NZ314265A - Multilayered compressed tablet for selective release of medicaments at controlled rates having one layer that increases at least 50% by volume on contact with gastric juices - Google Patents
Multilayered compressed tablet for selective release of medicaments at controlled rates having one layer that increases at least 50% by volume on contact with gastric juicesInfo
- Publication number
- NZ314265A NZ314265A NZ314265A NZ31426597A NZ314265A NZ 314265 A NZ314265 A NZ 314265A NZ 314265 A NZ314265 A NZ 314265A NZ 31426597 A NZ31426597 A NZ 31426597A NZ 314265 A NZ314265 A NZ 314265A
- Authority
- NZ
- New Zealand
- Prior art keywords
- layer
- tablet
- active ingredient
- pharmaceutical
- layers
- Prior art date
Links
- 210000004051 gastric juice Anatomy 0.000 title claims description 17
- 239000007891 compressed tablet Substances 0.000 title claims description 9
- 239000003814 drug Substances 0.000 title description 12
- 239000004480 active ingredient Substances 0.000 claims abstract description 84
- 230000008961 swelling Effects 0.000 claims abstract description 23
- 239000012530 fluid Substances 0.000 claims abstract description 16
- 210000002784 stomach Anatomy 0.000 claims abstract description 11
- 230000002496 gastric effect Effects 0.000 claims abstract description 9
- 230000002035 prolonged effect Effects 0.000 claims abstract description 5
- 210000000936 intestine Anatomy 0.000 claims abstract description 3
- 239000003826 tablet Substances 0.000 claims description 82
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 50
- 239000000203 mixture Substances 0.000 claims description 46
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- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 32
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 32
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 27
- 238000002360 preparation method Methods 0.000 claims description 27
- 239000008119 colloidal silica Substances 0.000 claims description 25
- 235000019359 magnesium stearate Nutrition 0.000 claims description 25
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- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 21
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- 239000000126 substance Substances 0.000 claims description 20
- 210000001035 gastrointestinal tract Anatomy 0.000 claims description 18
- 238000012360 testing method Methods 0.000 claims description 16
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- 230000004888 barrier function Effects 0.000 claims description 15
- -1 hydralazide Chemical compound 0.000 claims description 15
- 239000008101 lactose Substances 0.000 claims description 15
- 238000007906 compression Methods 0.000 claims description 14
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- 239000002671 adjuvant Substances 0.000 claims description 12
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- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims description 8
- 229960004150 aciclovir Drugs 0.000 claims description 8
- MKUXAQIIEYXACX-UHFFFAOYSA-N aciclovir Chemical compound N1C(N)=NC(=O)C2=C1N(COCCO)C=N2 MKUXAQIIEYXACX-UHFFFAOYSA-N 0.000 claims description 8
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- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 claims description 8
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- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 7
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 7
- 239000003085 diluting agent Substances 0.000 claims description 7
- 125000005456 glyceride group Chemical group 0.000 claims description 7
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 7
- 238000000338 in vitro Methods 0.000 claims description 7
- 239000000594 mannitol Substances 0.000 claims description 7
- 235000010355 mannitol Nutrition 0.000 claims description 7
- 239000001856 Ethyl cellulose Substances 0.000 claims description 6
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 6
- 230000009471 action Effects 0.000 claims description 6
- 239000013060 biological fluid Substances 0.000 claims description 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 6
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- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 6
- 229960000620 ranitidine Drugs 0.000 claims description 6
- VMXUWOKSQNHOCA-LCYFTJDESA-N ranitidine Chemical compound [O-][N+](=O)/C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 VMXUWOKSQNHOCA-LCYFTJDESA-N 0.000 claims description 6
- 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 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 5
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 5
