JP5608167B2 - 加工デンプンを含む医薬ペレット、およびそれの治療への応用 - Google Patents
加工デンプンを含む医薬ペレット、およびそれの治療への応用 Download PDFInfo
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- JP5608167B2 JP5608167B2 JP2011533328A JP2011533328A JP5608167B2 JP 5608167 B2 JP5608167 B2 JP 5608167B2 JP 2011533328 A JP2011533328 A JP 2011533328A JP 2011533328 A JP2011533328 A JP 2011533328A JP 5608167 B2 JP5608167 B2 JP 5608167B2
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- starch
- pellets
- vaginal
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- 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]
-
- 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
-
- 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
- A61P31/10—Antimycotics
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Urology & Nephrology (AREA)
- Endocrinology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
本出願は、2008年10月23日に出願された米国仮特許出願第61/107784号の利益を主張するものであり、その内容は参照により本明細書に組み込まれる。
a)1つもしくは複数の脱分枝デンプンと、場合により他の賦形剤および/または1つもしくは複数の活性薬剤とを混合して、乾燥粉末形態の均一な混合物を得て、これに適当な量の液体を加えて、可塑性の変形可能な湿塊を得るステップ、
b)ステップa)で得られた混合物を、穿孔メッシュを通して押出して、所望の長さおよび直径の円柱状の押出物を得るステップ、
c)該押出物を球状化して、球状のペレットの形態の製品を得るステップ、
d)該ペレットを乾燥するステップ、
e)場合により、該ペレットの表面上に少なくとも1つの活性薬剤を堆積させるステップ、および
f)場合により、該ペレットをコーティングするステップ。
それぞれ、メトロニダゾール50%、硝酸ミコナゾール25%、および酢酸メドロキシプロゲステロン20%を含有し、表1に記載の組成を有する試料A、B、およびCを調製した。これらの組成物は、必要に応じて加えられる量の水も含有していた。
この実施例では、微結晶性セルロースの非崩壊性ペレット(MCC)およびデンプンベースの崩壊性ペレットを、in−vivo挙動(膣内での分布および保持)について分析した。ペレットは、粉末製剤とも比較した。
微結晶性セルロースのペレット(MCC)(Cellets(登録商標)500μm、Pharmatrans−Sanaq、Basel、スイス)を非崩壊性ペレットとして使用した。
デンプンベースのペレットを押出/球状化により作製した。Turbula(登録商標)混合機(型式T2A、W.A.Bachofen、Basel、スイス)中で15分間、乾式混合を実施した。脱イオン水を用い、K字型の混合アームを備えた遊星形ミキサー(Kenwood Chef、Hampshire、UK)を使用して、粉末混合物を10分間造粒した。湿式混練段階の最初の30秒間、水を加えた。確実に水が均一に分布するように、混合ボウルに付着している材料を定期的に除去した。0.4mmの孔を有するドーム型の押出スクリーンを備えた一軸スクリュー押出機(Dome extruder lab 型式DG−L1、Fuji Paudal、東京、日本)を用い、押出速度50rpmで湿塊を押出した。斜めの網目状の表面形状をつけた摩擦板を有する球状化装置(Caleva Model 15、Caleva、Sturminster Newton、Dorset、UK)で、押出物を球状化した。球状化時間は3分、球状化速度は1000rpmであった。ペレットをオーブン(Memmert、Schwabach、ドイツ)中で40℃にて一晩乾燥させた。ふるい振盪機(Retsch、Haan、ドイツ)を用いて315〜800μmの画分を分離した。
10%ラクトース(α−Pharma、Braine−l’Alleud、ベルギー)/20%スキムミルク(Difco、Becton Dickinson、MA、USA)を脱イオン水中に分散させ、ペトリ皿に注ぎ、Amsco Finn Aqua GT4凍結乾燥機を用いて凍結乾燥させた。分散液を175分以内に1000mbarで−45℃に凍結させた。一次乾燥を0.8〜1mbarの間の圧力で−15℃にて13時間実施し、続いて、上昇させた温度(10℃)および減圧(0.1〜0.2mbar)下で7時間、二次乾燥を実施した。
Claims (9)
- アミラーゼ耐性の結晶性脱分枝デンプンと治療薬とを含む平均直径が300〜1000μmのペレットを含む膣内使用組成物。
- 膣坐薬、錠剤またはカプセル剤の形態である、請求項1に記載の組成物。
- 前記ペレットが、押出/球状化により調製される、請求項1に記載の組成物。
- 前記治療薬が、薬理活性物質である、請求項1に記載の組成物。
- 前記ペレットの調製中、前記治療薬が前記脱分枝デンプンと混ぜ合わせられる、請求項3に記載の組成物。
- 前記治療薬が前記ペレットの表面上に堆積している、請求項1に記載の組成物。
- 前記脱分枝デンプンが、高アミロースデンプンを用いて調製されたものである、請求項1に記載の組成物。
- 前記脱分枝デンプンが、プルラナーゼを用いて調製されたものである、請求項1に記載の組成物。
- 前記ペレットが経膣投与される、請求項1に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10778408P | 2008-10-23 | 2008-10-23 | |
US61/107,784 | 2008-10-23 | ||
