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RU2001110355A - NON-INFLUENCE OF FOOD PHARMACEUTICAL DOSED DRUG FORMS OF LONG-TERM ACTION CONTAINING MANY UNITS, AND METHOD FOR PRODUCING THEM - Google Patents

NON-INFLUENCE OF FOOD PHARMACEUTICAL DOSED DRUG FORMS OF LONG-TERM ACTION CONTAINING MANY UNITS, AND METHOD FOR PRODUCING THEM

Info

Publication number
RU2001110355A
RU2001110355A RU2001110355/14A RU2001110355A RU2001110355A RU 2001110355 A RU2001110355 A RU 2001110355A RU 2001110355/14 A RU2001110355/14 A RU 2001110355/14A RU 2001110355 A RU2001110355 A RU 2001110355A RU 2001110355 A RU2001110355 A RU 2001110355A
Authority
RU
Russia
Prior art keywords
polymer
active substance
mixture
particles
formulation according
Prior art date
Application number
RU2001110355/14A
Other languages
Russian (ru)
Other versions
RU2235540C2 (en
Inventor
Венката-Рангарао КАНИКАНТИ
Роланд Рупп
Эрих БРЭНДЕЛЬ
Клаус ВАЙЗЕМАНН
Эрнст ХАНТРАЙН
Original Assignee
Байер Акциенгезельшафт
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 DE19842753A external-priority patent/DE19842753A1/en
Application filed by Байер Акциенгезельшафт filed Critical Байер Акциенгезельшафт
Publication of RU2001110355A publication Critical patent/RU2001110355A/en
Application granted granted Critical
Publication of RU2235540C2 publication Critical patent/RU2235540C2/en

Links

Claims (12)

