ME01879B - Stabilna formulacija amorfnih perindopril soli, postupak njihove pripreme, posebno industrijske proizvodnje i njihova upotreba u terapiji hipertenzije - Google Patents
Stabilna formulacija amorfnih perindopril soli, postupak njihove pripreme, posebno industrijske proizvodnje i njihova upotreba u terapiji hipertenzijeInfo
- Publication number
- ME01879B ME01879B MEP-2014-54A MEP5414A ME01879B ME 01879 B ME01879 B ME 01879B ME P5414 A MEP5414 A ME P5414A ME 01879 B ME01879 B ME 01879B
- Authority
- ME
- Montenegro
- Prior art keywords
- preparation
- formulation
- added
- perindopril
- amorphous
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 6
- 238000002360 preparation method Methods 0.000 title claims 6
- 238000009472 formulation Methods 0.000 title claims 5
- 238000000034 method Methods 0.000 title claims 4
- IPVQLZZIHOAWMC-QXKUPLGCSA-N perindopril Chemical class 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 title claims 2
- 206010020772 Hypertension Diseases 0.000 title 1
- 238000002560 therapeutic procedure Methods 0.000 title 1
- 239000008187 granular material Substances 0.000 claims 5
- 229960002582 perindopril Drugs 0.000 claims 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 2
- 229940060367 inert ingredients Drugs 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- -1 perindopril sodium salt Chemical class 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 1
- 229920002261 Corn starch Polymers 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 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 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- 230000003276 anti-hypertensive effect Effects 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000008120 corn starch Substances 0.000 claims 1
- 229940099112 cornstarch Drugs 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000008240 homogeneous mixture Substances 0.000 claims 1
- 238000009776 industrial production Methods 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 229960003929 perindopril erbumine Drugs 0.000 claims 1
- IYNMDWMQHSMDDE-MHXJNQAMSA-N perindopril erbumine Chemical compound CC(C)(C)N.C1CCC[C@@H]2N(C(=O)[C@H](C)N[C@@H](CCC)C(=O)OCC)[C@H](C(O)=O)C[C@@H]21 IYNMDWMQHSMDDE-MHXJNQAMSA-N 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
- 239000007921 spray Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 229940074410 trehalose Drugs 0.000 claims 1
- 230000000304 vasodilatating effect Effects 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
- C07D209/04—Indoles; Hydrogenated indoles
- C07D209/30—Indoles; Hydrogenated indoles with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, directly attached to carbon atoms of the hetero ring
- C07D209/42—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
-
- 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
- A61K31/401—Proline; Derivatives thereof, e.g. captopril
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Cardiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
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Claims (5)
1.Postupak pripreme, posebno industrijske proizvodnje, stabilne formulacije amorfne perindopril natrijeve soli formule I: karakterizovan tako da je perindopril erbumin formule II:otopljen u vodi ili u mješavini alkohol/voda u bilo kojem omjeru, u ovu otopinu se dodaje natrijev hidrogen karbonate u omjeru 1 mol na 1 mol, dodaje se perindopril erbumin i cijeli se miješa i dodaje u formi spreja u homogenu mješavinu inertnih sastojaka za pripremu granula, suši se strujanjem toplog vazduha na temperaturi većoj od 40 °C, dodaju se supstance koje omogućavaju tabletiranje, homogenizira se i formuliše se granulat.
2. Proces prema zahtjevu 1, naznačen time da se kao inertni sastojci za pripremu granulata laktoze, laktoze u obliku monohidrata, trehaloze, kukuruznog skroba, mikrokristalinične celuloze, koriste talk i magnezijev stearat.
