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RU2005115855A - COMPOSITION OF TRAMADOL PROLONGED BY RELEASE WITH 24 HOUR ACTION - Google Patents

COMPOSITION OF TRAMADOL PROLONGED BY RELEASE WITH 24 HOUR ACTION Download PDF

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Publication number
RU2005115855A
RU2005115855A RU2005115855/15A RU2005115855A RU2005115855A RU 2005115855 A RU2005115855 A RU 2005115855A RU 2005115855/15 A RU2005115855/15 A RU 2005115855/15A RU 2005115855 A RU2005115855 A RU 2005115855A RU 2005115855 A RU2005115855 A RU 2005115855A
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Russia
Prior art keywords
hours
administration
plasma concentration
pharmaceutical composition
oral pharmaceutical
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RU2005115855/15A
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Russian (ru)
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RU2328275C2 (en
Inventor
Венсан ЛЕНАР (CA)
Венсан Ленар
Патриси Лаура ОУАДЖИ-НДЖИКИ (CA)
Патрисия Лаура Оуаджи-Нджики
Джонатан БЭЙКОН (CA)
Джонатан БЭЙКОН
Рашид УЗЕРУРУ (CA)
Рашид Узеруру
Сон ЖЕРВЭ (CA)
Соня Жервэ
Милу РАХМУНИ (CA)
Милу Рахмуни
Дэймон СМИТ (CA)
Дэймон Смит
Original Assignee
Лабофарм Инк. (CA)
Лабофарм Инк.
Лабофарм Юроп Лимитед (Ie)
Лабофарм Юроп Лимитед
Лабофарм (Барбадос) Лимитед (Bb)
Лабофарм (Барбадос) Лимитед
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Application filed by Лабофарм Инк. (CA), Лабофарм Инк., Лабофарм Юроп Лимитед (Ie), Лабофарм Юроп Лимитед, Лабофарм (Барбадос) Лимитед (Bb), Лабофарм (Барбадос) Лимитед filed Critical Лабофарм Инк. (CA)
Publication of RU2005115855A publication Critical patent/RU2005115855A/en
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Publication of RU2328275C2 publication Critical patent/RU2328275C2/en

