HRP20110336T1 - Pretežno linearni efervescentni oralni oblik doziranja fentanila i postupci davanja - Google Patents
Pretežno linearni efervescentni oralni oblik doziranja fentanila i postupci davanja Download PDFInfo
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- HRP20110336T1 HRP20110336T1 HR20110336T HRP20110336T HRP20110336T1 HR P20110336 T1 HRP20110336 T1 HR P20110336T1 HR 20110336 T HR20110336 T HR 20110336T HR P20110336 T HRP20110336 T HR P20110336T HR P20110336 T1 HRP20110336 T1 HR P20110336T1
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- dosage form
- fentanyl
- amount
- weight
- tablet
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- 239000002552 dosage form Substances 0.000 title claims abstract 32
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 title claims abstract 16
- 229960002428 fentanyl Drugs 0.000 title claims abstract 16
- 238000000034 method Methods 0.000 title claims abstract 8
- 210000002200 mouth mucosa Anatomy 0.000 claims abstract 7
- 239000000203 mixture Substances 0.000 claims abstract 5
- 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 7
- 229930195725 Mannitol Natural products 0.000 claims 7
- 239000000594 mannitol Substances 0.000 claims 7
- 235000010355 mannitol Nutrition 0.000 claims 7
- 239000000126 substance Substances 0.000 claims 6
- 239000003826 tablet Substances 0.000 claims 6
- 229940071117 starch glycolate Drugs 0.000 claims 5
- 239000000945 filler Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 208000002193 Pain Diseases 0.000 claims 3
- 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 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 239000012458 free base Substances 0.000 claims 2
- 229960001021 lactose monohydrate Drugs 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 208000008035 Back Pain Diseases 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 1
- 206010058019 Cancer Pain Diseases 0.000 claims 1
- 208000004550 Postoperative Pain Diseases 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 239000002585 base Substances 0.000 claims 1
- 125000005587 carbonate group Chemical group 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000007891 compressed tablet Substances 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 208000004296 neuralgia Diseases 0.000 claims 1
- 208000021722 neuropathic pain Diseases 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 238000010979 pH adjustment Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 abstract 1
Classifications
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- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
- 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
-
- 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
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Physiology (AREA)
- Rheumatology (AREA)
- Nutrition Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Oblik doziranja naznačen time da sadrži 90 do 880 mikrograma fentanila, izračunato kao slobodna baza fentanila, ili ekvivalentnu količinu njegove soli, efervescentni par u količini od 5 do 85% težinskih od oblika doziranja, tvar za podešavanje pH u količini od 0,5 do 25% težinskih od oblika doziranja, škrob glikolat u količini od 0,25 do 20 težinskih od oblika doziranja, i manitol, a navedeni oblik doziranja je pogodan za dostavljanje navedenog fentanila kroz oralnu sluznicu pacijenta bukalnom, gingivalnom ili sublingvalnom primjenom. Patent sadrži još 19 patentnih zahtjeva.
Claims (20)
1. Oblik doziranja naznačen time da sadrži 90 do 880 mikrograma fentanila, izračunato kao slobodna baza fentanila, ili ekvivalentnu količinu njegove soli, efervescentni par u količini od 5 do 85% težinskih od oblika doziranja, tvar za podešavanje pH u količini od 0,5 do 25% težinskih od oblika doziranja, škrob glikolat u količini od 0,25 do 20 težinskih od oblika doziranja, i manitol, a navedeni oblik doziranja je pogodan za dostavljanje navedenog fentanila kroz oralnu sluznicu pacijenta bukalnom, gingivalnom ili sublingvalnom primjenom.
2. Oblik doziranja prema patentnom zahtjevu 1 naznačen time da je navedena tvar za podešavanje pH odabrana i dana u količini koja može pružiti promjenu u lokaliziranom pH od najmanje 0,5 pH jedinica.
3. Oblik doziranja prema patentnom zahtjevu 2 naznačen time da je navedena tvar za podešavanje pH karbonat ili bikarbonat.