PCT/US2009/061662 WO2010048389A2 (en) | 2008-10-23 | 2009-10-22 | Pharmaceutical pellets comprising modified starch and therapeutic applications therefor |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2012506861A JP2012506861A (ja) | 2012-03-22 |
JP2012506861A5 JP2012506861A5 (ja) | 2012-12-06 |
JP5608167B2 true JP5608167B2 (ja) | 2014-10-15 |
Family
ID=42118112
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011533328A Active JP5608167B2 (ja) | 2008-10-23 | 2009-10-22 | 加工デンプンを含む医薬ペレット、およびそれの治療への応用 |
Country Status (9)
Country | Link |
---|---|
US (2) | US20100105784A1 (ja) |
EP (1) | EP2344121B1 (ja) |
JP (1) | JP5608167B2 (ja) |
KR (1) | KR20110073618A (ja) |
CN (1) | CN102202648B (ja) |
BR (1) | BRPI0919869A2 (ja) |
RU (1) | RU2519715C2 (ja) |
TW (1) | TWI500429B (ja) |
WO (1) | WO2010048389A2 (ja) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SI2334378T1 (sl) | 2008-08-19 | 2014-07-31 | Xenoport, Inc. | Predzdravila metil hidrogen fumarata, njihovi farmacevtski sestavki in postopki uporabe |
JP6154803B2 (ja) * | 2011-05-02 | 2017-06-28 | アデア ファーマスーティカルズ,インコーポレイテッド | 膣投与のための迅速溶解性錠剤組成物 |
WO2014031892A1 (en) * | 2012-08-22 | 2014-02-27 | Xenoport, Inc. | Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof |
WO2014031844A1 (en) | 2012-08-22 | 2014-02-27 | Xenoport, Inc. | Methods of administering monomethyl fumarate and prodrugs thereof having reduced side effects |
WO2014160633A1 (en) | 2013-03-24 | 2014-10-02 | Xenoport, Inc. | Pharmaceutical compositions of dimethyl fumarate |
US9302977B2 (en) | 2013-06-07 | 2016-04-05 | Xenoport, Inc. | Method of making monomethyl fumarate |
US9421182B2 (en) | 2013-06-21 | 2016-08-23 | Xenoport, Inc. | Cocrystals of dimethyl fumarate |
JP2016534133A (ja) | 2013-09-06 | 2016-11-04 | ゼノポート,インコーポレイティド | (n,n−ジエチルカルバモイル)メチル メチル(2e)ブト−2−エン−1,4−ジオエートの結晶形態、その合成方法及び使用 |
US9999672B2 (en) | 2014-03-24 | 2018-06-19 | Xenoport, Inc. | Pharmaceutical compositions of fumaric acid esters |
WO2019213473A1 (en) * | 2018-05-04 | 2019-11-07 | The Procter & Gamble Company | Compositions and methods for treating vaginal dryness |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
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GB8723846D0 (en) * | 1987-10-10 | 1987-11-11 | Danbiosyst Ltd | Bioadhesive microsphere drug delivery system |
CH678697A5 (ja) * | 1989-04-03 | 1991-10-31 | Warner Lambert Co | |
US5468286A (en) * | 1989-10-25 | 1995-11-21 | National Starch And Chemical Investment Holding Corporation | Enzymatically debranched starches as tablet excipients |
US5281276A (en) * | 1992-03-25 | 1994-01-25 | National Starch And Chemical Investment Holding Corporation | Process for making amylase resistant starch from high amylose starch |
US5260068A (en) * | 1992-05-04 | 1993-11-09 | Anda Sr Pharmaceuticals Inc. | Multiparticulate pulsatile drug delivery system |
NL9201195A (nl) * | 1992-07-03 | 1994-02-01 | Tno | Preparaat voor de gereguleerde afgifte van een werkzame stof en werkwijze ter bereiding van een dergelijk preparaat. |