1. Способ получения пероральной препаративной формы пролонгированного действия с регулируемым не зависящим от влияния пищи высвобождением, отличающийся тем, что гидрофильный полимер гидрокси пропилцеллюлозы (ГПЦ) со средним молекулярным весом от 250000 до 1200000, в количестве 40-95 мас. %, в пересчете на смесь активного вещества и полимера, и молярной степенью замещения, по крайней мере, 3, в качестве материала, замедляющего разложение, комбинируют с, по крайней мере, одним фармацевтически активным веществом, и указанную смесь активного вещества и полимера превращают в маленькие частицы с диаметром от 0,2 до 3,0 мм, которые используют для получения активных пероральных форм и готовых лекарственных средств.1. A method of obtaining an oral sustained release formulation with controlled food-independent release, characterized in that the hydrophilic polymer of hydroxy propyl cellulose (GPC) with an average molecular weight of from 250,000 to 1,200,000, in an amount of 40-95 wt. %, in terms of a mixture of the active substance and the polymer, and a molar degree of substitution of at least 3, as a material that slows down the decomposition, is combined with at least one pharmaceutically active substance, and the specified mixture of the active substance and the polymer is converted into small particles with a diameter of 0.2 to 3.0 mm, which are used to obtain active oral forms and finished drugs. 2. Способ получения препаративной формы по п. 1, отличающийся тем, что используют ГПЦ в количестве 45-90 мас. %. 2. A method of obtaining a formulation according to claim 1, characterized in that HPC is used in an amount of 45-90 wt. % 3. Способ получения препаративной формы по п. 1, отличающийся тем, что используют ГПЦ со средним молекулярным весом от 350000 до 1150000. 3. The method of obtaining a formulation according to claim 1, characterized in that the use of GPC with an average molecular weight of from 350,000 to 1150000. 4. Способ получения препаративной формы по п. 1, отличающийся тем, что смесь активного вещества и полимера превращают в маленькие частицы с максимальным диаметром от 0,5 до 2 мм. 4. A method of obtaining a formulation according to claim 1, characterized in that the mixture of the active substance and the polymer is converted into small particles with a maximum diameter of from 0.5 to 2 mm. 5. Способ получения препаративных форм по п. 1, отличающийся тем, что частицы смеси активного вещества и полимера получают экструзией расплава и гранулированием. 5. A method of producing a formulation according to claim 1, characterized in that the particles of the mixture of the active substance and the polymer are obtained by melt extrusion and granulation. 6. Способ получения препаративных форм по п. 1, отличающийся тем, что частицы смеси активного вещества и полимера получают широко известными методами таблетирования. 6. A method of producing a formulation according to claim 1, characterized in that the particles of the mixture of the active substance and the polymer are obtained by widely known tabletting methods. 7. Способ получения препаративных форм по п. 1, отличающийся тем, что частицы смеси активного вещества и полимера получают в форме гранул, шариков, минитаблеток или зерен, которые в эффективной дозе помещают в капсулы. 7. A method of producing a formulation according to claim 1, characterized in that the particles of the mixture of the active substance and the polymer are obtained in the form of granules, balls, mini-tablets or grains, which are placed in capsules in an effective dose. 8. Способ получения препаративных форм по п. 1, отличающийся тем, что частицы смеси активного вещества и полимера дополнительно лакируют. 8. A method of obtaining a formulation according to claim 1, characterized in that the particles of the mixture of the active substance and the polymer additionally varnish. 9. Применение ГПЦ со средним молекулярным весом от 250000 до 1200000 для получения фармацевтических не зависящих от влияния пищи препаративных форм пролонгированного действия по п. 1. 9. The use of HPC with an average molecular weight of from 250,000 to 1,200,000 for the production of pharmaceutical drug-independent sustained release formulations according to claim 1. 10. Применение ГПЦ со средним молекулярным весом от 350000 до 1150000 в качестве основного замедляющего полимера и, в случае необходимости, небольшого количества другого гидрофильного полимера, такого как, например, полиметакриловый эфир, для получения не зависящих от влияния пищи препаративных форм пролонгированного действия по п. 1. 10. The use of HPC with an average molecular weight of 350,000 to 1150,000 as the main retarding polymer and, if necessary, a small amount of another hydrophilic polymer, such as, for example, polymethacrylic ester, to obtain sustained-release sustained-release formulations according to . 1. 11. Применение частиц смеси активного вещества и полимера по п. 1, для получения готовых лекарственных средств в виде капсул или таблеток. 11. The use of particles of a mixture of the active substance and the polymer according to claim 1, for the manufacture of finished drugs in the form of capsules or tablets. 12. Пероральные дозированные препаративные формы пролонгированного действия, содержащие множество единиц, с регулируемым не зависящим от влияния пищи высвобождением, получаемые по п. 1. 12. Oral dosage formulations of prolonged action, containing many units, with a controlled release independent of the effects of food, obtained according to claim 1.
RU2001110355/15A 1998-09-18 1999-09-17 Method for preparing oral preparative form with prolonged effect and regulated release of active substance depending on species and amount of stomach and digestive tract filling RU2235540C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19842753A DE19842753A1 (en) 1998-09-18 1998-09-18 Multiple-unit retard oral dosage formulation having controlled release independent of agitation and food effect, containing particles of combination of drug and hydroxypropyl cellulose
DE19842753.0 1998-09-18

Publications (2)

Publication Number Publication Date
RU2001110355A true RU2001110355A (en) 2003-03-10
RU2235540C2 RU2235540C2 (en) 2004-09-10

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU2001110355/15A RU2235540C2 (en) 1998-09-18 1999-09-17 Method for preparing oral preparative form with prolonged effect and regulated release of active substance depending on species and amount of stomach and digestive tract filling

Country Status (29)

Country Link
US (1) US6805881B1 (en)
EP (1) EP1113787B1 (en)
JP (1) JP2002526437A (en)
KR (1) KR100660072B1 (en)
CN (1) CN1178650C (en)
AT (1) ATE260645T1 (en)
AU (2) AU5861499A (en)
BG (1) BG105325A (en)
BR (1) BR9913839A (en)
CA (1) CA2344372C (en)
DE (2) DE19842753A1 (en)
DK (1) DK1113787T3 (en)
EE (1) EE04700B1 (en)
ES (1) ES2215404T3 (en)
HK (1) HK1040932B (en)
HR (1) HRP20010198A2 (en)
HU (1) HUP0103669A3 (en)
ID (1) ID28735A (en)
IL (2) IL141532A0 (en)
NO (1) NO20011211D0 (en)
NZ (1) NZ510563A (en)
PL (1) PL195543B1 (en)
PT (1) PT1113787E (en)
RU (1) RU2235540C2 (en)
SK (1) SK285099B6 (en)
TR (1) TR200100756T2 (en)
UA (1) UA73097C2 (en)
WO (2) WO2000016747A1 (en)
ZA (1) ZA200101485B (en)

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