JP5952774B2 - フリーズドライされた一定形状の形成物を調製する方法 - Google Patents
フリーズドライされた一定形状の形成物を調製する方法 Download PDFInfo
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- JP5952774B2 JP5952774B2 JP2013097360A JP2013097360A JP5952774B2 JP 5952774 B2 JP5952774 B2 JP 5952774B2 JP 2013097360 A JP2013097360 A JP 2013097360A JP 2013097360 A JP2013097360 A JP 2013097360A JP 5952774 B2 JP5952774 B2 JP 5952774B2
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- solution
- formation
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q5/00—Preparations for care of the hair
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
- A61K8/733—Alginic acid; Salts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/18—Antioxidants, e.g. antiradicals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
- A61P23/02—Local anaesthetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
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- 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
- C08L5/04—Alginic acid; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Polymers & Plastics (AREA)
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- Pain & Pain Management (AREA)
- Immunology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
性の単位成形からなる。この組成物は、ペーストを鋳型の空洞に入れ、続いて凍結乾燥を行うことにより製造される。EP-A-0352190の目的は、表面に何らかの風味をもた
せた、水への溶解が早い経口薬を提供することであり、上記組成物を身体表面へ適用することについての記載はない。同様に、EP-A-399902は、表面に風味をもたせた、水
への溶解が早い経口薬に使用される、フリーズドライによって製造された組成物を開示している。US-A-4758598には、経口用のみに使用され、フリーズドライによって製
造される組成物が開示されている。US-A-4079018には、経口による医薬品投与用
の可溶性添加材料が開示されている。US4695463は、投与が制御されている経口投与システムを開示している。更に、EP-A-0412449にはフリーズドライによる組成
物が開示されているが、一定の形状にはなっていない。上記先行技術文献はいずれも、皮膚への適用の過程で容易に溶解し、且つ活性物質キャリアとして機能する比較的大型で一定形状の形成物が製造され得るという可能性について開示していない。
てもよい。本発明において特に好ましいのはアルギナートであり、ナトリウムアルギナートが特に好ましい。低粘度の骨格形成剤が好ましく、特にカルシウムを含まないナトリウムアルギナート(カルシウム含有量<3wt%、更に好ましくは2wt%、更に好ましくは1.5wt%、のナトリウムアルギナート)が好ましい。つまり、上記ナトリウムアルギナートの粘度は好ましくは2000mPa.s未満であり、更に好ましくは1000mPa.s未満であり、最も好ましくは100mPa.s未満である。(つまり、99mlの蒸留水中に1gの上記骨格形成剤を20℃及びpH値6〜8で溶かした水溶液(1%水溶液w/w)の粘度が、それぞれ2000mPa.s未満、1000mPa.s未満、100mPa.s未満である。)ナトリウムアルギナート等の低粘度の骨格形成剤を使用することは、一方で、作成方法に関する理由によって好ましい。また他方で、そのような低粘度の骨格形成剤を適用すると、形成物が水を加えた場合には高い水溶性を示し、又は高い分解度又は溶解度を示す。よって、皮膚への高い分散度を示す。特に、低粘度のアルギナートを使用すると、本発明に使用される形成物が高い溶解度を示す。
ドロキシ酸、α-ケト酸、β-ケト酸等の刺激性の副作用を有する活性物質、レチノイド(レチノール、レチナール、レチノイド酸)、アントラリン(ジオキシアントラノ-ル)、
アントラノイド、過酸化物(特にベンゾイル過酸化物)、ミノキシジル、リチウム塩、代謝拮抗物質、ビタミンD及びその誘導体;カテコール、フラボノイド、セラミド。脂肪性
物質として、パラフィン油やバセリン油等のミネラル油、シリコーン油、ココナッツ油、スイートアーモンド油、アプリコット油、コーン油、ホホバ油、オリーブ油、アボガド油、胡麻油、椰子油、ユーカリ油、ローズマリー油、ラベンダー油、パイン油、タイム油、はっか油、カルダモン油、オレンジ花油、大豆油、ブラン油、コメ油、菜種油、海狸香油、麦胚芽油及びそれより抽出されたビタミンE、マツヨイグサ油等の植物性油、植物性レ
シチン(大豆レシチン)、植物より抽出されたスフィンゴ脂質/セラミド、獣脂、ラノリン等の動物性油又は脂質、ブチル油、脂肪酸エステル、脂肪アルコールのエステル、皮膚温度に対応した溶解度の蝋(蜜蝋、ブラジルロウヤシ、キャンデリア蝋等の動物蝋、微晶質蝋等のミネラル蝋、ポリエチレン蝋、シリコーン蝋等の合成蝋)。その他、例えば、C
