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NZ771802B2 - Pharmaceutical compositions comprising meloxicam - Google Patents

Pharmaceutical compositions comprising meloxicam Download PDF

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Publication number
NZ771802B2
NZ771802B2 NZ771802A NZ77180219A NZ771802B2 NZ 771802 B2 NZ771802 B2 NZ 771802B2 NZ 771802 A NZ771802 A NZ 771802A NZ 77180219 A NZ77180219 A NZ 77180219A NZ 771802 B2 NZ771802 B2 NZ 771802B2
Authority
NZ
New Zealand
Prior art keywords
dosage form
rizatriptan
meloxicam
gastric fluid
human
Prior art date
Application number
NZ771802A
Other versions
NZ771802A (en
Inventor
Herriot Tabuteau
Original Assignee
Axsome Therapeutics Inc
Filing date
Publication date
Application filed by Axsome Therapeutics Inc filed Critical Axsome Therapeutics Inc
Priority claimed from PCT/US2019/040495 external-priority patent/WO2020010196A1/en
Publication of NZ771802A publication Critical patent/NZ771802A/en
Publication of NZ771802B2 publication Critical patent/NZ771802B2/en

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Classifications

    • 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
    • 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
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • 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
    • A61K47/50—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
    • A61K9/20—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
    • 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
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Disclosed herein are compositions comprising a drug such as a triptan (e.g. rizatriptan) and/or an NSAID (e.g. meloxicam) in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability, solubility, or pharmacokinetics of the drug for the treatment of conditions such as pain.

Claims (20)

1. Use of a composition comprising a meloxicam, at least 400 mg of a bicarbonate, and a rizatriptan in the manufacture of a medicament for treating migraine in a human being suffering from migraine; wherein the human being has a history of inadequate response to prior migraine treatments; wherein the 5 composition is in a dosage form when administered to the human being; and wherein the T of rizatriptan in the human being after administering the dosage form is shorter than that would result from administering a reference dosage form comprising a) the same amount of rizatriptan; b) no meloxicam; and c) no bicarbonate.
2. The use of claim 1, wherein about 8 mg to about 13 mg of the rizatriptan is present in the dosage 10 form based upon the weight of the rizatriptan in the free base form.
3. The use of claim 1 or claim 2, wherein the rizatriptan is present in a salt form in an amount that is a molar equivalent amount of about 10 mg of the rizatriptan in the free base form.
4. The use of any one of claims 1 to 3, wherein the rizatriptan is present as rizatriptan benzoate.
5. The use of any one of claims 1 to 4, wherein the dosage form contains about 15 mg to about 25 15 mg of the meloxicam.
6. The use of any one of claims 1 to 5, wherein the dosage form contains about 20 mg of the meloxicam.
7. The use of any one of claims 1 to 6, wherein the dosage form further comprises a cyclodextrin.
8. The use of claim 7, wherein the dosage form contains about 100 mg to about 175 mg of the 20 cyclodextrin.
9. The use of claim 7 or claim 8, wherein the dosage form contains about 100 mg to about 140 mg of the cyclodextrin.
10. The use of any one of claims 1 to 9, wherein the bicarbonate comprises sodium bicarbonate.
11. The use of any one of claims 1 to 10, wherein the dosage form contains about 400 mg to about 25 600 mg of the bicarbonate.
12. The use of any one of claims 1 to 11, wherein the dosage form contains about 500 mg of sodium bicarbonate.
13. The use of any one of claims 1 to 12, wherein the dosage form contains about 50% to about 90% of the bicarbonate by weight.
14. The use of any one of claims 1 to 13, wherein the dosage form has the property that 15 minutes after the dosage form is added to a simulated gastric fluid, the amount of the meloxicam dissolved in the 5 simulated gastric fluid of the human being is greater than the amount of the meloxicam that is dissolved in the simulated gastric fluid of the human being as a result of adding a reference dosage form to the simulated gastric fluid, wherein the reference dosage form contains: 1) the same amount of meloxicam, 2) no bicarbonate, and 3) no rizatriptan.
15. The use of any one of claims 1 to 14, wherein the dosage form has the property that 15 minutes 10 after the dosage form is added to a simulated gastric fluid, the percentage of the rizatriptan dissolved in the simulated gastric fluid is greater than the percentage of the meloxicam.
16. The use of any one of claims 1 to 15, wherein the human being experiences pain relief sooner than would be experienced as a result of orally administering a reference dosage form containing: 1) the same amount of meloxicam, 2) no bicarbonate, and 3) no rizatriptan. 15
17. The use of any one of claims 1 to 16, wherein the dosage form has the property that 30 minutes after the dosage form is added to a simulated gastric fluid, at least about 50% of the rizatriptan in the dosage form is dissolved in the simulated gastric fluid.
18. The use of any one of claims 1 to 17, wherein the dosage form has the property that 30 minutes after the dosage form is added to a simulated gastric fluid, at least about 50% of the meloxicam in the 20 dosage form is dissolved in the simulated gastric fluid.
19. The use of any one of claims 1 to 18, wherein the T of meloxicam in the human being after administering the dosage form is less than about 1 hour.
20. The use of any one of claims 1 to 19, wherein the T of rizatriptan in the human being after administering the dosage form is less than about 2 hours.
NZ771802A 2019-07-03 Pharmaceutical compositions comprising meloxicam NZ771802B2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862693871P 2018-07-03 2018-07-03
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
PCT/US2019/040495 WO2020010196A1 (en) 2018-07-03 2019-07-03 Pharmaceutical compositions comprising meloxicam

Publications (2)

Publication Number Publication Date
NZ771802A NZ771802A (en) 2024-07-26
NZ771802B2 true NZ771802B2 (en) 2024-10-30

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