Pharmaceutical composition for the acute treatment of migraine and other forms of headache
AssigneeCss Pharma L.L.C.
InventorsGuillermo Antonio GARCIA PITTALUGA, Julio César VILLAMIL TORRES, Sankar SHANMUGAM, Camilo REY FERRO
Life of this patent
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Abstract
A pharmaceutical composition for intranasal administration and manufacturing method of preparations containing a combination of ibuprofen and ketoprofen at a fraction of the dose required when the same active ingredients are administered orally, useful in the treatment of migraine and other forms of headache.
Claims19
A pharmaceutical composition for intranasal administration and treatment of migraines and other forms of headaches, comprising:
- ibuprofen at a concentration ranging from 0.20% to 4.0% (w/v) which, when applied to an individual's nasal mucosa, provides an ibuprofen dose ranging from 0.4 mg to 8 mg per dosage unit;
- and
- ketoprofen at a concentration ranging from 0.0125% to 0.240% (w/v) which when applied to the nasal mucosa, provides a ketoprofen dose ranging from 0.025 mg to 0.48 mg per dosage unit.
A method of manufacturing a pharmaceutical composition for intranasal administration and treatment of migraines and other forms of headaches, comprising the dissolution of individual ingredients in their respective solvents, followed by sequential mixing of the resultant solutions in a specified order to prevent precipitation or recrystallization, as detailed in the following steps:
- dissolving methyl paraben and propylparaben in propylene glycol to produce a paraben concentrated solution, and further diluting the paraben concentrated solution in water resulting in a CFB01 solution;
- dissolving the isotonizing agents, as well as the component of the buffer system in solution CBF01, resulting in a Buffer solution;
- dissolving sodium chloride and sodium bicarbonate, in a mixture of CBF01 solution and water;
- heating of the solution of sodium chloride, sodium bicarbonate, CBF01 solution, and water to 50° C.±5° C. and dissolving one or more active ingredients, ibuprofen and ketoprofen;
- cooling the solution to room temperature and the further dissolving sodium hyaluronate;
- verifying pH;
- making up to volume with water;
- and
- verifying the osmolarity of the composition.
A device for the delivery of a pharmaceutical composition for intranasal administration and treatment of migraines and other forms of headaches, comprising:
- ibuprofen at a concentration ranging from 0.20% to 4.0% (w/v) which, when applied to an individual's nasal mucosa, provides an ibuprofen dose ranging from 0.4 mg to 8 mg per dosage unit;
- and
- ketoprofen at a concentration ranging from 0.0125% to 0.240% (w/v) which when applied to the nasal mucosa, provides a ketoprofen dose ranging from 0.025 mg to 0.48 mg per dosage unit.
Dependencies are inferred from the claim text.