LT5379B - Reguliuojamo atpalaidavimo betahistino kompozicijos - Google Patents
Reguliuojamo atpalaidavimo betahistino kompozicijos Download PDFInfo
- Publication number
- LT5379B LT5379B LT2006009A LT2006009A LT5379B LT 5379 B LT5379 B LT 5379B LT 2006009 A LT2006009 A LT 2006009A LT 2006009 A LT2006009 A LT 2006009A LT 5379 B LT5379 B LT 5379B
- Authority
- LT
- Lithuania
- Prior art keywords
- tablets according
- betahistine
- coating
- tablet
- hydrophilic
- Prior art date
Links
- UUQMNUMQCIQDMZ-UHFFFAOYSA-N betahistine Chemical group CNCCC1=CC=CC=N1 UUQMNUMQCIQDMZ-UHFFFAOYSA-N 0.000 title claims abstract description 23
- 229960004536 betahistine Drugs 0.000 title claims abstract description 21
- 239000000203 mixture Substances 0.000 title claims abstract description 15
- 238000013270 controlled release Methods 0.000 title claims abstract description 9
- 229920001477 hydrophilic polymer Polymers 0.000 claims abstract description 22
- 239000011247 coating layer Substances 0.000 claims abstract description 19
- 150000007522 mineralic acids Chemical class 0.000 claims abstract description 5
- 150000007524 organic acids Chemical class 0.000 claims abstract description 5
- 150000003839 salts Chemical class 0.000 claims abstract description 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 4
- 239000008187 granular material Substances 0.000 claims abstract description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 20
- 239000011248 coating agent Substances 0.000 claims description 13
- 238000000576 coating method Methods 0.000 claims description 13
- 239000000945 filler Substances 0.000 claims description 13
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 11
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 11
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 11
- 239000000454 talc Substances 0.000 claims description 11
- 229910052623 talc Inorganic materials 0.000 claims description 11
- 239000010453 quartz Substances 0.000 claims description 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicon dioxide Inorganic materials O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 9
- 239000004480 active ingredient Substances 0.000 claims description 7
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 6
- 229920000642 polymer Polymers 0.000 claims description 6
- 239000002253 acid Substances 0.000 claims description 5
- 229920002472 Starch Polymers 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 3
- 239000004408 titanium dioxide Substances 0.000 claims description 3
- 239000000654 additive Substances 0.000 claims description 2
- 230000000996 additive effect Effects 0.000 claims description 2
- 235000010443 alginic acid Nutrition 0.000 claims description 2
- 229920000615 alginic acid Polymers 0.000 claims description 2
- 159000000007 calcium salts Chemical class 0.000 claims description 2
- 235000010980 cellulose Nutrition 0.000 claims description 2
- 229920002678 cellulose Polymers 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims description 2
- 239000006185 dispersion Substances 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- 150000002148 esters Chemical class 0.000 claims description 2
- 150000002170 ethers Chemical class 0.000 claims description 2
- 150000002433 hydrophilic molecules Chemical class 0.000 claims description 2
- 230000002209 hydrophobic effect Effects 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 239000002966 varnish Substances 0.000 claims description 2
- 239000008199 coating composition Substances 0.000 claims 2
- 229920002126 Acrylic acid copolymer Polymers 0.000 claims 1
- 229920002125 Sokalan® Polymers 0.000 claims 1
- 229960001392 betahistine hydrochloride Drugs 0.000 claims 1
- 239000000975 dye Substances 0.000 claims 1
