HRP20161602T1 - Postupak priprave čvrstog farmaceutskog pripravka - Google Patents
Postupak priprave čvrstog farmaceutskog pripravka Download PDFInfo
- Publication number
- HRP20161602T1 HRP20161602T1 HRP20161602TT HRP20161602T HRP20161602T1 HR P20161602 T1 HRP20161602 T1 HR P20161602T1 HR P20161602T T HRP20161602T T HR P20161602TT HR P20161602 T HRP20161602 T HR P20161602T HR P20161602 T1 HRP20161602 T1 HR P20161602T1
- Authority
- HR
- Croatia
- Prior art keywords
- perindopril
- preparation
- salt
- hydrate
- indapamide
- Prior art date
Links
- 239000007787 solid Substances 0.000 title claims 4
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 238000000034 method Methods 0.000 claims 12
- IPVQLZZIHOAWMC-QXKUPLGCSA-N perindopril Chemical compound C1CCC[C@H]2C[C@@H](C(O)=O)N(C(=O)[C@H](C)N[C@@H](CCC)C(=O)OCC)[C@H]21 IPVQLZZIHOAWMC-QXKUPLGCSA-N 0.000 claims 8
- 229960002582 perindopril Drugs 0.000 claims 8
- 150000003839 salts Chemical class 0.000 claims 8
- 238000002360 preparation method Methods 0.000 claims 7
- NDDAHWYSQHTHNT-UHFFFAOYSA-N indapamide Chemical compound CC1CC2=CC=CC=C2N1NC(=O)C1=CC=C(Cl)C(S(N)(=O)=O)=C1 NDDAHWYSQHTHNT-UHFFFAOYSA-N 0.000 claims 6
- 229960004569 indapamide Drugs 0.000 claims 6
- 229910052806 inorganic carbonate Inorganic materials 0.000 claims 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 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 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 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical group [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 2
- 229960004977 anhydrous lactose Drugs 0.000 claims 2
- 235000010216 calcium carbonate Nutrition 0.000 claims 2
- 229960001375 lactose Drugs 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- NKWPZUCBCARRDP-UHFFFAOYSA-L calcium bicarbonate Chemical compound [Ca+2].OC([O-])=O.OC([O-])=O NKWPZUCBCARRDP-UHFFFAOYSA-L 0.000 claims 1
- 229910000020 calcium bicarbonate Inorganic materials 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 238000007580 dry-mixing Methods 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- 235000014380 magnesium carbonate Nutrition 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 claims 1
- 239000000758 substrate Substances 0.000 claims 1
- YBRBMKDOPFTVDT-UHFFFAOYSA-N tert-butylamine Chemical compound CC(C)(C)N YBRBMKDOPFTVDT-UHFFFAOYSA-N 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Indole Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (17)
1. Postupak priprave čvrstog farmaceutskog pripravka perindoprila, ili njegove soli, naznačen time što obuhvaća
(i) suho miješanje perindoprila, ili njegove soli, s najmanje jednim anorganskim karbonatom, najmanje jednom podlogom, te izborno drugim komponenata, i
(ii) suhu obradu smjese dobivene u koraku (i) u željeni čvrsti oblik.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što pripravak sadrži sol perindoprila s terc-butilaminom.
3. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je anorganski karbonat natrijev karbonat, natrijev hidrogenkarbonat, magnezijev karbonat, kalcijev karbonat ili kalcijev hidrogenkarbonat.
4. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što molarni omjer između perindoprila, ili njegove soli, i anorganskog karbonata iznosi 1 do 0,1-0,9, po mogućnosti 1 do 0,50-0,83.
5. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što je podloga mikrokristalna celuloza, laktoza, ili njihova smjesa.
6. Postupak u skladu s patentnim zahtjevom 5, naznačen time što mikrokristalna celuloza ima sadržaj vlage od 0,3 do 5,0%, težinski, po mogućnosti 0,3 do 1,5%, težinski.
7. Postupak u skladu s patentnim zahtjevom 5 ili 6, naznačen time što je laktoza bezvodna laktoza.
8. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što se korak (ii) provodi izravnim komprimiranjem smjese.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što pripravak također sadrži indapamid, ili njegov hidrat.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što je hidrat indapamid hemihidrat.
11. Postupak u skladu s patentnim zahtjevom 9 ili 10, naznačen time što 90%, volumno, čestica indapamida, ili njegovog hidrata, ima veličinu manju od 80 µm.
12. Postupak u skladu s patentnim zahtjevom 11, naznačen time što 90%, volumno, čestica indapamida, ili njegovog hidrata, ima veličinu manju od 70 µm.
