JP5021456B2 - ヘキシレングリコール、所望によりオレイルアルコール、ジメチルイソソルバイドおよび/または中鎖トリグリセリドを含むピメクロリムス泡状組成物 - Google Patents
ヘキシレングリコール、所望によりオレイルアルコール、ジメチルイソソルバイドおよび/または中鎖トリグリセリドを含むピメクロリムス泡状組成物 Download PDFInfo
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- JP5021456B2 JP5021456B2 JP2007506729A JP2007506729A JP5021456B2 JP 5021456 B2 JP5021456 B2 JP 5021456B2 JP 2007506729 A JP2007506729 A JP 2007506729A JP 2007506729 A JP2007506729 A JP 2007506729A JP 5021456 B2 JP5021456 B2 JP 5021456B2
- Authority
- JP
- Japan
- Prior art keywords
- composition
- pimecrolimus
- medium chain
- amount
- hexylene glycol
- 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.)
- Expired - Fee Related
Links
Classifications
-
- 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
-
- 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
- A61K9/122—Foams; Dry foams
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
-
- 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
- A61P17/10—Anti-acne agents
-
- 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
- A61P17/14—Drugs for dermatological disorders for baldness or alopecia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dispersion Chemistry (AREA)
- Dermatology (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Transplantation (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
i)C3−8アルカノールおよび/またはC1−8アルカンジオール;
ii)脂肪アルコール;および
iii)下記から選択されるさらなる溶媒:
a)アルカンカルボン酸アルキルエステルおよび/またはアルカンジカルボン酸アルキルエステルおよび/または
b)親水性補成分および/または
c)トリグリセリド;
さらに所望によりさらなる常用的賦形剤から成る3成分混合物を含む担体賦形剤中にアスコマイシンを含む、実質的にエタノールおよび水を含まない、局所用医薬組成物を記載する。
i)ヘキシレングリコール;
ii)所望によりオレイルアルコール;および
iii)ジメチルイソソルバイドおよび/または中鎖トリグリセリド;
から成る油性溶媒の混合物ならびに:
iv)オレイルアルコールが存在しないとき、25%未満の量の水;
v)少なくとも1種の増粘剤(consistency agent);
vi)少なくとも1種の防腐剤;および
vii)少なくとも1種の界面活性剤/乳化剤(emulgator);および泡形成用高圧ガス;
さらに所望によりさらなる常用的賦形剤を含む担体賦形剤中にピメクロリムスを含む、実質的にエタノールおよび水を含まない泡状医薬組成物に関する;
以後短く“本発明の組成物”と呼ぶ。
i')ヘキシレングリコール;
ii')オレイルアルコール;および
iii')ジメチルイソソルバイドおよび中鎖トリグリセリド;
から成る油性溶媒の3成分混合物、さらに:
v')少なくとも1種の増粘剤;
vi')少なくとも1種の防腐剤;および
vii')少なくとも1種の界面活性剤/乳化剤;および泡形成用高圧ガス;
さらに所望によりさらなる常用的賦形剤を含む担体賦形剤中にピメクロリムスを含む、実質的にエタノールおよび水を含まない組成物である。
i')ヘキシレングリコール;
ii')オレイルアルコール;および
iii')ジメチルイソソルバイドおよび中鎖トリグリセリド;
さらに:
v')ヒドロキシプロピルセルロースおよび/またはステアリルアルコール;
vi')エチレングリコールフェニルエーテルとのp−ヒドロキシ安息香酸エステル;および
vii')グリセリルモノステアレートおよび非イオン性糖エステル;および泡形成用高圧ガスから成る。
i”)ヘキシレングリコール;および
iii”)ジメチルイソソルバイドおよび/または中鎖トリグリセリド;
から成る油性溶媒の2成分混合物、
さらに:
iv”)25%未満の量の水;
v”)少なくとも1種の増粘剤;
vi”)少なくとも1種の防腐剤;および