3. Stabilna formulacija granulata amorfne perindopril sodium soli koji se dobije u skladu sa postupkom u zahtjevima 1-2.
4. Formulacija u skladu sa zahtjevom 3, naznačena time da je u obliku granula, tablete ili kapsule.
5. Upotreba formulacije u skladu sa patentnim zahtjevima 3-4 za pripremu lijeka koji ima antihipertenzivno i vazodilatatorno djelovanje.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200500314 | 2005-11-17 | ||
| SI200600177A SI22339A (sl) | 2006-07-31 | 2006-07-31 | Stabilna formulacija amorfnega perindopril erbumina, postopek za njeno pripravo v industrijskem merilu in njena uporaba za zdravljenje hipertenzije |
| EP06813152.3A EP1948224B1 (en) | 2005-11-17 | 2006-11-08 | Stable formulation of amorphous perindopril salts, a process for their preparation, especially industrial preparation, and their use in the therapy of hypertension |
| PCT/SI2006/000034 WO2007058634A1 (en) | 2005-11-17 | 2006-11-08 | Stable formulation of amorphous perindopril salts, a process for their preparation, especially industrial preparation, and their use in the therapy of hypertension |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME01879B true ME01879B (me) | 2014-12-20 |
Family
ID=37801135
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2014-54A ME01879B (me) | 2005-11-17 | 2006-11-08 | Stabilna formulacija amorfnih perindopril soli, postupak njihove pripreme, posebno industrijske proizvodnje i njihova upotreba u terapiji hipertenzije |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP1948224B1 (me) |
| HR (1) | HRP20140476T1 (me) |
| ME (1) | ME01879B (me) |
| PL (1) | PL1948224T3 (me) |
| PT (1) | PT1948224E (me) |
| RS (1) | RS53324B (me) |
| RU (1) | RU2429878C2 (me) |
| SI (1) | SI1948224T1 (me) |
| WO (1) | WO2007058634A1 (me) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI22542A (sl) * | 2007-06-04 | 2008-12-31 | Diagen D.O.O. | Stabilna formulacija amorfnih soli perindoprila, postopek za njeno pripravo v industrijskem merilu in njena uporaba za zdravljenje hipertenzije |
| SI22543A (sl) | 2007-06-27 | 2008-12-31 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Nove soli perindoprila |
| ES2652187T3 (es) | 2009-04-03 | 2018-01-31 | Ocera Therapeutics, Inc. | Fenilacetato de l-ornitina y métodos para elaborar el mismo |
| EP2625162B1 (en) | 2010-10-06 | 2019-03-13 | Ocera Therapeutics, Inc. | Methods of making l-ornithine phenyl acetate |
| WO2016178591A2 (en) | 2015-05-05 | 2016-11-10 | Gene Predit, Sa | Genetic markers and treatment of male obesity |
| WO2024261477A1 (en) | 2023-06-20 | 2024-12-26 | Yaqrit Limited | Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4743450A (en) | 1987-02-24 | 1988-05-10 | Warner-Lambert Company | Stabilized compositions |
| SI9111842A (sl) | 1991-11-25 | 1998-04-30 | Krka | Stabilna formulacija soli enalaprila, postopek za njeno pripravo in njena uporaba |
| US5573780A (en) | 1995-08-04 | 1996-11-12 | Apotex Usa Inc. | Stable solid formulation of enalapril salt and process for preparation thereof |
| CN1469737A (zh) * | 2000-10-16 | 2004-01-21 | ��һ��������ҩ��ʽ���� | 口腔内快速崩解的药用组合物及其制备方法 |
| AU2003217916A1 (en) | 2002-03-08 | 2003-09-22 | Teva Pharmeceuticals Usa, Inc. | Stable formulations of angiotensin converting enzyme (ace) inhibitors |
| US6698481B1 (en) * | 2002-04-03 | 2004-03-02 | Runflatamerica Corporation | Wheel well obstructor having means for accommodating a plurality of different depths of a wheel well of a wheel rim |
| SI21704A (en) * | 2004-01-14 | 2005-08-31 | Lek Farmacevtska Druzba Dd | New crystal form of perindopril, procedure of its preparation, pharmaceutical preparations containing this form and their application in treatment of hypertensia |
| SI21703A (en) * | 2004-01-14 | 2005-08-31 | Lek Farmacevtska Druzba Dd | Inclusion complexes of perindopril, procedure of their preparation, pharmaceutical compositions containing these complexes and their application in treatment of hypertensia |
| PT1729739T (pt) | 2004-03-29 | 2016-12-01 | Servier Lab | Processo para a preparação de uma composição farmacêutica sólida |
-
2006
- 2006-11-08 RS RS20140267A patent/RS53324B/sr unknown
- 2006-11-08 WO PCT/SI2006/000034 patent/WO2007058634A1/en not_active Ceased
- 2006-11-08 ME MEP-2014-54A patent/ME01879B/me unknown
- 2006-11-08 EP EP06813152.3A patent/EP1948224B1/en active Active
- 2006-11-08 PL PL06813152T patent/PL1948224T3/pl unknown
- 2006-11-08 HR HRP20140476TT patent/HRP20140476T1/hr unknown
- 2006-11-08 RU RU2008123615/15A patent/RU2429878C2/ru not_active IP Right Cessation
- 2006-11-08 PT PT68131523T patent/PT1948224E/pt unknown
- 2006-11-08 SI SI200631785T patent/SI1948224T1/sl unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PT1948224E (pt) | 2014-06-12 |
| SI1948224T1 (sl) | 2014-07-31 |
| RU2429878C2 (ru) | 2011-09-27 |
| WO2007058634A1 (en) | 2007-05-24 |
| WO2007058634B1 (en) | 2007-07-26 |
| RU2008123615A (ru) | 2009-12-27 |
| PL1948224T3 (pl) | 2014-10-31 |
| RS53324B (sr) | 2014-10-31 |
| EP1948224B1 (en) | 2014-03-12 |
| HRP20140476T1 (hr) | 2014-07-18 |
| EP1948224A1 (en) | 2008-07-30 |
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