United States Patent:  5,948,414

Assignee:  Nouveau Technologies, Inc. (Tequesta, FL)

Filed:  March 24, 1998

This invention relates to an improved herbal-based decongestant and antihistamine nasal spray which includes known constituents in specific ratios and further includes a saponin. The invention further relates to a method for treating nasal congestion which results in enhanced decongestant action and surprising curative effects.

Summary of the Invention

The instant invention is directed to a composition containing pharmaceutically effective amounts, as said amounts relate to a nasal spray, of a decongestant, an antihistamine, a preservative, an aromatic, an emulsifier and an adjuvant; and to a method of use thereof. In use the composition is diluted to useful concentrations via the inclusion of water, preferably purified waters such as filtered, distilled, sterilized and demineralized water. In a preferred embodiment, demineralized water is utilized. It is known that the mucus film found in the nasal passageways plays an important part in the bodies defense mechanism by the constant beating of the cilia, whereby movement of this film toward the nasopharynx is accomplished, carrying with it trapped particles to be expectorated or swallowed. This mucus film is rich in lysozymes and contains glycoproteins and immunoglobulins. Lysozymes are an important defense against bacteria because they easily digest the lipid and carbohydrate cell walls of some bacteria and are responsible for the digestion of the cell walls of pollens and the subsequent release of antigenic substances. It is with this fact in mind that the inventor has added a specific amount of a triterpene saponin to the composition being discussed. By the addition of the triterpene saponin to the composition a surprising effect has been determined. Inclusion of triterpene saponin enhances the benefit of the antigenic substances produced by the action of the lysozymes contained in the mucus film found in the nasal passages.

In a preferred embodiment, the instant invention is defined as a composition comprising, in combination, effective amounts, as recommended for a nasal spray environment, of a decongestant commonly referred to as naphazoline hydrochloride; a preservative commonly referred to as benzalkonium chloride; an antihistamine commonly referred to as chlorpheniramine maleate; an aromatic material selected from the group consisting of menthol, azulen, camphor, eucalyptus oil and mixtures thereof; an emulsifier, which broadly comprises a chemical dispersing agent and which is preferably selected from the class of emulsifiers containing a combination of hydrophobic and hydrophilic substituents, particularly a combination of glycerol-polyethylene glycol ricinoleate, fatty acid esters of polyethyleneglycol and polyethylene glycol and ethoxylated glycerol, and, in a most preferred embodiment comprises an emulsifying agent available from BASF Aktiengesellschaft and marketed under the tradename CREMOPHOR EL; an adjuvant commonly referred to as triterpene saponin that carries the equivalent of a DAB-9 purity rating as set forth by the German government; and water, preferably demineralized water.

The composition of the instant invention, utilizing FDA approved components, is unique in that the individual components, when incorporated at specific ratios of the total product, offer an improved antihistamine and decongestant product that delivers the prompt and prolonged desired effects heretofore not achievable.

Claim 1 of 24 Claims

1. A nasal spray composition comprising in combination pharmaceutically effective amounts of:

a decongestant selected from the group consisting of naphazoline hydrochloride, ephedrine, oxymetazoline hydrochloride, phenylephrine hydrochloride, xylometaxoline hydrochloride and mixtures thereof;

an antihistamine selected from the group consisting of brompheniramine maleate, chlorpheniramine maleate, doxylamine succinate, phenindamine tartrate, pheniramine maleate, promethazine maleate, pyrilamine maleate, thonzylamine hydrochloride, and mixtures thereof;

an aromatic selected from the group consisting of natural oils or extracts therefrom such as camphor, eucalyptus oil, menthol, azulen and mixtures thereof;

an emulsifier selected from the class of emulsifiers containing a combination of hydrophobic and hydrophilic substituents, particularly a combination of glycerolpolyethylene glycol ricinoleate, fatty acid esters of polyethyleneglycol and polyethylene glycol and ethoxylated glycerol;

a triterpene saponin adjuvant; and

water.

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