FTA論文「CosmeticIngredient Handbook」(第一版、1998年、the Cosmetic, Toiletry and FragranceAssociation, Inc. (米国ワシントン))に記載の油、多不飽和脂肪
酸、必須脂肪酸(例えばγ-リノレン酸)、酵素、補酵素、酵素抑制剤、水和剤、皮膚鎮
静剤、洗剤又は泡立て剤、無機又は合成艶消し充填剤、研摩剤等の、美的用途に適した全ての油。
クトン)、ホップフラワー(例えばホップビター)、extr.パッシフロラ、リンドウ(例
えばエタノール抽出物)、例えばアロイン含有アロエベラ抽出液等のアンスラキノン含有チンキ剤、花粉抽出物、藻類抽出物、カンゾウの根抽出物、椰子抽出物、キントラノオ(例えば母液)、ヤドリギ(例えば水性エタノールエッセンス)、フィトステロール(例えばβ-シトステロール)、ムレインの花(例えば水性アルコール抽出物)、モウセンゴケ
(例えばリキュール-ワイン抽出物)、サジー実(例えばこれより得られた抽出液、又は
サジー油)、ウスベニタチアロイの根、抽出物、サクラソウの根抽出物、ゼニアオイ、コンフリー、ツタ、ホーステール、オオバコ(例えば圧搾された抽出液)、イラクサ、クサノオウ、パセリからの新鮮な野菜抽出物;ノロラエナ・ロバタ(Norolaena lobata)、タゲテス ルキダ、テオマ・シエムス(Teeoma siems)、モモルディカ カランティア、アロエベラ抽出物からの野菜抽出物。
染料及び顔料、防腐剤、可塑剤、潤滑剤、スリップ添加剤等である。スクアランが特に好ましい補助物質である。
未満であり、好ましくは1000mPa.s未満であり、特に好ましくは100mPa.s未満であり、前記形成物は骨格形成剤としてのプロテインを含まない、ことを特徴とする。
びカプセルの分解時間」を計測する方法で計測した場合、好ましくは4分未満であり、更に好ましくは1分未満である(直径が9mmの形成物の場合、20分未満で識別可能な核はなく、完全に水和する)。
)少なくとも一のバイオポリマーと、任意的に添加された生理的効果のある一以上の活性物質と、同じく任意的に添加された一以上の補助物質を含む溶液又は懸濁液を作成するステップ;(b)前記溶液を鋳型に注入するステップ;(c)前記鋳型中の溶液を凝固させるステップ;(d)前記凝固溶液をフリーズドライ処理して形成物を形成するステップ。
アルギナートを有する基本構成
2g Protanal LF 10/60 (Naアルギナート)
98g 水
2gのNaアルギナート(Protanal LF 10/60)を98gの水に通し、撹拌する(
2g溶液w/w)。この均一な(脱ガスされた)溶液を鋳型に注入し、空気を吹き付けて凝
固させる。その後鋳型から取り出し、周知の方法によりフリーズドライ処理する。およそ110の球体が得られる。
スクワランを有するアルギナート
2g Protanal LF 10/60 (Naアルギナート)
1g スクワラン
97g 水
2gのNaアルギナートを97gの水に通し、撹拌して均一に混合する。続いて1gのスクワランを加えて撹拌する。この均一な(脱ガスされた)溶液を鋳型に注入し、空気を吹き付けて凝固させる。その後鋳型から取り出し、周知の方法によりフリーズドライ処理する。
スクワラン及びグリセリンを有するアルギナート
2.0g Protanal LF 10/60 (Naアルギナート)
0.9g スクワラン
0.6g グリセリン
96.5g 水
2gのNaアルギナートを96.5gの水に溶解させて撹拌する。続いて0.9gのスクワランと0.6gのグリセリンからなる混合物を加えて撹拌する。この均一な(脱ガスされた)溶液を鋳型に注入し、空気を吹き付けて凝固させる。その後鋳型から取り出し、周知の方法によりフリーズドライ処理する。
スクワラン及び尿素を有するアルギナート
2.0g Protanal LF 10/60 (Naアルギナート)
1.0g スクワラン
1.0g 尿素
96.0g 水
2gのNaアルギナートと1.0gの尿素を96.0gの水に溶解させて撹拌する。続いて1gのスクワランを加えて撹拌する。この均一な(脱ガスされた)溶液を鋳型に注入し、空気を吹き付けて凝固させる。その後鋳型から取り出し、周知の方法によりフリーズドライ処理する。
スクワラン及びセラミドを有するアルギナート
2.0g Protanal LF 10/60 (Naアルギナート)
1.5g スクワラン
0.01g セラミド
96.4g 水
2gのNaアルギナートを96.4gの水に溶解させて撹拌する。続いて1.5gのスクワランと0.01gのセラミドからなる混合物を加えて撹拌する。この均一な(脱ガスされた)溶液を鋳型に注入し、空気を吹き付けて凝固させる。その後鋳型から取り出し、周知の方法によりフリーズドライ処理する。
Claims (3)
- 身体表面に適用するフリーズドライされた一定形状の形成物を調製する方法であって、低粘度の溶解性アルギナートからなる一の骨格形成剤と、任意的に添加された一以上の活性物質と、同じく任意的に添加された一以上の補助物質とを含み、直径が少なくとも5mmの球状の幾何形状である凝固溶液または懸濁液をフリーズドライ処理する工程を備え、
前記凝固溶液または懸濁液は、前記活性物質、前記補助物質及び水の他には前記骨格形成剤のみを含み、
前記補助物質は、界面活性剤、分散剤、乳化剤、pH値調整剤、共存溶媒、染料、防腐剤及びスクアランよりなる群から選択される一以上の補助物質であり、
前記骨格形成剤は、カルシウム含有量が3wt%未満のナトリウムアルギナートであり、
前記形成物は、直径が少なくとも5mmの球形の幾何形状を有し、かつ前記形成物を水で湿らせ、または一以上の活性物質及び/又は一以上の補助物質を含む水溶液で湿らせると、溶液又はゲルとなるとき、前記形成物の溶解速度が、Pharm EUに基づく実験機器を用いて「錠剤及びカプセルの分解時間」を計測する方法で計測すると、4分未満である、
ことを特徴とする形成物を調製する方法。 - 請求項1に記載のフリーズドライされた一定形状の形成物を調製する方法において、
前記方法が、
(a)低粘度の溶解性アルギナートからなる一の骨格形成剤と、任意的に添加された一以上の活性物質と、同じく任意的に添加された一以上の補助物質と、を含む溶液又は懸濁液を作製するステップと、