13. Čvrsti farmaceutski pripravak perindoprila, ili njegove soli, naznačen time što sadrži
(a) perindopril, ili njegovu sol,
(b) mikrokristalnu celulozu, sa sadržajem vlage od 0,3 do 5,0%, težinski, i bezvodnu laktozu,
(c) najmanje jedan anorganski karbonat, gdje molarni omjer između perindoprila, ili njegove soli, i anorganskog karbonata iznosi 1 do 0,1-0,9, i
(d) izborno druge komponente.
14. Pripravak u skladu s patentnim zahtjevom 13, naznačen time što molarni omjer između perindoprila, ili njegove soli, i anorganskog karbonata iznosi 1 do 0,50-0,83.
15. Pripravak u skladu s patentnim zahtjevom 13 ili 14, naznačen time što mikrokristalna celuloza ima sadržaj vlage od 0,3 do 1,5%, težinski.
16. Pripravak u skladu s patentnim zahtjevom 15, naznačen time što dodatno sadrži indapamid, ili njegov hidrat.
17. Pripravak u skladu s patentnim zahtjevom 16, naznačen time što 90%, volumno, čestica indapamida, ili njegovog hidrata, ima veličinu manju od 80 µm.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE200410019845 DE102004019845A1 (de) | 2004-03-29 | 2004-03-29 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
| DE102004059521A DE102004059521A1 (de) | 2004-12-09 | 2004-12-09 | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
| EP05730288.7A EP1729739B1 (en) | 2004-03-29 | 2005-03-29 | Process for preparing a solid pharmaceutical composition |
| PCT/EP2005/003277 WO2005094793A1 (en) | 2004-03-29 | 2005-03-29 | Process for preparing a solid pharmaceutical composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161602T1 true HRP20161602T1 (hr) | 2016-12-30 |
Family
ID=34963866
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161602TT HRP20161602T1 (hr) | 2004-03-29 | 2016-11-30 | Postupak priprave čvrstog farmaceutskog pripravka |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US20070172524A1 (hr) |
| EP (1) | EP1729739B1 (hr) |
| JP (1) | JP4948392B2 (hr) |
| CY (1) | CY1118180T1 (hr) |
| DK (1) | DK1729739T3 (hr) |
| EA (1) | EA011712B1 (hr) |
| ES (1) | ES2603856T3 (hr) |
| HR (1) | HRP20161602T1 (hr) |
| HU (1) | HUE031058T2 (hr) |
| LT (1) | LT1729739T (hr) |
| NO (1) | NO20064934L (hr) |
| PL (1) | PL1729739T3 (hr) |
| PT (1) | PT1729739T (hr) |
| WO (1) | WO2005094793A1 (hr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005094793A1 (en) | 2004-03-29 | 2005-10-13 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Process for preparing a solid pharmaceutical composition |
| SI21800A (sl) * | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
| BRPI0615607A2 (pt) * | 2005-08-30 | 2011-05-24 | Lek Pharmaceuticals | composição farmacêutica compreendendo perindopril ou seus sais |
| RS53324B (en) | 2005-11-17 | 2014-10-31 | Silverstone Pharma Est. | STABLE FORMULATION OF AMORPHIC SALES OF PERINDOPRIL, PROCEDURE FOR THEIR PREPARATION, IN PARTICULAR INDUSTRIAL PREPARATION, AND THEIR USE IN HYPERTENSION THERAPY |
| EP1815857A1 (en) | 2006-02-02 | 2007-08-08 | LEK Pharmaceuticals D.D. | A pharmaceutical composition comprising perindopril |
| WO2007120930A2 (en) * | 2006-04-19 | 2007-10-25 | Teva Pharmaceutical Industries Ltd. | Stable pharmaceutical compositions of 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivatives |
| JP2009537538A (ja) * | 2006-05-15 | 2009-10-29 | アカドイア プハルマセウチカルス インコーポレーテッド | ピマバンセリン医薬製剤 |
| WO2008068577A2 (en) * | 2006-12-01 | 2008-06-12 | Glenmark Pharmaceuticals Limited | Pharmaceutical compositions |
| TWI435917B (zh) | 2006-12-27 | 2014-05-01 | Fujifilm Corp | 顏料分散組成物、硬化性組成物、彩色濾光片及其製造方法 |
| SI22543A (sl) | 2007-06-27 | 2008-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nove soli perindoprila |
| US20120142766A1 (en) * | 2007-11-21 | 2012-06-07 | Evolva Sa | Substituted 1,3-dioxanes and their uses |
| CN102665764A (zh) * | 2009-12-22 | 2012-09-12 | Fmc有限公司 | 可用作可再压实药物赋形剂的微晶纤维素和碳酸钙组合物 |
| PL227900B1 (pl) | 2012-11-15 | 2018-01-31 | Adamed Spolka Z Ograniczona Odpowiedzialnoscia | Kompozycja farmaceutyczna zawierająca inhibitor ACE i bloker kanałów wapniowych, sposób jej wytwarzania i jednostka dawkowania zawierająca tę kompozycję |
