BR112021004053A2 - composições de filme oral e formas de dosagem tendo perfis de dissolução de ativo precisos - Google Patents

composições de filme oral e formas de dosagem tendo perfis de dissolução de ativo precisos Download PDF

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Publication number
BR112021004053A2
BR112021004053A2 BR112021004053-6A BR112021004053A BR112021004053A2 BR 112021004053 A2 BR112021004053 A2 BR 112021004053A2 BR 112021004053 A BR112021004053 A BR 112021004053A BR 112021004053 A2 BR112021004053 A2 BR 112021004053A2
Authority
BR
Brazil
Prior art keywords
film
commercially available
hydrochloride
active
minutes
Prior art date
Application number
BR112021004053-6A
Other languages
English (en)
Portuguese (pt)
Inventor
Alexander Mark Schobel
Stephen Wargacki
Vincent J. Buono
Susan Shumard
Christopher James Santee
Original Assignee
Aquestive Therapeutics, 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
Application filed by Aquestive Therapeutics, Inc. filed Critical Aquestive Therapeutics, Inc.
Publication of BR112021004053A2 publication Critical patent/BR112021004053A2/pt

Links

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
    • 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic 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
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Zoology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
BR112021004053-6A 2018-09-07 2019-09-05 composições de filme oral e formas de dosagem tendo perfis de dissolução de ativo precisos BR112021004053A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862728187P 2018-09-07 2018-09-07
US62/728,187 2018-09-07
US201862732720P 2018-09-18 2018-09-18
US62/732,720 2018-09-18
PCT/US2019/049725 WO2020051317A1 (en) 2018-09-07 2019-09-05 Oral film compositions and dosage forms having precise active dissolution profiles

Publications (1)

Publication Number Publication Date
BR112021004053A2 true BR112021004053A2 (pt) 2021-05-25

Family

ID=68425244

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021004053-6A BR112021004053A2 (pt) 2018-09-07 2019-09-05 composições de filme oral e formas de dosagem tendo perfis de dissolução de ativo precisos

Country Status (7)

Country Link
US (5) US11541002B2 (https=)
EP (1) EP3846778A1 (https=)
JP (2) JP7637616B2 (https=)
CN (2) CN112955124A (https=)
BR (1) BR112021004053A2 (https=)
CA (1) CA3110997A1 (https=)
WO (1) WO2020051317A1 (https=)

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CA3210706A1 (en) * 2021-03-09 2022-09-15 Alexander Mark Schobel Dosage forms having equivalent biocomparable profiles
CN113311124B (zh) * 2021-06-08 2023-11-14 湖南慧泽生物医药科技有限公司 模拟药剂在体释放及吸收过程的二室模型实验装置
CN115671078A (zh) * 2021-07-28 2023-02-03 上海博志研新药物技术有限公司 一种依匹斯汀口溶膜组合物、其制备方法及应用
KR20240093850A (ko) * 2021-10-22 2024-06-24 어퀘스티브 테라퓨틱스, 아이엔씨. 개선된 안정성 프로파일을 갖는 약제학적 조성물
CN114010575B (zh) * 2021-10-22 2024-06-28 江苏谛奇医药科技有限公司 新斯的明及其衍生物的新制剂
CN116211833A (zh) * 2021-11-30 2023-06-06 南京海辰药业股份有限公司 一种咪唑立宾口腔速溶膜剂及其制备方法
CN114983984B (zh) * 2022-07-26 2023-09-01 山东达因海洋生物制药股份有限公司 一种用于哮喘治疗复方口溶膜剂及其制备方法
CN119909044A (zh) * 2023-10-31 2025-05-02 浙江紫藤药业科技有限公司 一种口腔膜剂及其制备方法
JP7659339B1 (ja) 2023-11-21 2025-04-09 東海カプセル株式会社 ピモベンダンを含有する経口フィルム製剤
CN117414352A (zh) * 2023-11-22 2024-01-19 湖北广济医药科技有限公司 一种瑞美吉泮口溶膜剂及其制备方法
CN117631135B (zh) 2024-01-25 2024-04-09 四川大学 一种双功能柔性水凝胶光纤及其制备方法和应用
CN118576571B (zh) * 2024-05-31 2025-02-14 浙江大学 一种药物释放曲线可定制的口服膜剂及其制备方法
WO2025261492A1 (zh) * 2024-06-20 2025-12-26 广州玻思韬控释药业有限公司 一种秋水仙碱膜剂
WO2026002015A1 (zh) * 2024-06-26 2026-01-02 浙江同源康医药股份有限公司 依达拉奉口腔溶膜速释制剂组合物及其制剂和用途
WO2026024790A1 (en) * 2024-07-23 2026-01-29 Aquestive Therapeutics, Inc. Methods of administering enhanced delivery epinephrine and prodrug compositions
CN119139272A (zh) * 2024-09-02 2024-12-17 华中药业股份有限公司 一种艾司唑仑口腔速溶膜剂及其制备方法
CN118903065B (zh) * 2024-10-12 2025-02-07 山东则正医药技术有限公司 一种卢美哌隆口溶膜掩味组合物、其制备方法及应用
CN119970685B (zh) * 2025-02-18 2025-10-14 杭州成邦医药科技有限公司 一种卢美哌隆或其盐的膜剂与其制备方法

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Also Published As

Publication number Publication date
JP7637616B2 (ja) 2025-02-28
US20250339367A1 (en) 2025-11-06
US20230149304A1 (en) 2023-05-18
US20200101009A1 (en) 2020-04-02
CN112955124A (zh) 2021-06-11
CN120789028A (zh) 2025-10-17
US20230145752A1 (en) 2023-05-11
US12290597B2 (en) 2025-05-06
JP2021536466A (ja) 2021-12-27
JP2025093925A (ja) 2025-06-24
US12403090B2 (en) 2025-09-02
US20260034059A1 (en) 2026-02-05
CA3110997A1 (en) 2020-03-12
US11541002B2 (en) 2023-01-03
EP3846778A1 (en) 2021-07-14
WO2020051317A1 (en) 2020-03-12

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B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]