Pharmaceutical composition containing sympathomimetic amine salt and co-distillable additive
AssigneeWyeth
InventorsDavid Hugh Giamalva, Gary Bruce Anderson
Life of this patent
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Abstract
A pharmaceutical composition is provided which contains a water soluble acid salt of a sympathomimetic amine, e.g., pseudoephedrine, and an additive, e.g., a volatile amine or other odorant, that is co-distillable, e.g., by steam distillation, with the sympathomimetic amine and/or its derivatives, e.g., its free base.
Claims17
A pharmaceutical composition comprising a mixture which contains:
- i) a water soluble acid salt of a sympathomimetic amine, and ii) an additive that is co-distillable with the sympathomimetic amine as a free base, hydrochloride salt, or sulfate salt, wherein the additive is an odorant or a mixture of two or more odorants in an amount from about 0.1 to 1 part total additive per 100 parts of the sympathomimetic amine as a free base, hydrochloride salt, or sulfate salt, wherein the odorant or the mixture of two or more odorants selected from the group consisting of camphor, triethyl citrate, methyl anthranil, isoamyl acetate, geranyl acetate, linalool, alpha ionone, ortho-nitroacetophenone, and ortho-aminoacetophenone.
A method of reducing the isolatability of a water soluble acid salt of a sympathomimetic amine from a pharmaceutical composition containing said acid salt of a sympathomimetic amine, which comprises including within said pharmaceutical composition an odorant or a mixture of two or more odorants which is co-distillable with the sympathomimetic amine as a free base, hydrochloride salt, or sulfate salt, in an amount from about 0.1 to 1 part total additive per 100 parts of said amine as a free base, hydrochloride salt, or sulfate salt.
Dependencies are inferred from the claim text.