JP7431724B2 - 増強された透過を有する医薬組成物 - Google Patents

増強された透過を有する医薬組成物 Download PDF

Info

Publication number
JP7431724B2
JP7431724B2 JP2020517586A JP2020517586A JP7431724B2 JP 7431724 B2 JP7431724 B2 JP 7431724B2 JP 2020517586 A JP2020517586 A JP 2020517586A JP 2020517586 A JP2020517586 A JP 2020517586A JP 7431724 B2 JP7431724 B2 JP 7431724B2
Authority
JP
Japan
Prior art keywords
film
acid
pharmaceutical composition
less
epinephrine
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
JP2020517586A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020535176A5 (ko
JP2020535176A (ja
Inventor
マーク ショベル アレクサンダー
マリー バージャン ステファニー
ポール ワルガクキ ステファン
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
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 US15/724,234 external-priority patent/US11273131B2/en
Application filed by 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 filed Critical 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
Publication of JP2020535176A publication Critical patent/JP2020535176A/ja
Publication of JP2020535176A5 publication Critical patent/JP2020535176A5/ja
Priority to JP2023188095A priority Critical patent/JP2024012484A/ja
Application granted granted Critical
Publication of JP7431724B2 publication Critical patent/JP7431724B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/075Ethers or acetals
    • A61K31/085Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/11Aldehydes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/55131,4-Benzodiazepines, e.g. diazepam or clozapine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/55131,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/55171,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2020517586A 2017-09-27 2018-09-27 増強された透過を有する医薬組成物 Active JP7431724B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023188095A JP2024012484A (ja) 2017-09-27 2023-11-02 増強された透過を有する医薬組成物

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201715717856A 2017-09-27 2017-09-27
US15/717,856 2017-09-27
US15/724,234 US11273131B2 (en) 2016-05-05 2017-10-03 Pharmaceutical compositions with enhanced permeation
US15/724,234 2017-10-03
US201862735822P 2018-09-24 2018-09-24
US62/735,822 2018-09-24
PCT/US2018/053026 WO2019067667A1 (en) 2017-09-27 2018-09-27 PHARMACEUTICAL COMPOSITIONS WITH ENHANCED PERMEATION

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023188095A Division JP2024012484A (ja) 2017-09-27 2023-11-02 増強された透過を有する医薬組成物

Publications (3)

Publication Number Publication Date
JP2020535176A JP2020535176A (ja) 2020-12-03
JP2020535176A5 JP2020535176A5 (ko) 2021-11-11
JP7431724B2 true JP7431724B2 (ja) 2024-02-15

Family

ID=63858167

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020517586A Active JP7431724B2 (ja) 2017-09-27 2018-09-27 増強された透過を有する医薬組成物
JP2023188095A Pending JP2024012484A (ja) 2017-09-27 2023-11-02 増強された透過を有する医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023188095A Pending JP2024012484A (ja) 2017-09-27 2023-11-02 増強された透過を有する医薬組成物

Country Status (8)

