパリノイドである。好ましくは、以下に詳述するように、ヘパリノイドはヘパリンである。典型的には、以下に詳述するように、局所麻酔薬はリドカインである。典型的には、以下に詳述するように、緩衝液はリン酸緩衝液、特にリン酸ナトリウム緩衝液である。しかしながら、重炭酸緩衝液およびトリス緩衝液を含むがこれらに限定されない他の緩衝液が、代替的には、用いられてもよい。
(1)ヒト細胞および血液と適合性の等張またはほぼ等張の溶液を提供する浸透圧成分、
(2)下部尿路障害を処置、回復、または予防するに十分な量の、膀胱上皮の表面に対する前記組成物の存続を可能にする化合物、
(3)下部尿路障害を処置、回復、または予防するに十分な量の抗菌剤、
(4)下部尿路障害を処置、回復、または予防するに十分な量の抗真菌剤、
(5)下部尿路障害を処置、回復、または予防するに十分な量の血管収縮剤、
(6)保存剤、ならびに
(7)抗炎症剤
が挙げられる。
(1)ヘパリノイドを、固体または水性液体のいずれかとして、単位用量あたり約100単位から約250,000単位、または、代替的には、単位用量あたり約0.5mgから約1250mgの量で提供するステップ、
(2)局所麻酔薬を、固体または水性液体のいずれかとして、単位用量あたり約5mgから約1000mgの量で提供するステップ、
(3)ヘパリノイドと局所麻酔薬とを組み合わせるステップ、ならびに
(4)ステップ(3)のヘパリノイドと局所麻酔薬との組合せを、ヘパリノイドおよび即時作用性麻酔薬の両方と適合性の緩衝液および水酸化ナトリウムと水酸化カリウムとからなる群から選択される塩基の可能な添加により、約6.8より高く約8.3までのpH値に緩衝して、安定な溶液を形成するステップ
を含む。
(1)ヘパリノイドを、固体または水性液体のいずれかとして、単位用量あたり約100単位から約250,000単位、または、代替的には、単位用量あたり約0.5mgから約1250mgの量で提供するステップ、
(2)ヘパリノイドを、ヘパリノイドおよび後で添加される局所麻酔薬の両方と適合性の緩衝液により、約6.8より高く約8.3までのpH値に緩衝するステップ、
(3)局所麻酔薬を、固体または水性液体のいずれかとして、単位用量あたり約5mgから約1000mgの量で、ステップ(2)の緩衝されたヘパリノイドに添加して、ヘパリノイド、局所麻酔薬、および緩衝液を含む溶液を形成するステップ、ならびに
(4)必要な場合、ステップ(3)の溶液を約6.8より高く約8.3までのpH値に再緩衝して、安定な溶液を形成するステップ
を含む。
(1)ヘパリノイドおよび即時作用性麻酔薬を混合する工程であって、ヘパリノイドおよび即時作用性麻酔薬が最終生成物におけるよりもわずかに濃縮されている液体形態を生成する工程、
(2)緩衝液を添加する工程であって、(1)の溶液において約7.0から7.3のpHを得る工程、ならびに
(3)水酸化ナトリウムを用いて、および必要に応じて水を添加して、pHを約7.1から約8.3の範囲の値に上昇させる工程であって、ヘパリノイドおよび即時作用性麻酔薬の所望の最終濃度を達成する工程
によって調製される。
の有機アルミニウム化合物であり得る。
(1)16.67g/Lのヘパリンナトリウム、
(2)13.33g/Lのリドカイン塩酸塩、
(3)0.028Mの濃度を得るための、10.03g/LのNa2HPO4・12H2O、および
(4)必要に応じて、pHを調製するための、0.02N NaOH。
(比較例)
実施例1は、ストッパーとオーバーシールとを備えたガラスバイアルで保存した場合の、200mgのリドカイン、50,000USP単位のヘパリン、およびリン酸緩衝液を含有する溶液の安定性を示す。
(実施例2)
環状オレフィンポリマー注射器およびポリプロピレン注射器、ならびにガラスにおける、ヘパリン、リドカイン、およびリン酸緩衝液を含む組成物の安定性
(1)1.6gのヘパリンナトリウム、
(2)1.42gのリドカイン塩酸塩、
(3)1.003gのNa2HPO4・12H2O、
(4)1.0mLの2N NaOH、および
