JP2002504069A - 複合エストロゲンの医薬組成物およびその使用方法 - Google Patents
複合エストロゲンの医薬組成物およびその使用方法Info
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- JP2002504069A JP2002504069A JP50777097A JP50777097A JP2002504069A JP 2002504069 A JP2002504069 A JP 2002504069A JP 50777097 A JP50777097 A JP 50777097A JP 50777097 A JP50777097 A JP 50777097A JP 2002504069 A JP2002504069 A JP 2002504069A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/566—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol having an oxo group in position 17, e.g. estrone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Reproductive Health (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.女性における閉経期近辺、閉経期および閉経期後の障害のホルモン治療のた めの、経口投与が可能な固体単位剤形をした医薬組成物であって、 遊離水が約2.5重量%より少なく、合計した水が2.5重量%より多い粉 末状の結合型エストロゲン組成物を形成している、1種以上の有機賦形剤にコ ーティングされた結合型エストロゲンを含んでなり、該固体単位剤形が水分バ リアーのコーティングを施されている、上記の医薬組成物。 2.有機賦形剤が1種以上のゲル形成性ヒドロキシアルキルアルキルセルロース と1種のヒドロキシアルキルセルロースとの混合物を含み、該有機賦形剤が固 体単位剤形の重量の約1/3以上を構成する、請求項1に記載の医薬組成物。 3.ゲル形成性有機賦形剤が1種以上のヒドロキシプロピルメチルセルロースと 0〜33%のメチルセルロースまたは他のセルロースエーテルとの混合物であ る、請求項2に記載の医薬組成物。 4.粉末状の結合型エストロゲン組成物が少なくとも約40重量%の非ゲル形成 性有機賦形剤をさらに含む、請求項1に記載の医薬組成物。 5.非ゲル形成性有機賦形剤がラクトース、マンニトールおよびセルロース誘導 体よりなる群から選択される、請求項4に記載の医薬組成物。 6.結合型エストロゲンがエストロンの、エクイリンの、17-α-ジヒドロエクイ リンの、17-β-ジヒドロエクイリンのおよび17-α-エストラジオールの硫酸エ ステルナトリウムよりなる群から選択される、請求項1に記載の医薬組成物。 7.水分バリアーのコーティングがエチルセルロースを含んでなる、請求項1に 記載の医薬組成物。 8.水分バリアーのコーティングが固体単位剤形の全重量の0.5〜8.0%で ある、請求項7に記載の医薬組成物。 9.重量基準で、約30〜70%のゲル形成性有機賦形剤および約30〜70% の非ゲル形成性有機賦形剤をさらに含んでなる、請求項1に記載の医薬組成物 。 10.1種以上の結合型エストロゲンおよび担体を含有する持続放出性医薬組成物 を調製する方法であって、 (a)密閉系内の流動床中に浮上させた1種以上の有機賦形剤に結合型エスト ロゲンの溶液をスプレーし、 (b)工程(a)で形成された混合物を乾燥させて、この混合物が約2.5重量% より少ない遊離水および約2.5重量%より多い合計水を含むようにし、 (c)工程(b)で形成された混合物を錠剤に成形し、そして (d)該錠剤に、セルロースエーテル類、メタクリル酸およびフタレート類を 含む群から選択されたフィルムコーティングを施す、 ことを含んでなる上記の方法。 11.結合型エストロゲンがエストロンの、エクイリンの、17-α-ジヒドロエクイ リンの、17-β-ジヒドロエクイリンのおよび17-α-エストラジオールの硫酸エ ステルナトリウムよりなる群から選択される、請求項10に記載の方法。 12.有機賦形剤混合物が少なくとも約30重量%の水性ゲル形成性有機賦形剤を 含む、請求項10に記載の方法。 13.ゲル形成性有機賦形剤がヒドロキシプロピルメチルセルロース、カルボキシ メチルセルロースナトリウムおよびヒドロキシプロピルセルロースよりなる群 から選択される、請求項12に記載の方法。 14.有機賦形剤混合物が約30〜70重量%の非ゲル形成性賦形剤を含有する、 請求項10に記載の方法。 15.非ゲル形成性賦形剤がラクトース、マンニトールおよびセルロース誘導体よ りなる群から選択される、請求項14に記載の方法。 16.固体単位剤形が錠剤である、請求項1に記載の医薬組成物。 17.水分バリアーのコーティングを施した後の前記錠剤の上に付着された少なく とも1種の付加的ホルモンをさらに含んでなる、請求項16に記載の医薬組成 物。 18.前記ホルモンがプロゲステロン、メドロキシプロゲステロン、酢酸メドロキ シプロゲステロン、テストステロン、メチルテストステロンおよびこれらの組 合せよりなる群から選択される、請求項17に記載の医薬組成物。 19.前記ホルモンがポリマーフィルムにより前記錠剤に結合されている、請求項 17に記載の医薬組成物。 20.ポリマーフィルムがヒドロキシプロピルメチルセルロースおよびエチルセル ロース水性分散液よりなる群から選択される、請求項19に記載の医薬組成物 。 21.ポリマーフィルムおよび少なくとも1種の付加的ホルモンを含む1つの外側 コーティングとともに2以上のコーティングをさらに含んでなる、請求項17 に記載の医薬組成物。 22.前記ホルモンがプロゲステロン、メドロキシプロゲステロン、酢酸メドロキ シプロゲステロン、テストステロン、メチルテストステロンおよびこれらの組 合せよりなる群から選択される、請求項21に記載の医薬組成物。 23.前記ホルモンが微粉砕される、請求項22に記載の医薬組成物。 24.ポリマーフィルムが約10〜30重量%の固形分を含む、請求項21に記載 の医薬組成物。 25.ポリマーフィルムが界面活性剤をさらに含む、請求項24に記載の医薬組成 物。 26.界面活性剤がポリオキシエチレン(20)ソルビタンモノラウレート、ポリオキ シエチレン(20)ソルビタンモノパルミテート、ポリオキシエチレン(20)ソルビ タンモノステアレート、ポリオキシエチレン(20)ソルビタンモノオレエートお よびポリオキシエチレン(20)ソルビタントリオレエートよりなる群から選択さ れる、請求項25に記載の医薬組成物。 27.ポリマーフィルムが可塑剤をさらに含む、請求項21に記載の医薬組成物。 28.可塑剤がセバシン酸ジブチルおよびクエン酸トリエチルよりなる群から選択 される、請求項27に記載の医薬組成物。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US50769595A | 1995-07-26 | 1995-07-26 | |
