JP2012517987A5 - 吸入用の医薬組成物のｆｐｄ特性を設定する方法 - Google Patents
吸入用の医薬組成物のｆｐｄ特性を設定する方法 Download PDFInfo
- Publication number
- JP2012517987A5 JP2012517987A5 JP2011549610A JP2011549610A JP2012517987A5 JP 2012517987 A5 JP2012517987 A5 JP 2012517987A5 JP 2011549610 A JP2011549610 A JP 2011549610A JP 2011549610 A JP2011549610 A JP 2011549610A JP 2012517987 A5 JP2012517987 A5 JP 2012517987A5
- Authority
- JP
- Japan
- Prior art keywords
- setting
- excipient
- fpd
- inhalation
- pharmaceutical composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 239000004480 active ingredient Substances 0.000 claims 4
- 239000003814 drug Substances 0.000 claims 3
- 229940079593 drugs Drugs 0.000 claims 3
- 239000000969 carrier Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000000546 pharmaceutic aid Substances 0.000 claims 2
- GUBGYTABKSRVRQ-UUNJERMWSA-N Lactose Natural products O([C@@H]1[C@H](O)[C@H](O)[C@H](O)O[C@@H]1CO)[C@H]1[C@@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1 GUBGYTABKSRVRQ-UUNJERMWSA-N 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 239000010419 fine particle Substances 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 230000002685 pulmonary Effects 0.000 claims 1
- 229940021597 salmeterol and fluticasone Drugs 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
Claims (3)
- 吸入用の医薬組成物の微粒子量（ＦＰＤ）特性を設定する方法であって、
前記組成物は、２種の活性成分であるサルメテロール及びフルチカゾン又はそれらの薬学的に許容しうる塩、溶媒化合物若しくはエステルと、２種の薬学的に許容しうる賦形剤であってｄ５０値がそれぞれ１２５−１４５μｍ及び５０−１００μｍである賦形剤と、を含み、
前記活性成分の各々が異なる賦形剤に独立して付着しており、
前記方法は、
ａ）前記２種の活性成分及び前記２種の薬学的に許容しうる賦形剤を提供するステップであって、賦形剤のｄ５０値が１２５−１４５μｍ及び５０−１００μｍであるステップと；
ｂ）１種の活性成分と１種の賦形剤との予備混和物をそれぞれ形成させるステップと；
ｃ）薬物画分を提供するために、２種の予備混和物を混合するステップと；
ｄ）前記薬物画分を患者の肺系に送達することが可能な適切な送達装置に、その薬物画分を導入するステップと；
を含み、
２種の異なる予備混和物に使用される前記賦形剤の重量比を１〜５の間の特定の値に設定することによって、前記ＦＰＤの設定が実施されることを特徴とする、方法。 - 前記賦形剤が担体である、請求項１に記載の方法。
- 前記担体がラクトースである、請求項２に記載の方法。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09153082.4 | 2009-02-18 | ||
| EP09153082A EP2221048A1 (en) | 2009-02-18 | 2009-02-18 | Pharmaceutical composition for inhalation |
| PCT/EP2010/052026 WO2010094731A2 (en) | 2009-02-18 | 2010-02-18 | Pharmaceutical composition for inhalation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2012517987A JP2012517987A (ja) | 2012-08-09 |
| JP2012517987A5 true JP2012517987A5 (ja) | 2013-04-04 |
Family
ID=40810348
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011549610A Pending JP2012517987A (ja) | 2009-02-18 | 2010-02-18 | 吸入用の医薬組成物 |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US8840930B2 (ja) |
| EP (2) | EP2221048A1 (ja) |
| JP (1) | JP2012517987A (ja) |
| KR (1) | KR20110120283A (ja) |
| CN (1) | CN102325523B (ja) |
| AR (1) | AR075516A1 (ja) |
| AU (1) | AU2010215490B2 (ja) |
| BR (1) | BRPI1008598A2 (ja) |
| CA (1) | CA2749231C (ja) |
| CY (1) | CY1119216T1 (ja) |
| DK (1) | DK2398464T3 (ja) |
| EA (1) | EA021123B1 (ja) |
| ES (1) | ES2607210T3 (ja) |
| HK (1) | HK1160034A1 (ja) |
| HR (1) | HRP20170014T1 (ja) |
| HU (1) | HUE030618T2 (ja) |
| IL (1) | IL214036A (ja) |
| LT (1) | LT2398464T (ja) |
| MX (1) | MX341250B (ja) |
| NZ (1) | NZ594026A (ja) |
| PL (1) | PL2398464T3 (ja) |
| PT (1) | PT2398464T (ja) |
| RS (1) | RS55527B1 (ja) |
| RU (1) | RU2493833C2 (ja) |
| SI (1) | SI2398464T1 (ja) |
