HRP20161634T1 - Novi pripravak alfentanila za liječenje akutne boli - Google Patents
Novi pripravak alfentanila za liječenje akutne boli Download PDFInfo
- Publication number
- HRP20161634T1 HRP20161634T1 HRP20161634TT HRP20161634T HRP20161634T1 HR P20161634 T1 HRP20161634 T1 HR P20161634T1 HR P20161634T T HRP20161634T T HR P20161634TT HR P20161634 T HRP20161634 T HR P20161634T HR P20161634 T1 HRP20161634 T1 HR P20161634T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- alfentanil
- preparation according
- carrier particles
- administration
- Prior art date
Links
- IDBPHNDTYPBSNI-UHFFFAOYSA-N N-(1-(2-(4-Ethyl-5-oxo-2-tetrazolin-1-yl)ethyl)-4-(methoxymethyl)-4-piperidyl)propionanilide Chemical compound C1CN(CCN2C(N(CC)N=N2)=O)CCC1(COC)N(C(=O)CC)C1=CC=CC=C1 IDBPHNDTYPBSNI-UHFFFAOYSA-N 0.000 title claims 7
- 229960001391 alfentanil Drugs 0.000 title claims 7
- 208000002193 Pain Diseases 0.000 title claims 6
- 239000000203 mixture Substances 0.000 title claims 6
- 208000005298 acute pain Diseases 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 14
- 239000002245 particle Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 4
- 239000002253 acid Substances 0.000 claims 3
- 239000003795 chemical substances by application Substances 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
- 239000011859 microparticle Substances 0.000 claims 3
- 230000036470 plasma concentration Effects 0.000 claims 3
- 239000000463 material Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 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 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 230000002378 acidificating effect Effects 0.000 claims 1
- 239000002131 composite material Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 238000002405 diagnostic procedure Methods 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 238000007580 dry-mixing Methods 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 210000002200 mouth mucosa Anatomy 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 239000006190 sub-lingual tablet Substances 0.000 claims 1
- 229940098466 sublingual tablet Drugs 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical group [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 claims 1
- 235000019801 trisodium phosphate Nutrition 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-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
- A61K31/435—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
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
-
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/20—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
- A61K9/2013—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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pain & Pain Management (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Zoology (AREA)
- Rheumatology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (17)
1. Farmaceutski pripravak pogodan za sublingvalnu isporuku, kao i za brzo oslobađanje alfentanila iz njega i/ili brzo uzimanje alfentanila kroz sluznicu usta, koji sadrži smjesu naznačenu time da sadrži:
(a) mikročestice alfentanila, ili njegove farmaceutski prihvatljive soli, te su navedene mikročestice iskazane na površinama većih čestica nosača;
(b) slabu bazu; i
(c) spoj koji je slaba kiselina, te je navedena kiselina predstavljena u bliskoj smjesi s mikročesticama alfentanila ili njegovom soli, tako što se nalazi bilo:
(1) unutar čestica nosača, tako da navedene čestice nosača sadrže kompozit od:
(i) navedenog kiselog materijala; i
(ii) drugog materijala čestica nosača; ili
(2) na površinama čestica nosača.
2. Pripravak prema zahtjevu 1, naznačen time da kiselina je limunska kiselina.
3. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da slaba baza sadrži fosfat.
4. Pripravak prema zahtjevu 3, naznačen time da slaba baza je trinatrijev fosfat.
5. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da čestice nosača sadrže manitol.
6. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da dodatno sadrži sredstvo za razgradnju.
7. Pripravak prema zahtjevu 6, naznačen time da sredstvo za razgradnju je super sredstvo za razgradnju odabrano od natrijeve kroskarmeloze, natrijevog škrobnog glikolata, umreženog polivinilpirolidona ili od njihove smjese.
8. Pripravak prema zahtjevu 1, naznačen time da je baza topiva u vodi.
9. Pripravak prema bilo kojem od prethodnih zahtjeva naznačen time da je u obliku tablete prikladne za sublingvalnu primjenu.
10. Postupak za pripremanje pripravka kao što je definirano u bilo kojem od zahtjeva 1 do 9, naznačen time da sadrži suho miješanje čestica nosača s alfentanilom ili njegovom soli.
11. Postupak za pripremanje sublingvalne tablete kao što je definirano u zahtjevu 9, naznačen time da sadrži direktno komprimiranje ili sabijanje pripravka kao što je definirano u bilo kojem od zahtjeva 1 do 8.
12. Pripravak kao što je definirano u bilo kojem od zahtjeva 1 do 9 naznačen time da je za uporabu u postupku liječenja boli.
13. Pripravak za uporabu kao što je definirano u zahtjevu 12, naznačen time da bol je umjerena do jaka bol.
14. Pripravak za uporabu kao što je definirano u zahtjevu 13, naznačen time da je liječenje kratkotrajno.
15. Pripravak za uporabu kao što je definirano u zahtjevu 13 ili zahtjevu 14, naznačen time da je bol povezana sa dijagnostičkim postupkom, kirurškim postupkom ili postupkom povezanim s njegom.
16. Pripravak za uporabu kao što je definirano u zahtjevu 15 naznačen time da se pripravak primjenjuje ne više od oko 20 minuta prije postupka.
