JP5153049B2 - 膣感染を処置又は予防するための低濃度のペルオキサイド - Google Patents
膣感染を処置又は予防するための低濃度のペルオキサイド Download PDFInfo
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- JP5153049B2 JP5153049B2 JP2003539722A JP2003539722A JP5153049B2 JP 5153049 B2 JP5153049 B2 JP 5153049B2 JP 2003539722 A JP2003539722 A JP 2003539722A JP 2003539722 A JP2003539722 A JP 2003539722A JP 5153049 B2 JP5153049 B2 JP 5153049B2
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Classifications
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- A—HUMAN NECESSITIES
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/0012—Galenical forms characterised by the site of application
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- Communicable Diseases (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
関連出願へのクロスリファレンス
本願は、その内容が明白に本書において参考として援用される2001年10月29日に出願した米国仮出願第60/330,683号の利益を主張する。
本発明は、膣感染を処置又は予防するための薬学的組成物に関する。当該薬学的組成物は、概して、過剰なペルオキサイド濃度にすることなく、長時間に渡り非常に低濃度のペルオキサイドを放出及び維持して酸素放出の利益をもたらすと同時に時間をかけてpHを低下させる生体接着性持続的放出性処方物の相乗作用ミックス(synergistic mix)を含む。本発明は、また、本書において開示される薬学的組成物を用いて膣感染を処置する方法に関する。
膣感染は、女性の間でよくある問題である。細菌性膣炎(Bacterial Vaginosis )(BV)は、感染性膣炎の最もよくある形態であり、症候性の症例の45%を占め、また無症候性の性的に活発な女性の15%において存在すると推定される。Breen, J. ed., The Gynecologist and the Older Patient, pp. 304−305 (1988)を参照のこと。多菌性の膣感染は、膣におけるラクトバチルス属(lactobacilli)の付随的減少を伴う嫌気性生物の数の増加によって引き起こされると信じられている。膣におけるラクトバチルス属細菌数の減少は、二重の影響(即ち、(i)栄養素をめぐる競合の低下、及び(ii)存在する乳酸量の減少)をもたらし、それゆえ、膣における日和見病原体(この増殖は、通常、ラクトバチルス属によって抑制されている)の増殖を可能にする。BVに関係する主要な病原体は、ガルドネレラヴァギナリス属(Gardnerella vaginalis)及びモビランカス属(Mobiluncus)種の嫌気性菌であると考えられている。しかしながら、多数の他の病原性嫌気性菌もまた、膣の病気の病因に関与すると考えられている。Kaufman et al., Benign Diseases of the Vulva and Vagina, 3rd ed., pp. 401−418 (1989)を参照のこと。従って、BVは、広域スペクトルの処置を要求する広域スペクトルの感染であると考えられる。