(5)100mLの総容量にするための精製水
を含む組成物を使用した。この組成物は、
(1)16g/Lのヘパリンナトリウム、
(2)14.2g/Lのリドカイン塩酸塩、
(3)0.028Mの濃度を得るための、10.03g/LのNa2HPO4・12H2O、および
(4)必要に応じて、pHを調製するための、0.02N NaOH
を含む。
Claims (64)
- (i)ガラス、または(ii)環状高密度ポリエチレン、高密度無核ポリプロピレン、環状オレフィンポリマー、および環状オレフィンコポリマーからなる群から選択されるプラスチックから構築されている注射器またはバイアルに包装された、グリコサミノグリカン、局所麻酔薬、および緩衝液を含む組成物を含む製品。
- 前記グリコサミノグリカンがヘパリノイドである、請求項1に記載の製品。
- 前記ヘパリノイドが、ヘパリン、コンドロイチン硫酸、ヘパラン硫酸、ヒアルロン酸、ケラタン硫酸、デルマタン硫酸、ヒアルロナン、ペントサンポリ硫酸ナトリウム、ダルテパリン、およびエノキサパリンからなる群から選択される、請求項2に記載の製品。
- 前記ヘパリノイドがヘパリンである、請求項3に記載の製品。
- 前記ヘパリンがヘパリンナトリウムである、請求項4に記載の製品。
- 前記ヘパリンが約2,000ダルトンから約8,000ダルトンの分子量を有するヘパリンである、請求項4に記載の製品。
- 前記ヘパリンが約8,000ダルトンから約40,000ダルトンの分子量を有するヘパリンである、請求項4に記載の製品。
- 前記ヘパリンが、ヘパリン1ミリグラムあたり少なくとも130USP単位を含有する、請求項4に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり約1000単位のヘパリンから約250,000単位のヘパリンを含む、請求項4に記載の製品。
- 前記製品に含まれる前記組成物の前記ヘパリンの濃度が、前記組成物1ミリリットルあたり約1,000単位のヘパリンから、1ミリリットルあたり約6,000単位のヘパリンである、請求項4に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり1,000単位、5,000単位、10,000単位、15,000単位、20,000単位、25,000単位、30,000単位、35,000単位、40,000単位、45,000単位、50,000単位、55,000単位、60,000単位、65,000単位、70,000単位、75,000単位、80,000単位、85,000単位、90,000単位、95,000単位、100,000単位、110,000単位、120,000単位、130,000単位、140,000単位、150,000単位、160,000単位、170,000単位、180,000単位、190,000単位、200,000単位、210,000単位、220,000単位、230,000単位、240,000単位、および250,000単位からなる群から選択される量のヘパリンを含む、請求項9に記載の製品。
- 前記製品に含まれる前記組成物の前記ヘパリンの濃度が、前記組成物1ミリリットルあたり1,000単位、1,500単位、2,000単位、2,500単位、3,000単位、3,500単位、4,000単位、4,500単位、5,000単位、5,500単位、および6,000単位からなる群から選択される、請求項10に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、約40,000単位のヘパリンを含む、請求項9に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、約50,000単位のヘパリンを含む、請求項9に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、約60,000単位のヘパリンを含む、請求項9に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり約0.5mgから約1250mgの量のヘパリンを含む、請求項4に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり1mg、5mg、25mg、50mg、75mg、100mg、125mg、150mg、175mg、200mg、225mg、250mg、275mg、300mg、325mg、350mg、375mg、400mg、425mg、450mg、475mg、500mg、550mg、600mg、650mg、700mg、750mg、800mg、850mg、900mg、950mg、1000mg、1050mg、1100mg、1150mg、1200mg、および1250mgからなる群から選択される量のヘパリンを含む、請求項16に記載の製品。
- 前記ヘパリノイドがペントサンポリ硫酸ナトリウムであり、前記組成物が前記組成物の単位用量あたり約1mgから約600mgのペントサンポリ硫酸ナトリウムを含む、請求項3に記載の製品。
- 前記ヘパリノイドがヘパラン硫酸であり、前記組成物が前記組成物の単位用量あたり約0.5mgから約10,000mgのヘパラン硫酸を含む、請求項3に記載の製品。
- 前記ヘパリノイドがヒアルロン酸であり、前記組成物が前記組成物の単位用量あたり約5mgから約600mgのヒアルロン酸を含む、請求項3に記載の製品。
- 前記ヘパリノイドがコンドロイチン硫酸であり、前記組成物が前記組成物の単位用量あたり約1mgから約10,000mgのコンドロイチン硫酸を含む、請求項3に記載の製品。
- 前記局所麻酔薬が、ベンゾカイン、リドカイン、テトラカイン、ブピバカイン、コカイン、エチドカイン、メピバカイン、プラモキシン、プリロカイン、プロカイン、クロロプロカイン、オキシプロカイン、プロパラカイン、ロピバカイン、ジクロニン、ジブカイン、プロポキシカイン、デキシバカイン、ジアモカイン、ヘキシルカイン、レボブピバカイン、ピロカイン、リソカイン、ロドカイン、ならびに薬学的に許容されるそれらの誘導体および生物学的等価体、ならびにそれらの組合せからなる群から選択される、請求項1に記載の製品。
- 前記局所麻酔薬が、リドカイン、ブピバカイン、メピバカイン、ベンゾカイン、テトラカイン、エチドカイン、プリロカイン、およびジブカイン、ならびにそれらの組合せからなる群から選択される、請求項22に記載の製品。
- 前記局所麻酔薬がリドカインである、請求項23に記載の製品。
- 前記リドカインがリドカイン塩酸塩である、請求項24に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり約10mgから約400mgの量のリドカインを含む、請求項24に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が、前記組成物の単位用量あたり10mg、20mg、30mg、40mg、50mg、60mg、70mg、80mg、90mg、100mg、110mg、120mg、130mg、140mg、150mg、160mg、170mg、180mg、190mg、200mg、220mg、240mg、260mg、280mg、300mg、320mg、340mg、360mg、380mg、および400mgからなる群から選択される量のリドカインを含む、請求項26に記載の製品。
- 前記製品に含まれる前記組成物の前記リドカインの濃度が約5mg/mLから約20mg/mLである、請求項24に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が10mLの1%リドカインを含む、請求項24に記載の製品。
- 前記製品に含まれる前記組成物の単位用量が16mLの2%リドカインを含む、請求項24に記載の製品。
