Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams
AssigneeDr. Falk Pharma GmbH
InventorsNorbert Otterbeck, Reimund Kuhn
Life of this patent
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Abstract
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent which may be water, an alcohol such as ethanol, isopropanol or propylene glycol, or a water/alcohol mixture. The solution preferably also contains a stabilizer such as sodium ethylenediaminetetraacetic acid, cyclodextrins or mixtures thereof. The stable budesonide solution is useful as the active ingredient in a rectal enema or a rectal foam.
Claims22
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol.
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, which comprises 0.001 to 0.1% by weight of budesonide.
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, further comprising 0.05 to 1.0% by weight of cyclodextrins.
A process for producing a stable budesonide-containing solution with a pH not exceeding 6.0 which comprises dissolving the budesonide in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture, with the alcohol selected from the group consisting of ethanol, isopropanol and propylene glycol, and adjusting the pH of the budesonide solution to a value not exceeding 6.0.
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, further comprising 0.001 to 0.1% by weight of sodium ethylenediaminetetraacetic acid.
A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, comprising 0.001 to 0.1% by weight of budesonide and stabilizing additives selected from the group consisting of 0.001 to 0.1% by weight of sodium ethylene-diaminetetraacetic acid, 0.05 to 1.0% by weight of cyclodextrins and a mixture of said amounts of sodium ethylene-diaminetetraacetic acid and cyclodextrins.
Dependencies are inferred from the claim text.