vii”)少なくとも1種の界面活性剤/乳化剤;および泡形成用高圧ガス;
さらに所望によりさらなる慣習的賦形剤を含む担体賦形剤中にピメクロリムスを含む。
i”)ヘキシレングリコール;および
iii”)中鎖トリグリセリドおよび所望によりジメチルイソソルバイド;
さらに:
iv”)25%未満の量の水;
v”)ポリビニルピロリドンおよびステアリルアルコール;
vi”)エチレングリコールフェニルエーテルとのp−ヒドロキシ安息香酸エステル;および
vii”)グリセリルモノステアレートおよびレシチン;および泡形成用高圧ガスから成る。
すなわち{[1E−(1R,3R,4S)]1R,9S,12S,13R、14S,17R,18E、21S,23S,24R,25S,27R}−12−[2−(4−クロロ−3−メトキシシクロヘキシル)−1−メチルビニル]−17−エチル−1,14−ジヒドロキシ−23,25−ジメトキシ−13,19,21,27−テトラメチル−11,28−ジオキサ−4−アザトリシクロ[22.3.1.0(4,9)]オクタコス−18−エン−2,3,10,16−テトラオンである。
付加的水は、存在するとき好ましくは約1%から約20%、とりわけ約5%から約15%の量である。
“組成物の総重量”は、界面活性剤/乳化剤を含むが、高圧ガスは含まない総重量を言及すると理解すべきである。
活性剤成分は、遊離形または、そのような形が存在するならば、薬学的に許容される塩形であり得る。
a)発泡性担体またはその一部を含む貯蔵部、および、活性成分と担体の残りの部分を含む貯蔵部を有する密封容器;および
b)発泡性担体から泡を発生させる手段
を含む、装置を提供する。
本ゲルを滅菌してよく、これは一般に医学的使用に望まれる。滅菌は、組成物の、例えば約100℃から約125℃の温度で、例えば30分より短いオートクレーブにより行い得る。
−容易で急速な適用;
−表面のでこぼこへの適合;
−疾患領域の隔離;
−組織の冷却;
−感染予防のための抗菌作用;
−組織との生体適合性;および/または
−湿性環境の維持。
実施例2に準じるが、溶媒i)として5.0g ヘキシレングリコールのみを使用し、そして溶媒ii)として5.0g ジメチルイソソルバイドをトリグリセリドに加えて包含させる。
Claims (4)
- 担体賦形剤中にピメクロリムスを含み、エタノールを含まない泡状医薬組成物であって、当該担体賦形剤は
(A)組成物の総重量の少なくとも40%の量であって、かつ:
i)ヘキシレングリコール;および
iii)ジメチルイソソルバイドおよび/または中鎖トリグリセリドを必須成分とし、さらに
ii)オレイルアルコールを含んでいるか、または含んでいない
油性溶媒の混合物、および
(B)
iv)ヒドロキシプロピルセルロース、ポリビニルピロリドンおよびステアリルアルコールからなる群から選択される少なくとも1種の増粘剤(consistency agent);
v)エチレングリコールフェニルエーテルとのp−ヒドロキシ安息香酸エステルである防腐剤;
vi)グリセリルモノステアレート、非イオン性糖エステルおよびレシチンからなる群から選択される少なくとも1種の界面活性剤/乳化剤(emulgator);および
vii)ブタン/プロパン80/20である泡形成用高圧ガス
を含む、組成物;ただし、当該担体賦形剤は、(ii)オレイルアルコールが存在しないとき5〜15%の量の水をさらに含む。 - i')ヘキシレングリコール;
ii')オレイルアルコール;または5〜15%の量の水;
iii')ジメチルイソソルバイドおよび中鎖トリグリセリド;
iv')ヒドロキシプロピルセルロースおよびステアリルアルコール;
v')エチレングリコールフェニルエーテルとのp−ヒドロキシ安息香酸エステル;
vi')グリセリルモノステアレートおよび非イオン性糖エステル;および
vii')ブタン/プロパン80/20
から成る担体賦形剤中にピメクロリムスを含む、請求項1記載の組成物。 - i”)ヘキシレングリコール;
ii”)10%の量の水;
iii”)中鎖トリグリセリド;
iv”)ポリビニルピロリドンおよびステアリルアルコール;
v”)エチレングリコールフェニルエーテルとのp−ヒドロキシ安息香酸エステル;
vi”)グリセリルモノステアレートおよびレシチン;および
vii”)ブタン/プロパン80/20
から成る担体賦形剤中にピメクロリムスを含む、請求項1記載の組成物。 - 炎症性および過増殖性皮膚疾患ならびに免疫介在疾患の皮膚症状の処置に使用するための、請求項1から3のいずれかに記載の組成物。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0408070.1 | 2004-04-08 | ||
GB0408076A GB0408076D0 (en) | 2004-04-08 | 2004-04-08 | Pharmaceutical formulations |
GB0408070A GB0408070D0 (en) | 2004-04-08 | 2004-04-08 | Pharmaceutical formulations |
GB0408076.8 | 2004-04-08 | ||
PCT/EP2005/003669 WO2005097068A1 (en) | 2004-04-08 | 2005-04-07 | Pimecrolimus foam composition containing hexylene glycol, optionally oleyl alcohol, dimethylisosorbide and/or medium chain triglycerides |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2007532508A JP2007532508A (ja) | 2007-11-15 |
