NZ779449B2 - Ready-to-use injectable formulations - Google Patents

Ready-to-use injectable formulations Download PDF

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Publication number
NZ779449B2
NZ779449B2 NZ779449A NZ77944920A NZ779449B2 NZ 779449 B2 NZ779449 B2 NZ 779449B2 NZ 779449 A NZ779449 A NZ 779449A NZ 77944920 A NZ77944920 A NZ 77944920A NZ 779449 B2 NZ779449 B2 NZ 779449B2
Authority
NZ
New Zealand
Prior art keywords
composition
ready
amount
cefovecin
total weight
Prior art date
Application number
NZ779449A
Other versions
NZ779449A (en
Inventor
Todd P Physical Foster
Vijaya Bharti Physical Joshi
Laibin Physical Luo
Original Assignee
Zoetis Services Llc
Filing date
Publication date
Application filed by Zoetis Services Llc filed Critical Zoetis Services Llc
Priority claimed from PCT/US2020/021060 external-priority patent/WO2020181024A1/en
Publication of NZ779449A publication Critical patent/NZ779449A/en
Publication of NZ779449B2 publication Critical patent/NZ779449B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54Heterocyclic 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
    • A61K31/542Heterocyclic 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 heterocyclic ring systems
    • A61K31/545Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

Abstract

The invention describes a ready-to-use injectable cephalosporin composition with reasonable viscosity, resuspendability, and syringeability attributes for injection as an antibiotic for animals. The composition claimed comprises a biocompatible oil that is propylene glycol dicaprylate/dicaprate in the amount of 58w/w% to 68w/w% of the total weight of the composition and a non-aqueous solvent that is benzyl benzoate in the amount of 18w/w% to 22w/w% of the total weight of the composition.

Claims (13)

Claims
1. A ready-to-use injectable suspension composition comprising a osporin which is cefovecin or cefovecin sodium, wherein the composition comprises a biocompatible oil that is propylene glycol dicaprylate/dicaprate in the amount of 58w/w% to 68w/w% of the total weight of the composition and a non-aqueous solvent that is benzyl benzoate in the amount of 18w/w% to 22w/w% of the total weight of the composition.
2. The ready-to-use composition of Claim 1, n the benzyl benzoate is in the amount of 20w/w% of the total weight of the composition and the propylene glycol dicaprylate/dicaprate is in the amount of 61w/w% to 64w/w% of the total weight of the composition.
3. The ready-to-use composition of Claim 2, wherein the cephalosporin is cefovecin sodium.
4. The ready-to-use composition of Claim 3, wherein the cefovecin of cefovecin sodium in the composition is in the amount of mL to 180mg/mL and the composition is to be administered by subcutaneous injection.
5. A ready-to-use injectable suspension composition comprising cefovecin sodium and wherein the cefovecin of cefovecin sodium in the composition is in the amount of mL to 180mg/mL; a biocompatible oil that is propylene glycol ylate/dicaprate in the amount of 60w/w% to 65w/w% of the total weight of the composition and a ueous solvent that is benzyl benzoate in the amount of 18w/w% to 22w/w% of the total weight of the composition.
6. The ready-to-use ition of Claim 5, wherein the concentration of cefovecin in the composition is 160mg/mL.
7. The ready-to-use composition of Claim 6, wherein the composition is to be administered by subcutaneous injection.
8. The ready-to-use composition of any one of Claims 1 to 6 which is for treating a bacterial infection in a companion animal.
9. The ready-to-use composition of Claim 8, wherein the companion animal is canine or feline.
10. A method of treating a bacterial ion in a companion animal in need thereof, by administering an effective amount of a cephalosporin which is cefovecin or cefovecin sodium in a ready-to-use injectable composition in any one of Claims 1 to 6.
11. The method of Claim 10, wherein the companion animal is canine or .
12. A ready-to-use injectable suspension composition comprising a cephalosporin, a biocompatible oil, and a ueous solvent, wherein the non-aqueous solvent is benzyl benzoate in the amount of about 20w/w% of the total weight of the composition, and the biocompatible oil is propylene glycol dicaprylate/dicaprate in the amount of about 61w/w% to about 64w/w% of the total weight of the ition, and the cephalosporin is cefovecin sodium wherein cefovecin of cin sodium is in an amount of about mL.
13. The ready-to-use composition of any one of Claims 1, 5 or 12, substantially as herein described with reference to any one of the examples and/or
NZ779449A 2020-03-05 Ready-to-use injectable formulations NZ779449B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962814440P 2019-03-06 2019-03-06
PCT/US2020/021060 WO2020181024A1 (en) 2019-03-06 2020-03-05 Ready-to-use injectable formulations

Publications (2)

Publication Number Publication Date
NZ779449A NZ779449A (en) 2023-11-24
NZ779449B2 true NZ779449B2 (en) 2024-02-27

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