JP2020535232A - 透過エンハンサーを含む送達医薬組成物 - Google Patents

透過エンハンサーを含む送達医薬組成物 Download PDF

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JP2020535232A
JP2020535232A JP2020538776A JP2020538776A JP2020535232A JP 2020535232 A JP2020535232 A JP 2020535232A JP 2020538776 A JP2020538776 A JP 2020538776A JP 2020538776 A JP2020538776 A JP 2020538776A JP 2020535232 A JP2020535232 A JP 2020535232A
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pharmaceutical composition
composition according
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acid
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JP2020535232A5 (https=
Inventor
ポール ワルガクキ ステファン
ポール ワルガクキ ステファン
クマル カインサン ラジェシュ
クマル カインサン ラジェシュ
マーク ショベル アレクサンダー
マーク ショベル アレクサンダー
Original Assignee
アクエスティブ セラピューティクス インコーポレイテッド
アクエスティブ セラピューティクス インコーポレイテッド
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Publication of JP2020535232A publication Critical patent/JP2020535232A/ja
Publication of JP2020535232A5 publication Critical patent/JP2020535232A5/ja
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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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 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
    • A61K47/08—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
    • A61K47/16—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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/30—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
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2020538776A 2017-09-26 2018-09-26 透過エンハンサーを含む送達医薬組成物 Pending JP2020535232A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024108581A JP2024156672A (ja) 2017-09-26 2024-07-05 透過エンハンサーを含む送達医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762563534P 2017-09-26 2017-09-26
US62/563,534 2017-09-26
PCT/US2018/052927 WO2019067596A1 (en) 2017-09-26 2018-09-26 ADMINISTRATIVE PHARMACEUTICAL COMPOSITIONS CONTAINING PERMEATION PROMOTERS

Related Child Applications (1)

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JP2024108581A Division JP2024156672A (ja) 2017-09-26 2024-07-05 透過エンハンサーを含む送達医薬組成物

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JP2020535232A true JP2020535232A (ja) 2020-12-03
JP2020535232A5 JP2020535232A5 (https=) 2021-11-11

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JP2020538776A Pending JP2020535232A (ja) 2017-09-26 2018-09-26 透過エンハンサーを含む送達医薬組成物
JP2024108581A Pending JP2024156672A (ja) 2017-09-26 2024-07-05 透過エンハンサーを含む送達医薬組成物

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Country Link
US (1) US20190091281A1 (https=)
EP (1) EP3687508A1 (https=)
JP (2) JP2020535232A (https=)
KR (1) KR20200059269A (https=)
CN (1) CN111148512A (https=)
BR (1) BR112020005875A2 (https=)
CA (1) CA3076751A1 (https=)
IL (2) IL273477B2 (https=)
WO (1) WO2019067596A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL313551A (en) * 2017-09-27 2024-08-01 Aquestive Therapeutics Inc Enhanced delivery epinephrine and prodrug compositions
US11648197B2 (en) 2018-06-28 2023-05-16 Arx, Llc Dispensing method for producing dissolvable unit dose film constructs
US12440472B2 (en) * 2021-06-16 2025-10-14 Intelgenx Corp. Stable tryptamine oral films

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6357528A (ja) * 1986-08-18 1988-03-12 サンド・アクチエンゲゼルシャフト 新規製剤
US20110257096A1 (en) * 2004-08-25 2011-10-20 Aegis Therapeutics, Inc. Compositions for drug administration
US20110311621A1 (en) * 2010-03-16 2011-12-22 Paul Salama Pharmaceutical compositions and methods of delvery
JP2015521996A (ja) * 2012-07-06 2015-08-03 レオ ファーマ アクティーゼルスカブ 活性成分を皮膚に送達するためのフィルム形成ポリマーを含む局所用組成物

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2193891B (en) * 1986-08-18 1990-07-25 Sandoz Ltd Nasal pharmaceutical composition containing a somatostatin anologue.
US5879690A (en) * 1995-09-07 1999-03-09 Perricone; Nicholas V. Topical administration of catecholamines and related compounds to subcutaneous muscle tissue using percutaneous penetration enhancers
US20030124176A1 (en) * 1999-12-16 2003-07-03 Tsung-Min Hsu Transdermal and topical administration of drugs using basic permeation enhancers
US7425292B2 (en) 2001-10-12 2008-09-16 Monosol Rx, Llc Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
US7666337B2 (en) 2002-04-11 2010-02-23 Monosol Rx, Llc Polyethylene oxide-based films and drug delivery systems made therefrom
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
SE0302924D0 (sv) * 2003-11-05 2003-11-05 Camurus Ab Pharmaceutical composition having a cationic excipient
US20060073173A1 (en) * 2004-10-04 2006-04-06 Maria Banach Large-scale manufacturing process for the production of pharmaceutical compositions
ZA200711040B (en) * 2005-06-03 2009-04-29 Acrux Dds Pty Ltd Method and composition for transdermal drug delivery
WO2011071860A2 (en) 2009-12-07 2011-06-16 Alnylam Pharmaceuticals, Inc. Compositions for nucleic acid delivery
IE20100174A1 (en) * 2010-03-25 2012-02-29 Trinity College Dublin Transdermal administration of peptides
WO2012070028A1 (en) * 2010-11-26 2012-05-31 University Of The Witwatersrand, Johannesburg A pharmaceutical dosage form
FR3013589B1 (fr) * 2013-11-28 2017-03-31 Soc D'exploitation De Produits Pour Les Ind Chimiques Seppic Composition d'alkyl polyglucosides et d'acides gras cationisees
US20170119660A1 (en) * 2015-10-29 2017-05-04 Solubest Ltd Pharmaceutical compositions for transmucosal delivery

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6357528A (ja) * 1986-08-18 1988-03-12 サンド・アクチエンゲゼルシャフト 新規製剤
US20110257096A1 (en) * 2004-08-25 2011-10-20 Aegis Therapeutics, Inc. Compositions for drug administration
US20110311621A1 (en) * 2010-03-16 2011-12-22 Paul Salama Pharmaceutical compositions and methods of delvery
JP2015521996A (ja) * 2012-07-06 2015-08-03 レオ ファーマ アクティーゼルスカブ 活性成分を皮膚に送達するためのフィルム形成ポリマーを含む局所用組成物

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Zur bukkalen Applikation und Absorption des Oktapeptids Octreotid", DOCTORAL THESIS, JPN6022046265, 1990, ISSN: 0005397196 *
JOURNAL OF CONTROLLED RELEASE, vol. 21, JPN6022046267, 1992, pages 155 - 164, ISSN: 0005397197 *

Also Published As

Publication number Publication date
JP2024156672A (ja) 2024-11-06
IL273477B2 (en) 2024-08-01
IL273477B1 (en) 2024-04-01
BR112020005875A2 (pt) 2020-09-29
CA3076751A1 (en) 2019-04-04
EP3687508A1 (en) 2020-08-05
KR20200059269A (ko) 2020-05-28
IL273477A (en) 2020-05-31
US20190091281A1 (en) 2019-03-28
CN111148512A (zh) 2020-05-12
WO2019067596A1 (en) 2019-04-04
IL311142A (en) 2024-04-01

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