NO324680B1 - Mikrogranuler, som inneholder diltiazem som aktivt prinsipp, for vedvarende frigjoring og gelatinkapsler som omfatter mikrogranulene. - Google Patents
Mikrogranuler, som inneholder diltiazem som aktivt prinsipp, for vedvarende frigjoring og gelatinkapsler som omfatter mikrogranulene. Download PDFInfo
- Publication number
- NO324680B1 NO324680B1 NO19982738A NO982738A NO324680B1 NO 324680 B1 NO324680 B1 NO 324680B1 NO 19982738 A NO19982738 A NO 19982738A NO 982738 A NO982738 A NO 982738A NO 324680 B1 NO324680 B1 NO 324680B1
- Authority
- NO
- Norway
- Prior art keywords
- layer
- microgranules according
- microgranules
- active principle
- surfactant
- Prior art date
Links
- 238000013268 sustained release Methods 0.000 title claims 8
- 239000012730 sustained-release form Substances 0.000 title claims 8
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 title claims 4
- 229960004166 diltiazem Drugs 0.000 title claims 4
- 239000007903 gelatin capsule Substances 0.000 title claims 2
- 239000004014 plasticizer Substances 0.000 claims 10
- 239000011230 binding agent Substances 0.000 claims 9
- 239000004094 surface-active agent Substances 0.000 claims 9
- 230000007935 neutral effect Effects 0.000 claims 6
- 239000011248 coating agent Substances 0.000 claims 5
- -1 alkylbenzene sulfonates Chemical class 0.000 claims 4
- 239000000314 lubricant Substances 0.000 claims 4
- 229910052783 alkali metal Inorganic materials 0.000 claims 3
- 150000001340 alkali metals Chemical class 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- XNGIFLGASWRNHJ-UHFFFAOYSA-N o-dicarboxybenzene Natural products OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 claims 3
- 239000003945 anionic surfactant Substances 0.000 claims 2
- 239000000969 carrier Substances 0.000 claims 2
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- CXMXRPHRNRROMY-UHFFFAOYSA-N sebacic acid Chemical compound OC(=O)CCCCCCCCC(O)=O CXMXRPHRNRROMY-UHFFFAOYSA-N 0.000 claims 2
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 150000008051 alkyl sulfates Chemical class 0.000 claims 1
- 229940045714 alkyl sulfonate alkylating agent Drugs 0.000 claims 1
- 150000008052 alkyl sulfonates Chemical class 0.000 claims 1
- 239000002280 amphoteric surfactant Substances 0.000 claims 1
- 125000000129 anionic group Chemical group 0.000 claims 1
- 125000002091 cationic group Chemical group 0.000 claims 1
- 239000003093 cationic surfactant Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002736 nonionic surfactant Substances 0.000 claims 1
- 150000007524 organic acids Chemical class 0.000 claims 1
- 229920000193 polymethacrylate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 239000001069 triethyl citrate Substances 0.000 claims 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 1
- 235000013769 triethyl citrate Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen- Or Sulfur-Containing Heterocyclic Ring Compounds With Rings Of Six Or More Members (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR9515361A FR2742660B1 (fr) | 1995-12-22 | 1995-12-22 | Nouvelles formes de microgranules a liberation prolongee contenant du diltiazem comme principe actif |
PCT/FR1996/002040 WO1997023219A1 (fr) | 1995-12-22 | 1996-12-23 | Microgranules a liberation prolongee contenant du diltiazem comme principe actif |
Publications (3)
Publication Number | Publication Date |
---|---|
NO982738D0 NO982738D0 (no) | 1998-06-12 |
