RU2005130771A - Композиции и способы профилактики и лечения эндотоксин-связанных заболеваний и состояний - Google Patents
Композиции и способы профилактики и лечения эндотоксин-связанных заболеваний и состояний Download PDFInfo
- Publication number
- RU2005130771A RU2005130771A RU2005130771/15A RU2005130771A RU2005130771A RU 2005130771 A RU2005130771 A RU 2005130771A RU 2005130771/15 A RU2005130771/15 A RU 2005130771/15A RU 2005130771 A RU2005130771 A RU 2005130771A RU 2005130771 A RU2005130771 A RU 2005130771A
- Authority
- RU
- Russia
- Prior art keywords
- specified
- antioxidant
- composition according
- solution
- compound
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 16
- 239000000203 mixture Substances 0.000 title claims 14
- 230000002265 prevention Effects 0.000 title claims 2
- 201000010099 disease Diseases 0.000 title 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title 1
- 239000003963 antioxidant agent Substances 0.000 claims 9
- 230000003078 antioxidant effect Effects 0.000 claims 9
- 150000001875 compounds Chemical class 0.000 claims 8
- 239000000243 solution Substances 0.000 claims 7
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims 6
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 6
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims 6
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 6
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims 6
- 150000002016 disaccharides Chemical class 0.000 claims 6
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims 6
- 230000001986 anti-endotoxic effect Effects 0.000 claims 4
- 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 4
- VHJLVAABSRFDPM-UHFFFAOYSA-N 1,4-dithiothreitol Chemical compound SCC(O)C(O)CS VHJLVAABSRFDPM-UHFFFAOYSA-N 0.000 claims 3
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims 3
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 3
- 239000004258 Ethoxyquin Substances 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- BGNXCDMCOKJUMV-UHFFFAOYSA-N Tert-Butylhydroquinone Chemical compound CC(C)(C)C1=CC(O)=CC=C1O BGNXCDMCOKJUMV-UHFFFAOYSA-N 0.000 claims 3
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims 3
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims 3
- 235000019285 ethoxyquin Nutrition 0.000 claims 3
- DECIPOUIJURFOJ-UHFFFAOYSA-N ethoxyquin Chemical compound N1C(C)(C)C=C(C)C2=CC(OCC)=CC=C21 DECIPOUIJURFOJ-UHFFFAOYSA-N 0.000 claims 3
- 229940093500 ethoxyquin Drugs 0.000 claims 3
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 3
- 239000000473 propyl gallate Substances 0.000 claims 3
- 235000010388 propyl gallate Nutrition 0.000 claims 3
- 229940075579 propyl gallate Drugs 0.000 claims 3
- 229940001482 sodium sulfite Drugs 0.000 claims 3
- 235000010265 sodium sulphite Nutrition 0.000 claims 3
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims 3
- 229940001474 sodium thiosulfate Drugs 0.000 claims 3
- 235000019345 sodium thiosulphate Nutrition 0.000 claims 3
- 239000004250 tert-Butylhydroquinone Substances 0.000 claims 3
- 235000019281 tert-butylhydroquinone Nutrition 0.000 claims 3
- 208000037487 Endotoxemia Diseases 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 229910001415 sodium ion Inorganic materials 0.000 claims 2
- 239000003381 stabilizer Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 125000000185 sucrose group Chemical group 0.000 claims 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000000693 micelle Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 238000004659 sterilization and disinfection Methods 0.000 claims 1
Classifications
-
- 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
- A61K31/739—Lipopolysaccharides
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/203—Retinoic acids ; Salts thereof
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
-
- 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
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61P31/02—Local antiseptics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D303/00—Compounds containing three-membered rings having one oxygen atom as the only ring hetero atom
- C07D303/02—Compounds containing oxirane rings
- C07D303/12—Compounds containing oxirane rings with hydrocarbon radicals, substituted by singly or doubly bound oxygen atoms
- C07D303/18—Compounds containing oxirane rings with hydrocarbon radicals, substituted by singly or doubly bound oxygen atoms by etherified hydroxyl radicals
- C07D303/20—Ethers with hydroxy compounds containing no oxirane rings
- C07D303/22—Ethers with hydroxy compounds containing no oxirane rings with monohydroxy compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Toxicology (AREA)
- Oncology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Communicable Diseases (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Saccharide Compounds (AREA)
Claims (22)
2. Композиция по п.1, где указанный антиоксидант выбран из группы, состоящей из бутилированного гидроксианизола, бутилированного гидрокситолуола, пропилгаллата, сульфита натрия, тиосульфата натрия, монотиоглицерина, трет-бутилгидрохинона, этоксихина, дитиотреитола и их производных.
3. Композиция по п.1, где указанным антиоксидантом является бутилированный гидроксианизол.
4. Композиция по п.1, дополнительно включающая дисахаридный стабилизирующий агент.
5. Композиция по п.4, где указанным дисахаридом является лактоза.