Country Link
EP (1) EP3687509A1 (ko)
JP (2) JP7431724B2 (ko)
KR (1) KR20200060457A (ko)
CN (1) CN111132670A (ko)
BR (1) BR112020005967A2 (ko)
CA (1) CA3076815A1 (ko)
IL (1) IL273479A (ko)
WO (1) WO2019067667A1 (ko)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11273131B2 (en) 2016-05-05 2022-03-15 Aquestive Therapeutics, Inc. Pharmaceutical compositions with enhanced permeation
JP2019519487A (ja) 2016-05-05 2019-07-11 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 送達増強エピネフリン組成物
BR112022008294A2 (pt) * 2019-11-01 2022-07-26 Aquestive Therapeutics Inc Composições de profármaco e métodos de tratamento
AU2020403651A1 (en) 2019-12-09 2022-07-07 Nicoventures Trading Limited Oral product comprising a cannabinoid
US11839602B2 (en) 2020-11-25 2023-12-12 Nicoventures Trading Limited Oral cannabinoid product with lipid component
CN114894675B (zh) * 2022-05-06 2024-04-19 江苏省农业科学院 一种农药助剂在植物叶片表面渗透行为的比较方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004043450A (ja) 2002-05-16 2004-02-12 Kyukyu Yakuhin Kogyo Kk 速溶性フィルム状製剤
WO2008149440A1 (ja) 2007-06-07 2008-12-11 Sato Pharmaceutical Co., Ltd. 速溶性及び可撓性を有するフィルム製剤
JP2009084177A (ja) 2007-09-28 2009-04-23 Kowa Co 塩酸フェニレフリン含有速溶性フィルム製剤及びその製造方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050042271A1 (en) * 1999-11-19 2005-02-24 Xel Herbaceuticals, Inc . Transdermal delivery system for alkaloids of aconitum species
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
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US7666337B2 (en) 2002-04-11 2010-02-23 Monosol Rx, Llc Polyethylene oxide-based films and drug delivery systems made therefrom
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
JP2004131495A (ja) * 2002-09-17 2004-04-30 Nippon Boehringer Ingelheim Co Ltd 非ステロイド系抗炎症剤の局所送達用医薬組成物
US20040127531A1 (en) * 2002-11-21 2004-07-01 Lu Guang Wei Adhesive coated sheet for dermal delivery of a selective cyclooxygenase-2 inhibitor
EA009623B1 (ru) * 2003-04-30 2008-02-28 Пэдью Фарма Л.П. Устойчивая к манипуляциям дозировочная форма для трансдермального введения
CA2993999C (en) * 2015-08-05 2023-07-25 University Of Rochester Antimicrobial compositions comprising mupirocin and neomycin
KR102536696B1 (ko) * 2016-05-05 2023-05-25 어퀘스티브 테라퓨틱스, 아이엔씨. 향상된 투과성을 가지는 약물학적 조성물

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004043450A (ja) 2002-05-16 2004-02-12 Kyukyu Yakuhin Kogyo Kk 速溶性フィルム状製剤
WO2008149440A1 (ja) 2007-06-07 2008-12-11 Sato Pharmaceutical Co., Ltd. 速溶性及び可撓性を有するフィルム製剤
JP2009084177A (ja) 2007-09-28 2009-04-23 Kowa Co 塩酸フェニレフリン含有速溶性フィルム製剤及びその製造方法

Also Published As

Publication number Publication date
CA3076815A1 (en) 2019-04-04
IL273479A (en) 2020-05-31
KR20200060457A (ko) 2020-05-29
WO2019067667A1 (en) 2019-04-04
EP3687509A1 (en) 2020-08-05
JP2020535176A (ja) 2020-12-03
CN111132670A (zh) 2020-05-08
BR112020005967A2 (pt) 2020-10-06
JP2024012484A (ja) 2024-01-30

Similar Documents

Publication Publication Date Title
KR102536696B1 (ko) 향상된 투과성을 가지는 약물학적 조성물
US12023309B2 (en) Enhanced delivery epinephrine compositions
JP7431724B2 (ja) 増強された透過を有する医薬組成物
JP2023159150A (ja) 増強された送達のエピネフリン及びプロドラッグ組成物
US20190022022A1 (en) Pharmaceutical compositions with enhanced permeation
US20180125977A1 (en) Enhanced delivery epinephrine compositions
US20190022023A1 (en) Enhanced delivery epinephrine and prodrug compositions
US11273131B2 (en) Pharmaceutical compositions with enhanced permeation
US20180104195A1 (en) Enhanced delivery epinephrine compositions
JP2020535232A (ja) 透過エンハンサーを含む送達医薬組成物
US20240148673A1 (en) Enhanced delivery epinephrine and prodrug compositions
US20240016734A1 (en) Enhanced delivery epinephrine and prodrug compositions
CN118414150A (zh) 具有增强的稳定性特征的药物组合物

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210924

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210924

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20221018

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230117

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230414

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20230704

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231102

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20231110

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20231205

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20231207

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240202

R150 Certificate of patent or registration of utility model

Ref document number: 7431724

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150