JP5021456B2 true JP5021456B2 (ja) | 2012-09-05 |
Family
ID=34964902
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007506729A Expired - Fee Related JP5021456B2 (ja) | 2004-04-08 | 2005-04-07 | ヘキシレングリコール、所望によりオレイルアルコール、ジメチルイソソルバイドおよび/または中鎖トリグリセリドを含むピメクロリムス泡状組成物 |
Country Status (16)
Country | Link |
---|---|
US (1) | US9168224B2 (ja) |
EP (1) | EP1734927B8 (ja) |
JP (1) | JP5021456B2 (ja) |
KR (1) | KR101239446B1 (ja) |
AU (1) | AU2005230401B2 (ja) |
BR (1) | BRPI0509708B8 (ja) |
CA (1) | CA2556993C (ja) |
CY (1) | CY1113060T1 (ja) |
DK (1) | DK1734927T3 (ja) |
ES (1) | ES2389443T3 (ja) |
HK (1) | HK1099211A1 (ja) |
PL (1) | PL1734927T3 (ja) |
PT (1) | PT1734927E (ja) |
RU (1) | RU2375044C2 (ja) |
SI (1) | SI1734927T1 (ja) |
WO (1) | WO2005097068A1 (ja) |
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US9849142B2 (en) | 2009-10-02 | 2017-12-26 | Foamix Pharmaceuticals Ltd. | Methods for accelerated return of skin integrity and for the treatment of impetigo |
US9149658B2 (en) | 2010-08-02 | 2015-10-06 | Guided Therapy Systems, Llc | Systems and methods for ultrasound treatment |
WO2015021382A2 (en) | 2013-08-08 | 2015-02-12 | Novan, Inc. | Topical compositions and methods of using the same |
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US2198582A (en) * | 1937-10-01 | 1940-04-23 | Dow Chemical Co | Ether esters of para hydroxy benzoic acid |
US3244589A (en) * | 1962-10-26 | 1966-04-05 | Sunnen | Alkyl phenoxy polyethoxy ether spermicidal aerosol |
AU565146B2 (en) * | 1983-10-24 | 1987-09-03 | Connetics Australia Pty Ltd | Foamable biocide composition |
US5679324A (en) * | 1994-07-08 | 1997-10-21 | The Procter & Gamble Co. | Aerosol foamable fragrance composition |
JPH08133979A (ja) * | 1994-09-16 | 1996-05-28 | Sando Yakuhin Kk | 局所適用薬剤組成物 |
EP0786986B1 (en) * | 1994-10-26 | 2002-03-20 | Novartis AG | Use of an unsaturated fatty alcohol |
JPH10114659A (ja) * | 1996-10-11 | 1998-05-06 | Nippon Fine Chem Co Ltd | 皮膚外用剤 |
JPH11199444A (ja) * | 1998-01-09 | 1999-07-27 | Cosmo Products Kk | 白髪の予防・治療剤 |
GB9826656D0 (en) * | 1998-12-03 | 1999-01-27 | Novartis Ag | Organic compounds |
US6440437B1 (en) * | 2000-01-24 | 2002-08-27 | Kimberly-Clark Worldwide, Inc. | Wet wipes having skin health benefits |
JP2001097848A (ja) * | 1999-09-30 | 2001-04-10 | Kobayashi Pharmaceut Co Ltd | 外用剤組成物 |
