WO2011077169A3 - Pharmaceutical preparation comprising sufentanil - Google Patents

Pharmaceutical preparation comprising sufentanil Download PDF

Info

Publication number
WO2011077169A3
WO2011077169A3 PCT/GB2010/052210 GB2010052210W WO2011077169A3 WO 2011077169 A3 WO2011077169 A3 WO 2011077169A3 GB 2010052210 W GB2010052210 W GB 2010052210W WO 2011077169 A3 WO2011077169 A3 WO 2011077169A3
Authority
WO
WIPO (PCT)
Prior art keywords
sufentanil
formulation
pharmaceutical preparation
water
provides
Prior art date
Application number
PCT/GB2010/052210
Other languages
French (fr)
Other versions
WO2011077169A2 (en
Inventor
Steven Sansom
Eddie O'keeffe
Original Assignee
Norwich Pharma Technologies Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Norwich Pharma Technologies Limited filed Critical Norwich Pharma Technologies Limited
Publication of WO2011077169A2 publication Critical patent/WO2011077169A2/en
Publication of WO2011077169A3 publication Critical patent/WO2011077169A3/en

Links

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
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/08—Solutions
    • 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)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A pharmaceutical formulation to be delivered sublingually by spray comprising: sufentanil or a pharmaceutically acceptable salt thereof; an alcohol; and water and/or an aqueous buffer. Preferably the formulation comprises 0.01 %w/w sufentanil citrate, 0.1 %w/w sodium saccharin, 17.99 %w/w ethanol; and 81.90 %w/w water.The formulation is primarily for analgesia. The invention also provides for the use of sufentanil as a sublingual spray for the treatment of pain, and provides a single use sublingual spray canister pre-loaded with the formulation.
PCT/GB2010/052210 2009-12-24 2010-12-23 Pharmaceutical preparation WO2011077169A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0922537.6 2009-12-24
GB0922537A GB2476494A (en) 2009-12-24 2009-12-24 Formulation for the sublingual delivery of sufentanil

Publications (2)

Publication Number Publication Date
WO2011077169A2 WO2011077169A2 (en) 2011-06-30
WO2011077169A3 true WO2011077169A3 (en) 2012-03-15

Family

ID=41716886

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2010/052210 WO2011077169A2 (en) 2009-12-24 2010-12-23 Pharmaceutical preparation

Country Status (2)

Country Link
GB (1) GB2476494A (en)
WO (1) WO2011077169A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2487007B (en) * 2012-03-19 2013-06-05 Londonpharma Ltd COC containers and delivery devices for the sublingual administration of opioids
WO2016164158A1 (en) * 2015-04-09 2016-10-13 Insys Development Company, Inc. Ketorolac sublingual spray formulations

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030190290A1 (en) * 2000-06-22 2003-10-09 Calvin Ross Pharmaceutical compositions
WO2004043428A2 (en) * 2002-08-29 2004-05-27 Novadel Pharma Inc. Buccal, polar and non-polar spray or capsule containing drugs for treating pain
WO2004080382A2 (en) * 2003-03-11 2004-09-23 Arakis Ltd. Novel compositions containing fentanyl
WO2008100434A1 (en) * 2007-02-09 2008-08-21 Durect Corporation Transoral dosage forms comprising sufentanil and naloxone

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0514043D0 (en) * 2005-07-08 2005-08-17 Arakis Ltd Fentanyl formulation
GB2441129B (en) * 2006-08-26 2008-11-26 Norwich Pharma Technologies Ltd Dosage Dispensing Canister

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030190290A1 (en) * 2000-06-22 2003-10-09 Calvin Ross Pharmaceutical compositions
WO2004043428A2 (en) * 2002-08-29 2004-05-27 Novadel Pharma Inc. Buccal, polar and non-polar spray or capsule containing drugs for treating pain
WO2004080382A2 (en) * 2003-03-11 2004-09-23 Arakis Ltd. Novel compositions containing fentanyl
WO2008100434A1 (en) * 2007-02-09 2008-08-21 Durect Corporation Transoral dosage forms comprising sufentanil and naloxone

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"ETHANOL (96 PER CENT)", EUROPEAN PHARMACOPOEIA, 1 January 2005 (2005-01-01), pages 1545 - 1547, XP055016745, Retrieved from the Internet <URL:http://lib.njutcm.edu.cn/yaodian/ep/EP5.0/16_monographs/monographs_d-k/Ethanol%20(96%20per%20cent).pdf> [retrieved on 20120117] *

Also Published As

Publication number Publication date
GB0922537D0 (en) 2010-02-10
WO2011077169A2 (en) 2011-06-30
GB2476494A (en) 2011-06-29

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