- 前記緩衝液が、リン酸緩衝液、重炭酸緩衝液、トリス(トリス(ヒドロキシメチル)アミノメタン)緩衝液、MOPS緩衝液(3−(N−モルホリノ)プロパンスルホン酸)、HEPES(N−(2−ヒドロキシエチル)ピペラジン−N−(2−エタンスルホン酸)緩衝液、ACES(2−[(2−アミノ−2−オキソエチル)アミノ]エタンスルホン酸)緩衝液、ADA(N−(2−アセトアミド)2−イミノ二酢酸)緩衝液、AMPSO(3−[(1,1−ジメチル−2−ヒドロキシエチル)アミノ]−2−プロパンスルホン酸)緩衝液、BES(N,N−ビス(2−ヒドロキシエチル)−2−アミノエタンスルホン酸緩衝液、ビシン(N,N−ビス(2−ヒドロキシエチルグリシン)緩衝液、ビス−トリス(ビス−(2−ヒドロキシエチル)イミノ−トリス(ヒドロキシメチル)メタン緩衝液、CAPS(3−(シクロヘキシルアミノ)−1−プロパンスルホン酸)緩衝液、CAPSO(3−(シクロヘキシルアミノ)−2−ヒドロキシ−1−プロパンスルホン酸)緩衝液、CHES(2−(N−シクロヘキシルアミノ)エタンスルホン酸)緩衝液、DIPSO(3−[N,N−ビス(2−ヒドロキシエチル)アミノ]−2−ヒドロキシ−プロパンスルホン酸)緩衝液、HEPPS(N−(2−ヒドロキシエチルピペラジン)−N’−(3−プロパンスルホン酸)緩衝液、HEPPSO(N−(2−ヒドロキシエチル)ピペラジン−N’−(2−ヒドロキシプロパンスルホン酸)緩衝液、MES(2−(N−モルホリノ)エタンスルホン酸)緩衝液、トリエタノールアミン緩衝液、イミダゾール緩衝液、グリシン緩衝液、エタノールアミン緩衝液、MOPSO(3−(N−モルホリノ)−2−ヒドロキシプロパンスルホン酸)緩衝液、PIPES(ピペラジン−N,N’−ビス(2−エタンスルホン酸)緩衝液、POPSO(ピペラジン−N,N’−ビス(2−ヒドロキシプロパンスルホン酸(hydroxypropaneulfonic acid))緩衝液、TAPS(N−トリス[ヒドロキシメチル)メチル−3−アミノプロパンスルホン酸)緩衝液;TAPSO(3−[N−トリス(ヒドロキシメチル)メチルアミノ]−2−ヒドロキシ−プロパンスルホン酸)緩衝液、TES(N−トリス(ヒドロキシメチル)メチル−2−アミノエタンスルホン酸)緩衝液、トリシン(N−トリス(ヒドロキシメチル)メチルグリシン緩衝液)、2−アミノ−2−メチル−1,3−プロパンジオール緩衝液、および2−アミノ−2−メチル−1−プロパノール緩衝液、ならびにそれらの組合せからなる群から選択される、請求項1に記載の製品。
- 前記緩衝液が、リン酸緩衝液、重炭酸緩衝液、トリス緩衝液、およびそれらの組合せからなる群から選択される、請求項31に記載の製品。
- 前記緩衝液がリン酸緩衝液である、請求項32に記載の製品。
- 前記リン酸緩衝液がリン酸ナトリウム緩衝液である、請求項33に記載の製品。
- 前記緩衝液が重炭酸緩衝液である、請求項32に記載の製品。
- 前記重炭酸緩衝液が重炭酸ナトリウムである、請求項35に記載の製品。
- 前記緩衝液がトリス緩衝液である、請求項32に記載の製品。
- 前記製品に含まれる前記組成物が、
(a)ヒト細胞および血液と適合性の等張またはほぼ等張の溶液を提供する浸透圧成分、
(b)下部尿路障害を処置、回復、または予防するに十分な量の、膀胱上皮の表面に対する前記組成物の存続を可能にする化合物、
(c)下部尿路障害を処置、回復、または予防するに十分な量の抗菌剤、
(d)下部尿路障害を処置、回復、または予防するに十分な量の抗真菌剤、
(e)下部尿路障害を処置、回復、または予防するに十分な量の血管収縮剤、
(f)保存剤、ならびに
(g)抗炎症剤
からなる群から選択される追加の成分を含む、請求項1に記載の製品。 - 前記追加の成分が、塩化ナトリウム、デキストロース、スクロース、ラクトース、デキストラン40、デキストラン60、デンプン、およびマンニトールからなる群から選択される浸透圧成分である、請求項38に記載の製品。
- 前記追加の成分が、スルホンアミド、ペニシリン、トリメトプリムとスルファメトキサゾールとの組合せ、キノロン、メテナミン、ニトロフラントイン、セファロスポリン、カルバペネム、アミノグリコシド、テトラサイクリン、マクロライド、およびゲンタマイシンからなる群から選択される抗菌剤である、請求項38に記載の製品。