| SM (1) | SMT201700095B (ja) |
| UA (1) | UA102138C2 (ja) |
| WO (1) | WO2010094731A2 (ja) |
| ZA (1) | ZA201105532B (ja) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8236786B2 (en) | 2008-08-07 | 2012-08-07 | Pulmagen Therapeutics (Inflammation) Limited | Respiratory disease treatment |
| CA2814445A1 (en) | 2010-10-12 | 2012-04-19 | Cipla Limited | Pharmaceutical composition |
| CN102451173B (zh) * | 2010-10-22 | 2015-02-18 | 山东新时代药业有限公司 | 噻托溴铵胶囊型吸入粉雾剂 |
| TR201105367A2 (tr) * | 2011-06-02 | 2012-12-21 | Bi̇lgi̇ç Mahmut | Akış özellikleri geliştirilmiş bir kuru toz formülasyonu. |
| TR201205852A2 (tr) * | 2011-06-02 | 2012-12-21 | Bi̇lgi̇ç Mahmut | Geliştirilmiş yeni kuru toz formülasyonu. |
| WO2014028587A1 (en) * | 2012-08-14 | 2014-02-20 | Newgen Biopharma Corp. | Compositions comprising chitosan-drug conjugates and methods of making and using the same |
| CN103860525B (zh) * | 2012-12-11 | 2016-04-06 | 天津药物研究院 | 一种含有效成分安立生坦的胶囊型吸入粉雾剂及其制备工艺 |
| WO2014177520A1 (en) * | 2013-04-29 | 2014-11-06 | Sanofi Sa | Inhalable pharmaceutical compositions and the inhaler devices containing them |
| AU2014261538A1 (en) * | 2013-04-29 | 2015-12-10 | Sanofi Sa | Inhalable pharmaceutical compositions and the inhaler devices containing them |
| US20160129207A1 (en) * | 2013-06-17 | 2016-05-12 | Arven Ilac Sanayi Ve Ticaret A.S. | Inhalation composition filling method |
| UA118861C2 (uk) | 2013-12-06 | 2019-03-25 | Оріон Корпорейшн | Спосіб отримання сухих порошкових композицій для інгаляцій |
| CN103784449A (zh) * | 2014-02-18 | 2014-05-14 | 青岛市城阳区人民医院 | 一种包含茚达特罗和噻托溴铵的药物组合产品 |
| PT109030B (pt) * | 2015-12-15 | 2019-09-25 | Hovione Farmaciência, S.A. | Preparação de partículas inaláveis de zafirlucaste |
| CN107095875B (zh) * | 2016-02-23 | 2022-03-18 | 天津金耀集团有限公司 | 一种昔奈酸沙美特罗丙酸氟替卡松复方粉吸入剂组合物 |
| CN108066329B (zh) * | 2016-11-11 | 2021-11-16 | 江苏恒瑞医药股份有限公司 | 一种吸入用氟替卡松或其衍生物的微粒的制备方法 |
| CN107823193B (zh) * | 2017-11-16 | 2021-02-05 | 广州迈达康医药科技有限公司 | 一种阿地溴铵吸入型粉雾剂及其制备方法 |
| WO2020031119A1 (en) | 2018-08-07 | 2020-02-13 | Norton (Waterford) Limited | Application of raman spectroscopy for the manufacture of inhalation powders |
| IL300652A (en) | 2020-08-14 | 2023-04-01 | Norton Waterford Ltd | Inhalable formulation of fluticasone propionate and albuterol sulfate |
| WO2022146255A1 (en) * | 2020-12-31 | 2022-07-07 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | A process for the preparation of dry powder compositions for inhalation |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4140689B4 (de) * | 1991-12-10 | 2007-11-22 | Boehringer Ingelheim Kg | Inhalationspulver und Verfahren zu ihrer Herstellung |
| AU756693B2 (en) | 1997-09-29 | 2003-01-23 | Novartis Ag | Stabilized bioactive preparations and methods of use |
| ITMI991582A1 (it) * | 1999-07-16 | 2001-01-16 | Chiesi Farma Spa | Polveri costituite da particelle aventi la superficie perfettamente levigata da utilizzare come veicoli per la preparazione di miscele inala |
| DE19947235A1 (de) * | 1999-09-30 | 2001-04-05 | Asta Medica Ag | Neue Kombination von Loteprednol und beta¶2¶-Adrenorezeptor-Agonisten |
| GB0012260D0 (en) * | 2000-05-19 | 2000-07-12 | Astrazeneca Ab | Novel composition |
| US8337816B2 (en) * | 2001-09-17 | 2012-12-25 | Glaxo Group Limited | Dry powder medicament formulations |
