RU99125113A - MANUFACTURE OF ORGANICALLY USED SOLID MEDICINAL FORMS WITH CONTROLLED ALLOCATION OF AN ACTIVE SUBSTANCE - Google Patents

MANUFACTURE OF ORGANICALLY USED SOLID MEDICINAL FORMS WITH CONTROLLED ALLOCATION OF AN ACTIVE SUBSTANCE

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Publication number
RU99125113A
RU99125113A RU99125113/14A RU99125113A RU99125113A RU 99125113 A RU99125113 A RU 99125113A RU 99125113/14 A RU99125113/14 A RU 99125113/14A RU 99125113 A RU99125113 A RU 99125113A RU 99125113 A RU99125113 A RU 99125113A
Authority
RU
Russia
Prior art keywords
active substance
tablets
content
solid dosage
active substances
Prior art date
Application number
RU99125113/14A
Other languages
Russian (ru)
Other versions
RU2193396C2 (en
Inventor
Михаел ДИТТГЕН
Забине Фрике
Карстен Тимпе
Хаген Гереке
Анетте ЭЙХАРД
Original Assignee
Йенафарм Гмбх Энд Ко., Кг.
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 DE19718012A external-priority patent/DE19718012C1/en
Application filed by Йенафарм Гмбх Энд Ко., Кг. filed Critical Йенафарм Гмбх Энд Ко., Кг.
Publication of RU99125113A publication Critical patent/RU99125113A/en
Application granted granted Critical
Publication of RU2193396C2 publication Critical patent/RU2193396C2/en

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Claims (3)

1. Процесс изготовления перорально применяемых твердых лекарственных форм с управляемым выделением активного вещества, характеризующийся тем, что а) по меньшей мере три из четырех упомянутых в разделе (б) и содержащих активное вещество или комбинацию из активных веществ составов таблеток (комприматов), варьируемых по их содержанию или количеству, комбинируются, причем они изготавливаются по известным технологиям посредством смешивания активных веществ с фармацевтически совместимыми вспомогательными веществами и/или веществами-носителями, а также посредством гранулирования, таблетирования и/или покрытия внешним слоем, б) благодаря чему создается фармацевтически необходимый выделяющий профиль активного вещества или комбинаций активных веществ, как, например, замедленное, равномерно распределенное, приспособленное к специальному ритму (пульсирующее) выделение, причем содержание таблеток (компримат) типа "А" из четырех типов выделяет не менее 75% своего состава активных веществ в течение 45 мин, следующее содержание таблеток (компримат) типа "В" выделяет 100% своего состава активных веществ не позднее чем через 3 ч по своему выделяющему профилю приблизительно порядка "0", оно получается в виде гидрофильных, липофильных матричных таблеток или в виде лакового покрытия с управляемой диффузией третье содержание таблеток (компримат) типа "С" с показателем концентрации водородных ионов (рН) на уровне 6-7,5 выделяет не менее 75% своего состава активных веществ в течение 45 мин, оно получается аналогично содержанию таблеток типа "А" с покрытием, не поддающемуся воздействию желудочного сока, четвертое содержание таблеток типа "D" с показателем концентрации водородных ионов (рН) на уровне 6-7,5 выделяет 100% своего состава активных веществ не позднее чем через 3 ч по своему выделяющему профилю приблизительно порядка "0", оно получается в виде матричных таблеток, не поддающихся воздействию желудочного сока, или в виде комбинаций не поддающихся воздействию желудочного сока лаковых покрытий с управляемой диффузией.1. The manufacturing process of orally used solid dosage forms with controlled release of the active substance, characterized in that a) at least three of the four mentioned in section (b) and containing the active substance or a combination of active substances, the compositions of the tablets (krimmatov), varying by their content or quantity are combined, and they are manufactured according to known technologies by mixing the active substances with pharmaceutically compatible excipients and / or carrier substances by means of granulation, pelletizing and / or coating with an external layer, b) due to which a pharmaceutically necessary excretory profile of the active substance or combinations of active substances is created, such as, for example, slow, uniformly distributed, adapted to a special rhythm (pulsating) excretion, the content of tablets (compress) type "A" of the four types releases at least 75% of its composition of active substances within 45 minutes, the following content of tablets (compress) type "B" emits 100% of its composition active substances no later than 3 hours in its release profile of approximately the order of "0", it is obtained in the form of hydrophilic, lipophilic matrix tablets or in the form of a varnish coating with controlled diffusion, the third content of tablets (compress) type "C" with an indicator of the concentration of hydrogen ions (pH) at a level of 6-7.5 releases at least 75% of its active substance composition within 45 minutes, it is obtained similarly to the content of type A tablets with a coating not amenable to the effects of gastric juice, the fourth tablet contains t PA "D" with an indicator of hydrogen ion concentration (pH) of 6-7.5 releases 100% of its active substance composition no later than 3 hours by its releasing profile of approximately the order of "0", it is obtained in the form of matrix tablets, not susceptible to gastric juice, or in the form of combinations of non-susceptible gastric juice varnishes with controlled diffusion. 2. Процесс изготовления перорально применяемых твердых лекарственных форм с управляемым выделением активного вещества в соответствии с пунктом патентной формулы 1, характеризующийся тем, что твердая лекарственная форма представлена в виде капсулы. 2. The manufacturing process of orally administered solid dosage forms with controlled release of the active substance in accordance with paragraph 1 of the patent claims, characterized in that the solid dosage form is presented in the form of a capsule. 3. Перорально применяемая твердая лекарственная форма с управляемым выделением активного вещества, получаемая в соответствии с технологией соответствующей пунктам патентной формулы 1 и/или 2. 3. Orally administered solid dosage form with controlled release of the active substance, obtained in accordance with the technology corresponding to the claims of patent claims 1 and / or 2.
RU99125113/14A 1997-04-29 1998-04-07 Method for manufacturing perorally applied solid medicinal forms at controlled release of an active substance RU2193396C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19718012A DE19718012C1 (en) 1997-04-29 1997-04-29 Process for the production of orally applicable solid pharmaceutical forms with controlled release of active substances
DE19718012.4 1997-04-29

Publications (2)

Publication Number Publication Date
RU99125113A true RU99125113A (en) 2001-08-20
RU2193396C2 RU2193396C2 (en) 2002-11-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU99125113/14A RU2193396C2 (en) 1997-04-29 1998-04-07 Method for manufacturing perorally applied solid medicinal forms at controlled release of an active substance

Country Status (19)

Country Link
US (1) US6117450A (en)
EP (1) EP0979069B1 (en)
JP (1) JP2002511849A (en)
AR (1) AR010414A1 (en)
AT (1) ATE286723T1 (en)
AU (1) AU8009998A (en)
BR (1) BR9809328A (en)
CA (1) CA2290017C (en)
CO (1) CO5070636A1 (en)
CZ (1) CZ300174B6 (en)
DE (2) DE19718012C1 (en)
ES (1) ES2236908T3 (en)
HU (1) HU226670B1 (en)
PL (1) PL191692B1 (en)
PT (1) PT979069E (en)
RU (1) RU2193396C2 (en)
SK (1) SK147999A3 (en)
UA (1) UA49952C2 (en)
WO (1) WO1998048782A1 (en)

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