- 前記追加の成分が、アムホテリシンB、イトラコナゾール、ケトコナゾール、フルコナゾール、ミコナゾール、およびフルシトシンからなる群から選択される抗真菌剤である、請求項38に記載の製品。
- 前記追加の成分が血管収縮剤であり、前記血管収縮剤がエピネフリンである、請求項38に記載の製品。
- 前記追加の成分が、膀胱上皮の表面に対する前記組成物の存続を可能にする化合物であり、膀胱上皮の表面に対する前記組成物の存続を可能にする前記化合物が、プルロニックF127ゲル、ルトロールゲル、N−イソプロピルアクリルアミド、エチルメタクリレート、N−アクリルオキシスクシンイミド、1〜2%のキシログルカンゾル、プルロニックとポリ(アクリル酸)とのグラフトコポリマー、プルロニック−キトサンヒドロゲル、および[ポリ(エチレングリコール)−ポリ[乳酸−co−グリコール酸]−ポリ(エチレングリコール)](PEG−PLGA−PEG)コポリマーからなる群から選択される熱可逆性ゲル化剤である、請求項38に記載の製品。
- 前記追加の成分が、パラベン、クロロブタノール、フェノール、ソルビン酸、およびチメロサールからなる群から選択される保存剤である、請求項38に記載の製品。
- 前記追加の成分が抗炎症剤である、請求項38に記載の製品。
- 前記抗炎症剤が、ヒドロコルチゾン、コルチゾン、ベクロメタゾンジプロピオネート、ベタメタゾン、デキサメタゾン、プレドニゾン、メチルプレドニゾロン、トリアムシノロン、フルオシノロンアセトニド、およびフルドロコルチゾンからなる群から選択されるステロイドである、請求項45に記載の製品。
- 前記抗炎症剤が、アセチルサリチル酸(アスピリン)、サリチル酸ナトリウム、トリサリチル酸コリンマグネシウム、サルサレート、ジフルニサル、スルファサラジン、オルサラジン、アセトアミノフェン、インドメタシン、スリンダク、トルメチン、ジクロフェナク、ケトロラク、イブプロフェン、ナプロキセン、フルルビプロフェン、ケトプロフェン、フェノプロフェン(fenoprofin)、オキサプロジン、メフェナム酸、メクロフェナム酸、ピロキシカム、メロキシカム、ナブメトン、ロフェコキシブ、セレコキシブ、エトドラク、ニメスリド、アセクロフェナク、アルクロフェナク、アルミノプロフェン、アンフェナク、アンピロキシカム、アパゾン、アラプロフェン、アザプロパゾン、ベンダザック、ベノキサプロフェン、ベンジダミン、ベルモプロフェン、ベンズピペリロン、ブロムフェナク、ブクロキシ酸、ブマジゾン、ブチブフェン、カルプロフェン、シミコキシブ、シンメタシン、シンノキシカム、クリダナク、クロフェゾン、クロニキシン、クロピラク、ダルブフェロン、デラコキシブ、ドロキシカム、エルテナク、エンフェナム酸、エピリゾール、エスフルルビプロフェン、エテンザミド、エトフェナメート、エトリコキシブ、フェルビナク、フェンブフェン、フェンクロフェナク、フェンクロズ酸、フェンクロジン、フェンドサール、フェンチアザク、フェプラゾン、フィレナドール、フロブフェン、フロリフェニン、フロスリド、フルビチンメタンスルホネート、フルフェナム酸、フルフェニサール、フルニキシン、フルノキサプロフェン、フルプロフェン、フルプロクアゾン、フロフェナク、イブフェナク、イムレコキシブ、インドプロフェン、イソフェゾラク、イソキセパク、イソキシカム、リコフェロン、ロブプロフェン、ロモキシカム、ロナゾラク、ロキソプロフェン(loxaprofen)、ルマリコキシブ、マブプロフェン、ミロプロフェン、モフェブタゾン、モフェゾラク、モラゾン、ネパファナク、ニフルム酸、ニトロフェナク、ニトロフルルビプロフェン、ニトロナプロキセン、オルパノキシン、オキサセプロール、オキシンダナク、オキシピナク、オキシフェンブタゾン、パミコグレル、パルセタサール、パレコキシブ、パルサルミド、ペルビプロフェン、ペメドラク、フェニルブタゾン、ピラゾラク、ピルプロフェン、プラノプロフェン、サリシン、サリチルアミド、サリチルサリチル酸、サチグレル、スドキシカム、スプロフェン、タルメタシン、タルニフルメート、タゾフェロン、テブフェロン、テニダップ、テノキシカム、テポキサリン、チアプロフェン酸、チアラミド、チルマコキシブ、チノリジン、チオピナク、チオキサプロフェン、トルフェナム酸、トリフルサール、トロペシン、ウルソール酸、バルデコキシブ、キシモプロフェン、ザルトプロフェン、ジドメタシン、およびゾメピラクからなる群から選択される非ステロイド性抗炎症剤である、請求項45に記載の製品。