- 229920002305 Schizophyllan Polymers 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 150000002334 glycols Chemical class 0.000 claims description 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 5
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 5
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 5
- 150000003839 salts Chemical class 0.000 claims description 5
- 239000011734 sodium Substances 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- 239000000454 talc Substances 0.000 claims description 5
- 229910052623 talc Inorganic materials 0.000 claims description 5
- 229920000858 Cyclodextrin Chemical class 0.000 claims description 4
- 108010061435 Enalapril Proteins 0.000 claims description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 4
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 4
- 229920002125 Sokalan® Polymers 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 4
- 229960000830 captopril Drugs 0.000 claims description 4
- FAKRSMQSSFJEIM-RQJHMYQMSA-N captopril Chemical compound SC[C@@H](C)C(=O)N1CCC[C@H]1C(O)=O FAKRSMQSSFJEIM-RQJHMYQMSA-N 0.000 claims description 4
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- 210000001198 duodenum Anatomy 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 230000035515 penetration Effects 0.000 claims description 4
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- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 3
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
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- LUEWUZLMQUOBSB-GFVSVBBRSA-N mannan Chemical class 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]2[C@H](O[C@@H](O[C@H]3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-GFVSVBBRSA-N 0.000 claims description 3
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
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- SGTNSNPWRIOYBX-UHFFFAOYSA-N 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 SGTNSNPWRIOYBX-UHFFFAOYSA-N 0.000 claims description 2
- XZIIFPSPUDAGJM-UHFFFAOYSA-N 6-chloro-2-n,2-n-diethylpyrimidine-2,4-diamine Chemical compound CCN(CC)C1=NC(N)=CC(Cl)=N1 XZIIFPSPUDAGJM-UHFFFAOYSA-N 0.000 claims description 2
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- 150000004649 carbonic acid derivatives Chemical class 0.000 claims description 2
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- 125000002091 cationic group Chemical group 0.000 claims description 2
- 229940083181 centrally acting adntiadrenergic agent methyldopa Drugs 0.000 claims description 2
- 229960001380 cimetidine Drugs 0.000 claims description 2
- CCGSUNCLSOWKJO-UHFFFAOYSA-N cimetidine Chemical compound N#CNC(=N/C)\NCCSCC1=NC=N[C]1C CCGSUNCLSOWKJO-UHFFFAOYSA-N 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
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- GBXSMTUPTTWBMN-XIRDDKMYSA-N enalapril Chemical compound C([C@@H](C(=O)OCC)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(O)=O)CC1=CC=CC=C1 GBXSMTUPTTWBMN-XIRDDKMYSA-N 0.000 claims description 2
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- OYFJQPXVCSSHAI-QFPUQLAESA-N enalapril maleate Chemical compound OC(=O)\C=C/C(O)=O.C([C@@H](C(=O)OCC)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(O)=O)CC1=CC=CC=C1 OYFJQPXVCSSHAI-QFPUQLAESA-N 0.000 claims description 2
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- XUFQPHANEAPEMJ-UHFFFAOYSA-N famotidine Chemical compound NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1 XUFQPHANEAPEMJ-UHFFFAOYSA-N 0.000 claims description 2
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- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical class OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims description 2
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- JQGSLEAUIGWBSR-UHFFFAOYSA-N 2,3-dihydroxypropyl docosanoate;2,3-dihydroxypropyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO.CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO JQGSLEAUIGWBSR-UHFFFAOYSA-N 0.000 description 1
- WLAMNBDJUVNPJU-UHFFFAOYSA-N 2-methylbutyric acid Chemical compound CCC(C)C(O)=O WLAMNBDJUVNPJU-UHFFFAOYSA-N 0.000 description 1
- 102220487426 Actin-related protein 2/3 complex subunit 3_K15M_mutation Human genes 0.000 description 1
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- 108010010803 Gelatin Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
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- 229930006000 Sucrose Natural products 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
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- 238000005516 engineering process Methods 0.000 description 1