| WO2016178591A2 (en) | 2015-05-05 | 2016-11-10 | Gene Predit, Sa | Genetic markers and treatment of male obesity |
| CN109700774A (zh) * | 2019-03-05 | 2019-05-03 | 上药东英（江苏）药业有限公司 | 一种培哚普利叔丁胺片及其粉末直压工艺 |
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| US4508729A (en) * | 1979-12-07 | 1985-04-02 | Adir | Substituted iminodiacids, their preparation and pharmaceutical compositions containing them |
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| US4425355A (en) * | 1981-02-17 | 1984-01-10 | Warner-Lambert Company | Substituted acyl derivatives of chair form of octahydro-1H-indole-2-carboxylic acids |
| US4743450A (en) | 1987-02-24 | 1988-05-10 | Warner-Lambert Company | Stabilized compositions |
| FR2620709B1 (fr) * | 1987-09-17 | 1990-09-07 | Adir | Procede de synthese industrielle du perindopril et de ses principaux intermediaires de synthese |
| FR2620703B1 (fr) * | 1987-09-17 | 1991-10-04 | Adir | Procede de synthese industrielle de l'acide perhydroindole carboxylique - 2(2s, 3as, 7as). application a la synthese de carboxyalkyl dipeptides |
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| PT1635792E (pt) * | 2003-06-26 | 2009-05-15 | Teva Pharma | Composições farmacêuticas estáveis de derivados do ácido 2-aza-biciclo[3.3.0]octano-3-carboxílico |
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| GB2404336A (en) * | 2003-07-30 | 2005-02-02 | Cipla Ltd | Stabilisation of therapeutic agents using a carbonate salt of an amino acid, preferably in the presence of a saccharide, & pharmaceutical compositions thereof |
| ES2334900T3 (es) * | 2003-09-01 | 2010-03-17 | Les Laboratoires Servier | Nuevo procedimiento de sintesis de esteres de n-((s)-1-carboxibutil)-(s)-alanina y su aplicacion a la sintesis de perindopril. |
| GB2394660A (en) * | 2003-12-17 | 2004-05-05 | Niche Generics Ltd | Stabilisation of pharmaceutical compositions comprising ACE inhibitor by absence of acidic excipients having large specific surface area, eg silicon dioxide |
| WO2005094793A1 (en) | 2004-03-29 | 2005-10-13 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Process for preparing a solid pharmaceutical composition |
| SI21800A (sl) * | 2004-05-14 | 2005-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nov postopek sinteze perindoprila |
-
2005
- 2005-03-29 WO PCT/EP2005/003277 patent/WO2005094793A1/en active Application Filing
- 2005-03-29 ES ES05730288.7T patent/ES2603856T3/es active Active
- 2005-03-29 EP EP05730288.7A patent/EP1729739B1/en not_active Revoked
- 2005-03-29 PL PL05730288T patent/PL1729739T3/pl unknown
- 2005-03-29 DK DK05730288.7T patent/DK1729739T3/en active
- 2005-03-29 LT LTEP05730288.7T patent/LT1729739T/lt unknown
- 2005-03-29 JP JP2007505484A patent/JP4948392B2/ja not_active Expired - Fee Related
- 2005-03-29 HU HUE05730288A patent/HUE031058T2/en unknown
- 2005-03-29 PT PT57302887T patent/PT1729739T/pt unknown
- 2005-03-29 EA EA200601608A patent/EA011712B1/ru not_active IP Right Cessation
- 2005-03-29 US US10/599,154 patent/US20070172524A1/en not_active Abandoned
-
2006
- 2006-10-27 NO NO20064934A patent/NO20064934L/no not_active Application Discontinuation
-
2009
- 2009-06-03 US US12/477,727 patent/US20100172995A1/en not_active Abandoned
-
2016
- 2016-11-03 CY CY20161101118T patent/CY1118180T1/el unknown
- 2016-11-30 HR HRP20161602TT patent/HRP20161602T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HUE031058T2 (en) | 2017-06-28 |
| NO20064934L (no) | 2006-10-27 |
| PL1729739T3 (pl) | 2017-04-28 |
| EA200601608A1 (ru) | 2007-02-27 |
| JP2007530623A (ja) | 2007-11-01 |
| JP4948392B2 (ja) | 2012-06-06 |
| CY1118180T1 (el) | 2017-06-28 |
| PT1729739T (pt) | 2016-12-01 |
| WO2005094793A1 (en) | 2005-10-13 |
| LT1729739T (lt) | 2016-11-10 |
| ES2603856T3 (es) | 2017-03-01 |
| DK1729739T3 (en) | 2016-10-31 |
| EA011712B1 (ru) | 2009-04-28 |
| EP1729739B1 (en) | 2016-09-28 |
| EP1729739A1 (en) | 2006-12-13 |
| US20070172524A1 (en) | 2007-07-26 |
| US20100172995A1 (en) | 2010-07-08 |
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