RU2001128233A - Способ изготовления фармацевтических лекарственных форм и их предшественников и фармацевтическая лекарственная форма - Google Patents
Способ изготовления фармацевтических лекарственных форм и их предшественников и фармацевтическая лекарственная формаInfo
- Publication number
- RU2001128233A RU2001128233A RU2001128233/15A RU2001128233A RU2001128233A RU 2001128233 A RU2001128233 A RU 2001128233A RU 2001128233/15 A RU2001128233/15 A RU 2001128233/15A RU 2001128233 A RU2001128233 A RU 2001128233A RU 2001128233 A RU2001128233 A RU 2001128233A
- Authority
- RU
- Russia
- Prior art keywords
- matrix
- dosage form
- active substance
- release
- extrusion
- Prior art date
Links
Classifications
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/2095—Tabletting processes
-
- 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
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Psychiatry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Compounds Of Unknown Constitution (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (19)
1. Способ изготовления фармацевтических лекарственных форм или их предшественников при помощи экструзии, отличающийся тем, что лекарственная форма имеет матрицу, которая главным образом заключает в себе действующее вещество, причем матрица содержит полисахарид, и/или его производное, и/или его комплекс, и/или любую смесь упомянутых веществ с другими веществами, и/или сахариды, и/или их производные, в качестве основной образующей матрицы, а также по меньшей мере одно фармацевтически эффективное вещество, при этом матрица создана за счет совместной экструзии с действующим веществом и обеспечивает высвобождение действующего вещества.
2. Способ по п.1, отличающийся тем, что высвобождение действующего вещества лекарственной формы регулируют за счет введения активирующих добавок и/или путем изменения параметров процесса экструзии, таких как температура, геометрия мундштуков и/или скорость экструзии.
3. Способ по одному из пп.1 и 2, отличающийся тем, что матрица является аморфной или частично аморфной.
4. Способ по одному из пп.1-3, отличающийся тем, что полисахаридом является крахмал или его производное.
5. Способ по одному из пп.1-4, отличающийся тем, что матрица является нерастворимой в воде.
6. Способ по одному из пп.1-5, отличающийся тем, что матрица представляет собой матрицу с контролируемым высвобождением действующего вещества.
7. Способ по одному из пп.1-6, отличающийся тем, что высвобождение действующего вещества лекарственной формы в основном следует функции лапидуса.
8. Способ по одному из пп.1-7, отличающийся тем, что высвобождение действующего вещества лекарственной формы может регулироваться в течение 24 ч или больше.
9. Способ по одному из пп.1-8, отличающийся тем, что по меньшей мере одно фармацевтически эффективное вещество присутствует в матрице в растворенном, твердом или жидком виде.
10. Фармацевтическая лекарственная форма, отличающаяся тем, что она имеет матрицу, которая главным образом заключает в себе действующее вещество, причем матрица содержит полисахарид, и/или его производное, и/или его комплекс, и/или любую смесь упомянутых веществ с другими веществами, и/или сахариды, и/или их производные, в качестве основной образующей матрицы, а также по меньшей мере одно фармацевтически эффективное вещество, при этом матрица создана за счет совместной экструзии с действующим веществом и обеспечивает высвобождение действующего вещества.
11. Лекарственная форма по п.10, отличающаяся тем, что высвобождение действующего вещества регулируют за счет введения активирующих добавок и/или путем изменения параметров процесса экструзии, таких как температура, геометрия мундштуков и/или скорость экструзии.
12. Лекарственная форма по одному из пп.10-11, отличающаяся тем, что матрица является аморфной или частично аморфной.
13. Лекарственная форма по одному из пп.10-12, отличающаяся тем, что полисахаридом является крахмал или его производное.
14. Лекарственная форма по одному из пп.10-13, отличающаяся тем, что матрица является нерастворимой в воде.
15. Лекарственная форма по одному из пп.10-14, отличающаяся тем, что матрица представляет собой матрицу с контролируемым высвобождением действующего вещества.
16. Лекарственная форма по одному из пп.10-15, отличающаяся тем, что высвобождение действующего вещества в основном следует функции лапидуса.
17. Лекарственная форма по одному из пп.10-16, отличающаяся тем, что высвобождение действующего вещества может регулироваться в течение 24 ч или больше.
18. Лекарственная форма по одному из пп.10-17, отличающаяся тем, что по меньшей мере одно фармацевтически эффективное вещество присутствует в матрице в растворенном, твердом или жидком виде.
