DE69109419T2 - Isosorbide-5-mononitrate enthaltende Tablette mit verzögerter Abgabe und Verfahren zu ihrer Herstellung. - Google Patents
Isosorbide-5-mononitrate enthaltende Tablette mit verzögerter Abgabe und Verfahren zu ihrer Herstellung.Info
- Publication number
- DE69109419T2 DE69109419T2 DE69109419T DE69109419T DE69109419T2 DE 69109419 T2 DE69109419 T2 DE 69109419T2 DE 69109419 T DE69109419 T DE 69109419T DE 69109419 T DE69109419 T DE 69109419T DE 69109419 T2 DE69109419 T2 DE 69109419T2
- Authority
- DE
- Germany
- Prior art keywords
- sustained release
- tablet according
- diluent
- mnis
- release tablet
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
- 238000000034 method Methods 0.000 title claims abstract description 11
- 229960003827 isosorbide mononitrate Drugs 0.000 title claims abstract description 9
- YWXYYJSYQOXTPL-SLPGGIOYSA-N isosorbide mononitrate Chemical compound [O-][N+](=O)O[C@@H]1CO[C@@H]2[C@@H](O)CO[C@@H]21 YWXYYJSYQOXTPL-SLPGGIOYSA-N 0.000 title claims abstract description 9
- 239000007950 delayed release tablet Substances 0.000 title 1
- 239000003085 diluting agent Substances 0.000 claims abstract description 24
- 230000008961 swelling Effects 0.000 claims abstract description 11
- 239000011159 matrix material Substances 0.000 claims abstract description 6
- 239000000843 powder Substances 0.000 claims abstract description 6
- 238000013268 sustained release Methods 0.000 claims abstract description 4
- 239000012730 sustained-release form Substances 0.000 claims abstract description 4
- 239000002245 particle Substances 0.000 claims abstract 2
- 239000003795 chemical substances by application Substances 0.000 claims description 11
- 239000004480 active ingredient Substances 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 10
- 239000000126 substance Substances 0.000 claims description 8
- 239000001913 cellulose Substances 0.000 claims description 6
- 229920002678 cellulose Polymers 0.000 claims description 6
- 235000010980 cellulose Nutrition 0.000 claims description 6
- 230000008719 thickening Effects 0.000 claims description 6
- 239000007888 film coating Substances 0.000 claims description 5
- 238000009501 film coating Methods 0.000 claims description 5
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 4
- 230000000694 effects Effects 0.000 claims description 4
- 239000000314 lubricant Substances 0.000 claims description 4
- 238000007873 sieving Methods 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 3
- 239000000654 additive Substances 0.000 claims description 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 239000004375 Dextrin Substances 0.000 claims description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 2
- 229920000881 Modified starch Polymers 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- 239000001506 calcium phosphate Substances 0.000 claims description 2
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 2
- 235000011010 calcium phosphates Nutrition 0.000 claims description 2
- 235000011132 calcium sulphate Nutrition 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- 239000000416 hydrocolloid Substances 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 2
- 235000019426 modified starch Nutrition 0.000 claims description 2
- 102000004169 proteins and genes Human genes 0.000 claims description 2
- 108090000623 proteins and genes Proteins 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 235000010356 sorbitol Nutrition 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 2
- 239000007939 sustained release tablet Substances 0.000 claims 11