NO982738L NO982738L (no) | 1998-08-21 |
NO324680B1 true NO324680B1 (no) | 2007-12-03 |
Family
ID=9485856
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
NO19982738A NO324680B1 (no) | 1995-12-22 | 1998-06-12 | Mikrogranuler, som inneholder diltiazem som aktivt prinsipp, for vedvarende frigjoring og gelatinkapsler som omfatter mikrogranulene. |
Country Status (27)
Country | Link |
---|---|
US (3) | US6228395B1 (xx) |
EP (1) | EP0868184B1 (xx) |
JP (1) | JP2000506500A (xx) |
KR (1) | KR100354054B1 (xx) |
CN (1) | CN1145488C (xx) |
AR (1) | AR004410A1 (xx) |
AT (1) | ATE238798T1 (xx) |
AU (1) | AU721949B2 (xx) |
BG (1) | BG63770B1 (xx) |
BR (1) | BR9612225A (xx) |
CA (1) | CA2242224C (xx) |
DE (1) | DE69627880T2 (xx) |
DK (1) | DK0868184T3 (xx) |
EA (1) | EA001721B1 (xx) |
EE (1) | EE04045B1 (xx) |
ES (1) | ES2198505T3 (xx) |
FR (1) | FR2742660B1 (xx) |
GE (1) | GEP20022629B (xx) |
HK (1) | HK1018400A1 (xx) |
HU (1) | HU224214B1 (xx) |
IL (1) | IL125047A (xx) |
NO (1) | NO324680B1 (xx) |
NZ (1) | NZ324739A (xx) |
PL (1) | PL186621B1 (xx) |
PT (1) | PT868184E (xx) |
WO (1) | WO1997023219A1 (xx) |
ZA (1) | ZA9610776B (xx) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2742660B1 (fr) * | 1995-12-22 | 1998-04-03 | Ethypharm Lab Prod Ethiques | Nouvelles formes de microgranules a liberation prolongee contenant du diltiazem comme principe actif |
US6162463A (en) * | 1997-05-01 | 2000-12-19 | Dov Pharmaceutical Inc | Extended release formulation of diltiazem hydrochloride |
FR2790668B1 (fr) * | 1999-03-12 | 2002-07-26 | D B F | Granules contenant une substance vegetale et leur procede de preparation |
EP1064938A1 (en) * | 1999-06-28 | 2001-01-03 | Sanofi-Synthelabo | Pharmaceutical dosage forms for controlled release producing at least a timed pulse |
EP1064937A1 (en) * | 1999-06-28 | 2001-01-03 | Sanofi-Synthelabo | Timed dual release dosage forms comprising a short acting hypnotic or a salt thereof |
US7179483B2 (en) | 2000-04-26 | 2007-02-20 | Watson Pharmaceuticals, Inc. | Compositions and methods for transdermal oxybutynin therapy |
FR2831546B1 (fr) * | 2001-10-31 | 2007-03-23 | Atofina | Materiau polymere thermoplastique pour supports d'enregistrement d'informations audio et/ou optiques |
BRPI0415242B8 (pt) * | 2003-10-10 | 2021-05-25 | Ethypharm Sa | microgrânulos de liberação gradual contendo extrato de gingko biloba e o processo para fabricar estes |
US20070122471A1 (en) * | 2003-12-25 | 2007-05-31 | Takeda Pharmaceutical Company Limited | Method of improving suitability for granulation |
JP2005306778A (ja) * | 2004-04-21 | 2005-11-04 | Basf Ag | 徐放性製剤及びその製造方法 |
WO2006013431A1 (en) * | 2004-07-29 | 2006-02-09 | Pfizer Limited | Stable controlled-release pharmaceutical formulation of eletriptan |
US8778395B2 (en) * | 2005-08-11 | 2014-07-15 | Andrx Labs, Llc | Diltiazem controlled release formulation and method of manufacture |
KR101486228B1 (ko) * | 2006-06-19 | 2015-01-26 | 알파마 파머슈티컬스 엘엘씨 | 약제학적 조성물 |
ITFI20110172A1 (it) | 2011-08-08 | 2013-02-09 | Valpharma Sa | Formulazione multiparticolata a rilascio modificato di diltiazem hcl. |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IE56999B1 (en) * | 1983-12-22 | 1992-03-11 | Elan Corp Plc | Pharmaceutical formulation |
IT1200217B (it) * | 1986-09-30 | 1989-01-05 | Valducci Roberto | Membrana per uso farmaceutico ed industriale |
DK173505B1 (da) * | 1987-02-20 | 2001-01-15 | Pharmatec Internat S R L | Fremgangsmåde til fremstilling af en diltiazempellet med langsom afgivelse og anvendelse af således fremstillede pelleter t |
