WO2026064392A1 - Combinaison de doses fixes de flovoxate et d'agonistes du récepteur adrénergique bêta-3, et formulations et procédés de fabrication associés - Google Patents

Combinaison de doses fixes de flovoxate et d'agonistes du récepteur adrénergique bêta-3, et formulations et procédés de fabrication associés

Info

Publication number
WO2026064392A1
WO2026064392A1 PCT/US2025/046767 US2025046767W WO2026064392A1 WO 2026064392 A1 WO2026064392 A1 WO 2026064392A1 US 2025046767 W US2025046767 W US 2025046767W WO 2026064392 A1 WO2026064392 A1 WO 2026064392A1
Authority
WO
WIPO (PCT)
Prior art keywords
flavoxate
formulation
release
pharmaceutically acceptable
adrenergic receptor
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.)
Pending
Application number
PCT/US2025/046767
Other languages
English (en)
Inventor
Sushma Paul BERLIA
Nishant BERLIA
Gurvinder Singh
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.)
Flavostar LLC
Original Assignee
Flavostar LLC
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 Flavostar LLC filed Critical Flavostar LLC
Publication of WO2026064392A1 publication Critical patent/WO2026064392A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/453—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with oxygen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des formulations de combinaison à dose fixe comprenant du flovoxate ou un sel pharmaceutiquement acceptable de celui-ci et au moins un agoniste du récepteur adrénergique β3, ainsi que des procédés de fabrication et d'utilisation de celles-ci pour traiter des symptômes associés aux maladies touchant la prostate, la vessie, les voies urinaires et la région pelvienne.
PCT/US2025/046767 2024-09-17 2025-09-17 Combinaison de doses fixes de flovoxate et d'agonistes du récepteur adrénergique bêta-3, et formulations et procédés de fabrication associés Pending WO2026064392A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463695499P 2024-09-17 2024-09-17
US63/695,499 2024-09-17

Publications (1)

Publication Number Publication Date
WO2026064392A1 true WO2026064392A1 (fr) 2026-03-26

Family

ID=98034745

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/046767 Pending WO2026064392A1 (fr) 2024-09-17 2025-09-17 Combinaison de doses fixes de flovoxate et d'agonistes du récepteur adrénergique bêta-3, et formulations et procédés de fabrication associés

Country Status (1)

Country Link
WO (1) WO2026064392A1 (fr)

Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0250374A1 (fr) 1986-06-17 1987-12-23 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.a. Système thérapeutique avec délivrance contrôlée de médicaments
EP0393572A2 (fr) 1989-04-20 1990-10-24 RECORDATI S.A. CHEMICAL and PHARMACEUTICAL COMPANY Comprimés contenant du flavoxate à libération contrôlée
US6346532B1 (en) 1997-10-17 2002-02-12 Yamanouchi Pharmaceutical Co., Ltd. Amide derivatives or salts thereof
US7342117B2 (en) 2001-10-30 2008-03-11 Astellas Pharma Inc. α-form or β-form crystal of acetanilide derivative
USRE44872E1 (en) 2002-11-07 2014-04-29 Astellas Pharma Inc. Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
US8772315B2 (en) 2007-11-02 2014-07-08 Astellas Pharma Inc. Pharmaceutical composition for treating overactive bladder
US20170128379A1 (en) 2014-06-30 2017-05-11 Rubicon Research Private Limited Modified release pharmaceutical preparations
US9655885B2 (en) 2011-05-18 2017-05-23 Dr. Reddy's Laboratories Ltd. Amorphous mirabegron and processes for crystal forms of mirabegron
WO2017186593A1 (fr) * 2016-04-25 2017-11-02 Synthon B.V. Comprimés comprenant du mirabegron et de la solifénacine
WO2017186598A1 (fr) 2016-04-25 2017-11-02 Synthon B.V. Composition de comprimé à libération modifiée comprenant du mirabegron
WO2020021422A1 (fr) 2018-07-21 2020-01-30 Berlia Sushma Paul Formulation à libération contrôlée comprenant du flavoxate
US10842780B2 (en) 2008-09-30 2020-11-24 Astellas Pharma Inc. Pharmaceutical composition for modified release
EP3777853A1 (fr) 2019-08-14 2021-02-17 Biohorm, S.L. Composition de mirabegron et ses utilisations
US20210052600A1 (en) 2017-12-27 2021-02-25 Takeda Pharmaceutical Company Limited Therapeutic agents for stress urinary incontinence and incotinence of feces
US20210205619A1 (en) 2016-01-21 2021-07-08 Cala Health, Inc. Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder
WO2023089553A1 (fr) 2021-11-19 2023-05-25 Berlia Sushma Paul Formulations à libération contrôlée de flavoxate et procédé de préparation de celles-ci
US11707451B2 (en) 2010-03-29 2023-07-25 Astellas Pharma Inc. Pharmaceutical composition for modified release