- 239000003826 tablet Substances 0.000 claims 7
- 239000000783 alginic acid Substances 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- 229960001126 alginic acid Drugs 0.000 claims 1
- 150000004781 alginic acids Chemical class 0.000 claims 1
- 238000004040 coloring Methods 0.000 claims 1
- 229920001206 natural gum Polymers 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 230000001747 exhibiting effect Effects 0.000 abstract 1
- 239000007970 homogeneous dispersion Substances 0.000 abstract 1
- 235000013339 cereals Nutrition 0.000 description 12
- 238000000338 in vitro Methods 0.000 description 6
- 230000036470 plasma concentration Effects 0.000 description 5
- 238000009472 formulation Methods 0.000 description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 206010002383 Angina Pectoris Diseases 0.000 description 2
- 206010019280 Heart failures Diseases 0.000 description 2
- 230000002051 biphasic effect Effects 0.000 description 2
- IZEKFCXSFNUWAM-UHFFFAOYSA-N dipyridamole Chemical compound C=12N=C(N(CCO)CCO)N=C(N3CCCCC3)C2=NC(N(CCO)CCO)=NC=1N1CCCCC1 IZEKFCXSFNUWAM-UHFFFAOYSA-N 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- RAGZEDHHTPQLAI-UHFFFAOYSA-L disodium;2',4',5',7'-tetraiodo-3-oxospiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate Chemical compound [Na+].[Na+].O1C(=O)C2=CC=CC=C2C21C1=CC(I)=C([O-])C(I)=C1OC1=C(I)C([O-])=C(I)C=C21 RAGZEDHHTPQLAI-UHFFFAOYSA-L 0.000 description 2
- 235000012732 erythrosine Nutrition 0.000 description 2
- 239000004174 erythrosine Substances 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000000859 sublimation Methods 0.000 description 2
- 230000008022 sublimation Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 229920002261 Corn starch Polymers 0.000 description 1
- 235000019759 Maize starch Nutrition 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- VEXNFKCQMGMBBJ-UHFFFAOYSA-N [1-(dimethylamino)-2-[(dimethylamino)methyl]butan-2-yl] benzoate Chemical compound CN(C)CC(CC)(CN(C)C)OC(=O)C1=CC=CC=C1 VEXNFKCQMGMBBJ-UHFFFAOYSA-N 0.000 description 1
- 239000003125 aqueous solvent Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000007580 dry-mixing Methods 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- IINNWAYUJNWZRM-UHFFFAOYSA-L erythrosin B Chemical compound [Na+].[Na+].[O-]C(=O)C1=CC=CC=C1C1=C2C=C(I)C(=O)C(I)=C2OC2=C(I)C([O-])=C(I)C=C21 IINNWAYUJNWZRM-UHFFFAOYSA-L 0.000 description 1
- 229940011411 erythrosine Drugs 0.000 description 1
- 230000004907 flux Effects 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 238000001033 granulometry Methods 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- FFQQCJGNKKIRMD-UHFFFAOYSA-N methyl n-(3-hydroxyphenyl)carbamate Chemical compound COC(=O)NC1=CC=CC(O)=C1 FFQQCJGNKKIRMD-UHFFFAOYSA-N 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000003449 preventive effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- MFSDELSXOVOZBJ-UHFFFAOYSA-M sodium;dodecyl sulfate;propane-1,2,3-triol Chemical compound [Na+].OCC(O)CO.CCCCCCCCCCCCOS([O-])(=O)=O MFSDELSXOVOZBJ-UHFFFAOYSA-M 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 239000002966 varnish Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9011133A FR2666506A1 (fr) | 1990-09-07 | 1990-09-07 | Comprime a liberation prolongee a base de 5-mononitrate d'isosorbide et son procede de preparation. |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE69109419D1 DE69109419D1 (de) | 1995-06-08 |
| DE69109419T2 true DE69109419T2 (de) | 1996-02-01 |
Family
ID=9400168
