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NZ730996B2 - Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease - Google Patents
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NZ730996B2 - Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease - Google Patents

Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease

Info

Publication number
NZ730996B2
NZ730996B2 NZ730996A NZ73099615A NZ730996B2 NZ 730996 B2 NZ730996 B2 NZ 730996B2 NZ 730996 A NZ730996 A NZ 730996A NZ 73099615 A NZ73099615 A NZ 73099615A NZ 730996 B2 NZ730996 B2 NZ 730996B2
Authority
NZ
New Zealand
Prior art keywords
compound
pharmaceutical composition
pharmaceutically acceptable
acceptable salt
alkyl
Prior art date
Application number
NZ730996A
Other versions
NZ730996A (en
Inventor
David Benoit Cardinal
Vincent S Chan
Kassibla E Dempah
Brian P Enright
Rodger F Henry
Raimundo Ho
Ye Huang
Alexander D Huters
Russell C Klix
Scott W Krabbe
Original Assignee
Abbvie Inc
Filing date
Publication date
Application filed by Abbvie Inc filed Critical Abbvie Inc
Priority to NZ769153A priority Critical patent/NZ769153B2/en
Priority claimed from PCT/US2015/056686 external-priority patent/WO2016065019A1/en
Publication of NZ730996A publication Critical patent/NZ730996A/en
Publication of NZ730996B2 publication Critical patent/NZ730996B2/en

Links

Classifications

    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/661Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/661Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • A61K31/6615Compounds having two or more esterified phosphorus acid groups, e.g. inositol triphosphate, phytic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C281/00Derivatives of carbonic acid containing functional groups covered by groups C07C269/00 - C07C279/00 in which at least one nitrogen atom of these functional groups is further bound to another nitrogen atom not being part of a nitro or nitroso group
    • C07C281/02Compounds containing any of the groups, e.g. carbazates
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C309/00Sulfonic acids; Halides, esters, or anhydrides thereof
    • C07C309/01Sulfonic acids
    • C07C309/02Sulfonic acids having sulfo groups bound to acyclic carbon atoms
    • C07C309/24Sulfonic acids having sulfo groups bound to acyclic carbon atoms of a carbon skeleton containing six-membered aromatic rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C47/00Compounds having —CHO groups
    • C07C47/20Unsaturated compounds having —CHO groups bound to acyclic carbon atoms
    • C07C47/277Unsaturated compounds having —CHO groups bound to acyclic carbon atoms containing ether groups, groups, groups, or groups
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07FACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02Phosphorus compounds
    • C07F9/06Phosphorus compounds without P—C bonds
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07FACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02Phosphorus compounds
    • C07F9/06Phosphorus compounds without P—C bonds
    • C07F9/08Esters of oxyacids of phosphorus
    • C07F9/09Esters of phosphoric acids
    • C07F9/094Esters of phosphoric acids with arylalkanols

Abstract

The present disclosure relates to pharmaceutical compositions comprising a phosphorylated carbidopa prodrug and a phosphorylated L-dopa prodrug, and the use thereof in the treatment of Parkinson's disease and associated conditions.

Claims (15)