4. Oblik doziranja prema patentnom zahtjevu 1 naznačen time da je navedeni manitol prisutan u količini od između 10 i 80% w/w.
5. Oblik doziranja prema patentnom zahtjevu 1 naznačen time da je komprimirana tableta.
6. Oblik doziranja prema patentnom zahtjevu 1 naznačen time da je omjer Cmax prema dozi između 2,0 i 4,0 pikograma/mL/mikrogramu.
7. Oblik doziranja prema patentnom zahtjevu 6 naznačen time da je omjer Cmax prema dozi između 2,5 i 3,5 pikograma/mL/mikrogramu.
8. Oblik doziranja prema patentnom zahtjevu 7 naznačen time da je omjer Cmax prema dozi između 2,7 i 3,6 pikograma/mL/mikrogramu.
9. Oblik doziranja naznačen time da sadrži 90 do 880 mikrograma fentanila, izračunato kao slobodna baza fentanila, ili ekvivalentnu količinu njegove soli, efervescentni par, tvar za podešavanje pH, navedena tvar za podešavanje je odabrana i dana u količini koja može pružiti promjenu u lokaliziranom pH od najmanje 0,5 pH jedinica, manitol i škrob glikolat, navedeni oblik doziranja je pogodan za dostavljanje navedenog fentanila kroz oralnu sluznicu pacijenta bukalnom, gingivalnom ili sublingvalnom primjenom i daje omjer Cmax prema dozi između 2,0 i 4,0 pikograma/mL/mikrogramu, pri čemu navedeni oblik doziranja treba biti u bliskom kontaktu sa navedenom oralnom sluznicom tijekom vremena dovoljnog da se dostavi terapeutski djelotvorna količina navedenog fentanila preko navedene oralne sluznice, za upotrebu kod liječenja boli.
10. Oblik doziranja za upotrebu prema zahtjevu 9, naznačen time da se navedeni oblik doziranja drži u kontaktu sa navedenom oralnom sluznicom u vremenu od između 10 i 30 minuta.
11. Oblik doziranja za upotrebu prema zahtjevu 9, naznačen time da se navedeni oblik doziranja drži u kontaktu sa navedenom oralnom sluznicom u vremenskom periodu dovoljnom da osigura apsorbciju barem 75% navedene doze fentanila u krvotok navedenog pacijenta..
12. Oblik doziranja za upotrebu prema zahtjevu 9, naznačen time da je navedena bol odabrana iz skupine koja se sastoji od cijelokupne boli zbog raka, boli u leđima, neuropatske boli, operativne boli ili post-operativne boli.
13. Postupak za izradu tablete za bukalnu, gingivalnu ili sublingvalnu primjenu fentanila naznačen time da sadrži korake: davanja fentanila ili njegove soli u količini od između 90 i 880 mikrograma po dozi mjereno kao baza fentanila, ili ekvivalentne količine njegove soli, pružanja efervescentnog para u količini od 5 do 85% težinskih od oblika doziranja, tvari za podešavanje pH u količini od 0,5 do 25% težinskih od oblika doziranja, škrob glikolata u količini od 0,25 do 20% težinskih od oblika doziranja i punila u količini od između 10% i 80% težinskih od oblika doziranja, pri čemu navedeno punilo obuhvaća manitol, te miješanja navedenog manitola, efervescentnog para, tvari za podešavanje pH, navedenog škrob glikolata i navedenog punila, te kompresije dobivene smjese u barem jednu tabletu.
14. Postupak prema patentnom zahtjevu 13 naznačen time da je navedeni manitol raspršivanjem sušeni manitol.
15. Postupak prema patentnom zahtjevu 13 naznačen time da nadalje sadrži korak dodavanja lubrikanta navedenoj smjesi prije kompresije smjese u barem jednu tabletu.
