WO2019191511A1 - Compositions and methods for treating pruritus - Google Patents

Compositions and methods for treating pruritus Download PDF

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Publication number
WO2019191511A1
WO2019191511A1 PCT/US2019/024706 US2019024706W WO2019191511A1 WO 2019191511 A1 WO2019191511 A1 WO 2019191511A1 US 2019024706 W US2019024706 W US 2019024706W WO 2019191511 A1 WO2019191511 A1 WO 2019191511A1
Authority
WO
WIPO (PCT)
Prior art keywords
percent
sde
pharmaceutical composition
pruritus
diisopropyl adipate
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.)
Ceased
Application number
PCT/US2019/024706
Other languages
English (en)
French (fr)
Inventor
Wendy Huang Chern
Chan-Jung LI
Shu-Wen Kuo
David Chih-Kuang CHOU
Yu-En TIEN
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.)
Shanghai Lumosa Therapeutics Co Ltd
Lumosa Therapeutics Co Ltd
Original Assignee
Shanghai Lumosa Therapeutics Co Ltd
Lumosa Therapeutics Co Ltd
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 to RU2020130919A priority Critical patent/RU2020130919A/ru
Priority to EP19776964.9A priority patent/EP3755328A4/en
Priority to AU2019243571A priority patent/AU2019243571A1/en
Priority to MX2020009813A priority patent/MX2020009813A/es
Priority to KR1020207027179A priority patent/KR20200138730A/ko
Priority to CN201980023503.1A priority patent/CN112040948A/zh
Priority to BR112020019094-2A priority patent/BR112020019094A2/pt
Priority to CA3094710A priority patent/CA3094710A1/en
Priority to JP2020551516A priority patent/JP2021525225A/ja
Application filed by Shanghai Lumosa Therapeutics Co Ltd, Lumosa Therapeutics Co Ltd filed Critical Shanghai Lumosa Therapeutics Co Ltd
Publication of WO2019191511A1 publication Critical patent/WO2019191511A1/en
Priority to IL277463A priority patent/IL277463A/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics

Definitions

  • the epidermis excluding the stratum corneum, which is the outermost layer, is a viable tissue.
  • the epidermis is not vascularized, and nutrients diffuse from the dermoepidermal junction to maintain its viability.
  • the sequence of layers from inside to outside are the germinative (or basal) layer, stratum spinosum, stratum granulosum, stratum lucidum, and stratum corneum.
  • the stratum corneum cells, corneocytes are dense, functionally dead, anucleated, and filled with keratin.
  • the stratum corneum arrangement is densely packed with corneocytes and intercellular lipids which form several bilayers surrounding the corneocytes.
  • nalbuphine exerts its clinical pharmacologic action by competitively antagonizing the opioid m-receptor and simultaneously acting as an agonist at the opioid k-receptor, and thus is a member of the“opioid agonist-antagonist” class of drugs that mechanistically work though this dual pharmacologic process.
  • Nalbuphine has been used to treat acute, chronic, and post-surgical pain.
  • At least one pharmaceutically acceptable excipient is a solvent.
  • the solvent is selected from PEG 400, diisopropyl adipate, benzyl benzoate, N-methyl-2-pyrrolidone, isopropyl myristate (IPM), caprylic/capric triglyceride, and liquid paraffin.
  • compositions disclosed herein further comprise an antioxidant.
  • the methods disclosed herein alleviate or partially alleviate at least one symptom of pruritus.
  • the method comprises administering the pharmaceutical compositions disclosed herein, wherein the subject does not experience opioid-related side effects or in which such side effects are reduced when compared with subjects to whom effective doses of opiate were administered systemically.
  • HPC HF hydroxypropylcellulose
  • formulations (TA-1 , TA-2, TA-3, and TA-4) were applied topically on the rostral portion of the back (2 x 2 cm region) at 4 hours prior to substance P challenge. 15 male ICR mice were used for each group. As reference, nalbuphine HCI was injected subcutaneously on the lower back region (different site as Substance P challenge). The scratching behavior was recorded for 30 minutes by visual observation immediately after substance P injection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2019/024706 2018-03-29 2019-03-28 Compositions and methods for treating pruritus Ceased WO2019191511A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CA3094710A CA3094710A1 (en) 2018-03-29 2019-03-28 Compositions and methods for treating pruritus
EP19776964.9A EP3755328A4 (en) 2018-03-29 2019-03-28 COMPOSITIONS AND METHODS OF TREATMENT FOR PRURITUS
AU2019243571A AU2019243571A1 (en) 2018-03-29 2019-03-28 Compositions and methods for treating pruritus
MX2020009813A MX2020009813A (es) 2018-03-29 2019-03-28 Composiciones y metodos para tratar el prurito.
KR1020207027179A KR20200138730A (ko) 2018-03-29 2019-03-28 가려움증 치료용 조성물 및 방법
RU2020130919A RU2020130919A (ru) 2018-03-29 2019-03-28 Композиции и способы для лечения зуда
BR112020019094-2A BR112020019094A2 (pt) 2018-03-29 2019-03-28 Composições e métodos para tratar prurido
CN201980023503.1A CN112040948A (zh) 2018-03-29 2019-03-28 治疗瘙痒的组合物和方法
JP2020551516A JP2021525225A (ja) 2018-03-29 2019-03-28 掻痒症を治療するための組成物及び方法
IL277463A IL277463A (en) 2018-03-29 2020-09-21 Vehicles and methods for treating itch