JPH07552B2 (ja) * | 1987-11-06 | 1995-01-11 | 田辺製薬株式会社 | 持効性製剤 |
FR2623714B1 (fr) * | 1987-11-26 | 1990-04-20 | Ethypharm Sa | Forme a liberation prolongee du diltiazem, et son medicament ainsi obtenu |
FR2624732B1 (fr) * | 1987-12-21 | 1991-02-15 | Synthelabo | Formulation pharmaceutique a liberation prolongee |
FR2630647B1 (fr) * | 1988-04-27 | 1991-08-16 | Sanofi Sa | Microbilles de diltiazem, leur procede de fabrication et compositions pharmaceutiques a liberation prolongee les contenant |
US5288505A (en) | 1991-06-26 | 1994-02-22 | Galephar P.R., Inc., Ltd. | Extended release form of diltiazem |
US5229135A (en) * | 1991-11-22 | 1993-07-20 | Prographarm Laboratories | Sustained release diltiazem formulation |
US5376384A (en) | 1992-12-23 | 1994-12-27 | Kinaform Technology, Inc. | Delayed, sustained-release pharmaceutical preparation |
US5834024A (en) * | 1995-01-05 | 1998-11-10 | Fh Faulding & Co. Limited | Controlled absorption diltiazem pharmaceutical formulation |
FR2742660B1 (fr) * | 1995-12-22 | 1998-04-03 | Ethypharm Lab Prod Ethiques | Nouvelles formes de microgranules a liberation prolongee contenant du diltiazem comme principe actif |
-
1995
- 1995-12-22 FR FR9515361A patent/FR2742660B1/fr not_active Expired - Lifetime
-
1996
- 1996-12-20 ZA ZA9610776A patent/ZA9610776B/xx unknown
- 1996-12-23 AT AT96943156T patent/ATE238798T1/de active
- 1996-12-23 US US09/091,646 patent/US6228395B1/en not_active Expired - Fee Related
- 1996-12-23 EE EE9800197A patent/EE04045B1/xx unknown
- 1996-12-23 GE GEAP19964360A patent/GEP20022629B/en unknown
- 1996-12-23 CA CA002242224A patent/CA2242224C/fr not_active Expired - Lifetime
- 1996-12-23 EP EP96943156A patent/EP0868184B1/fr not_active Expired - Lifetime
- 1996-12-23 HU HU9904129A patent/HU224214B1/hu active IP Right Grant
- 1996-12-23 JP JP9523365A patent/JP2000506500A/ja active Pending
- 1996-12-23 DK DK96943156T patent/DK0868184T3/da active
- 1996-12-23 IL IL12504796A patent/IL125047A/xx not_active IP Right Cessation
- 1996-12-23 WO PCT/FR1996/002040 patent/WO1997023219A1/fr active IP Right Grant
- 1996-12-23 CN CNB961997648A patent/CN1145488C/zh not_active Expired - Lifetime
- 1996-12-23 DE DE69627880T patent/DE69627880T2/de not_active Expired - Lifetime
- 1996-12-23 AR ARP960105884A patent/AR004410A1/es unknown
- 1996-12-23 KR KR10-1998-0704833A patent/KR100354054B1/ko not_active IP Right Cessation
- 1996-12-23 PT PT96943156T patent/PT868184E/pt unknown
- 1996-12-23 NZ NZ324739A patent/NZ324739A/xx not_active IP Right Cessation
- 1996-12-23 BR BR9612225A patent/BR9612225A/pt not_active IP Right Cessation
- 1996-12-23 PL PL96327567A patent/PL186621B1/pl unknown
- 1996-12-23 AU AU11983/97A patent/AU721949B2/en not_active Expired
- 1996-12-23 ES ES96943156T patent/ES2198505T3/es not_active Expired - Lifetime
- 1996-12-23 EA EA199800593A patent/EA001721B1/ru not_active IP Right Cessation
-
1998
- 1998-06-12 NO NO19982738A patent/NO324680B1/no not_active IP Right Cessation
- 1998-06-18 BG BG102555A patent/BG63770B1/bg unknown
-
1999
- 1999-08-10 HK HK99103442A patent/HK1018400A1/xx not_active IP Right Cessation
-
2001
- 2001-01-11 US US09/757,628 patent/US6383516B1/en not_active Expired - Lifetime
- 2001-12-03 US US09/998,911 patent/US6660296B2/en not_active Expired - Lifetime
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
MK1K | Patent expired |