JP2008505902A - 局所抗菌処方 - Google Patents
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- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/02—Contraceptive devices; Pessaries; Applicators therefor for use by males
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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Abstract
Description
本発明は、一般に、抗菌活性、さらに特定すると、抗−HIV特性を有する化合物の処方に関する。
ヒト免疫不全ウイルス(HIV)感染および関連した疾患は、全世界における重大な公衆衛生上の問題である。HIV/AIDSの問題への1つのアプローチは、HIVの伝染リスクを減らし、それにより、新たに感染する患者数を減らすことにある。処置法または治療法が利用可能となっても、最初の段階での感染の予防は、防御の最前線として残りそうである。医学的、生理学的および経済的な理由のために、AIDSに罹った患者を治療するよりもむしろ、初期感染を予防する方が好ましい。
本発明は、ヌクレオチド逆転写酵素阻害剤(NRTIs)、好ましくは、[2−(6−アミノ−プリン−9−イル)−1−メチル−エトキシメチル]−ホスホン酸(テノホビル、PMPA)、またはそれらの生理学的な機能誘導体(これは、局所(例えば、膣、直腸など)適用に適当である)およびHIV感染を予防する際のそれらの使用に関する。
さて、本発明の特定の実施態様を詳細に言及するが、それらの例は、添付の図面で説明されている。本発明は、列挙した請求の実施態様に関連して記述されているものの、それらは、本発明をこれらの実施態様に限定するとは解釈されないことが分かる。逆に、本発明は、全ての代替物、改良および均等物を含むと解釈され、これらは、請求の範囲で規定した本発明の範囲内に含まれ得る。
特に明記しない限り、本明細書中で使用する以下の用語および語句は、以下の意味を有すると解釈される:
「生理学的な機能誘導体」との用語は、所定のNRTIと同じまたはほぼ同じ生理学的機能を有する薬学的に活性な化合物を意味する。本明細書中で使用する「生理学的な機能誘導体」との用語には、以下のいずれかが挙げられる:生理学的に受容可能な塩、エーテル、エステル、プロドラッグ、溶媒和物、立体異性体(鏡像異性体、ジアステレオマー、あるいは立体異性的に富んだまたはラセミ混合物を含めて)、およびレシピエントに投与するとこのような化合物あるいはそれらの抗菌活性代謝物または残渣を(直接的または間接的に)提供できる任意の他の化合物。
成分を精製水で湿潤顆粒化することにより、続いて、ステアリン酸マグネシウムを加えて圧縮することにより、この処方を調製する。このハイプロメロースは、粘度等級を変えて利用できる。
活性成分 300
ハイプロメロース 112
ラクトース一水和物 53
前ゼラチン化デンプ 28
ステアリン酸マグネシウム 7
精製水 十分な量
薬剤の放出は、約6〜8時間にわたって行い、そして12時間後に完了する。
成分a、b、cおよびeを湿潤顆粒化することより、次いで、この物質を押出機を使用して押し出すことにより、続いて、押出物を球体化(spheronization)して乾燥することにより、以下の徐放カプセル処方を製造する。次いで、乾燥したペレットを徐放膜(d)または重合体で被覆する。最終生成物を、ツーピース硬質ゼラチンまたはヒドロキシプロピルメチルセルロースカプセルに充填する。
(a)活性成分 300
(b)微結晶セルロース 125
(c)ラクトース一水和物 125
(d)エチルセルロース 13
(e)精製水 十分な量
(f)ゼラチンカプセル
(処方C(経口懸濁液))
活性成分を他の成分と成分と混合し、そして乾燥粉末として充填する。精製水を加え、そして使用前に十分に混合する。
Confectioner’s Sugar 2000mg
シメチコン 300mg
メチルパラベン 30mg
プロピルパラベン 10mg
香料、ピーチ 500mg
精製 5.00mLにするのに十分な量
(処方D(座薬))
Witepsol H15の5分の1を、最大45℃で、蒸気ジャケット付きパンにて融解する。活性成分を200ミクロンの篩にかけ、そして切削ヘッドを取り付けたSilversonを使用して、滑らかな分散液が得られるまで、混合しつつ、溶融した基剤に加える。この混合物を45℃で維持し、その懸濁液に残りのWitepsol H15を加え、そして均一な混合を確保するために、撹拌する。継続して撹拌しつつ、全懸濁液を250ミクロンのステンレス鋼スクリーンに通し、40℃まで冷却する。38℃〜40℃の温度で、この混合物2.02gを、適当な2mLプラスチック鋳型に充填する。これらの座薬を室温まで冷却する。
活性成分 300
Hard Fat、B.P.(Witepsol H15−Dynamit Nobel)
1770
(処方E(膣用座薬))
活性成分 300mg
ヘキサントリオール 100mg
ポリエチレングリコール 1500 十分な量
(処方F(膣用クリーム))
