AU2017312811B2 - Liquid naloxone spray - Google Patents

Liquid naloxone spray Download PDF

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Publication number
AU2017312811B2
AU2017312811B2 AU2017312811A AU2017312811A AU2017312811B2 AU 2017312811 B2 AU2017312811 B2 AU 2017312811B2 AU 2017312811 A AU2017312811 A AU 2017312811A AU 2017312811 A AU2017312811 A AU 2017312811A AU 2017312811 B2 AU2017312811 B2 AU 2017312811B2
Authority
AU
Australia
Prior art keywords
formulation
formulations
naloxone
liquid spray
contain
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2017312811A
Other languages
English (en)
Other versions
AU2017312811A1 (en
AU2017312811A8 (en
Inventor
Kiran AMANCHA
Shivani CHILAMPALLI
Venkat R. Goskonda
Eshwaran Narayanan
Thrimoorthy Potta
Ningxin YAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hikma Pharmaceuticals USA Inc
Original Assignee
Hikma Pharmaceuticals USA Inc
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
Priority claimed from US15/238,909 external-priority patent/US10722510B2/en
Priority claimed from US15/601,331 external-priority patent/US10617686B2/en
Application filed by Hikma Pharmaceuticals USA Inc filed Critical Hikma Pharmaceuticals USA Inc
Publication of AU2017312811A1 publication Critical patent/AU2017312811A1/en
Publication of AU2017312811A8 publication Critical patent/AU2017312811A8/en
Assigned to HIKMA PHARMACEUTICALS USA INC. reassignment HIKMA PHARMACEUTICALS USA INC. Request for Assignment Assignors: INSYS DEVELOPMENT COMPANY, INC.
Application granted granted Critical
Publication of AU2017312811B2 publication Critical patent/AU2017312811B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0043—Nose
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2017312811A 2016-08-17 2017-08-10 Liquid naloxone spray Active AU2017312811B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US15/238,909 US10722510B2 (en) 2014-07-08 2016-08-17 Liquid naloxone spray
US15/238,909 2016-08-17
US15/601,331 US10617686B2 (en) 2014-07-08 2017-05-22 Liquid naloxone spray
US15/601,331 2017-05-22
PCT/US2017/046198 WO2018034920A1 (en) 2016-08-17 2017-08-10 Liquid naloxone spray

Publications (3)

Publication Number Publication Date
AU2017312811A1 AU2017312811A1 (en) 2019-03-07
AU2017312811A8 AU2017312811A8 (en) 2019-03-14
AU2017312811B2 true AU2017312811B2 (en) 2023-03-16

Family

ID=61197156

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2017312811A Active AU2017312811B2 (en) 2016-08-17 2017-08-10 Liquid naloxone spray

Country Status (7)

Country Link
EP (1) EP3500261A4 (enExample)
JP (2) JP7114570B2 (enExample)
CN (1) CN109922805A (enExample)
AU (1) AU2017312811B2 (enExample)
CA (1) CA3033897C (enExample)
MA (1) MA45995A (enExample)
WO (1) WO2018034920A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8580801B2 (en) 2008-07-23 2013-11-12 Robert I. Henkin Phosphodiesterase inhibitor treatment
EP3108245B1 (en) 2014-02-18 2020-07-22 Robert I. Henkin Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell
CN109922805A (zh) * 2016-08-17 2019-06-21 因塞斯发展股份有限公司 液体纳洛酮喷雾
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions
EA202191506A1 (ru) * 2018-12-19 2021-10-08 Нортик Холдингз Инк. Терапевтическая композиция интраназального лидокаина
US11129795B2 (en) 2019-02-21 2021-09-28 Pharmaceutical Productions, Inc. Naloxone formulations for sublingual and/or buccal administration
CN112138250B (zh) * 2019-06-28 2023-04-14 四川普锐特药业有限公司 保持给药均一度的药物流体分配器及右美托咪定鼻喷器
WO2021158957A1 (en) 2020-02-05 2021-08-12 Summit Biosciences Inc. Drug products for intranasal administration and uses thereof
KR20240134157A (ko) * 2022-01-06 2024-09-06 시라노 테라퓨틱스, 아이엔씨. 파킨슨 치료제의 개선된 코 투여

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015136373A1 (en) * 2014-03-14 2015-09-17 Lightlake Therapeutics Inc. Nasal drug products and methods of their use
WO2016007245A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US585A (en) 1838-01-27 Apparatus for extinguishing sparks in the chimneys oe steam-boilers
US14730A (en) 1856-04-22 Improvement in corn-harvesters
CN1575795A (zh) * 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 盐酸纳洛酮鼻腔喷雾剂
US8627816B2 (en) * 2011-02-28 2014-01-14 Intelliject, Inc. Medicament delivery device for administration of opioid antagonists including formulations for naloxone
SG194927A1 (en) * 2011-05-13 2013-12-30 Euro Celtique Sa Intranasal pharmaceutical dosage forms comprising naloxone
EP2915525B1 (en) * 2011-09-19 2021-08-11 Orexo AB Sublingual abuse-resistant tablets comprising buprenorphine and naloxone
US8940052B2 (en) 2012-07-26 2015-01-27 DePuy Synthes Products, LLC Expandable implant
CA2795324C (en) * 2012-11-09 2015-07-14 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
DK3043777T3 (da) 2013-09-10 2020-07-20 Fresh Cut Dev Llc Sublingual buprenorphinspray
CN103637987B (zh) 2013-12-09 2015-12-02 韩彬 羟考酮的液体药物组合物
CA2875384A1 (en) 2013-12-20 2015-06-20 AntiOP, Inc. Intranasal naloxone compositions and methods of making and using same
US9480644B2 (en) 2014-03-14 2016-11-01 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use
CN109922805A (zh) 2016-08-17 2019-06-21 因塞斯发展股份有限公司 液体纳洛酮喷雾

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015136373A1 (en) * 2014-03-14 2015-09-17 Lightlake Therapeutics Inc. Nasal drug products and methods of their use
WO2016007245A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray

Also Published As

Publication number Publication date
CA3033897C (en) 2024-03-26
JP7455157B2 (ja) 2024-03-25
AU2017312811A1 (en) 2019-03-07
MA45995A (fr) 2019-06-26
JP2019528278A (ja) 2019-10-10
EP3500261A1 (en) 2019-06-26
CA3033897A1 (en) 2018-02-22
CN109922805A (zh) 2019-06-21
JP2022119843A (ja) 2022-08-17
JP7114570B2 (ja) 2022-08-08
EP3500261A4 (en) 2020-05-06
AU2017312811A8 (en) 2019-03-14
WO2018034920A1 (en) 2018-02-22

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Legal Events

Date Code Title Description
TH Corrigenda

Free format text: IN VOL 33 , NO 9 , PAGE(S) 1310 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME INSYS DEVELOPMENT COMPANY, INC., APPLICATION NO. 2017312811, UNDER INID (72) ADD CO-INVENTOR NARAYANAN, ESHWARAN

PC1 Assignment before grant (sect. 113)

Owner name: HIKMA PHARMACEUTICALS USA INC.

Free format text: FORMER APPLICANT(S): INSYS DEVELOPMENT COMPANY, INC.

FGA Letters patent sealed or granted (standard patent)