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862650108P 2018-03-29 2018-03-29
US62/650,108 2018-03-29

Publications (1)

Publication Number Publication Date
WO2019191511A1 true WO2019191511A1 (en) 2019-10-03

Family

ID=68054657

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/024706 Ceased WO2019191511A1 (en) 2018-03-29 2019-03-28 Compositions and methods for treating pruritus

Country Status (13)

Country Link
US (2) US20190298702A1 (https=)
EP (1) EP3755328A4 (https=)
JP (1) JP2021525225A (https=)
KR (1) KR20200138730A (https=)
CN (1) CN112040948A (https=)
AU (1) AU2019243571A1 (https=)
BR (1) BR112020019094A2 (https=)
CA (1) CA3094710A1 (https=)
IL (1) IL277463A (https=)
MX (1) MX2020009813A (https=)
RU (1) RU2020130919A (https=)
TW (1) TWI729371B (https=)
WO (1) WO2019191511A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116134038A (zh) * 2020-06-30 2023-05-16 德米拉公司 Irak4抑制剂及其局部用途

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113797167B (zh) * 2020-06-16 2024-05-10 苏州恩华生物医药科技有限公司 一种塞纳布啡的储库制剂
WO2022175973A1 (en) * 2021-02-18 2022-08-25 Navin Saxena Research And Technology Private Limited An injectable composition for long term delivery of nalbuphine or nalbuphine ester prodrug or its salts and use thereof

Citations (5)

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Publication number Priority date Publication date Assignee Title
US3538107A (en) * 1965-10-07 1970-11-03 Ici Ltd Aryl-thiazolyl-acetic acid derivatives
US6225321B1 (en) * 1997-06-05 2001-05-01 Oliver Yoa-Pu Hu Long analgesic acting nalbuphine polyester derivative and method of use
EP1149836A1 (en) * 2000-04-27 2001-10-31 Oliver Yoa-Pu Hu Polynalbuphine derivatives
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof
US20140112957A1 (en) * 2012-10-19 2014-04-24 Oliver Yao-Pu Hu Analegisic (Sebacoyl dinalbuphine ester) PLGA controlled release formulation form

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US5229130A (en) * 1991-12-20 1993-07-20 Cygnus Therapeutics Systems Vegetable oil-based skin permeation enhancer compositions, and associated methods and systems
US6503944B1 (en) * 1999-05-26 2003-01-07 The Andrew Jergens Company Anhydrous skin care composition
US6967023B1 (en) * 2000-01-10 2005-11-22 Foamix, Ltd. Pharmaceutical and cosmetic carrier or composition for topical application
US20070093517A1 (en) * 2005-10-24 2007-04-26 Gary Newton Local anesthetic compositions
CA2788440A1 (en) * 2010-02-26 2011-09-01 Xenon Pharmaceuticals Inc. Pharmaceutical compositions of spiro-oxindole compound for topical administration and their use as therapeutic agents
EP2788028B1 (en) * 2011-12-08 2019-03-27 Rigel Pharmaceuticals, Inc. Topical formulation for administering a compound
MX2016016404A (es) * 2014-06-13 2017-11-30 Trevi Therapeutics Inc Metodos para el tratamiento del prurito.
EP3302477B1 (en) * 2015-05-28 2024-02-07 Lumosa Therapeutics Co., Ltd. Pharmaceutical formulations for sustained release of sebacoyl dinalbuphine ester

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3538107A (en) * 1965-10-07 1970-11-03 Ici Ltd Aryl-thiazolyl-acetic acid derivatives
US6225321B1 (en) * 1997-06-05 2001-05-01 Oliver Yoa-Pu Hu Long analgesic acting nalbuphine polyester derivative and method of use
EP1149836A1 (en) * 2000-04-27 2001-10-31 Oliver Yoa-Pu Hu Polynalbuphine derivatives
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof
US20140112957A1 (en) * 2012-10-19 2014-04-24 Oliver Yao-Pu Hu Analegisic (Sebacoyl dinalbuphine ester) PLGA controlled release formulation form

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3755328A4 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116134038A (zh) * 2020-06-30 2023-05-16 德米拉公司 Irak4抑制剂及其局部用途
EP4172163A4 (en) * 2020-06-30 2024-07-24 Dermira, Inc IRAK4 INHIBITORS AND TOPICAL USES THEREOF

Also Published As

Publication number Publication date
BR112020019094A2 (pt) 2020-12-29
US20220362226A1 (en) 2022-11-17
EP3755328A4 (en) 2021-11-10
IL277463A (en) 2020-11-30
JP2021525225A (ja) 2021-09-24
TW202002977A (zh) 2020-01-16
AU2019243571A1 (en) 2020-10-15
CN112040948A (zh) 2020-12-04
RU2020130919A3 (https=) 2022-04-29
KR20200138730A (ko) 2020-12-10
MX2020009813A (es) 2020-11-11
US20190298702A1 (en) 2019-10-03
TWI729371B (zh) 2021-06-01
RU2020130919A (ru) 2022-04-29
EP3755328A1 (en) 2020-12-30
CA3094710A1 (en) 2019-10-03

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