CA2211778A1 (en) * | 1997-08-14 | 1999-02-14 | Francois Carriere | Preparation of pregelatinized high amylose starch and debranched starch useful as an excipient for controlled release of active agents |
CA2368094C (en) * | 1998-04-22 | 2007-10-09 | Glasgow Caledonian University | Orally administrable compositions comprising cation cross-linked polysaccharide and a polymer digestible in the lower gastrointestinal tract |
US7262170B2 (en) * | 1998-04-26 | 2007-08-28 | Zhongming Zeng | Pharmaceutical composition for reducing vaginal acidity and treatment of vaginitis, and the use thereof |
US7238677B2 (en) * | 2003-03-28 | 2007-07-03 | Kimberly-Clark Worldwide, Inc. | Prevention of urogenital infections |
US7276486B2 (en) * | 2004-03-15 | 2007-10-02 | Kimberly-Clark Worldwide, Inc. | Compositions for vaginal treatment |
US20050214364A1 (en) * | 2004-03-23 | 2005-09-29 | Hutman Herbert W | Products and methods for treating vaginal infections |
US8318230B2 (en) * | 2005-05-02 | 2012-11-27 | Henkel Ag & Co. Kgaa | Use of debranched starch in extrusion-spheronization pharmaceutical pellets |
BRPI0602614A (pt) * | 2005-05-02 | 2006-12-26 | Nat Starch Chem Invest | utilização de amido desramificado na extrusão - esferonização de pelotas farmacêuticas |
EP1872775A1 (en) * | 2006-06-29 | 2008-01-02 | Polichem S.A. | Use of a hydrophilic matrix comprising a polyacrylic acid derivative, a cellulose ether and a disintegrant for the manufacture of a medicament for treating female genital disorders |
-
2009
- 2009-10-22 JP JP2011533328A patent/JP5608167B2/ja active Active
- 2009-10-22 RU RU2011120438/15A patent/RU2519715C2/ru not_active IP Right Cessation
- 2009-10-22 WO PCT/US2009/061662 patent/WO2010048389A2/en active Application Filing
- 2009-10-22 EP EP09744012.7A patent/EP2344121B1/en active Active
- 2009-10-22 CN CN200980142499.7A patent/CN102202648B/zh not_active Expired - Fee Related
- 2009-10-22 US US12/603,917 patent/US20100105784A1/en not_active Abandoned
- 2009-10-22 KR KR1020117011716A patent/KR20110073618A/ko not_active Application Discontinuation
- 2009-10-22 BR BRPI0919869A patent/BRPI0919869A2/pt not_active IP Right Cessation
- 2009-10-23 TW TW098136057A patent/TWI500429B/zh not_active IP Right Cessation
-
2012
- 2012-04-24 US US13/454,592 patent/US20120207823A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
TW201021850A (en) | 2010-06-16 |
WO2010048389A3 (en) | 2010-10-07 |
EP2344121B1 (en) | 2017-07-12 |
EP2344121A2 (en) | 2011-07-20 |
WO2010048389A2 (en) | 2010-04-29 |
KR20110073618A (ko) | 2011-06-29 |
CN102202648A (zh) | 2011-09-28 |
JP2012506861A (ja) | 2012-03-22 |
CN102202648B (zh) | 2014-07-23 |
US20120207823A1 (en) | 2012-08-16 |
BRPI0919869A2 (pt) | 2015-12-15 |
RU2519715C2 (ru) | 2014-06-20 |
TWI500429B (zh) | 2015-09-21 |
RU2011120438A (ru) | 2012-11-27 |
US20100105784A1 (en) | 2010-04-29 |
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