EA010826B1 - Лекарственная форма фентанила для перорального применения, способ ее получения и способы лечения - Google Patents
Лекарственная форма фентанила для перорального применения, способ ее получения и способы лечения Download PDFInfo
- Publication number
- EA010826B1 EA010826B1 EA200601253A EA200601253A EA010826B1 EA 010826 B1 EA010826 B1 EA 010826B1 EA 200601253 A EA200601253 A EA 200601253A EA 200601253 A EA200601253 A EA 200601253A EA 010826 B1 EA010826 B1 EA 010826B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- dosage form
- fentanyl
- dose
- max
- amount
- Prior art date
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- ZTERWYZERRBKHF-UHFFFAOYSA-N magnesium iron(2+) oxygen(2-) Chemical compound [Mg+2].[O-2].[Fe+2].[O-2] ZTERWYZERRBKHF-UHFFFAOYSA-N 0.000 description 1
- YUXGMGTTWAVBPN-UHFFFAOYSA-N magnesium;octadecanoic acid;oxygen(2-) Chemical compound [O-2].[Mg+2].CCCCCCCCCCCCCCCCCC(O)=O YUXGMGTTWAVBPN-UHFFFAOYSA-N 0.000 description 1
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- 230000003533 narcotic effect Effects 0.000 description 1
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
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- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
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- 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
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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
- A61K31/21—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
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Rheumatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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 (2)
| Publication Number | Publication Date |
|---|---|
| EA200601253A1 EA200601253A1 (ru) | 2006-12-29 |
| EA010826B1 true EA010826B1 (ru) | 2008-12-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA200601253A EA010826B1 (ru) | 2003-12-31 | 2004-12-30 | Лекарственная форма фентанила для перорального применения, способ ее получения и способы лечения |
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| US (3) | US7862832B2 (https=) |
| EP (1) | EP1708686B1 (https=) |
| JP (2) | JP2007517054A (https=) |
| KR (1) | KR101184138B1 (https=) |
| CN (1) | CN102078310B (https=) |
| AT (1) | ATE498395T1 (https=) |
| AU (1) | AU2004311880B2 (https=) |
| BR (1) | BRPI0418228B8 (https=) |
| CA (1) | CA2548915C (https=) |
| CY (1) | CY1111458T1 (https=) |
| DE (1) | DE602004031462D1 (https=) |
| DK (1) | DK1708686T3 (https=) |
| EA (1) | EA010826B1 (https=) |
| HR (1) | HRP20110336T1 (https=) |
| IL (1) | IL176449A (https=) |
| ME (1) | ME01300B (https=) |
| NO (1) | NO338714B1 (https=) |
| NZ (1) | NZ548216A (https=) |
| PL (1) | PL1708686T3 (https=) |
| PT (1) | PT1708686E (https=) |
| RS (1) | RS51713B (https=) |
| WO (1) | WO2005065319A2 (https=) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9486527B2 (en) | 2009-05-08 | 2016-11-08 | Emplicure Ab | Composition for sustained drug delivery comprising geopolymeric binder |
| US10251834B2 (en) | 2010-09-07 | 2019-04-09 | Emplicure Ab | Transdermal drug administration device |
| US10543203B2 (en) | 2009-03-04 | 2020-01-28 | Emplicure Ab | Abuse resistant formula |
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|---|---|---|---|---|
| US6974590B2 (en) * | 1998-03-27 | 2005-12-13 | Cima Labs Inc. | Sublingual buccal effervescent |
