CO2021010380A2 - Pharmaceutical compositions comprising meloxicam - Google Patents

Pharmaceutical compositions comprising meloxicam

Info

Publication number
CO2021010380A2
CO2021010380A2 CONC2021/0010380A CO2021010380A CO2021010380A2 CO 2021010380 A2 CO2021010380 A2 CO 2021010380A2 CO 2021010380 A CO2021010380 A CO 2021010380A CO 2021010380 A2 CO2021010380 A2 CO 2021010380A2
Authority
CO
Colombia
Prior art keywords
meloxicam
migraine
rizatriptan
pain
administered
Prior art date
Application number
CONC2021/0010380A
Other languages
Spanish (es)
Inventor
Herriot Tabuteau
Original Assignee
Axsome 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 Axsome Therapeutics Inc filed Critical Axsome Therapeutics Inc
Publication of CO2021010380A2 publication Critical patent/CO2021010380A2/en

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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

RESUMEN DE LA INVENCIÓN Se describe en la presente composiciones que comprenden un NSAID como meloxicam y/o rizatriptan en combinación con una ciclodextrina y/o un carbonato o un bicarbonato. Estas composiciones pueden ser oralmente administradas, por ejemplo, para mejorar la biodisponibilidad o farmacocinéticas del NSAID para el tratamiento de dolor como migraña, artritis, y otras afecciones. También se describen aquí métodos para tratar el dolor, como migraña, que comprenden administrar meloxicam y rizatriptan a un ser humano que sufre de dolor, como migraña. Para la migraña, estos métodos pueden ser particularmente útiles cuando el meloxicam y el rizatriptan son administrados mientras el ser humano está sufriendo de un ataque agudo de dolor de migraña o aura de migraña. En algunas modalidades, la combinación de meloxicam y rizatriptan pueden ser administrados en una forma que resulta en una Tmax de meloxicam de 3 horas o menos.SUMMARY OF THE INVENTION Compositions comprising an NSAID such as meloxicam and / or rizatriptan in combination with a cyclodextrin and / or a carbonate or a bicarbonate are described herein. These compositions can be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also described herein are methods of treating pain, such as migraine, which comprise administering meloxicam and rizatriptan to a human suffering from pain, such as migraine. For migraine, these methods can be particularly useful when meloxicam and rizatriptan are administered while the human is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan can be administered in a manner that results in a meloxicam Tmax of 3 hours or less.

CONC2021/0010380A 2019-02-06 2021-08-06 Pharmaceutical compositions comprising meloxicam CO2021010380A2 (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962802198P 2019-02-06 2019-02-06
US201962803756P 2019-02-11 2019-02-11
US201962835613P 2019-04-18 2019-04-18
US201962846311P 2019-05-10 2019-05-10
US201962860705P 2019-06-12 2019-06-12
US201962895956P 2019-09-04 2019-09-04
US201962895933P 2019-09-04 2019-09-04
US201962955905P 2019-12-31 2019-12-31
PCT/US2020/017046 WO2020163620A1 (en) 2019-02-06 2020-02-06 Pharmaceutical compositions comprising meloxicam

Publications (1)

Publication Number Publication Date
CO2021010380A2 true CO2021010380A2 (en) 2021-09-30

Family

ID=71947112

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0010380A CO2021010380A2 (en) 2019-02-06 2021-08-06 Pharmaceutical compositions comprising meloxicam

Country Status (17)

Country Link
EP (1) EP3920909A4 (en)
JP (3) JP7237386B2 (en)
KR (1) KR20210118880A (en)
CN (1) CN113423397A (en)
AU (2) AU2020218253B2 (en)
BR (1) BR112021015467A2 (en)
CA (2) CA3213549A1 (en)
CL (1) CL2021002070A1 (en)
CO (1) CO2021010380A2 (en)
CR (1) CR20210420A (en)
EC (1) ECSP21060962A (en)
IL (1) IL285389A (en)
MA (1) MA54904A (en)
MX (1) MX2021009435A (en)
PE (1) PE20212157A1 (en)
SG (1) SG11202107926XA (en)
WO (1) WO2020163620A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024502041A (en) * 2020-12-31 2024-01-17 アクスサム セラピューティクス インコーポレイテッド Pharmaceutical compositions containing meloxicam

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1126841B1 (en) * 1998-11-02 2004-12-15 Merck & Co., Inc. Combinations of a 5ht1b/1d agonist and a selective cox-2 inhibitor for the treatment of migraine
US20040214861A1 (en) * 2003-03-28 2004-10-28 Pharmacia Corporation Compositions of a cyclooxygenase-2 selective inhibitors and 5-HT1B1D antagonists for the treatment and prevention of migraine
US8268791B2 (en) * 2004-08-25 2012-09-18 Aegis Therapeutics, Llc. Alkylglycoside compositions for drug administration
US20090068262A1 (en) * 2007-04-04 2009-03-12 Ilan Zalit Rapid dissolution of combination products
ES2769949T3 (en) * 2009-05-13 2020-06-29 Cydex Pharmaceuticals Inc Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of preparing and using them
US9821075B2 (en) * 2015-02-10 2017-11-21 Axsome Therapeutics, Inc. Pharmaceutical compositions comprising meloxicam
AU2016218992C1 (en) * 2015-02-10 2019-09-26 Axsome Therapeutics, Inc. Pharmaceutical compositions comprising meloxicam
SI3256138T1 (en) * 2015-11-25 2022-07-29 Axsome Therapeutics, Inc. Pharmaceutical compositions comprising meloxicam
CN109952314A (en) * 2016-09-23 2019-06-28 泰瓦制药国际有限公司 Treat intractable migraine
PT3565550T (en) * 2017-01-04 2021-01-20 Axsome Therapeutics Inc Pharmaceutical compositions comprising meloxicam
US10471014B2 (en) * 2017-01-04 2019-11-12 Axsome Therapeutics, Inc. Pharmaceutical compositions comprising meloxicam
CN110612103B (en) * 2017-05-10 2023-08-22 艾克萨姆治疗公司 Pharmaceutical composition comprising meloxicam

Also Published As

Publication number Publication date
MX2021009435A (en) 2021-09-10
EP3920909A4 (en) 2022-11-30
MA54904A (en) 2021-12-15
WO2020163620A1 (en) 2020-08-13
ECSP21060962A (en) 2021-11-30
EP3920909A1 (en) 2021-12-15
JP2023062144A (en) 2023-05-02
JP2022519670A (en) 2022-03-24
AU2020218253A1 (en) 2021-08-12
CA3128940A1 (en) 2020-08-13
SG11202107926XA (en) 2021-08-30
CR20210420A (en) 2021-12-22
JP2024026732A (en) 2024-02-28
AU2020218253B2 (en) 2023-02-23
JP7237386B2 (en) 2023-03-13
IL285389A (en) 2021-09-30
CN113423397A (en) 2021-09-21
BR112021015467A2 (en) 2021-10-05
JP7420990B2 (en) 2024-01-23
AU2023202545A1 (en) 2023-05-18
CA3128940C (en) 2023-11-07
PE20212157A1 (en) 2021-11-09
KR20210118880A (en) 2021-10-01
CL2021002070A1 (en) 2022-04-01
CA3213549A1 (en) 2020-08-13

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