16. Postupak prema patentnom zahtjevu 15 naznačen time da nadalje sadrži korak mješanja navedenog lubrikanta sa navedenim fentanilom, efervescentnim parom, tvari za podešavanje pH, škrob glikolatom i navedenim punilom prije kompresije dobivene smjese u barem jednu tabletu.
17. Postupak prema patentnom zahtjevu 16 naznačen time da je navedena tableta komprimirana do tvrdoće od između 5 i 100 Newton-a.
18. Postupak prema patentnom zahtjevu 13 naznačen time da je navedena tableta komprimirana do tvrdoće od između 15 i 100 Newton-a.
19. Oblik doziranja prema patentnom zahtjevu 1 ili 9, naznačen time da oblik doziranja sadrži ne više od približno 10% težinskih laktoza monohidrata ili mikrokristalne celuloze i ne više od približno 4% unakrsno povezanog PVP.
20. Oblik doziranja prema patentnom zahtjevu 1 ili 9, naznačen time da je oblik doziranja oslobođen od svih osim slučajnih količina laktoza monohidrata, mikrokristalne celuloze ili unakrsno povezanog PVP.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US53361903P | 2003-12-31 | 2003-12-31 | |
| US61566504P | 2004-10-04 | 2004-10-04 | |
| PCT/US2004/043703 WO2005065319A2 (en) | 2003-12-31 | 2004-12-30 | Generally linear effervescent oral fentanyl dosage form and methods of administering |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20110336T1 true HRP20110336T1 (hr) | 2011-07-31 |
Family
ID=34753002
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20110336T HRP20110336T1 (hr) | 2003-12-31 | 2011-05-06 | Pretežno linearni efervescentni oralni oblik doziranja fentanila i postupci davanja |
Country Status (23)
| Country | Link |
|---|---|
| US (3) | US7862832B2 (hr) |
| EP (1) | EP1708686B1 (hr) |
| JP (2) | JP2007517054A (hr) |
| KR (1) | KR101184138B1 (hr) |
| CN (1) | CN102078310B (hr) |
| AT (1) | ATE498395T1 (hr) |
| AU (1) | AU2004311880B2 (hr) |
| BR (1) | BRPI0418228B8 (hr) |
| CA (1) | CA2548915C (hr) |
| CY (1) | CY1111458T1 (hr) |
| DE (1) | DE602004031462D1 (hr) |
| DK (1) | DK1708686T3 (hr) |
| EA (1) | EA010826B1 (hr) |
| HK (1) | HK1100480A1 (hr) |
| HR (1) | HRP20110336T1 (hr) |
| IL (1) | IL176449A (hr) |
| ME (1) | ME01300B (hr) |
| NO (1) | NO338714B1 (hr) |
| NZ (1) | NZ548216A (hr) |
| PL (1) | PL1708686T3 (hr) |
| PT (1) | PT1708686E (hr) |
| RS (1) | RS51713B (hr) |
| WO (1) | WO2005065319A2 (hr) |
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| US6974590B2 (en) * | 1998-03-27 | 2005-12-13 | Cima Labs Inc. | Sublingual buccal effervescent |
| US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
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| JP5244318B2 (ja) * | 2003-12-31 | 2013-07-24 | シーマ・ラブス、インコーポレイテッド | 発泡性経口アヘン薬投薬形態およびアヘン薬の投与方法 |
| KR101184138B1 (ko) * | 2003-12-31 | 2012-09-19 | 시마 랩스 인크. | 일반적인 선형 발포성 경구 펜타닐 투약 제형 및 투여 방법 |
| US7858121B2 (en) * | 2003-12-31 | 2010-12-28 | Cima Labs, Inc. | Effervescent oral fentanyl dosage form and methods of administering fentanyl |
| US7658945B2 (en) * | 2004-02-17 | 2010-02-09 | Transcept Pharmaceuticals, Inc. | Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof |
| US20070225322A1 (en) * | 2005-05-25 | 2007-09-27 | Transoral Pharmaceuticals, Inc. | Compositions and methods for treating middle-of-the night insomnia |
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