US507,695 | 1995-07-26 | ||
US08/690,407 | 1996-07-25 | ||
US08/690,407 US5908638A (en) | 1995-07-26 | 1996-07-25 | Pharmaceutical compositions of conjugated estrogens and methods for their use |
PCT/US1996/012295 WO1997004753A1 (en) | 1995-07-26 | 1996-07-26 | Pharmaceutical compositions of conjugated estrogens and methods for their use |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2002504069A true JP2002504069A (ja) | 2002-02-05 |
JP4017664B2 JP4017664B2 (ja) | 2007-12-05 |
Family
ID=27055947
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP50777097A Expired - Lifetime JP4017664B2 (ja) | 1995-07-26 | 1996-07-26 | 複合エストロゲンの医薬組成物およびその使用方法 |
Country Status (10)
Country | Link |
---|---|
US (1) | US5908638A (ja) |
EP (1) | EP0840599B1 (ja) |
JP (1) | JP4017664B2 (ja) |
CN (1) | CN100421652C (ja) |
AT (1) | ATE401062T1 (ja) |
CA (1) | CA2227887C (ja) |
DE (1) | DE69637601D1 (ja) |
ES (1) | ES2310415T3 (ja) |
TW (1) | TW457092B (ja) |
WO (2) | WO1997004752A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2001199878A (ja) * | 1999-09-13 | 2001-07-24 | Lab Del Dr Esteve Sa | 酸に不安定ベンズイミダゾールを含有する修飾された放出特性の経口用固形製剤 |
JP2004500396A (ja) * | 2000-03-10 | 2004-01-08 | エンデヴァー・ファーマシューティカルズ | 抱合エストロゲンの医薬組成物並びにエストロゲン化合物を含む混合物の分析法 |
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1996
- 1996-07-16 WO PCT/US1996/011797 patent/WO1997004752A1/en active Application Filing
- 1996-07-25 US US08/690,407 patent/US5908638A/en not_active Expired - Lifetime
- 1996-07-26 CA CA002227887A patent/CA2227887C/en not_active Expired - Lifetime
- 1996-07-26 ES ES96926781T patent/ES2310415T3/es not_active Expired - Lifetime
- 1996-07-26 EP EP96926781A patent/EP0840599B1/en not_active Revoked
- 1996-07-26 WO PCT/US1996/012295 patent/WO1997004753A1/en active Application Filing
- 1996-07-26 CN CNB961971169A patent/CN100421652C/zh not_active Expired - Lifetime
- 1996-07-26 DE DE69637601T patent/DE69637601D1/de not_active Revoked
- 1996-07-26 JP JP50777097A patent/JP4017664B2/ja not_active Expired - Lifetime
- 1996-07-26 AT AT96926781T patent/ATE401062T1/de not_active IP Right Cessation
- 1996-12-06 TW TW085115116A patent/TW457092B/zh not_active IP Right Cessation
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2001199878A (ja) * | 1999-09-13 | 2001-07-24 | Lab Del Dr Esteve Sa | 酸に不安定ベンズイミダゾールを含有する修飾された放出特性の経口用固形製剤 |
JP2004500396A (ja) * | 2000-03-10 | 2004-01-08 | エンデヴァー・ファーマシューティカルズ | 抱合エストロゲンの医薬組成物並びにエストロゲン化合物を含む混合物の分析法 |
Also Published As
Publication number | Publication date |
---|---|
EP0840599B1 (en) | 2008-07-16 |
TW457092B (en) | 2001-10-01 |
WO1997004752A1 (en) | 1997-02-13 |
US5908638A (en) | 1999-06-01 |
CA2227887C (en) | 2005-10-25 |
JP4017664B2 (ja) | 2007-12-05 |
CN1197387A (zh) | 1998-10-28 |
EP0840599A4 (en) | 2006-02-08 |
DE69637601D1 (de) | 2008-08-28 |
WO1997004753A1 (en) | 1997-02-13 |
ES2310415T3 (es) | 2009-01-01 |
CN100421652C (zh) | 2008-10-01 |
CA2227887A1 (en) | 1997-02-13 |
ATE401062T1 (de) | 2008-08-15 |
EP0840599A1 (en) | 1998-05-13 |
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