19. Применение лекарственной формы по пп.10-18 для производства гранулята для таблетирования и для заполнения капсул, а также для дополнительной обработки с использованием технологии литьевого формования, в качестве активирующей добавки при прямом таблетировании и/или для производства моноблочных фармацевтических лекарственных форм.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19918325.2 | 1999-04-22 | ||
| DE19918325A DE19918325A1 (de) | 1999-04-22 | 1999-04-22 | Verfahren zur Herstellung von Arzneiformen mit regulierter Wirkstofffreisetzung mittels Extrusion |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2208436C2 RU2208436C2 (ru) | 2003-07-20 |
| RU2001128233A true RU2001128233A (ru) | 2004-02-27 |
Family
ID=7905525
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2001128233/14A RU2208436C2 (ru) | 1999-04-22 | 2000-04-20 | Способ изготовления фармацевтических лекарственных форм и их предшественников и фармацевтическая лекарственная форма |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US8557286B1 (ru) |
| EP (2) | EP1171101B1 (ru) |
| JP (2) | JP4575599B2 (ru) |
| KR (1) | KR100511113B1 (ru) |
| CN (1) | CN1214783C (ru) |
| AT (1) | ATE356617T1 (ru) |
| AU (1) | AU763609B2 (ru) |
| BR (1) | BR0009927B1 (ru) |
| CA (1) | CA2372025C (ru) |
| CY (1) | CY1106478T1 (ru) |
| DE (3) | DE19918325A1 (ru) |
| DK (1) | DK1171101T3 (ru) |
| ES (1) | ES2284495T3 (ru) |
| HU (1) | HU227001B1 (ru) |
| IL (1) | IL145755A0 (ru) |
| PT (1) | PT1171101E (ru) |
| RU (1) | RU2208436C2 (ru) |
| WO (1) | WO2000064415A1 (ru) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP2266564B1 (en) | 1997-12-22 | 2013-03-13 | Euro-Celtique S.A. | Pharmaceutical oral dosage form comprising a combination of an opioid agonist and an opioid antagonist |
| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| DE19918325A1 (de) * | 1999-04-22 | 2000-10-26 | Euro Celtique Sa | Verfahren zur Herstellung von Arzneiformen mit regulierter Wirkstofffreisetzung mittels Extrusion |
| JP4522652B2 (ja) | 2001-05-11 | 2010-08-11 | エンドー ファーマシューティカルズ， インコーポレイティド | 乱用防止制御放出オピオイド投薬形態 |
| EP1429735A2 (de) * | 2001-09-26 | 2004-06-23 | Klaus-Jürgen Steffens | Verfahren und vorrichtung zur herstellung von granulaten umfassend mindestens einen pharmazeutischen wirkstoff |
| LT2425824T (lt) | 2002-04-05 | 2017-07-25 | Euro-Celtique S.A. | Farmacinis preparatas, turintis oksikodono ir naloksono |
| EP1479381A1 (en) * | 2003-05-19 | 2004-11-24 | Euro-Celtique S.A. | Pharmaceutical dosage form comprising a solid solution |
| EP1604667A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the restless leg syndrome |
| EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
| US8367105B2 (en) | 2004-11-10 | 2013-02-05 | Teva Pharmaceutical Industries, Ltd. | Compressed solid dosage form manufacturing process well-suited for use with drugs of low aqueous solubility and compressed solid dosage forms made thereby |
| EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
| DE102007028869A1 (de) | 2007-06-22 | 2008-12-24 | Ratiopharm Gmbh | Verfahren zur Herstellung eines Arzneimittels enthaltend Tadalafil |
| HUE042105T2 (hu) | 2009-03-10 | 2019-06-28 | Euro Celtique Sa | Oxikodont és naloxont tartalmazó azonnali hatóanyagleadású orális gyógyászati készítmények |
| DE102011011889B4 (de) | 2011-02-21 | 2015-11-05 | Leistritz Extrusionstechnik Gmbh | Vorrichtung und Verfahren zur kontinuierlichen Herstellung von biplan geschnittenen Formkörpern enthaltend wenigstens einen Füllstoff |