| US20030091629A1 (en) * | 1998-03-27 | 2003-05-15 | Cima Labs Inc. | Sublingual buccal effervescent |
| US20030118645A1 (en) * | 1998-04-29 | 2003-06-26 | Pather S. Indiran | Pharmaceutical compositions for rectal and vaginal administration |
| US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
| KR100889069B1 (ko) | 1999-10-29 | 2009-03-17 | 유로-셀티크 소시에떼 아노뉨 | 서방성 하이드로코돈 제형 |
| AU2738302A (en) | 2000-10-30 | 2002-05-15 | Euro Celtique Sa | Controlled release hydrocodone formulations |
| US20030068356A1 (en) * | 2001-07-10 | 2003-04-10 | Pather S. Indiran | Sequential drug delivery systems |
| US7862833B2 (en) * | 2003-12-31 | 2011-01-04 | Cima Labs, Inc. | Effervescent oral opiate dosage forms and methods of administering opiates |
| CN102078310B (zh) | 2003-12-31 | 2013-01-23 | 奇马实验室公司 | 大体线性的泡腾口服芬太尼剂型和施用方法 |
| WO2005065317A2 (en) | 2003-12-31 | 2005-07-21 | Cima Labs Inc. | Effervescent oral fentanyl dosage form |
| EP1715853A4 (en) | 2004-02-17 | 2012-07-18 | Transcept Pharmaceuticals Inc | COMPOSITIONS FOR THE DISTRIBUTION OF HYPNOTICS IN THE FIELD OF MUNICHCHLEIMHÄUTE AND USE METHOD THEREOF |
| US20070225322A1 (en) * | 2005-05-25 | 2007-09-27 | Transoral Pharmaceuticals, Inc. | Compositions and methods for treating middle-of-the night insomnia |
| US20070123562A1 (en) * | 2005-05-25 | 2007-05-31 | Transoral Pharmaceuticals, Inc. | Compositions and methods for treating middle-of-the-night insomnia |
| US20070287740A1 (en) * | 2005-05-25 | 2007-12-13 | Transcept Pharmaceuticals, Inc. | Compositions and methods of treating middle-of-the night insomnia |
| US20070020186A1 (en) * | 2005-07-22 | 2007-01-25 | Alpex Pharma S.A. | Solid dosage formulations of narcotic drugs having improved buccal adsorption |
| 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 |
| US8535714B2 (en) | 2006-01-06 | 2013-09-17 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US8357114B2 (en) | 2006-01-06 | 2013-01-22 | Acelrx Pharmaceuticals, Inc. | Drug dispensing device with flexible push rod |
| US8865743B2 (en) | 2006-01-06 | 2014-10-21 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US9066847B2 (en) * | 2007-01-05 | 2015-06-30 | Aceirx Pharmaceuticals, Inc. | Storage and dispensing devices for administration of oral transmucosal dosage forms |
| US8753308B2 (en) | 2006-01-06 | 2014-06-17 | Acelrx Pharmaceuticals, Inc. | Methods for administering small volume oral transmucosal dosage forms using a dispensing device |
| US8202535B2 (en) | 2006-01-06 | 2012-06-19 | Acelrx Pharmaceuticals, Inc. | Small-volume oral transmucosal dosage forms |
| US8252328B2 (en) * | 2006-01-06 | 2012-08-28 | Acelrx Pharmaceuticals, Inc. | Bioadhesive drug formulations for oral transmucosal delivery |
| US9289583B2 (en) * | 2006-01-06 | 2016-03-22 | Acelrx Pharmaceuticals, Inc. | Methods for administering small volume oral transmucosal dosage forms using a dispensing device |
| US8252329B2 (en) | 2007-01-05 | 2012-08-28 | Acelrx Pharmaceuticals, Inc. | Bioadhesive drug formulations for oral transmucosal delivery |
| US20070260491A1 (en) * | 2006-05-08 | 2007-11-08 | Pamela Palmer | System for delivery and monitoring of administration of controlled substances |
| US20080069891A1 (en) | 2006-09-15 | 2008-03-20 | Cima Labs, Inc. | Abuse resistant drug formulation |