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- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
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- WBHHMMIMDMUBKC-QJWNTBNXSA-M ricinoleate Chemical compound CCCCCC[C@@H](O)C\C=C/CCCCCCCC([O-])=O WBHHMMIMDMUBKC-QJWNTBNXSA-M 0.000 description 1
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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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT96MI000311A IT1282650B1 (it) | 1996-02-19 | 1996-02-19 | Compressa farmaceutica,caratterizzata da elevato aumento di volume a contatto con liquidi biologici |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| NZ314265A true NZ314265A (en) | 1997-07-27 |
Family
ID=11373320
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NZ314265A NZ314265A (en) | 1996-02-19 | 1997-02-18 | Multilayered compressed tablet for selective release of medicaments at controlled rates having one layer that increases at least 50% by volume on contact with gastric juices |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US5780057A (en:Method) |
| EP (2) | EP1382331B1 (en:Method) |
| JP (1) | JP3251190B2 (en:Method) |
| AT (2) | ATE264670T1 (en:Method) |
| AU (1) | AU719170B2 (en:Method) |
| CA (1) | CA2197941C (en:Method) |
| DE (1) | DE69728710T2 (en:Method) |
| DK (1) | DK0795324T3 (en:Method) |
| ES (2) | ES2219709T3 (en:Method) |
| IT (1) | IT1282650B1 (en:Method) |
| NZ (1) | NZ314265A (en:Method) |
| PT (1) | PT795324E (en:Method) |
Families Citing this family (145)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5534263A (en) * | 1995-02-24 | 1996-07-09 | Alza Corporation | Active agent dosage form comprising a matrix and at least two insoluble bands |
| CA2173818A1 (fr) * | 1996-04-10 | 1997-10-11 | Francois Chouinard | Comprime pharmaceutique a liberation controlee contenant un support a base d'amylose reticule et d'hydroxypropylmethylcellulose |
| US5804165A (en) * | 1996-07-24 | 1998-09-08 | Arnold; Michael J. | Antiplaque oral composition |
| DE19640062B4 (de) * | 1996-09-28 | 2006-04-27 | Lts Lohmann Therapie-Systeme Ag | Orale Zubereitung, enthaltend in einer in wässrigem Medium quellbaren Matrix wenigstens einen pharmazeutischen Wirkstoff |
| US6046177A (en) * | 1997-05-05 | 2000-04-04 | Cydex, Inc. | Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations |
| IT1294760B1 (it) * | 1997-09-03 | 1999-04-12 | Jagotec Ag | Procedimento per la preparazione di compresse farmaceutiche in grado di cedere,secondo schemi predeterminabili, principi attivi poco |
| IN186245B (en:Method) * | 1997-09-19 | 2001-07-14 | Ranbaxy Lab Ltd | |
| GB9724186D0 (en) | 1997-11-14 | 1998-01-14 | British Tech Group | Low temperature coatings |
| PE20000066A1 (es) * | 1997-12-22 | 2000-02-09 | Schering Corp | Formas de dosificacion solida de ribavirina administrables oralmente y proceso de fabricacion |
| KR20010052557A (ko) * | 1998-06-05 | 2001-06-25 | 로즈 암스트롱, 크리스틴 에이. 트러트웨인 | 산화마그네슘을 사용한, ａｃｅ 억제제 함유 조성물의안정화 |
| IL141339A0 (en) * | 1998-09-25 | 2002-03-10 | Delsys Pharmaceutical Corp | Liquid pharmaceutical for oral delivery |
| US6416786B1 (en) | 1998-12-11 | 2002-07-09 | Nostrum Pharmaceuticals, Inc. | Sustained release tablet containing hydrocolloid and cellulose ether |
| US6797283B1 (en) | 1998-12-23 | 2004-09-28 | Alza Corporation | Gastric retention dosage form having multiple layers |
| US6635281B2 (en) | 1998-12-23 | 2003-10-21 | Alza Corporation | Gastric retaining oral liquid dosage form |
| US6432448B1 (en) | 1999-02-08 | 2002-08-13 | Fmc Corporation | Edible coating composition |
| US6723342B1 (en) | 1999-02-08 | 2004-04-20 | Fmc Corporation | Edible coating composition |
| MY121470A (en) * | 1999-05-03 | 2006-01-28 | Ranbaxy Lab Ltd | Stable solid pharmaceutical compositions containing enalapril maleate |
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- 1997-02-19 CA CA002197941A patent/CA2197941C/en not_active Expired - Lifetime
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| DE69728710T2 (de) | 2005-04-07 |
| EP1382331B1 (en) | 2011-10-26 |
| DE69728710D1 (de) | 2004-05-27 |
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| ATE530173T1 (de) | 2011-11-15 |
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| ATE264670T1 (de) | 2004-05-15 |
| AU1477697A (en) | 1997-08-28 |
| ES2376199T8 (es) | 2012-04-04 |
| ITMI960311A1 (it) | 1997-08-19 |
| EP1382331A1 (en) | 2004-01-21 |
| ES2376199T3 (es) | 2012-03-09 |
| JP3251190B2 (ja) | 2002-01-28 |
| ES2219709T3 (es) | 2004-12-01 |
| DK0795324T3 (da) | 2004-08-16 |
| CA2197941A1 (en) | 1997-08-20 |
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| EXPY | Patent expired |