本発明は、膣感染を処置又は予防するための薬学的組成物に関する。薬学的組成物は、ペルオキサイドソースと生体接着性持続的放出性ポリマー処方物の相乗作用ミックスを含む。本発明の1つの実施形態において、相乗作用ミックスは、通常少なくとも12時間、そしてしばしば48時間より長い時間に渡りペルオキサイドを放出するようデザインされる。本発明の更なる実施形態において、相乗作用ミックスは、1時間当たり0.1重量%より少ない量でペルオキサイドを放出する。本発明の更なる実施形態において、相乗作用ミックスは、0.1重量%より少ないペルオキサイドを含む。これらの実施形態の各々において放出されるペルオキサイドが酸素濃度を治療的に増大させるのに十分な量であるのと同時に、持続的放出性ポリマーがpHを低下させ、それにより、膣を滅菌したり又は正常に望ましい局所的な膣フローラを有意に殺したりすることなく、BVの原因となる嫌気性生物の増殖を有意に抑制する。嫌気性生物に環境を支配させないうちに、BVを予防又は処置するべきである。
本発明は、長期間に渡り予期せぬほど低い濃度のペルオキサイドを使用し、膣を滅菌し又は正常に望ましい局所的な膣フローラを有意に殺し或いは膣の敏感な組織の著しい刺激を引き起こすペルオキサイドを用いることなく、膣感染を処置又は予防することによって有利な効果を与えることに基づく。
以下の実施例は、本発明の好ましい実施形態の例示である。全てのパーセンテージは、別段に示されない限り、調製された処方物の重量パーセントに基づき、全ての合計は100重量%である。これらの実施例において例示の目的に使用されるペルオキサイドソースは、カルバミドペルオキサイド及びベンゾイルペルオキサイドであるが、上記に説明したように、いくつかの異なるペルオキサイドソースを使用することができる。
Claims (18)
- 細菌又は酵母感染を処置するための膣への局所投与用の薬学的組成物であって、該組成物は、ペルオキサイドのソース及び生体接着性持続的放出性処方物を含み、該持続的放出性処方物が生体接着性で水膨潤性で水不溶性の架橋されたポリカルボキシリックポリマーを含む組成物であり、該組成物は患者へ局所投与したときに1時間当たり0.1重量%より少ない量で、膣における酸素濃度を高めるのに十分な量で少なくとも12時間の間ペルオキサイドを放出し且つ膣のpHを治療的に低下させ、膣の滅菌又は正常に望ましい局所的な膣フローラの有意な殺傷を起こさないように処方される、組成物。
- 前記ポリマーがポリカルボフィルである、請求項1に記載の組成物。
- ペルオキサイドソースが約0.01mg〜約500mgの量で存在する、請求項2に記載の組成物。
- ペルオキサイドソースが約0.1mg〜約75mgの量で存在する、請求項2に記載の組成物。
- 前記組成物が、1用量当たり約1g〜約2.5gの量で投与されるように処方され且つ該組成物中のペルオキサイド量が約0.01mg〜約100mgである、単一投薬形態における、請求項4に記載の組成物。
- ペルオキサイド量が約0.1〜約75mgである、請求項5に記載の組成物。
- ペルオキサイドソースがカルバミドペルオキサイドである、請求項1に記載の組成物。
- カルバミドペルオキサイドが、約0.01重量%〜約15重量%の量で存在する、請求項7に記載の組成物。
- 少なくとも24時間の間ペルオキサイドを放出する、請求項1に記載の組成物。
- 少なくとも48時間の間ペルオキサイドを放出する、請求項2に記載の組成物。
- 細菌又は酵母感染を処置するための膣への局所投与用の薬学的組成物であって、該組成物は、ペルオキサイドのソース及び生体接着性持続的放出性処方物を含み、該持続的放出性処方物が生体接着性で水膨潤性で水不溶性の架橋されたポリカルボキシリックポリマーを含む組成物であり、該組成物は0.1重量%より少ないペルオキサイドを含み且つ患者へ局所投与したときに膣における酸素濃度を治療的に増大し且つ膣のpHを治療的に低下させ、膣の滅菌又は正常に望ましい局所的な膣フローラの有意な殺傷を起こさないように処方される、組成物。
- 前記ポリマーがポリカルボフィルである、請求項11に記載の組成物。
- ペルオキサイドソースがカルバミドペルオキサイドである、請求項12に記載の組成物。
- ペルオキサイドが、約0.034重量%〜約0.085重量%の量である、請求項13に記載の組成物。
- 前記組成物が、単一投薬当たり約1g〜約2.5gの量で投与されるように処方される、投薬形態における、請求項11に記載の組成物。
- 処方物におけるペルオキサイド量が、0.01mg〜100mgである、請求項11に記載の組成物。
- ペルオキサイドのソース及び生体接着性持続的放出性処方物が相乗作用有効量で存在する、請求項1又は11に記載の組成物。
- 請求項1〜17のいずれか1項に記載の組成物を含む、膣感染の処置又は予防のための薬
剤(agent)。
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