HRP20151063T1 - Kruti pripravci koji sadrže flurbiprofen, postupci za njihovu pripravu i njihova uporaba - Google Patents
Kruti pripravci koji sadrže flurbiprofen, postupci za njihovu pripravu i njihova uporaba Download PDFInfo
- Publication number
- HRP20151063T1 HRP20151063T1 HRP20151063TT HRP20151063T HRP20151063T1 HR P20151063 T1 HRP20151063 T1 HR P20151063T1 HR P20151063T T HRP20151063T T HR P20151063TT HR P20151063 T HRP20151063 T HR P20151063T HR P20151063 T1 HRP20151063 T1 HR P20151063T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- flurbiprofen
- amount
- preparation according
- pharmaceutically acceptable
- Prior art date
Links
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 title 1
- 239000008247 solid mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 10
- 229960002390 flurbiprofen Drugs 0.000 claims 7
- SYTBZMRGLBWNTM-UHFFFAOYSA-N flurbiprofen Chemical compound FC1=CC(C(C(O)=O)C)=CC=C1C1=CC=CC=C1 SYTBZMRGLBWNTM-UHFFFAOYSA-N 0.000 claims 5
- 239000007787 solid Substances 0.000 claims 5
- GNWCZBXSKIIURR-UHFFFAOYSA-N (2-docosanoyloxy-3-hydroxypropyl) docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(CO)OC(=O)CCCCCCCCCCCCCCCCCCCCC GNWCZBXSKIIURR-UHFFFAOYSA-N 0.000 claims 2
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 235000006679 Mentha X verticillata Nutrition 0.000 claims 2
- 235000002899 Mentha suaveolens Nutrition 0.000 claims 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 claims 2
- 229960004998 acesulfame potassium Drugs 0.000 claims 2
- 235000010358 acesulfame potassium Nutrition 0.000 claims 2
- 239000000619 acesulfame-K Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 229920001531 copovidone Polymers 0.000 claims 2
- 150000002148 esters Chemical class 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 206010061218 Inflammation Diseases 0.000 claims 1
- 239000003242 anti bacterial agent Substances 0.000 claims 1
- 230000000844 anti-bacterial effect Effects 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 235000019568 aromas Nutrition 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 229940061600 flurbiprofen 8.75 mg Drugs 0.000 claims 1
- 235000013355 food flavoring agent Nutrition 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 239000007937 lozenge Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
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
- A61K9/2004—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0063—Periodont
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (11)
1. Kruti farmaceutski pripravak za proizvodnju oralnih oblika doziranja, u obliku pastila, naznačen time da je bez glukoze i sadrži:
- flurbiprofen, ili njegovu farmaceutski prihvatljivu sol ili ester, u količini od između 2.5 do 20.0 mg, te farmaceutski prihvatljive pomoćne tvari, prema sljedećim postocima:
- Flurbiprofen: 0.25-1.0% (w/w)
- sredstvo(a) za podmazivanje: glicerol dibehenat, 1.0-5.0% (w/w)
- zaslađivač(i): kalijev acesulfam, 0.5-5.0% (w/w)
- sredstvo(a) za razrjeđivanje: manitol, 84.0-98.0% (w/w)
- vezivno sredstvo(a): kopovidon, 0.25-5.0% (w/w).
2. Kruti farmaceutski pripravak prema zahtjevu 1 naznačen time da u svakoj jedinici doziranja sadrži količinu flurbiprofena od 5.0 do 15.0 mg.
3. Kruti farmaceutski pripravak prema zahtjevu 2 naznačen time da sadrži jedno ili više dodatnih sredstava odabranih od sredstava za aromu, sredstva za neprozirnost, pufera, antioksidansa, antibakterijskih, te antiseptičkih sredstava.
4. Kruti farmaceutski pripravak prema zahtjevu 3 naznačen time da sadrži arome, naročito aromu mente u količini od 2.0% do 10.0% (w/w) u odnosu na težinu pripravka.
5. Farmaceutski pripravak prema zahtjevu 4 naznačen time da je količina flurbiprofena u svakoj jedinici doziranja u količini od između 5.0 i 15.0 mg.
6. Farmaceutski pripravak prema zahtjevu 1 naznačen time da sadrži flurbiprofen, ili njegovu farmaceutski prihvatljivu sol ili ester i farmaceutski prihvatljive pomoćne tvari u slijedećim količinama u svakoj jedinici doziranja: flurbiprofen 8.75 mg, glicerol dibehenat 20.00 mg, kalijev acesulfam 8.00 mg, manitol 913.25 mg i kopovidon 5.00 mg.