| US20050201948A1 (en) * | 2002-04-12 | 2005-09-15 | Ellison Mark Jason H | Excipient for use in dry powder inhalation preparations |
| GB2395900A (en) * | 2002-12-04 | 2004-06-09 | Elan Drug Delivery Ltd | Therapeutic composition for respiratory delivery |
| US20040152720A1 (en) * | 2002-12-20 | 2004-08-05 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Powdered medicaments containing a tiotropium salt and salmeterol xinafoate |
| SI1718336T1 (sl) * | 2004-02-06 | 2008-10-31 | Meda Pharma Gmbh & Co Kg | Nova kombinacija antiholinergika in beta mimetikov za zdravljenje respiratornih bolezni |
| BRPI0606283A2 (pt) * | 2005-03-16 | 2009-06-09 | Elan Pharma Int Ltd | formulações de antagonista de receptor de leucotrieno/corticosteróide em nanopartìcula |
| GB0714134D0 (en) * | 2007-07-19 | 2007-08-29 | Norton Healthcare Ltd | Dry-powder medicament |
-
2009
- 2009-02-18 EP EP09153082A patent/EP2221048A1/en not_active Withdrawn
-
2010
- 2010-02-18 NZ NZ594026A patent/NZ594026A/xx not_active IP Right Cessation
- 2010-02-18 EA EA201190108A patent/EA021123B1/ru not_active IP Right Cessation
- 2010-02-18 WO PCT/EP2010/052026 patent/WO2010094731A2/en active Application Filing
- 2010-02-18 MX MX2011008659A patent/MX341250B/es active IP Right Grant
- 2010-02-18 LT LTEP10711610.5T patent/LT2398464T/lt unknown
- 2010-02-18 HU HUE10711610A patent/HUE030618T2/en unknown
- 2010-02-18 CA CA2749231A patent/CA2749231C/en not_active Expired - Fee Related
- 2010-02-18 PL PL10711610T patent/PL2398464T3/pl unknown
- 2010-02-18 KR KR1020117018559A patent/KR20110120283A/ko not_active Application Discontinuation
- 2010-02-18 CN CN201080007956.4A patent/CN102325523B/zh not_active Expired - Fee Related
- 2010-02-18 RS RS20161193A patent/RS55527B1/sr unknown
- 2010-02-18 EP EP10711610.5A patent/EP2398464B1/en active Active
- 2010-02-18 BR BRPI1008598A patent/BRPI1008598A2/pt not_active Application Discontinuation
- 2010-02-18 SI SI201031353A patent/SI2398464T1/sl unknown
- 2010-02-18 PT PT107116105T patent/PT2398464T/pt unknown
- 2010-02-18 JP JP2011549610A patent/JP2012517987A/ja active Pending
- 2010-02-18 RU RU2011133322/15A patent/RU2493833C2/ru not_active IP Right Cessation
- 2010-02-18 AU AU2010215490A patent/AU2010215490B2/en not_active Ceased
- 2010-02-18 DK DK10711610.5T patent/DK2398464T3/en active
- 2010-02-18 ES ES10711610.5T patent/ES2607210T3/es active Active
- 2010-02-18 US US13/202,081 patent/US8840930B2/en not_active Expired - Fee Related
- 2010-02-18 UA UAA201110089A patent/UA102138C2/uk unknown
- 2010-02-18 AR ARP100100474A patent/AR075516A1/es unknown
-
2011
- 2011-07-12 IL IL214036A patent/IL214036A/en not_active IP Right Cessation
- 2011-07-27 ZA ZA2011/05532A patent/ZA201105532B/en unknown
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2012
- 2012-01-26 HK HK12100760.4A patent/HK1160034A1/zh not_active IP Right Cessation
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2016
- 2016-12-23 CY CY20161101340T patent/CY1119216T1/el unknown
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2017
- 2017-01-05 HR HRP20170014TT patent/HRP20170014T1/hr unknown
- 2017-02-10 SM SM201700095T patent/SMT201700095B/it unknown
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