活性成分 300mg
非イオン性自己乳化基剤 4g
水 残量〜100g
(処方G(膣用噴霧発泡体))
活性成分 300mg
ポリエチレングリコール 6000 2g
非イオン性乳化剤 2g
水 85g
フレオン12/144(70:30) 10g
(処方H(膣用ゲル))
テノホビル 1.00
(重量%)
ヒドロキシエチルセルロース、NF(Natrasol(登録商標)・250H) 2.50
プロピルパラベン、NF 0.02
メチルパラベン、NF 0.18
エデト酸二ナトリウム、USP 0.05
グリセリン、USP 20.00
クエン酸、USP 1.00
精製水、USP 75.25
全量 100.00
水酸化ナトリウムおよび塩酸を10重量%溶液として使用して、pHを目標の4.4に調節する。メチルパラベンおよびプロピルパラベンを、加熱したグリセリンに溶解する。ヒドロキシエチルセルロースを加え、そして分散させて、有機相を形成する。エデト酸二ナトリウムおよびクエン酸を精製水に溶解し、テノホビルを加えて分散させ、pHを4.4に調節し、そして溶液を0.22μmフィルターに通して透明にする。水相および有機相を混合し、十分に撹拌し、次いで、チューブまたは塗布器に充填する。
1%BIDを使用したテノホビル膣用ゲルは、禁欲的および性的に活発なHIV(−)およびHIV(+)の女性に十分に許容され、全身吸収が限られており、そして膣ミクロフローラに対する潜在的に有益な効果を有していた。
Claims (12)
- 感染した動物におけるHIV感染の症状または影響を予防する方法であって、該動物に、薬学的に受容可能なビヒクルと組み合わせてNRTIの有効量を含有する局所処方の予防有効量を投与する工程を包含する、方法。
- 前記NRTIが、[2−(6−アミノ−プリン−9−イル)−1−メチル−エトキシメチル]−ホスホン酸ジイソプロポキシカルボニルオキシメチルエステル(テノホビル)またはそれらの生理学的な機能誘導体を含有する、請求項1に記載の方法。
- 前記処方が、約0.2〜約2重量パーセントのテノホビルを含有する、請求項2に記載の方法。
- 前記NRTIが、テノホビルの生理学的な機能誘導体を含有し、該誘導体が、以下の構造を有する、請求項1に記載の方法:
R3は、H、C1〜C6アルキル、C1〜C6置換アルキル、またはCH2OR8であり、ここで、R8は、C1〜C6アルキル、C1〜C6ヒドロキシアルキルまたはC1〜C6ハロアルキルである;
R4およびR5は、別個に、H、NH2、NHRおよびNR2から選択され、ここで、Rは、C1〜C6アルキルである;そして
R6およびR7は、別個に、HおよびC1〜C6アルキルから選択される、
方法。 - NRTIと、局所適用に適当な薬学的に受容可能な媒体とを含有する、医薬処方。
- [2−(6−アミノ−プリン−9−イル)−1−メチル−エトキシメチル]−ホスホン酸ジイソプロポキシカルボニルオキシメチルエステル(テノホビル)またはそれらの生理学的な機能誘導体と、局所適用に適当な薬学的に受容可能な媒体とを含有する、医薬処方。
- 前記NRTIが、テノホビルの生理学的な機能誘導体を含有し、該誘導体が、以下の構造を有する、請求項5に記載の処方:
R3は、H、C1〜C6アルキル、C1〜C6置換アルキル、またはCH2OR8であり、ここで、R8は、C1〜C6アルキル、C1〜C6ヒドロキシアルキルまたはC1〜C6ハロアルキルである;
R4およびR5は、別個に、H、NH2、NHRおよびNR2から選択され、ここで、Rは、C1〜C6アルキルである;そして
R6およびR7は、別個に、HおよびC1〜C6アルキルから選択される、
処方。 - 請求項5〜7に記載のゲル処方。
- 請求項5〜7に記載のクリーム処方。
- 請求項5〜7に記載の発泡体処方。
- 請求項5〜7に記載の座薬処方。
- 請求項5〜7に記載の処方で被覆されたコンドーム。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US58683904P | 2004-07-09 | 2004-07-09 | |
US60/586,839 | 2004-07-09 | ||
PCT/US2005/023492 WO2006017044A2 (en) | 2004-07-09 | 2005-07-01 | Topical antiviral formulations |
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JP2012185587A Division JP2012255021A (ja) | 2004-07-09 | 2012-08-24 | 局所抗菌処方 |
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JP2008505902A true JP2008505902A (ja) | 2008-02-28 |
JP2008505902A5 JP2008505902A5 (ja) | 2008-08-07 |
JP5121451B2 JP5121451B2 (ja) | 2013-01-16 |
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JP2007520399A Expired - Fee Related JP5121451B2 (ja) | 2004-07-09 | 2005-07-01 | 局所抗菌処方 |