(b)直径が少なくとも5mmの球状の幾何形状に対応した形の空洞を有する鋳型に前記溶液を注入するステップと、
(c)前記鋳型中の溶液を凝固させるステップと、
(d)前記凝固溶液をフリーズドライ処理して、直径が少なくとも5mmの球状の幾何形状を有するフリーズドライされた一定形状の形成物を形成するステップと、
を備える、
ことを特徴とする形成物を調製する方法。 - 請求項2に記載のフリーズドライされた一定形状の形成物を調製する方法において、
前記ステップ(a)における前記骨格形成剤の濃度が、前記溶液の全体量に対して0.1wt%〜20wt%である、
ことを特徴とする形成物を調製する方法。
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DE2003117982 DE10317982A1 (de) | 2003-04-17 | 2003-04-17 | Verwendung von Formkörpern zur äußeren Anwendung |
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EP (1) | EP1551373B1 (ja) |
JP (5) | JP2006504799A (ja) |
AU (1) | AU2003276011A1 (ja) |
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DE102006038629A1 (de) * | 2006-08-17 | 2008-02-21 | Dr. Suwelack Skin & Health Care Ag | Stabilisierte Wirkstoffzusammensetzung |
US9023369B2 (en) | 2009-04-22 | 2015-05-05 | Ralf Malessa | Freeze-dried composition of active substances |
BRPI1001317A8 (pt) | 2009-04-22 | 2016-09-13 | Dr Suwelack Skin & Health Care Ag | Artigo moldado secado por congelamento contendo fosfato de ascorbila de magnésio |
JP2010254691A (ja) * | 2009-04-22 | 2010-11-11 | Dr Suwelack Skin & Health Care Ag | コーティングされた凍結乾燥成型品 |
GB2561818B (en) * | 2017-03-30 | 2020-01-15 | Phyto Sophos Ltd | Plant extract compositions |
MX2023003016A (es) | 2020-09-22 | 2023-04-10 | Swimc Llc | Composiciones de recubrimiento que contienen quitosana. |
CN115670941A (zh) * | 2021-07-23 | 2023-02-03 | 嘉药学校财团法人嘉南药理大学 | 机能性悬浮造型晶球及其制造方法 |
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-
2003
- 2003-09-30 JP JP2005501273A patent/JP2006504799A/ja active Pending
- 2003-09-30 US US10/531,346 patent/US9023333B2/en not_active Expired - Lifetime
- 2003-09-30 EP EP03808702.9A patent/EP1551373B1/de not_active Expired - Lifetime
- 2003-09-30 AU AU2003276011A patent/AU2003276011A1/en not_active Abandoned
- 2003-09-30 WO PCT/EP2003/010853 patent/WO2004035023A1/de active Application Filing
- 2003-09-30 ES ES03808702.9T patent/ES2529568T3/es not_active Expired - Lifetime
- 2003-10-15 TW TW092128575A patent/TWI262796B/zh active
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Publication number | Publication date |
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TW200413023A (en) | 2004-08-01 |
WO2004035023A8 (de) | 2004-06-03 |
US9023333B2 (en) | 2015-05-05 |
ES2529568T3 (es) | 2015-02-23 |
AU2003276011A1 (en) | 2004-05-04 |
JP2010280704A (ja) | 2010-12-16 |
EP1551373A1 (de) | 2005-07-13 |
JP2006504799A (ja) | 2006-02-09 |
WO2004035023A1 (de) | 2004-04-29 |
JP2018002746A (ja) | 2018-01-11 |
EP1551373B1 (de) | 2014-11-12 |
US20050281849A1 (en) | 2005-12-22 |
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TWI262796B (en) | 2006-10-01 |
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