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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
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Однократная суточная пероральная фармацевтическая композиция контролируемого высвобождения трамадола или его соли, которая при первоначальном введении одной дозы обеспечивает начало обезболивающего эффекта не позднее чем через 2 ч и обезболивающий эффект которой продолжается по меньшей мере 24 ч после введения.1. A single daily oral pharmaceutical composition for the controlled release of tramadol or its salt, which, upon initial administration of a single dose, provides the onset of the analgesic effect no later than 2 hours and the analgesic effect of which continues at least 24 hours after administration. 2. Однократная суточная пероральная фармацевтическая композиция по п.1, которая при первоначальном введении одной дозы обеспечивает среднюю концентрацию в плазме, составляющую по меньшей мере 50 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме по меньшей мере 50 нг/мл в течение по меньшей мере 22 ч после введения.2. The single daily oral pharmaceutical composition according to claim 1, which, upon initial administration of a single dose, provides an average plasma concentration of at least 50 ng / ml no later than 2 hours after administration and continues to provide an average plasma concentration of at least 50 ng / ml for at least 22 hours after administration. 3. Однократная суточная пероральная фармацевтическая композиция по п.1, которая содержит примерно 200 мг трамадола или его соли.3. A single daily oral pharmaceutical composition according to claim 1, which contains about 200 mg of tramadol or its salt. 4. Однократная суточная пероральная фармацевтическая композиция по п.2, которая при первоначальном введении одной дозы обеспечивает среднюю концентрацию в плазме по меньшей мере 100 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме по меньшей мере 100 нг/мл в течение по меньшей мере 22 ч после введения.4. The single daily oral pharmaceutical composition according to claim 2, which, upon initial administration of a single dose, provides an average plasma concentration of at least 100 ng / ml no later than 2 hours after administration and continues to provide an average plasma concentration of at least 100 ng / ml for at least 22 hours after administration. 5. Однократная суточная пероральная фармацевтическая композиция по п.2, где средняя максимальная концентрация в плазме (Сmax) составляет меньше средней концентрации в плазме, полученной через 24 ч после введения (С24h), взятой 2,2 раза.5. The single daily oral pharmaceutical composition according to claim 2, wherein the average maximum plasma concentration (C max ) is less than the average plasma concentration obtained 24 hours after administration (C 24h ) taken 2.2 times. 6. Однократная суточная пероральная фармацевтическая композиция по п.5, где средняя максимальная концентрация в плазме (Сmax) меньше средней концентрации в плазме, полученной через 24 ч после введения (С24h), взятой 2,3 раза.6. The single daily oral pharmaceutical composition according to claim 5, wherein the average maximum plasma concentration (C max ) is less than the average plasma concentration obtained 24 hours after administration (C 24h ) taken 2.3 times. 7. Однократная суточная пероральная фармацевтическая композиция по пп. 1, 2, 3, 4, 5 или 6, где среднее время [поддержания] средней максимальной концентрации в плазме (tmax) составляет от 2 до 10 ч.7. A single daily oral pharmaceutical composition according to claims. 1, 2, 3, 4, 5 or 6, where the average time [maintenance] of the average maximum plasma concentration (t max ) is from 2 to 10 hours 8. Однократная суточная пероральная фармацевтическая композиция по п.1, содержащая по меньшей мере 100 мг трамадола или его соли, которая при первоначальном введении одной дозы обеспечивает среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 11 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 12 нг/мл в течение по меньшей мере 24 ч после введения.8. The single daily oral pharmaceutical composition according to claim 1, containing at least 100 mg of tramadol or its salt, which, upon initial administration of a single dose, provides an average plasma concentration of O-desmethyltramadol of at least 11 ng / ml no later than 2 hours after administration and continues to provide an average plasma concentration of O-desmethyltramadol of at least 12 ng / ml for at least 24 hours after administration. 9. Однократная суточная пероральная фармацевтическая композиция п.8, содержащая 200 мг трамадола или его соли, которая при первоначальном введении одной дозы обеспечивает среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 24 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 25 нг/мл в течение по меньшей мере 24 ч после введения.9. The single daily oral pharmaceutical composition of claim 8, containing 200 mg of tramadol or a salt thereof, which upon initial administration of a single dose provides an average plasma concentration of O-desmethyltramadol of at least 24 ng / ml no later than 2 hours after administration and continues provide an average plasma concentration of O-desmethyltramadol of at least 25 ng / ml for at least 24 hours after administration. 