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Pharmaceutical composition containing sympathomimetic amine salt and co-distillable additive

A pharmaceutical composition and sympathetic nerve technology are applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, pharmaceutical formulas, etc., and can solve problems such as limiting efficacy.

Inactive Publication Date: 2009-04-29
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Although the various methods set forth above inhibit the isolation of sympathomimetic amines or otherwise inhibit illicit synthetic attempts, techniques have been developed to limit the effectiveness of these methods

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0071] Example 1 (comparison)

[0072] Conventional sympathomimetic amine-containing pharmaceutical tablets (Advil Allergy Sinus) were prepared according to well known formulation procedures. The tablets each contained 200 mg ibuprofen as a pain reliever / fever reducer, 30 mg pseudoephedrine hydrochloride as a decongestant and 2 mg chlorpheniramine maleate as an antihistamine. Tablets further contain carnauba wax, croscarmellose sodium, FD&C red aluminum lake No. 40, FD&C yellow aluminum lake No. 6, glyceryl behenate, hypromellose, iron oxide Iron oxide black, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, silicon dioxide, starch and titanium dioxide were used as inactive ingredients.

example 2

[0074] According to well-known formulation procedures, pharmaceutical tablets containing sympathomimetic amines were prepared according to Example 1, but further comprising the addition of methyl anthranilate additive co-distillable with pseudoephedrine free base in an amount sufficient to provide each The tablet contains about 6 mg of additives. The additive is added in a manner of being thoroughly mixed with pseudoephedrine hydrochloride.

example 3

[0076] According to well-known formulation procedures, pharmaceutical tablets containing sympathomimetic amines were prepared according to Example 1, but further comprising the addition of a menthol additive co-distillable with pseudoephedrine free base in an amount sufficient to provide about 10 mg per tablet additive.

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PUM

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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.

Description

technical field [0001] The present invention generally relates to pharmaceutical compositions comprising salts of sympathomimetic amines, wherein the amines are particularly difficult to isolate by distillation for use in illicit drug manufacture. Background technique [0002] As the name implies, sympathomimetic compounds exert biological effects similar to those produced by activation of the sympathetic nervous system. For example, the pharmaceutical compound pseudoephedrine acts as an indirect mimic by causing the release of norepinephrine from adrenergic nerve endings, thereby stimulating alpha- and beta-noradrenergic receptors, especially in blood vessels of the upper airway. Sympathetic agents. This in turn causes blood vessels to constrict and swollen tissue in the sinuses and nasal passages to shrink, making the compound useful as a decongestant. [0003] Despite the legitimate use of such sympathomimetic compounds, sympathomimetic compounds such as the ubiquitous ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K31/192A61K31/205A61K31/473A61K31/616A61K47/18A61K31/485
CPCA61K47/18A61K31/137A61K31/473A61K31/205A61K31/616A61K31/485A61K31/192A61K9/2013A61K45/06
Inventor 戴维·休·贾马尔瓦加里·布鲁斯·安德森
Owner WYETH LLC