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE69109419T Expired - Lifetime DE69109419T2 (de) | 1990-09-07 | 1991-09-05 | Isosorbide-5-mononitrate enthaltende Tablette mit verzögerter Abgabe und Verfahren zu ihrer Herstellung. |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5334393A (https=) |
| EP (1) | EP0477061B1 (https=) |
| AT (1) | ATE121936T1 (https=) |
| DE (1) | DE69109419T2 (https=) |
| ES (1) | ES2073701T3 (https=) |
| FR (1) | FR2666506A1 (https=) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK103393D0 (da) * | 1993-09-15 | 1993-09-15 | Ferrosan As | Praeparat |
| BE1009380A3 (nl) * | 1995-03-14 | 1997-03-04 | Universiteit Gent Lab Voor Far | Stabiliserend samenstelling voor suspensie. |
| AU735799C (en) * | 1997-02-28 | 2005-04-28 | Regents Of The University Of California, The | Methods and compositions for optimisation of oxygen transport by cell-free systems |
| US5851555A (en) * | 1997-08-15 | 1998-12-22 | Fuisz Technologies Ltd. | Controlled release dosage forms containing water soluble drugs |
| AR017512A1 (es) * | 1997-08-22 | 2001-09-12 | Smithkline Beecham Corp | Tabletas de metilcelulosa rapidamente desintegrables para administracion por via oral y procedimiento para prepararlas |
| ES2255490T3 (es) * | 1999-03-31 | 2006-07-01 | Janssen Pharmaceutica N.V. | Almidon pregelatinizado en una formulacion de liberacion controlada. |
| JP4696210B2 (ja) * | 2000-06-07 | 2011-06-08 | トーアエイヨー株式会社 | イソソルビド‐５‐モノニトレートを有効成分とする徐放性錠剤及びその製造方法 |
| KR100446818B1 (ko) * | 2001-11-06 | 2004-09-01 | 김재윤 | 질산 이소소르비드 서방성 펠렛 제형 |
| TWI338583B (en) * | 2004-05-20 | 2011-03-11 | Otsuka Pharma Co Ltd | Solid pharmaceutical formulation |
| US20080286343A1 (en) * | 2007-05-16 | 2008-11-20 | Dzenana Cengic | Solid form |
| JP7764378B2 (ja) * | 2020-07-13 | 2025-11-05 | キリンホールディングス株式会社 | フィルムコーティング錠剤 |
| CN113476416B (zh) * | 2021-08-03 | 2022-02-18 | 北京阳光诺和药物研究股份有限公司 | 一种治疗血管舒张的药物组合物 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3328094A1 (de) * | 1983-08-04 | 1985-02-21 | H. Trommsdorff GmbH & Co, 5110 Alsdorf | Phlegmatisierte pharmazeutische zubereitung von explosionsfaehigen salpetersaeureestern |
| DE3328894A1 (de) * | 1983-08-10 | 1985-02-28 | Kathrein-Werke Kg, 8200 Rosenheim | Antennen-kombination |
| GB8524001D0 (en) * | 1985-09-30 | 1985-11-06 | Glaxo Group Ltd | Pharmaceutical composition |
| IT1187750B (it) * | 1985-10-15 | 1987-12-23 | Eurand Spa | Procedimento per la preparazione di compresse,anche a rilascio prolungato,di iscsorbide-5-mononitrato stabilizzato e formulazioni cosi' ottenute |
| FR2618073B1 (fr) * | 1987-07-16 | 1990-09-07 | Pf Medicament | Comprimes de type a matrice hydrophile a base de salbutamol et leur procede de preparation |
-
1990
- 1990-09-07 FR FR9011133A patent/FR2666506A1/fr active Granted
-
1991
- 1991-09-05 ES ES91402377T patent/ES2073701T3/es not_active Expired - Lifetime
- 1991-09-05 AT AT91402377T patent/ATE121936T1/de not_active IP Right Cessation
- 1991-09-05 DE DE69109419T patent/DE69109419T2/de not_active Expired - Lifetime
- 1991-09-05 EP EP91402377A patent/EP0477061B1/fr not_active Expired - Lifetime
- 1991-09-09 US US07/756,810 patent/US5334393A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| FR2666506B1 (https=) | 1994-12-16 |
| EP0477061A1 (fr) | 1992-03-25 |
| DE69109419D1 (de) | 1995-06-08 |
| FR2666506A1 (fr) | 1992-03-13 |
| ATE121936T1 (de) | 1995-05-15 |
| US5334393A (en) | 1994-08-02 |
| ES2073701T3 (es) | 1995-08-16 |
| EP0477061B1 (fr) | 1995-05-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8364 | No opposition during term of opposition |