6. Композиция по п.4, где указанным дисахаридом является сахароза.
7. Композиция по п.1, где указанная композиция включает ионы натрия в количестве 0,5-10 мМ.
8. Композиция по п.1, где указанная композиция включает ионы натрия в количестве ≤ 2 мМ.
9. Композиция по п.1, где размер мицелл указанного соединения составляет около 7-9 нм.
10. Способ получения фармацевтической композиции, включающей антиэндотоксиновое соединение, причем указанный способ включает смешивание указанного соединения и антиоксиданта.
12. Способ по п.10, где указанный антиоксидант выбран из группы, состоящей из бутилированного гидроксианизола, бутилированного гидрокситолуола, пропилгаллата, сульфита натрия, тиосульфата натрия, монотиоглицерина, трет-бутилгидрохинона, этоксихина, дитиотреитола и их производных.
13. Способ по п.10, где указанным антиоксидантом является бутилированный гидроксианизол.
14. Способ получения фармацевтической композиции, включающей антиэндотоксиновое соединение, причем указанный способ включает стадии
(i) растворения указанного антиэндотоксинового соединения в водном растворе гидроксида натрия;
(ii) добавления дисахаридного стабилизатора к указанному раствору;
(iii) добавления антиоксиданта к указанному раствору;
(iv) понижения рН указанного раствора;
(v) фильтрационной стерилизации указанного раствора; и
(vi) лиофилизации указанного раствора.
15. Способ по п.14, где указанным дисахаридом является лактоза.
16. Способ по п.14, где указанным дисахаридом является сахароза.
17. Способ по п.14, где указанный антиоксидант выбран из группы, состоящей из бутилированного гидроксианизола, бутилированного гидрокситолуола, пропилгаллата, сульфита натрия, тиосульфата натрия, монотиоглицерина, трет-бутилгидрохинона, этоксихина, дитиотреитола и их производных.
18. Способ по п.14, где указанным антиоксидантом является бутилированный гидроксианизол.
19. Способ по п.14, где указанный рН указанного раствора понижают приблизительно до рН 7-8, используя раствор фосфорной кислоты.
20. Способ по п.14, где указанная стадия лиофилизации включает использование температуры хранения 0-20°C.
21. Способ профилактики или лечения эндотоксемии у пациента, причем указанный способ включает введение указанному пациенту композиции по п.1.
22. Применение композиции по п.1 в профилактике или лечении эндотоксемии.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US45202203P | 2003-03-05 | 2003-03-05 | |
| US60/452,022 | 2003-03-05 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2005130771A true RU2005130771A (ru) | 2006-01-27 |
Family
ID=32962682
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2005130771/15A RU2005130771A (ru) | 2003-03-05 | 2004-03-05 | Композиции и способы профилактики и лечения эндотоксин-связанных заболеваний и состояний |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20080095786A9 (ru) |
| EP (1) | EP1601661A2 (ru) |
| JP (1) | JP2006519872A (ru) |
| KR (1) | KR20060002795A (ru) |
| CN (1) | CN1780824A (ru) |
| AU (1) | AU2004218358A1 (ru) |
| BR (1) | BRPI0408077A (ru) |
| CA (1) | CA2516629A1 (ru) |
| MX (1) | MXPA05009428A (ru) |
| NO (1) | NO20054346L (ru) |
| RU (1) | RU2005130771A (ru) |
| WO (1) | WO2004078142A2 (ru) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030130212A1 (en) * | 1999-01-14 | 2003-07-10 | Rossignol Daniel P. | Administration of an anti-endotoxin drug by intravenous infusion |
| KR100841813B1 (ko) | 2000-02-18 | 2008-06-26 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 미셀 |
| AU2002323106A1 (en) * | 2001-08-10 | 2003-02-24 | Eisai Co., Ltd. | Treatment and prevention of heat shock protein-associated diseases and conditions |
| CA2618439A1 (en) * | 2005-08-12 | 2007-02-22 | Astellas Pharma Inc. | Technique for stabilization of yw753 reparation |
| KR101457418B1 (ko) * | 2009-10-23 | 2014-11-04 | 삼성전자주식회사 | 계층적 부호화 단위의 크기에 따른 비디오 부호화 방법과 그 장치, 및 비디오 복호화 방법과 그 장치 |
| CN104321061B (zh) * | 2012-03-28 | 2017-10-24 | 马里兰大学巴尔的摩校区 | 依立托伦或其药学上可接受的盐在制备治疗正粘病毒感染的药物中的用途 |
