PHARMACEUTICAL COMPOSITIONS COMPRISING PLANT EXTRACTS AND METHODS FOR REDUCING DURATION OF A COMMON COLD USING SAME

• US 20150231191A1
• Filed: 04/29/2015
• Published: 08/20/2015
• Est. Priority Date: 01/23/2014
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Matrixx Initiatives Incorporated (Church & Dwight Company Incorporated)
• Inventors: Clarot, Timothy L., Ascarate, Arlene M.
• Granted Patent: US 9,555,069 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/30 Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
• CPC Class Codes: A61K 36/42 Cucurbitaceae (Cucumber family)
• CPC Class Codes: A61K 36/515 Gentiana
• CPC Class Codes: A61K 36/88 Liliopsida (monocotyledons)
• CPC Class Codes: A61K 36/896 Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0043 Nose

Abstract

The present disclosure describes pharmaceutical compositions and methods for reducing duration, intensity, and/or bothersomeness of common colds in humans and for reducing severity or duration of common cold symptoms such as nasal congestion, runny nose, watery eyes, dry/scratchy throat and sneezing in humans exhibiting such symptoms. The compositions herein comprise extracts of at least one of Luffa Operculata (L. operculata), S. officinale (V. sabadilla), and Galphimia Glauca (G. glauca) in a pharmaceutically acceptable carrier, and in various embodiments, comprise a mixture of all three Luffa Operculata (L. operculata) 10% extract MT, S. officinale (V. sabadilla) 3× extract, and Galphimia Glauca (G. glauca) 10% extract MT in a pharmaceutically acceptable carrier.

Claims

1. (canceled)

2. A method for treating an upper respiratory infection, said method comprising:

nasally administering to a human in need thereof a therapeutically effective amount of a composition comprising;

(a) a total of from about 0.001 wt. % to about 0.5 wt. % of at least one or combination of L. operculata 10 wt. % extract (MT), S. officinale 3×

extract, and G. glauca 10 wt. % extract (MT);

(b) a thickener at from about 0.001 wt. % to about 10 wt. %; and

(c) a pharmaceutically acceptable carrier comprising at least about 90 wt. % water, wherein each wt. % is based on the total weight of the composition.

3. The method according to claim 2, wherein said thickener is selected from the group consisting of carboxymethyl cellulose, carboxyethyl cellulose, hydroxyethyl cellulose, hydrophobically modified hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, microcrystalline cellulose, nitrocellulose, polyvinyl alcohol, polyvinylpyrrolidone, polyvinylmethacrylate, polyacrylates, acrylic acid/vinyl pyrrolidone cross-polymer, carboxyvinyl polymers, polyvinylacetate, polyvinyl co-polymers, polyurethanes, starch, modified starch, dextrin, xanthan gum, agar, alginic acid, alginate, pectin, gelatin, and mixtures thereof.

4. The method according to claim 2, wherein said composition further comprises from about 0.01 wt. % to about 10 wt. % of an organic acid, and from about 0.01 wt. % to about 10 wt. % of an alkaline material.

5. The method according to claim 4, wherein said organic acid is selected from the group consisting of formic acid, carbonic acid, acetic acid, lactic acid, oxalic acid, propionic acid, valeric acid, enanthic acid, pelargonic acid, butyric acid, lauric acid, docosahexaenoic acid, eicosapentaenoic acid, pyruvic acid, acetoacetic acid, benzoic acid, salicylic acid, aldaric acid, fumaric acid, glutaconic acid, traumatic acid, muconic acid, malonic acid, malic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, azelaic acid, abietic acid, pimaric acid, sebacic acid, phthalic acid, isophthalic acid, terephthalic acid, maleic acid, citric acid, and mixtures thereof.

6. The method according to claim 4, wherein said alkaline material is chosen from the group consisting of NaOH, KOH, NH₃, sodium acetate, sodium succinate, disodium succinate, monosodium citrate, disodium citrate, trisodium citrate, NaH₂PO₄, Na₂HPO₄, Na₃PO₄, KH₂PO₄, K₂HPO₄, K₃PO₄, NaHSO₄, Na₂SO₄, KHSO₄, K₂SO₄, NaHCO₃, Na₂CO₃, KHCO₃, K₂CO₃, NaH₃P₂O₇, Na₂H₂P₂O₇, Na₃HP₂O₇, Na₄P₂O₇, KH₃P₂O₇, K₂H₂P₂O₇, K₃HP₂O₇, K₄P₂O₇, and mixtures thereof.