- 238000005550 wet granulation Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 2
- 239000004150 EU approved colour Substances 0.000 abstract 1
- 229940006093 opthalmologic coloring agent diagnostic Drugs 0.000 abstract 1
- 238000000338 in vitro Methods 0.000 description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 8
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 8
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 8
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 7
- 229960004543 anhydrous citric acid Drugs 0.000 description 7
- XVDFMHARQUBJRE-UHFFFAOYSA-N hydron;n-methyl-2-pyridin-2-ylethanamine;dichloride Chemical compound Cl.Cl.CNCCC1=CC=CC=N1 XVDFMHARQUBJRE-UHFFFAOYSA-N 0.000 description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 7
- 239000008108 microcrystalline cellulose Substances 0.000 description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 description 7
- 239000003086 colorant Substances 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 229940124549 vasodilator Drugs 0.000 description 2
- 239000003071 vasodilator agent Substances 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 1
- 239000002518 antifoaming agent Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 229960004106 citric acid Drugs 0.000 description 1
- 150000001860 citric acid derivatives Chemical class 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- -1 dihydrochloride Chemical compound 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000003605 opacifier Substances 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 239000008184 oral solid dosage form Substances 0.000 description 1
- 239000008016 pharmaceutical coating Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000013049 sediment Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03015172A EP1493435B1 (en) | 2003-07-04 | 2003-07-04 | Controlled Release Compositions of Betahistine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| LT2006009A LT2006009A (en) | 2006-06-27 |
| LT5379B true LT5379B (lt) | 2006-10-25 |
Family
ID=33427119
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| LT2006009A LT5379B (lt) | 2003-07-04 | 2006-02-01 | Reguliuojamo atpalaidavimo betahistino kompozicijos |
Country Status (17)
| Country | Link |
|---|---|
| EP (1) | EP1493435B1 (pl) |
| CN (1) | CN1816323A (pl) |
| AT (1) | ATE395048T1 (pl) |
| CY (1) | CY1108551T1 (pl) |
| DE (1) | DE60320965D1 (pl) |
| DK (1) | DK1493435T3 (pl) |
| EA (1) | EA011569B1 (pl) |
| EC (1) | ECSP066267A (pl) |
| ES (1) | ES2306827T3 (pl) |
| GE (1) | GEP20084349B (pl) |
| LT (1) | LT5379B (pl) |
| MX (1) | MXPA06000090A (pl) |
| PL (1) | PL379374A1 (pl) |
| PT (1) | PT1493435E (pl) |
| SI (1) | SI1493435T1 (pl) |
| TN (1) | TNSN05326A1 (pl) |
| WO (1) | WO2005004850A1 (pl) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8802139B2 (en) | 2003-06-26 | 2014-08-12 | Intellipharmaceutics Corp. | Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient |
| US10624858B2 (en) | 2004-08-23 | 2020-04-21 | Intellipharmaceutics Corp | Controlled release composition using transition coating, and method of preparing same |
| US10064828B1 (en) | 2005-12-23 | 2018-09-04 | Intellipharmaceutics Corp. | Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems |
| US10960077B2 (en) | 2006-05-12 | 2021-03-30 | Intellipharmaceutics Corp. | Abuse and alcohol resistant drug composition |
| CN102046170B (zh) | 2008-05-27 | 2012-11-28 | 墨尔本大学 | 治疗患有咽鼓管功能障碍的哺乳动物的方法 |
| DE102012105528A1 (de) * | 2012-06-25 | 2014-01-02 | Hennig Arzneimittel Gmbh & Co. Kg | Arzneiform zur Freisetzung von Wirkstoffen |
| WO2015053620A1 (en) * | 2013-10-07 | 2015-04-16 | Disphar International B.V. | Betahistine composition |
