RU2002100365A - Mesalazine-based pharmaceutical composition for oral administration with controlled release of the active ingredient - Google Patents

Mesalazine-based pharmaceutical composition for oral administration with controlled release of the active ingredient

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Publication number
RU2002100365A
RU2002100365A RU2002100365/14A RU2002100365A RU2002100365A RU 2002100365 A RU2002100365 A RU 2002100365A RU 2002100365/14 A RU2002100365/14 A RU 2002100365/14A RU 2002100365 A RU2002100365 A RU 2002100365A RU 2002100365 A RU2002100365 A RU 2002100365A
Authority
RU
Russia
Prior art keywords
active ingredient
tablets
lipophilic
composition according
matrix
Prior art date
Application number
RU2002100365/14A
Other languages
Russian (ru)
Other versions
RU2245148C2 (en
Inventor
Роберто ВИЛЛА
Массимо ПЕДРАНИ
Мауро АЙАНИ
Лоренцо ФОССАТИ
Original Assignee
Космо С.П.А.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from IT1999MI001316A external-priority patent/ITMI991316A1/en
Application filed by Космо С.П.А. filed Critical Космо С.П.А.
Publication of RU2002100365A publication Critical patent/RU2002100365A/en
Application granted granted Critical
Publication of RU2245148C2 publication Critical patent/RU2245148C2/en

Links

Claims (11)

1. Фармацевтические композиции для перорального введения с регулируемым высвобождением активного ингредиента, содержащие в качестве активного ингредиента 5-аминосалициловую кислоту, включающие:1. Pharmaceutical compositions for oral administration with controlled release of the active ingredient, containing 5-aminosalicylic acid as the active ingredient, including: a) внутреннюю липофильную матрицу, состоящую из веществ с температурой плавления ниже 90°С, в которую включен активный ингредиент в виде глобул, по меньшей мере, частично;a) an internal lipophilic matrix consisting of substances with a melting point below 90 ° C, which includes the active ingredient in the form of globules, at least partially; b) внешнюю гидрофильную матрицу, в которой диспергирована липофильная матрица;b) an external hydrophilic matrix in which the lipophilic matrix is dispersed; c) необязательно другие эксципиенты.c) optionally other excipients. 2. Композиции по п.1, в которых липофильная матрица состоит из веществ, выбранных из ненасыщенных и/или гидрированных жирных кислот, их солей, сложных эфиров или амидов, моно-, ди- или триглицеридов жирных кислот, восков, церамидов, производных холестерина.2. The composition according to claim 1, in which the lipophilic matrix consists of substances selected from unsaturated and / or hydrogenated fatty acids, their salts, esters or amides, mono-, di- or triglycerides of fatty acids, waxes, ceramides, cholesterol derivatives . 3. Композиции по п.1 или 2, где 5-аминосалициловую кислоту включают в виде глобул в расплавленную липофильную матрицу при смешивании, экструзии и/или гранулировании.3. The composition according to claim 1 or 2, where 5-aminosalicylic acid is included in the form of globules in a molten lipophilic matrix by mixing, extrusion and / or granulation. 4. Композиции по любому из предшествующих пунктов, в которых гидрофильная матрица состоит из соединений, образующих гидрогель.4. Compositions according to any one of the preceding paragraphs, in which the hydrophilic matrix consists of compounds forming a hydrogel. 5. Композиции по п.4, в которых гидрофильная матрица состоит из соединений, выбранных из полимеров или сополимеров акриловой или метакриловой кислоты, алкилвинильных полимеров, гидроксиалкилцеллюлоз, карбоксиалкилцеллюлоз, полисахаридов, декстринов, пектинов, крахмалов и производных альгиновой кислоты, природных или синтетических смол.5. The composition according to claim 4, in which the hydrophilic matrix consists of compounds selected from polymers or copolymers of acrylic or methacrylic acid, vinyl vinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives of alginic acid, natural or synthetic resins. 6. Композиции по любому из предшествующих пунктов, включающие устойчивое в желудке внешнее покрытие.6. Compositions according to any one of the preceding paragraphs, including a stable outer coating in the stomach. 7. Композиции по п.6, в которых устойчивое в желудке покрытие состоит из полимеров метакриловой кислоты или производных целлюлозы.7. The composition according to claim 6, in which a stomach-stable coating consists of polymers of methacrylic acid or cellulose derivatives. 8. Композиции по любому из предшествующих пунктов в виде таблеток, капсул, мини-таблеток, где активный ингредиент полностью содержится в липофильной матрице.8. Compositions according to any one of the preceding paragraphs in the form of tablets, capsules, mini-tablets, where the active ingredient is completely contained in the lipophilic matrix. 9. Композиции по любому из пп.1-7 в виде таблеток, капсул, мини-таблеток, где активный ингредиент диспергирован как в гидрофильной, так и липофильной матрицах.9. Compositions according to any one of claims 1 to 7 in the form of tablets, capsules, mini-tablets, where the active ingredient is dispersed in both hydrophilic and lipophilic matrices. 10. Композиции по любому из предшествующих пунктов, в которых процентное содержание активного ингредиента составляет от 80 до 95% от общей массы композиции.10. Compositions according to any one of the preceding paragraphs, in which the percentage of active ingredient is from 80 to 95% by weight of the total composition. 11. Способ получения композиции по пп.1-10, который включает:11. A method of obtaining a composition according to claims 1-10, which includes: a) гранулирование из расплава, по меньшей мере, части активного ингредиента с липофильными эксципиентами, температура плавления которых ниже 90°С;a) melt granulation of at least a portion of the active ingredient with lipophilic excipients, the melting point of which is below 90 ° C; b) смешивание гранул со стадии а) с гидрофильными эксципиентами и последующее формование таблеток или прессование.b) mixing the granules from step a) with hydrophilic excipients and subsequent molding of the tablets or compression.
RU2002100365/15A 1999-06-14 2000-06-08 Mesalazine-base pharmaceutical composition for oral administration with sustained-release active component RU2245148C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT1999MI001316A ITMI991316A1 (en) 1999-06-14 1999-06-14 ORAL PHARMACEUTICAL COMPOSITIONS WITH MODIFIED RELEASE OF MESALAZINE
ITMI99A001316 1999-06-14

Publications (2)

Publication Number Publication Date
RU2002100365A true RU2002100365A (en) 2003-09-20
RU2245148C2 RU2245148C2 (en) 2005-01-27

Family

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Family Applications (1)

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RU2002100365/15A RU2245148C2 (en) 1999-06-14 2000-06-08 Mesalazine-base pharmaceutical composition for oral administration with sustained-release active component

Country Status (18)

Country Link
US (1) US6773720B1 (en)
EP (2) EP1198226B1 (en)
JP (2) JP4727875B2 (en)
CN (2) CN100448448C (en)
AT (2) ATE324104T1 (en)
AU (1) AU5077200A (en)
CA (1) CA2377299C (en)
DE (2) DE60027608T2 (en)
DK (2) DK1198226T3 (en)
ES (2) ES2262749T3 (en)
HK (2) HK1046247B (en)
IT (1) ITMI991316A1 (en)
MX (1) MXPA01012888A (en)
NO (1) NO329402B1 (en)
PT (2) PT1198226E (en)
RU (1) RU2245148C2 (en)
TR (1) TR200200561T2 (en)
WO (1) WO2000076481A1 (en)

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