Claims:
1. A pharmaceutical composition comprising a first compound corresponding in structure to Formula (I): R2O NH2 (I) , or a pharmaceutically acceptable salt thereof, wherein R1 and R2 are each ndently ed from the group consisting of hydrogen, -P(O)(OH)2, and –R5–O– P(O)(OH)2; R5 is a alkyl; R6 is hydrogen or a C1-C4-alkyl; and provided that at least one of R1 and R2 is -P(O)(OH)2 or –R5–O–P(O)(OH)2; and a second compound corresponding in structure Formula (II): R4O (II) , or a pharmaceutically acceptable salt thereof, wherein R3 and R4 are each independently selected from the group consisting of hydrogen, -P(O)(OH)2, and –R5–O– P(O)(OH)2; R5 is a C1-C4-alkyl; R6 is hydrogen or a C1-C4-alkyl; and provided that at least one of R3 and R4 is -P(O)(OH)2 or –R5–O–P(O)(OH)2.
2. The pharmaceutical ition of Claim 1, wherein the first compound is O O HO P O HO NH2 (I-a) , HO P O NH2 OH (I-b) , HO O HO OH O HN O NH2 OH (I-c) , O HN HO P O O NH2 OH OH (I-d), HO NH2 O P OH HO (I-e), or HO H2N HO O (I-f).
3. The pharmaceutical composition of Claim 1 or 2 wherein the first compound is a compound corresponding in ure to Formula (I-b): HO P O NH2 OH (I-b) , or a pharmaceutically acceptable salt thereof.
4. The pharmaceutical composition of any one of Claims 1-3, wherein the second compound is O O HO P O HO (II-a) , HO P O OH (II-b) , HO O HO OH O NH2 OH (II-c) , HO P OH O HO (II-d), or HO P OH O (II-e).
5. The pharmaceutical composition of any one of Claims 1-4, wherein the second nd is a compound corresponding in structure to Formula (II-b): HO P O OH (II-b) , or a pharmaceutically acceptable salt thereof.
6. The pharmaceutical composition of any one of Claims 1-5, further comprising a pharmaceutically able carrier.
7. The pharmaceutical composition of any one of Claims 1-6, wherein the first compound or pharmaceutically acceptable salt thereof has a solubility of at least about 200 mg/ml in aqueous solution at about neutral pH, and the second compound or pharmaceutically acceptable salt thereof has a lity of at least about 400 mg/ml in s solution at about neutral pH.
8. The pharmaceutical composition of any one of Claims 1-7, wherein the composition r comprises water and is suitable for infusion.
9. The pharmaceutical composition of any one of Claims 1-8, wherein the combination is an aqueous combination suitable for subcutaneous administration.
10. The pharmaceutical composition of claim 1, comprising a first compound corresponding in structure to Formula (I-b): HO P O NH2 OH (I-b) , or a pharmaceutically able salt thereof; and a second compound corresponding in structure to Formula (II-b): HO P O OH (II-b) , or a pharmaceutically acceptable salt f; wherein the composition is an aqueous composition suitable for subcutaneous administration.
11. Use of the pharmaceutical composition of any one of Claims 1-10 in the manufacture of a medicament for treating Parkinson’s disease in a human subject in need thereof and/or providing rescue therapy in a human subject having Parkinson’s disease.
12. The use of Claim 11, wherein the medicament is formulated to have substantially continuous administration of the first compound and the second compound over a period of at least about 12 hours.
13. The use of Claim 11 or 12, wherein the medicament is formulated to be administered with another arkinson’s agent.
14. A compound corresponding in structure to a (I): R2O NH2 (I) , or a pharmaceutically acceptable salt thereof, n R1 and R2 are each independently selected from the group consisting of hydrogen, -P(O)(OH)2, and –R5–O– P(O)(OH)2; R5 is a C1-C4-alkyl; R6 is hydrogen or a C1-C4-alkyl; and provided that at least one of R1 and R2 is -P(O)(OH)2 or P(O)(OH)2.
15. The compound or salt of Claim 14, wherein the compound corresponds in structure to a (I-b): HO P O NH2 OH (I-b) . AbbVie Inc. By the Attorneys for the Applicant SPRUSON & FERGUSON
NZ730996A 2015-10-21 Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease NZ730996B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
NZ769153A NZ769153B2 (en) 2015-10-21 Carbidopa and L-dopa prodrugs and their use to treat Parkinson's disease

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462066771P 2014-10-21 2014-10-21
PCT/US2015/056686 WO2016065019A1 (en) 2014-10-21 2015-10-21 Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease

Publications (2)

Publication Number Publication Date
NZ730996A NZ730996A (en) 2024-04-26
NZ730996B2 true NZ730996B2 (en) 2024-07-30

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