JP2012185587A Pending JP2012255021A (ja) | 2004-07-09 | 2012-08-24 | 局所抗菌処方 |
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US (5) | US20080035155A1 (ja) |
EP (4) | EP2138162A3 (ja) |
JP (2) | JP5121451B2 (ja) |
KR (1) | KR101225707B1 (ja) |
CN (1) | CN1984640B (ja) |
AP (1) | AP2666A (ja) |
AR (1) | AR050424A1 (ja) |
AT (1) | ATE447396T1 (ja) |
AU (1) | AU2005272032B2 (ja) |
BR (1) | BRPI0513196A (ja) |
CA (1) | CA2570877C (ja) |
CY (1) | CY1109757T1 (ja) |
DE (1) | DE602005017497D1 (ja) |
DK (1) | DK1773296T3 (ja) |
EA (2) | EA017763B1 (ja) |
ES (1) | ES2336017T3 (ja) |
HK (1) | HK1103026A1 (ja) |
HR (2) | HRP20070040A2 (ja) |
IL (2) | IL180172A (ja) |
IS (1) | IS8584A (ja) |
MX (1) | MX2007000122A (ja) |
NO (1) | NO20070762L (ja) |
NZ (1) | NZ552172A (ja) |
PL (2) | PL1773296T3 (ja) |
PT (1) | PT1773296E (ja) |
RS (1) | RS51213B (ja) |
SI (1) | SI1773296T1 (ja) |
TW (1) | TW200612955A (ja) |
UA (1) | UA93354C2 (ja) |
WO (1) | WO2006017044A2 (ja) |
ZA (1) | ZA200700932B (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011513317A (ja) * | 2008-02-29 | 2011-04-28 | シェーリング コーポレイション | Hiv感染を防止するための予防薬としてのccr5アンタゴニストおよびhivの伝播を抑制する方法 |
JP2013528219A (ja) * | 2010-06-11 | 2013-07-08 | ギリアード サイエンシーズ, インコーポレイテッド | Hsv−2の伝播を防ぐための局所用抗ウイルス処方物 |
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IL152486A0 (en) | 2002-10-25 | 2003-05-29 | Meir Eini | Alcohol-free cosmetic and pharmaceutical foam carrier |
US9265725B2 (en) | 2002-10-25 | 2016-02-23 | Foamix Pharmaceuticals Ltd. | Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof |
US8486376B2 (en) | 2002-10-25 | 2013-07-16 | Foamix Ltd. | Moisturizing foam containing lanolin |
US7704518B2 (en) | 2003-08-04 | 2010-04-27 | Foamix, Ltd. | Foamable vehicle and pharmaceutical compositions thereof |
US7820145B2 (en) * | 2003-08-04 | 2010-10-26 | Foamix Ltd. | Oleaginous pharmaceutical and cosmetic foam |
US8119150B2 (en) | 2002-10-25 | 2012-02-21 | Foamix Ltd. | Non-flammable insecticide composition and uses thereof |
US20060233721A1 (en) * | 2002-10-25 | 2006-10-19 | Foamix Ltd. | Foam containing unique oil globules |
US20080138296A1 (en) | 2002-10-25 | 2008-06-12 | Foamix Ltd. | Foam prepared from nanoemulsions and uses |
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