| MX2021006547A (es) | 2018-12-17 | 2021-08-11 | Eisai R&D Man Co Ltd | Formulacion que comprende liposomas. |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5750664A (en) * | 1995-06-05 | 1998-05-12 | Eisai Co., Ltd. | Substituted liposaccharides useful in the treatment and prevention of endotoxemia |
| US6495532B1 (en) * | 1997-03-19 | 2002-12-17 | Sky High, Llc | Compositions containing lysophosphotidic acids which inhibit apoptosis and uses thereof |
| US6437006B1 (en) * | 1999-09-27 | 2002-08-20 | American Cyanamid Company | Pharmaceutical carrier formulation |
| WO2002089743A2 (en) * | 2001-05-09 | 2002-11-14 | The Regents Of The University Of Michigan | Use of compositions for treating rosacea |
-
2004
- 2004-03-05 CA CA002516629A patent/CA2516629A1/en not_active Abandoned
- 2004-03-05 JP JP2006509152A patent/JP2006519872A/ja not_active Withdrawn
- 2004-03-05 KR KR1020057016441A patent/KR20060002795A/ko not_active Withdrawn
- 2004-03-05 MX MXPA05009428A patent/MXPA05009428A/es not_active Application Discontinuation
- 2004-03-05 AU AU2004218358A patent/AU2004218358A1/en not_active Abandoned
- 2004-03-05 BR BRPI0408077-7A patent/BRPI0408077A/pt not_active IP Right Cessation
- 2004-03-05 US US10/547,599 patent/US20080095786A9/en not_active Abandoned
- 2004-03-05 WO PCT/US2004/006713 patent/WO2004078142A2/en not_active Ceased
- 2004-03-05 EP EP04718037A patent/EP1601661A2/en not_active Withdrawn
- 2004-03-05 RU RU2005130771/15A patent/RU2005130771A/ru not_active Application Discontinuation
- 2004-03-05 CN CNA2004800117700A patent/CN1780824A/zh active Pending
-
2005
- 2005-09-20 NO NO20054346A patent/NO20054346L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| AU2004218358A1 (en) | 2004-09-16 |
| WO2004078142A2 (en) | 2004-09-16 |
| JP2006519872A (ja) | 2006-08-31 |
| CA2516629A1 (en) | 2004-09-16 |
| BRPI0408077A (pt) | 2006-02-14 |
| CN1780824A (zh) | 2006-05-31 |
| NO20054346D0 (no) | 2005-09-20 |
| KR20060002795A (ko) | 2006-01-09 |
| WO2004078142A3 (en) | 2004-12-23 |
| NO20054346L (no) | 2005-11-04 |
| US20080095786A9 (en) | 2008-04-24 |
| US20060222655A1 (en) | 2006-10-05 |
| EP1601661A2 (en) | 2005-12-07 |
| MXPA05009428A (es) | 2005-12-12 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US5589491A (en) | Injection and injection kit containing omeprazole and its analogs | |
| JP2005511642A5 (ru) | ||
| CN101528218A (zh) | 治疗粘膜炎的组合物和方法 | |
| US4942167A (en) | Pharmaceutical compositions of piroxicam in aqueous solutions and process for their preparation | |
| KR101052705B1 (ko) | 아미노글리코시드계 항생물질 및 브롬페낙을 함유하는수용액 제제 | |
| ES2664951T3 (es) | Composiciones que comprenden glicosaminoglicanos de baja viscosidad y uso de dicha composición en terapia de cistitis crónica | |
| EP0145779A4 (en) | PREPARATION AND PROCESS FOR THE TREATMENT OF ACNE. | |
| CA2044143C (en) | Method of preventing or limiting reperfusion damage | |
| EP1494659B1 (en) | Pharmaceutical composition comprising an alpha-ketoalkanoic acid ester or -amide and lactic acid or a lactic acid salt | |
| JP5108517B2 (ja) | 治療活性剤、クエン酸または共役塩基、および二酸化塩素を含む安定化された組成物 | |
| RU2005130771A (ru) | Композиции и способы профилактики и лечения эндотоксин-связанных заболеваний и состояний | |
| WO2003086324A3 (en) | Preparation and use of a stable formulation of allosteric effector compounds | |
| EP0233615B1 (en) | Aqueous preparation and method of preparation thereof | |
| CN101347412B (zh) | 三水合氨磷汀结晶冻干制剂及其制备方法 | |
| JPH115744A (ja) | ヒアルロン酸含有の外用水溶液製剤 | |
| US5244913A (en) | Compositions and methods for dissolving body calculi | |
| JP3954115B2 (ja) | 注射剤および注射剤キット | |
| JPS59139316A (ja) | コクシジユ−ム症用の薬品 | |
| RU2002121772A (ru) | Фармацевтическая композиция для внутримышечных инъекций, содержащая локсопрофен | |
| JPH075456B2 (ja) | 点眼液 | |
| KR20140019040A (ko) | 텔비부딘을 함유하는 경구 제약 용액제 | |
| JP2006514063A5 (ru) | ||
| WO2009095269A1 (de) | Verwendung von tetrahydropyrimidinen | |
| US4918108A (en) | Method of improving the absorption of injected antibacterial substances | |
| KR101435244B1 (ko) | 목시플록사신 수성 제형 및 이의 제조방법 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20080619 |