ME02644B - Novi preparati alfentanila za tretman akutnog bola - Google Patents
Novi preparati alfentanila za tretman akutnog bolaInfo
- Publication number
- ME02644B ME02644B MEP-2017-9A MEP20179A ME02644B ME 02644 B ME02644 B ME 02644B ME P20179 A MEP20179 A ME P20179A ME 02644 B ME02644 B ME 02644B
- Authority
- ME
- Montenegro
- Prior art keywords
- preparation
- alfentanil
- carrier particles
- treatment
- pain
- 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 4
- 208000005298 acute pain Diseases 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 18
- 238000000034 method Methods 0.000 claims 7
- 239000002245 particle Substances 0.000 claims 7
- 239000002253 acid Substances 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 4
- 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
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- 230000036470 plasma concentration Effects 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 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
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 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
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 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
- 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
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000006190 sub-lingual tablet Substances 0.000 claims 1
- 229940098466 sublingual tablet Drugs 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Rheumatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (17)
1. Farmaceutski preparat pogodan za sublingvalnu isporuku, kao i za brzo oslobađanje alfentanila i/ili za brzu resorpciju alfentanila putem oralne sluzokože, koji sadrži smešu sastavljenu od:(a) mikročestica alfentanila, ili njegove farmaceutski prihvatljive soli, naznačenih time, što se mikročestice nalaze na površinama većih čestica nosača;(b) slabe baze; i(c) jedinjenja koje predstavlja slabu kiselinu, naznačenog time, što je kiselina prisutna u bliskoj smeši sa mikročesticama alfentanila ili njegove soli i što je kiselina prisutna bilo:(1) unutar čestica nosača, odnosno tako da navedene čestice nosača sadrže kompozit: (i) navedenog materijala kiseline; i (ii) drugih materijala koji se upotrebljavaju za pripremu čestica nosača; ili (2) na površinama čestica nosača.
2. Preparat prema patentnom zahtjevu 1, naznačen time što kiselina označava limunsku kiselinu.
3. Preparat prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što slaba baza sadrži fosfat.
4. Preparat prema patentnom zahtjevu 3, naznačen time što slaba baza označava trinatrijum fosfat.
5. Preparat prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što čestice nosača sadrže manitol.
6. Farmaceutski preparat prema bilo kojem od prethodnih patentnih zahtjeva koji dalje sadrži sredstvo za razlaganje (dezintegrans).
7. Preparat prema patentnom zahtjevu 6, naznačen time što sredstvo za razlaganje označava superdezintegrans izabran iz grupe koju čine kroskarmeloza-natrijum, natrijum skrob glikolat, umreženi polivinilpirolidon ili njihova smeša.
8. Preparat prema patentnom zahtjevu 1, naznačen time, što je baza rastvorljiva u vodi.
9. Preparat prema bilo kom od prethodnih patentnih zahtjeva, naznačen time što je preparat u obliku tablete koja je pogodna za sublingvalnu primenu.
10. Postupak pripreme preparata definisanog bilo kojim od patentnih zahtjeva od 1 do 9, koji sadrži čestice nosača izmešane postupkom suvog mešanja sa alfentanilom ili njegovom solju.
11. Postupak pripreme sublingvalne tablete definisan u patentnom zahtjevu 9, naznačen time, što postupak obuhvata direktnu kompresiju ili sabijanje preparata definisanog bilo kojim od patetnih zahtjeva od 1 do 8.
12. Preparat prema bilo kojem od patentnih zahtjeva od 1 do 9 za upotrebu u postupku tretmana bola.
13. Preparat za upotrebu prema patentnom zahtjevu 12, naznačen time što bol označava bol umjerenog do jakog intenziteta.
14. Preparat za upotrebu prema patentnom zahtjevu 13, naznačen time, što tretman označava kratkotrajan tretman.
15. Preparat za upotrebu pprema patentnom zahtjevu 13 ili patentnim zahtjevom 14, naznačen time što bol prati dijagnostičke, hirurške ili procedure njege pacijenata.
16. Preparat za upotrebu pema patentnom zahtjevu 15, naznačen time što se preparat primjenjuje u vremenskom periodu koji nije veći od oko 20 minuta prije procedure.