| DE102011015370A1 (de) * | 2011-03-29 | 2012-10-04 | Emodys Gmbh | Matrix für eine orale Darreichungsform, Verfahren zu deren Herstellung sowie Verwendung derselben |
| MY175307A (en) * | 2011-12-21 | 2020-06-18 | Bayer Ip Gmbh | Preparations comprising amorphous emodepside |
| EP3024461B1 (en) | 2013-07-23 | 2020-05-13 | Euro-Celtique S.A. | A combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation |
| EP3459527B1 (en) | 2017-09-20 | 2022-11-23 | Tillotts Pharma Ag | Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization |
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-
1999
- 1999-04-22 DE DE19918325A patent/DE19918325A1/de not_active Withdrawn
-
2000
- 2000-04-20 DK DK00927010T patent/DK1171101T3/da active
- 2000-04-20 CA CA002372025A patent/CA2372025C/en not_active Expired - Fee Related
- 2000-04-20 EP EP00927010A patent/EP1171101B1/de not_active Expired - Lifetime
- 2000-04-20 AT AT00927010T patent/ATE356617T1/de active
- 2000-04-20 EP EP07103714A patent/EP1839651A1/de not_active Withdrawn
- 2000-04-20 CN CNB008064199A patent/CN1214783C/zh not_active Expired - Fee Related
- 2000-04-20 KR KR10-2001-7013353A patent/KR100511113B1/ko not_active Expired - Fee Related
- 2000-04-20 HU HU0200843A patent/HU227001B1/hu not_active IP Right Cessation
- 2000-04-20 JP JP2000613406A patent/JP4575599B2/ja not_active Expired - Fee Related
- 2000-04-20 BR BRPI0009927-9A patent/BR0009927B1/pt not_active IP Right Cessation
- 2000-04-20 DE DE20022720U patent/DE20022720U1/de not_active Expired - Lifetime
- 2000-04-20 RU RU2001128233/14A patent/RU2208436C2/ru active
- 2000-04-20 IL IL14575500A patent/IL145755A0/xx not_active IP Right Cessation
- 2000-04-20 WO PCT/EP2000/003612 patent/WO2000064415A1/de not_active Ceased
- 2000-04-20 DE DE50014164T patent/DE50014164D1/de not_active Expired - Lifetime
- 2000-04-20 AU AU45542/00A patent/AU763609B2/en not_active Ceased
- 2000-04-20 PT PT00927010T patent/PT1171101E/pt unknown
- 2000-04-20 US US09/980,727 patent/US8557286B1/en not_active Expired - Fee Related
- 2000-04-20 ES ES00927010T patent/ES2284495T3/es not_active Expired - Lifetime
-
2007
- 2007-04-04 JP JP2007098734A patent/JP5022086B2/ja not_active Expired - Lifetime
- 2007-06-11 CY CY20071100766T patent/CY1106478T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ATE356617T1 (de) | 2007-04-15 |
| AU763609B2 (en) | 2003-07-31 |
| ES2284495T3 (es) | 2007-11-16 |
| JP5022086B2 (ja) | 2012-09-12 |
| JP2007211019A (ja) | 2007-08-23 |
| JP2002542276A (ja) | 2002-12-10 |
| CN1347315A (zh) | 2002-05-01 |
| CN1214783C (zh) | 2005-08-17 |
| EP1171101B1 (de) | 2007-03-14 |
| BR0009927A (pt) | 2002-01-08 |
| DE50014164D1 (de) | 2007-04-26 |
| DK1171101T3 (da) | 2007-07-16 |
| DE19918325A1 (de) | 2000-10-26 |
| IL145755A0 (en) | 2002-07-25 |
| JP4575599B2 (ja) | 2010-11-04 |
| PT1171101E (pt) | 2007-06-08 |
| US8557286B1 (en) | 2013-10-15 |
| BR0009927B1 (pt) | 2011-12-27 |
| RU2208436C2 (ru) | 2003-07-20 |
| KR20010112440A (ko) | 2001-12-20 |
| HU227001B1 (en) | 2010-04-28 |
| KR100511113B1 (ko) | 2005-08-31 |
| DE20022720U1 (de) | 2002-02-28 |
| AU4554200A (en) | 2000-11-10 |
| HUP0200843A3 (en) | 2003-04-28 |
| CY1106478T1 (el) | 2012-01-25 |
| CA2372025A1 (en) | 2000-11-02 |
| WO2000064415A1 (de) | 2000-11-02 |
| EP1171101A1 (de) | 2002-01-16 |
| EP1839651A1 (de) | 2007-10-03 |
| CA2372025C (en) | 2007-09-25 |
| HUP0200843A2 (hu) | 2002-07-29 |
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