GB0003932D0 (en) * | 2000-02-18 | 2000-04-12 | Novartis Ag | Pharmaceutical compositions |
GB0108498D0 (en) | 2001-04-04 | 2001-05-23 | Novartis Ag | Organic Compounds |
GB0218996D0 (en) | 2002-08-14 | 2002-09-25 | Novartis Ag | Organic compounds |
US7820145B2 (en) * | 2003-08-04 | 2010-10-26 | Foamix Ltd. | Oleaginous pharmaceutical and cosmetic foam |
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2005
- 2005-04-07 DK DK05733580.4T patent/DK1734927T3/da active
- 2005-04-07 ES ES05733580T patent/ES2389443T3/es active Active
- 2005-04-07 JP JP2007506729A patent/JP5021456B2/ja not_active Expired - Fee Related
- 2005-04-07 CA CA2556993A patent/CA2556993C/en not_active Expired - Fee Related
- 2005-04-07 EP EP05733580.4A patent/EP1734927B8/en active Active
- 2005-04-07 KR KR1020067020770A patent/KR101239446B1/ko active IP Right Grant
- 2005-04-07 PT PT05733580T patent/PT1734927E/pt unknown
- 2005-04-07 WO PCT/EP2005/003669 patent/WO2005097068A1/en active Application Filing
- 2005-04-07 US US11/547,226 patent/US9168224B2/en active Active
- 2005-04-07 RU RU2006138998/15A patent/RU2375044C2/ru active
- 2005-04-07 SI SI200531566T patent/SI1734927T1/sl unknown
- 2005-04-07 BR BRPI0509708A patent/BRPI0509708B8/pt not_active IP Right Cessation
- 2005-04-07 PL PL05733580T patent/PL1734927T3/pl unknown
- 2005-04-07 AU AU2005230401A patent/AU2005230401B2/en not_active Ceased
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Also Published As
Publication number | Publication date |
---|---|
EP1734927A1 (en) | 2006-12-27 |
AU2005230401A1 (en) | 2005-10-20 |
EP1734927B8 (en) | 2013-10-23 |
JP2007532508A (ja) | 2007-11-15 |
BRPI0509708B8 (pt) | 2021-05-25 |
KR20070024507A (ko) | 2007-03-02 |
CY1113060T1 (el) | 2016-04-13 |
US20080181854A1 (en) | 2008-07-31 |
HK1099211A1 (en) | 2007-08-10 |
PT1734927E (pt) | 2012-09-05 |
ES2389443T3 (es) | 2012-10-26 |
RU2006138998A (ru) | 2008-05-20 |
WO2005097068A1 (en) | 2005-10-20 |
US9168224B2 (en) | 2015-10-27 |
AU2005230401B2 (en) | 2008-11-27 |
RU2375044C2 (ru) | 2009-12-10 |
BRPI0509708B1 (pt) | 2018-12-04 |
DK1734927T3 (da) | 2012-09-24 |
EP1734927B1 (en) | 2012-06-13 |
PL1734927T3 (pl) | 2012-10-31 |
KR101239446B1 (ko) | 2013-03-06 |
SI1734927T1 (sl) | 2012-09-28 |
CA2556993A1 (en) | 2005-10-20 |
BRPI0509708A (pt) | 2007-09-18 |
CA2556993C (en) | 2013-05-21 |
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