10. Однократная суточная пероральная фармацевтическая композиция по п.8, содержащая 300 мг трамадола или его соли, которая при первоначальном введении одной дозы обеспечивает среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 32 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 32 нг/мл в течение по меньшей мере 24 ч после введения.10. The single daily oral pharmaceutical composition of claim 8, containing 300 mg of tramadol or a salt thereof, which upon initial administration of a single dose provides an average plasma concentration of O-desmethyltramadol of at least 32 ng / ml no later than 2 hours after administration and continues to provide an average plasma concentration of O-desmethyltramadol of at least 32 ng / ml for at least 24 hours after administration. 11. Однократная суточная пероральная фармацевтическая композиция по п.8, содержащая 200 мг трамадола или его соли, которая при первоначальном введении 400 мг обеспечивает среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 50 нг/мл не позднее чем через 2 ч после введения и продолжает обеспечивать среднюю концентрацию в плазме О-десметилтрамадола по меньшей мере 50 нг/мл в течение по меньшей мере 24 ч после введения.11. The single daily oral pharmaceutical composition of claim 8, containing 200 mg of tramadol or a salt thereof, which upon initial administration of 400 mg provides an average plasma concentration of O-desmethyltramadol of at least 50 ng / ml no later than 2 hours after administration and continues to provide an average plasma concentration of O-desmethyltramadol of at least 50 ng / ml for at least 24 hours after administration. 12. Однократная суточная пероральная фармацевтическая композиция по любому из пп.1, 2, 3, 4, 5, 6 или 11, где указанная композиция представляет собой таблетку.12. A single daily oral pharmaceutical composition according to any one of claims 1, 2, 3, 4, 5, 6, or 11, wherein said composition is a tablet. 13. Композиция по пп.1, 2, 3, 4, 5 или 6, где от 10 до 40% средства высвобождается из композиции от 0 и примерно до 2 часов измерения, примерно от 30 до 60% средства высвобождается из композиции от 2 и примерно до 7 ч измерения, примерно от 50 до 80% средства высвобождается из композиции от 7 и примерно до 12 ч измерения, и примерно от 80 до 100% средства высвобождается из композиции примерно через 20 ч измерения.13. The composition according to claims 1, 2, 3, 4, 5 or 6, where from 10 to 40% of the agent is released from the composition from 0 and up to about 2 hours of measurement, about 30 to 60% of the agent is released from the composition of 2 and up to about 7 hours of measurement, about 50 to 80% of the agent is released from the composition from about 7 and about 12 hours of measurement, and about 80 to 100% of the agent is released from the composition after about 20 hours of measurement. 14. Однократная суточная пероральная фармацевтическая композиция по п.1, которая имеет скорость растворения in vitro при измерении с помощью устройства HPLC-USP 1 Типа при 100 об./мин в 50 мМ натрий-фосфатном буфере при рН 6,8 примерно от 5 примерно до 30% через 1 ч; примерно от 15 примерно до 40% через 2 ч; примерно от 20 примерно до 50% через 4 ч; примерно от 30 примерно до 70% через 8 ч; примерно от 40 примерно до 90% через 12 ч; примерно от 50 примерно до 100% через 16 ч; примерно от 60 примерно до 100% через 24 ч.14. The single daily oral pharmaceutical composition according to claim 1, which has an in vitro dissolution rate as measured by an HPLC-USP Type 1 device at 100 rpm in 50 mM sodium phosphate buffer at a pH of 6.8 from about 5 about up to 30% after 1 h; from about 15 to about 40% after 2 hours; from about 20 to about 50% after 4 hours; from about 30 to about 70% after 8 hours; from about 40 to about 90% after 12 hours; from about 50 to about 100% after 16 hours; from about 60 to about 100% after 24 hours 15. Однократная суточная пероральная фармацевтическая композиция по п.14, которая содержит 200 мг трамадола или его соли.15. A single daily oral pharmaceutical composition according to claim 14, which contains 200 mg of tramadol or its salt.
RU2005115855/15A 2002-10-25 2003-10-27 Composed tramadole of prolonged release with 24- hour action RU2328275C2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US28102602A 2002-10-25 2002-10-25
US10/281,026 2002-10-25
US51037803P 2003-10-10 2003-10-10
US60/510,378 2003-10-10

Publications (2)

Publication Number Publication Date
RU2005115855A true RU2005115855A (en) 2006-01-20
RU2328275C2 RU2328275C2 (en) 2008-07-10

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RU2005115855/15A RU2328275C2 (en) 2002-10-25 2003-10-27 Composed tramadole of prolonged release with 24- hour action

Country Status (11)

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JP (1) JP2006507277A (en)
KR (1) KR20050083816A (en)
AR (1) AR045972A1 (en)
AU (1) AU2003275855B2 (en)
CA (1) CA2503155A1 (en)
IL (1) IL168114A (en)
NO (1) NO20052479L (en)
PT (1) PT1594460E (en)
RU (1) RU2328275C2 (en)
UA (1) UA84277C2 (en)
WO (1) WO2004037222A2 (en)

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AU2003275855B2 (en) 2009-04-23
UA84277C2 (en) 2008-10-10

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