17. Pripravak za uporabu kao što je definirano u bilo kojem od zahtjeva 12 do 16, naznačen time da postupak liječenja boli obuhvaća sublingvalnu primjenu pacijentu koji je čovjek kojem je potreban tretman s farmaceutskim pripravkom koji sadrži između oko 30 µg i oko 3,000 µg alfentanila ili njegove farmaceutski prihvatljive soli, pri čemu navedena primjena dovodi do krivulje koncentracija plazme prema vremenu nakon navedene primjene koja ima:
(I) tmax (vrijeme do maksimalne koncentracije u plazmi) koje je između oko 10 i oko 25 minuta nakon navedene primjene; i/ili
(II) tlast (vrijeme do posljednje mjerljive koncentracije u plazmi) koje nije više od oko 300 minuta nakon navedene primjene; te proizvoljno,
(III) Cmax (maksimalna koncentracija u plazmi) koja je između oko 10 i oko 100 ng po mL plazme.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1207701.2A GB201207701D0 (en) | 2012-05-02 | 2012-05-02 | New pharmaceutical composition |
| GBGB1221130.6A GB201221130D0 (en) | 2012-11-23 | 2012-11-23 | New pharmaceutical composition |
| EP13727314.0A EP2849730B1 (en) | 2012-05-02 | 2013-05-01 | New alfentanil composition for the treatment of acute pain |
| PCT/GB2013/051131 WO2013164620A1 (en) | 2012-05-02 | 2013-05-01 | New alfentanil composition for the treatment of acute pain |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161634T1 true HRP20161634T1 (hr) | 2017-01-13 |
Family
ID=48577134
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161634TT HRP20161634T1 (hr) | 2012-05-02 | 2016-12-05 | Novi pripravak alfentanila za liječenje akutne boli |
| HRP20181761TT HRP20181761T1 (hr) | 2012-05-02 | 2018-10-25 | Novi pripravak alfentanila za liječenje akutne boli |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181761TT HRP20181761T1 (hr) | 2012-05-02 | 2018-10-25 | Novi pripravak alfentanila za liječenje akutne boli |
Country Status (34)
| Country | Link |
|---|---|
| US (4) | US8815911B2 (hr) |
| EP (2) | EP2849730B1 (hr) |
| JP (1) | JP6275696B2 (hr) |
| KR (1) | KR20150005695A (hr) |
| CN (1) | CN104427978B (hr) |
| AU (1) | AU2013255640B2 (hr) |
| BR (1) | BR112014027213A8 (hr) |
| CA (1) | CA2871805A1 (hr) |
| CL (1) | CL2014002979A1 (hr) |
| CO (1) | CO7170181A2 (hr) |
| CY (2) | CY1118570T1 (hr) |
| DK (2) | DK3150199T3 (hr) |
| EA (1) | EA028110B1 (hr) |
| ES (2) | ES2614757T3 (hr) |
| HK (1) | HK1203399A1 (hr) |
| HR (2) | HRP20161634T1 (hr) |
| HU (1) | HUE031792T2 (hr) |
| IL (1) | IL235272B (hr) |
| IN (1) | IN2014MN02156A (hr) |
| LT (2) | LT3150199T (hr) |
| ME (1) | ME02644B (hr) |
| MX (1) | MX360665B (hr) |
| NZ (1) | NZ701428A (hr) |
| PE (1) | PE20142444A1 (hr) |
| PH (1) | PH12014502407B1 (hr) |
| PL (2) | PL3150199T3 (hr) |
| PT (2) | PT2849730T (hr) |
| RS (2) | RS55489B1 (hr) |
| SG (1) | SG11201407081PA (hr) |
| SI (2) | SI2849730T1 (hr) |
| SM (1) | SMT201700086B (hr) |
| TR (1) | TR201815935T4 (hr) |
| WO (1) | WO2013164620A1 (hr) |
| ZA (1) | ZA201407559B (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130071477A1 (en) | 2011-09-19 | 2013-03-21 | Orexo Ab | New abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
| SI2849730T1 (sl) * | 2012-05-02 | 2017-02-28 | Orexo Ab | Novi sestavek alfentanila za zdravljenje akutne bolečine |
| WO2017180659A1 (en) * | 2016-04-11 | 2017-10-19 | Arizona Board Of Regents On Behalf Of University Of Arizona | Opioid receptor modulators |
| JP7023054B2 (ja) * | 2017-04-05 | 2022-02-21 | 東和薬品株式会社 | レベチラセタム含有医薬組成物及びその製造方法 |
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| US5785989A (en) * | 1985-05-01 | 1998-07-28 | University Utah Research Foundation | Compositions and methods of manufacturing of oral dissolvable medicaments |
| US5288497A (en) | 1985-05-01 | 1994-02-22 | The University Of Utah | Compositions of oral dissolvable medicaments |
| DE19749724A1 (de) | 1997-11-11 | 1999-06-10 | Gruenenthal Gmbh | Verwendung einer Kombination aus Opioid und alpha-adrenergem Agonisten in Schmerzmitteln |
| SE9803239D0 (sv) | 1998-09-24 | 1998-09-24 | Diabact Ab | Composition for the treatment of acute pain |
| SE9803240D0 (sv) | 1998-09-24 | 1998-09-24 | Diabact Ab | A pharmaceutical composition having a rapid action |
| GB9904911D0 (en) | 1999-03-03 | 1999-04-28 | Scherer Ltd R P | Pharmaceutical compositions |
| US6264981B1 (en) | 1999-10-27 | 2001-07-24 | Anesta Corporation | Oral transmucosal drug dosage using solid solution |
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| JP4850346B2 (ja) | 2001-03-15 | 2012-01-11 | 救急薬品工業株式会社 | 粘膜貼付剤 |
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| US20070104763A1 (en) * | 2005-11-10 | 2007-05-10 | Navinta Llc | Composition of fentanyl citrate oral solid transmucosal dosage form, excipient and binding material therefore, and methods of making |
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