| ES2862209T3 (es) | 2017-07-20 | 2021-10-07 | Intas Pharmaceuticals Ltd | Composiciones orales sólidas de liberación prolongada no pulsátil que contienen betahistina |
| CN111249237A (zh) * | 2019-12-21 | 2020-06-09 | 乐普恒久远药业有限公司 | 盐酸倍他司汀药物及其制备方法 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0016890A1 (fr) | 1977-07-22 | 1980-10-15 | Jean Sadia Cherqui | Nouvelle forme galénique d'administration de la bêtahistine |
| EP0397025A1 (en) | 1989-05-08 | 1990-11-14 | PRODOTTI FORMENTI S.r.l. | [2-(2-pyridyl)ethyl]-methylamine salts |
| EP0502642A1 (en) | 1991-03-07 | 1992-09-09 | Reckitt And Colman Products Limited | Sustained release compositions |
| EP1158963A1 (en) | 1999-03-05 | 2001-12-05 | FARMACEUTICI FORMENTI S.p.A. | Controlled-release compositions of betahistine |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2432313A1 (fr) * | 1978-08-01 | 1980-02-29 | Foulhoux Pierre | Nouvelle forme galenique de la betahistine et son procede d'obtention |
| GB2280604B (en) * | 1993-07-02 | 1997-04-30 | Resource Medical Limited | Processing of active agents |
-
2003
- 2003-07-04 EP EP03015172A patent/EP1493435B1/en not_active Expired - Lifetime
- 2003-07-04 DK DK03015172T patent/DK1493435T3/da active
- 2003-07-04 DE DE60320965T patent/DE60320965D1/de not_active Expired - Lifetime
- 2003-07-04 PT PT03015172T patent/PT1493435E/pt unknown
- 2003-07-04 AT AT03015172T patent/ATE395048T1/de not_active IP Right Cessation
- 2003-07-04 SI SI200331296T patent/SI1493435T1/sl unknown
- 2003-07-04 ES ES03015172T patent/ES2306827T3/es not_active Expired - Lifetime
-
2004
- 2004-06-16 GE GEAP20049148A patent/GEP20084349B/en unknown
- 2004-06-16 CN CN200480018863.6A patent/CN1816323A/zh active Pending
- 2004-06-16 MX MXPA06000090A patent/MXPA06000090A/es active IP Right Grant
- 2004-06-16 WO PCT/EP2004/006458 patent/WO2005004850A1/en not_active Ceased
- 2004-06-16 EA EA200501908A patent/EA011569B1/ru not_active IP Right Cessation
- 2004-06-16 PL PL379374A patent/PL379374A1/pl not_active Application Discontinuation
-
2005
- 2005-12-22 TN TNP2005000326A patent/TNSN05326A1/en unknown
-
2006
- 2006-01-02 EC EC2006006267A patent/ECSP066267A/es unknown
- 2006-02-01 LT LT2006009A patent/LT5379B/lt not_active IP Right Cessation
-
2008
- 2008-08-04 CY CY20081100817T patent/CY1108551T1/el unknown
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0016890A1 (fr) | 1977-07-22 | 1980-10-15 | Jean Sadia Cherqui | Nouvelle forme galénique d'administration de la bêtahistine |
| EP0397025A1 (en) | 1989-05-08 | 1990-11-14 | PRODOTTI FORMENTI S.r.l. | [2-(2-pyridyl)ethyl]-methylamine salts |
| IT1229237B (it) | 1989-05-08 | 1991-07-26 | Prodotti Formenti | Sali di (2-(piridil)etil) metilammina |
| EP0502642A1 (en) | 1991-03-07 | 1992-09-09 | Reckitt And Colman Products Limited | Sustained release compositions |
| EP1158963A1 (en) | 1999-03-05 | 2001-12-05 | FARMACEUTICI FORMENTI S.p.A. | Controlled-release compositions of betahistine |
Also Published As
| Publication number | Publication date |
|---|---|
| PT1493435E (pt) | 2008-08-14 |
| PL379374A1 (pl) | 2006-09-04 |
| GEP20084349B (en) | 2008-04-10 |
| CN1816323A (zh) | 2006-08-09 |
| DK1493435T3 (da) | 2008-09-08 |
| DE60320965D1 (de) | 2008-06-26 |
| CY1108551T1 (el) | 2014-04-09 |
| EA011569B1 (ru) | 2009-04-28 |
| ECSP066267A (es) | 2006-07-28 |
| ES2306827T3 (es) | 2008-11-16 |
| ATE395048T1 (de) | 2008-05-15 |
| EA200501908A1 (ru) | 2006-08-25 |
| TNSN05326A1 (en) | 2007-07-10 |
| EP1493435B1 (en) | 2008-05-14 |
| MXPA06000090A (es) | 2006-04-07 |
| WO2005004850A1 (en) | 2005-01-20 |
| EP1493435A1 (en) | 2005-01-05 |
| LT2006009A (en) | 2006-06-27 |
| SI1493435T1 (sl) | 2008-10-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM9A | Lapsed patents |
Effective date: 20110616 |