17. Preparat za upotrebu definisanu bilo kojim od patentnih zahtjeva od 12 do 16, naznačen time što postupak tretmana bola obuhvata sublingvalnu primenu humanom pacijentu kome je tretman potreban, farmaceutskog preparata koji sadrži između oko 30 µg i oko 3,000 µg alfentanila ili njegove farmaceutski prihvatljive soli, i što navedena primjena dovodi do krive zavisnosti koncentracije u plazmi i vremena nakon navedene primjene koju karakterišu: (I) tmax (vrijeme potrebno za postizanje maksimalne koncentracije u plazmi) između oko 10 i oko 25 minuta nakon navedene primjene; i/ili (II) tlast (vrijeme poslednje mjerljive koncentracije u plazmi) koji nije veće od oko 300 minuta nakon navedene primjene; i opciono, (III) Cmax (maksimalna koncentracija u plazmi) 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 |
|---|---|
| ME02644B true ME02644B (me) | 2017-06-20 |
Family
ID=48577134
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2017-9A ME02644B (me) | 2012-05-02 | 2013-05-01 | Novi preparati alfentanila za tretman akutnog bola |
Country Status (33)
| Country | Link |
|---|---|
| US (4) | US8815911B2 (me) |
| EP (2) | EP2849730B1 (me) |
| JP (1) | JP6275696B2 (me) |
| KR (1) | KR20150005695A (me) |
| CN (1) | CN104427978B (me) |
| AU (1) | AU2013255640B2 (me) |
| BR (1) | BR112014027213A8 (me) |
| CA (1) | CA2871805A1 (me) |
| CL (1) | CL2014002979A1 (me) |
| CO (1) | CO7170181A2 (me) |
| CY (2) | CY1118570T1 (me) |
| DK (2) | DK3150199T3 (me) |
| EA (1) | EA028110B1 (me) |
| ES (2) | ES2614757T3 (me) |
| HR (2) | HRP20161634T1 (me) |
| HU (1) | HUE031792T2 (me) |
| IL (1) | IL235272B (me) |
| IN (1) | IN2014MN02156A (me) |
| LT (2) | LT2849730T (me) |
| ME (1) | ME02644B (me) |
| MX (1) | MX360665B (me) |
| NZ (1) | NZ701428A (me) |
| PE (1) | PE20142444A1 (me) |
| PH (1) | PH12014502407A1 (me) |
| PL (2) | PL3150199T3 (me) |
| PT (2) | PT3150199T (me) |
| RS (2) | RS57951B1 (me) |
| SG (1) | SG11201407081PA (me) |
| SI (2) | SI3150199T1 (me) |
| SM (3) | SMT201700086T1 (me) |
| TR (1) | TR201815935T4 (me) |
| WO (1) | WO2013164620A1 (me) |
| ZA (1) | ZA201407559B (me) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2915525B1 (en) | 2011-09-19 | 2021-08-11 | Orexo AB | Sublingual abuse-resistant tablets comprising buprenorphine and naloxone |
| SG11201407081PA (en) * | 2012-05-02 | 2014-11-27 | Orexo Ab | New alfentanil composition for the treatment of acute pain |
| US10766925B2 (en) * | 2016-04-11 | 2020-09-08 | Arizona Board Of Regents On Behalf Of The 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 |
| CN115047109B (zh) * | 2022-06-17 | 2024-05-31 | 三明海关综合技术服务中心 | 一种检测食品中芬太尼类新精神活性物质的方法 |
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| US5288497A (en) | 1985-05-01 | 1994-02-22 | The University Of Utah | Compositions of oral dissolvable medicaments |
| US5785989A (en) * | 1985-05-01 | 1998-07-28 | University Utah Research Foundation | Compositions and methods of manufacturing 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 |
| SE9803240D0 (sv) | 1998-09-24 | 1998-09-24 | Diabact Ab | A pharmaceutical composition having a rapid action |
| SE9803239D0 (sv) | 1998-09-24 | 1998-09-24 | Diabact Ab | Composition for the treatment of acute pain |
| GB9904911D0 (en) | 1999-03-03 | 1999-04-28 | Scherer Ltd R P | Pharmaceutical compositions |
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2013
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