- 前記製品に含まれる前記組成物のpHが約6.8から約8.3である、請求項1に記載の製品。
- 前記製品に含まれる前記組成物のpHが約7.2から約7.6である、請求項48に記載の製品。
- 前記製品に含まれる前記組成物のpHが約7.5である、請求項49に記載の製品。
- 前記製品に含まれる前記組成物が、女性における細菌性膀胱炎、真菌/酵母性膀胱炎、膣前庭炎、外陰部痛、***疼痛症、尿道症候群、および子宮内膜症;男性における前立腺炎および慢性骨盤痛症候群;ならびに男性または女性における放射線誘発性膀胱炎、化学療法誘発性膀胱炎、間質性膀胱炎(膀胱痛症候群または過敏性膀胱症候群)、および過活動膀胱からなる群から選択される下部尿路障害を処置するために製剤化されている、請求項1に記載の製品。
- 前記製品に含まれる前記組成物が、間質性膀胱炎(膀胱痛症候群または過敏性膀胱症候群)を処置するために製剤化されている、請求項51に記載の製品。
- 前記注射器またはバイアルがガラスから構築されている、請求項1に記載の製品。
- 前記注射器またはバイアルが環状オレフィンポリマープラスチックから構築されている、請求項1に記載の製品。
- 前記注射器またはバイアルが環状オレフィンコポリマープラスチックから構築されている、請求項1に記載の製品。
- 前記注射器またはバイアルが高密度ポリエチレンから構築されている、請求項1に記載の製品。
- 前記注射器またはバイアルが高密度無核ポリプロピレンから構築されている、請求項1に記載の製品。
- 前記注射器またはバイアルが注射器である、請求項1に記載の製品。
- 前記注射器が20mLの容量を有する、請求項58に記載の製品。
- 前記注射器の筒の内側が、前記注射器への前記局所麻酔薬の付着を低減するためにコーティングされている、請求項58に記載の製品。
- 前記コーティングが、プラズマ蒸着法によって付着したシロキサンコーティングである、請求項60に記載の製品。
- 最終滅菌が施された、請求項1に記載の製品。
- 前記最終滅菌が加熱による滅菌である、請求項62に記載の製品。
- 加熱による前記滅菌がオートクレーブによって実施される、請求項63に記載の製品。
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WO2018191412A1 (en) | 2018-10-18 |
CA3061891A1 (en) | 2018-10-18 |
US20230137384A1 (en) | 2023-05-04 |
IL269962A (en) | 2019-12-31 |
AU2018251806B2 (en) | 2023-05-25 |
CN111787915A (zh) | 2020-10-16 |
EP3609483A1 (en) | 2020-02-19 |
AU2018251806A1 (en) | 2019-12-05 |
US20210283172A1 (en) | 2021-09-16 |
US11491179B2 (en) | 2022-11-08 |
WO2018191412A9 (en) | 2019-05-31 |
IL269962B1 (en) | 2024-03-01 |
MX2019012272A (es) | 2020-07-28 |
EP3609483A4 (en) | 2021-01-20 |
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