7. Farmaceutski pripravak prema zahtjevu 6 naznačen time da sadrži 45 mg balzamične arome mente.
8. Farmaceutski pripravak prema zahtjevu 6 naznačen time da sadrži količinu flurbiprofena od 0.25% do 1.0% (w/w) sa ukupnom težinom pripravka manjom od 2 g.
9. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 8 naznačen time da je za uporabu kao lijek.
10. Farmaceutski pripravak za uporabu prema zahtjevu 9 naznačen time da je za uporabu za liječenje upala usne šupljine.
11. Farmaceutski pripravak za uporabu prema zahtjevu 10 dodatno naznačen time da se flurbiprofen daje pacijentima u krutom stanju.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITBO2010A000731A IT1406107B1 (it) | 2010-12-13 | 2010-12-13 | Composizioni solide comprendenti antiinfiammatori non steroidei, processi per la loro preparazione e loro uso. |
| PCT/IB2011/055320 WO2012080882A1 (en) | 2010-12-13 | 2011-11-28 | Solid compositions containing nonsteroidal anti-inflammatory drugs, the processes for their preparation and their use. |
| EP11799845.0A EP2651392B1 (en) | 2010-12-13 | 2011-11-28 | Solid compositions containing flurbiprofen, the processes for their preparation and their use. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20151063T1 true HRP20151063T1 (hr) | 2015-11-06 |
Family
ID=43736763
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20151063TT HRP20151063T1 (hr) | 2010-12-13 | 2015-10-06 | Kruti pripravci koji sadrže flurbiprofen, postupci za njihovu pripravu i njihova uporaba |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP2651392B1 (hr) |
| DK (1) | DK2651392T3 (hr) |
| ES (1) | ES2547419T3 (hr) |
| HR (1) | HRP20151063T1 (hr) |
| HU (1) | HUE026092T2 (hr) |
| IT (1) | IT1406107B1 (hr) |
| PL (1) | PL2651392T3 (hr) |
| PT (1) | PT2651392E (hr) |
| RS (1) | RS54308B1 (hr) |
| SI (1) | SI2651392T1 (hr) |
| WO (1) | WO2012080882A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020204142A1 (ja) * | 2019-04-03 | 2020-10-08 | アステラス製薬株式会社 | 医薬組成物 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9705989D0 (en) * | 1997-03-22 | 1997-05-07 | Boots Co Plc | Therapeutic composition |
| GB9710521D0 (en) * | 1997-05-22 | 1997-07-16 | Boots Co Plc | Process |
| GB0113843D0 (en) * | 2001-06-07 | 2001-08-01 | Boots Co Plc | Therapeutic agents |
| CA2677125C (en) * | 2007-02-01 | 2018-07-10 | Myriad Genetics, Inc. | Drug substance preparations, pharmaceutical compositions and dosage forms |
| TR200703092A1 (tr) * | 2007-05-08 | 2008-12-22 | SANOVEL �LA� SAN. VE TiC. A.�. | Flurbiprofen ve kas gevşetici kombinasyonları |
-
2010
- 2010-12-13 IT ITBO2010A000731A patent/IT1406107B1/it active
-
2011
- 2011-11-28 PT PT117998450T patent/PT2651392E/pt unknown
- 2011-11-28 DK DK11799845.0T patent/DK2651392T3/en active
- 2011-11-28 WO PCT/IB2011/055320 patent/WO2012080882A1/en active Application Filing
- 2011-11-28 RS RS20150629A patent/RS54308B1/en unknown
- 2011-11-28 HU HUE11799845A patent/HUE026092T2/en unknown
- 2011-11-28 SI SI201130618T patent/SI2651392T1/sl unknown
- 2011-11-28 ES ES11799845.0T patent/ES2547419T3/es active Active
- 2011-11-28 PL PL11799845T patent/PL2651392T3/pl unknown
- 2011-11-28 EP EP11799845.0A patent/EP2651392B1/en active Active
-
2015
- 2015-10-06 HR HRP20151063TT patent/HRP20151063T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HUE026092T2 (en) | 2016-05-30 |
| PL2651392T3 (pl) | 2015-12-31 |
| EP2651392A1 (en) | 2013-10-23 |
| WO2012080882A1 (en) | 2012-06-21 |
| ES2547419T3 (es) | 2015-10-06 |
| DK2651392T3 (en) | 2015-10-12 |
| PT2651392E (pt) | 2015-10-29 |
| IT1406107B1 (it) | 2014-02-14 |
| SI2651392T1 (sl) | 2015-11-30 |
| EP2651392B1 (en) | 2015-08-19 |
| ITBO20100731A1 (it) | 2012-06-14 |
| RS54308B1 (en) | 2016-02-29 |
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