| US20070299687A1 (en) * | 2006-06-23 | 2007-12-27 | Pamela Palmer | Inpatient system for patient-controlled delivery of oral transmucosal medications dosed as needed |
| US8445018B2 (en) | 2006-09-15 | 2013-05-21 | Cima Labs Inc. | Abuse resistant drug formulation |
| US20080090874A1 (en) * | 2006-09-20 | 2008-04-17 | Messina John C Jr | Treatment of breakthrough pain in patients suffering from chronic low back pain |
| US20080132535A1 (en) * | 2006-11-30 | 2008-06-05 | Transcept Pharmaceuticals, Inc. | Stabilized Zolpidem Pharmaceutical Compositions |
| BRPI0719428A2 (pt) * | 2006-12-01 | 2014-02-25 | Cima Labs Inc | Forma de dosagem transmucosal oral sólida, método para tratar dependência de nicotina em um receptor que deseja tal tratamento, sistema de distribuição de nicotina transmucosal oral, e, método de substituíção de nicotina. |
| US20090214442A1 (en) * | 2006-12-01 | 2009-08-27 | Cephalon, Inc. | Oral Transmucosal Nicotine Dosage Form |
| CA2677281C (en) * | 2007-02-09 | 2019-10-29 | Durect Corporation | Transoral dosage forms comprising sufentanil and naloxone |
| US20080287494A1 (en) * | 2007-04-24 | 2008-11-20 | Cephalon, Inc. | Transmucosal treatment methods in patients with mucositis |
| NZ580967A (en) | 2007-05-01 | 2012-04-27 | Cephalon Inc | Composition comprising a bile salt and an effervescent excipient component for transmucosal delivery of polypeptides |
| EP2604257B1 (en) * | 2007-08-07 | 2017-06-28 | Acelrx Pharmaceuticals, Inc. | Oral transmucosal dosage forms comprising sufentanil and triazolam |
| ITMI20071971A1 (it) * | 2007-10-10 | 2009-04-11 | Altergon Sa | Composizione farmaceutica per la somministrazione sublinguale di progesterone, e metodo per la sua preparazione |
| US8945592B2 (en) | 2008-11-21 | 2015-02-03 | Acelrx Pharmaceuticals, Inc. | Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same |
| CA2798702A1 (en) | 2010-05-11 | 2011-11-17 | Cima Labs Inc. | Alcoholresistant metoprolol-containing extended-release oral dosage forms |
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| EP3150199B1 (en) | 2012-05-02 | 2018-08-08 | Orexo AB | New alfentanil composition for the treatment of acute pain |
| CN105407925A (zh) * | 2013-03-15 | 2016-03-16 | 迈兰公司 | 用于泡腾剂型的制造工艺 |
| NZ732808A (en) | 2014-12-23 | 2021-12-24 | Acelrx Pharmaceuticals Inc | Systems, devices and methods for dispensing oral transmucosal dosage forms |
| NO20171457A1 (no) * | 2016-12-20 | 2018-06-21 | X Ing As | Effervesent sugetablett |
| WO2018117855A1 (en) * | 2016-12-20 | 2018-06-28 | X-Ing As | Effervescent lozenge |
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| US6200604B1 (en) * | 1998-03-27 | 2001-03-13 | Cima Labs Inc. | Sublingual buccal effervescent |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US10543203B2 (en) | 2009-03-04 | 2020-01-28 | Emplicure Ab | Abuse resistant formula |
| US9486527B2 (en) | 2009-05-08 | 2016-11-08 | Emplicure Ab | Composition for sustained drug delivery comprising geopolymeric binder |
| EA027618B1 (ru) * | 2009-05-08 | 2017-08-31 | Эмпликюре Аб | Композиция для непрерывной доставки лекарственного средства, содержащая геополимерное связующее |
| US10092652B2 (en) | 2009-05-08 | 2018-10-09 | Emplicure Ab | Composition for sustained drug delivery comprising geopolymeric binder |
| US10251834B2 (en) | 2010-09-07 | 2019-04-09 | Emplicure Ab | Transdermal drug administration device |
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