Patent Citations (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0250374A1 (fr) 1986-06-17 1987-12-23 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.a. Système thérapeutique avec délivrance contrôlée de médicaments
EP0393572A2 (fr) 1989-04-20 1990-10-24 RECORDATI S.A. CHEMICAL and PHARMACEUTICAL COMPANY Comprimés contenant du flavoxate à libération contrôlée
US5165937A (en) 1989-04-20 1992-11-24 Recordati S.A., Chemical And Pharmaceutical Company Controlled release tablets containing flavoxate
US6346532B1 (en) 1997-10-17 2002-02-12 Yamanouchi Pharmaceutical Co., Ltd. Amide derivatives or salts thereof
US7342117B2 (en) 2001-10-30 2008-03-11 Astellas Pharma Inc. α-form or β-form crystal of acetanilide derivative
US7982049B2 (en) 2001-10-30 2011-07-19 Astellas Pharma Inc. α-form or β-form crystal of acetanilide derivative
USRE44872E1 (en) 2002-11-07 2014-04-29 Astellas Pharma Inc. Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
US8835474B2 (en) 2002-11-07 2014-09-16 Astellas Pharma Inc. Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
US8772315B2 (en) 2007-11-02 2014-07-08 Astellas Pharma Inc. Pharmaceutical composition for treating overactive bladder
US10842780B2 (en) 2008-09-30 2020-11-24 Astellas Pharma Inc. Pharmaceutical composition for modified release
US11707451B2 (en) 2010-03-29 2023-07-25 Astellas Pharma Inc. Pharmaceutical composition for modified release
US9655885B2 (en) 2011-05-18 2017-05-23 Dr. Reddy's Laboratories Ltd. Amorphous mirabegron and processes for crystal forms of mirabegron
US20170128379A1 (en) 2014-06-30 2017-05-11 Rubicon Research Private Limited Modified release pharmaceutical preparations
US20210205619A1 (en) 2016-01-21 2021-07-08 Cala Health, Inc. Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder
WO2017186598A1 (fr) 2016-04-25 2017-11-02 Synthon B.V. Composition de comprimé à libération modifiée comprenant du mirabegron
WO2017186593A1 (fr) * 2016-04-25 2017-11-02 Synthon B.V. Comprimés comprenant du mirabegron et de la solifénacine
US20210052600A1 (en) 2017-12-27 2021-02-25 Takeda Pharmaceutical Company Limited Therapeutic agents for stress urinary incontinence and incotinence of feces
WO2020021422A1 (fr) 2018-07-21 2020-01-30 Berlia Sushma Paul Formulation à libération contrôlée comprenant du flavoxate
EP3777853A1 (fr) 2019-08-14 2021-02-17 Biohorm, S.L. Composition de mirabegron et ses utilisations
WO2023089553A1 (fr) 2021-11-19 2023-05-25 Berlia Sushma Paul Formulations à libération contrôlée de flavoxate et procédé de préparation de celles-ci

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ABREU-MENDES P. ET AL.: "Pharmacology of the lower urinary tract: update on LUTS treatment", THERAPEUTIC ADVANCES IN UROLOGY, vol. 12, 1 January 2020 (2020-01-01), GB, XP093261364, ISSN: 1756-2872, Retrieved from the Internet <URL:https://journals.sagepub.com/doi/pdf/10.1177/1756287220922425> DOI: 10.1177/1756287220922425 *
SATYAVATHI KVENU MGAYATHRI PBHOJARAJU PKANTHAL LK: "Formulation and development of Flavoxate hydrochloride extended release capsules", INT J PHARM SCI RES, vol. 5, no. 5, 2014, pages 1949 - 56

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