7. The method according to claim 2, wherein said composition further comprises from about 0.001 wt. % to about 1 wt. % of an inhalant selected from the group consisting of anethole, menthol, eucalyptol, borneol, borneol acetate, camphor, 1,8-cineole, cinnamaldehyde, benzaldeyhde, citral, thujone, eugenol, limonene, geraniol, citronellol, citronellal, pinene, linalool, thymol, carvone, caryphyllene, linalyl acetate, methyl salicylate, and mixtures thereof.

8. The method according to claim 7, wherein said inhalant is selected from the group consisting of eucalyptol, eugenol, menthol, camphor, and mixtures thereof.

9. The method according to claim 2, wherein said composition further comprises from about 0.01 wt. % to about 10 wt. % of an α

-amino acid.

10. The method according to claim 9, wherein said α

-amino acid is chosen from the group consisting alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, L-lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, and mixtures thereof.

11. The method according to claim 2, wherein said composition further comprises from about 0.001 wt. % to about 10 wt. % of a surfactant.

12. The method according to claim 11, wherein said surfactant is selected from the group consisting of polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitol esters, polyoxyethylene esters, polyoxyethylene alcohols, and mixtures thereof.

13. The method according to claim 2, wherein said composition further comprises at least one drug active.

14. The method according to claim 13, wherein said drug active is selected from the group consisting of zanamivir, oseltamivir, abacavir, and mixtures thereof.

15. A method for treating an upper respiratory infection, said method comprising:

nasally administering to a human in need thereof a therapeutically effective amount of a composition comprising;

(a) from about 0.001 wt. % to about 0.5 wt. % of a mixture of L. operculata 10 wt. % extract (MT), S. officinale 3×

extract, and G. glauca 10 wt. % extract (MT);

(b) from about 0.001 wt. % to about 10 wt. % of a thickener;

(c) from about 0.001 wt. % to about 10 wt. % of a surfactant;

(d) from about 0.01 wt. % to about 10 wt. % of an organic acid;

(e) from about 0.01 wt. % to about 10 wt. % of an alkaline material;

(f) from about 0.001 wt. % to about 1 wt. % of an inhalant;

(g) from about 0.01 wt. % to about 10 wt. % of an α

-amino acid; and

(h) from about 90 wt. % to about 99 wt. % water, wherein each wt. % is based on the total weight of the composition.

16. The method according to claim 15, wherein said inhalant is selected from the group consisting of anethole, menthol, eucalyptol, borneol, borneol acetate, camphor, 1,8-cineole, cinnamaldehyde, benzaldeyhde, citral, thujone, eugenol, limonene, geraniol, citronellol, citronellal, pinene, linalool, thymol, carvone, caryphyllene, linalyl acetate, methyl salicylate, and mixtures thereof.

17. The method according to claim 15, wherein said inhalant is selected from the group consisting of eucalyptol, eugenol, menthol, camphor, and mixtures thereof.

18. The method according to claim 15, wherein said α

-amino acid is selected from the group consisting alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, L-lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, and mixtures thereof.

19. The method according to claim 15, wherein said α

-amino acid is selected from the group consisting of glycine, L-lysine, and mixtures thereof.

20. The method according to claim 15, wherein said composition further comprises 2-phenylethanol at a level of about 0.001 wt. % to about 1 wt. %, based on the total weight of the composition.

21. A method for treating an upper respiratory infection, said method comprising:

nasally administering to a human in need thereof a therapeutically effective amount of a composition comprising;

(a) from about 0.001 wt. % to about 0.5 wt. % of a mixture of L. operculata 10 wt. % extract (MT), S. officinale 3×

extract and G. glauca 10 wt. % extract (MT);

(b) from about 0.5 wt. % to about 1.5 wt. % of a cellulosic thickener;

(c) from about 0.01 wt. % to about 1 wt. % of a surfactant;

(d) from about 0.1 wt. % to about 1 wt. % of an organic acid;

(e) from about 0.1 to about 2 wt. % of at least one alkaline material;

(f) from about 0.001 wt. % to about 1 wt. % of an inhalant selected from the group consisting of eucalyptol, eugenol, menthol, camphor, and mixtures thereof;

(g) from about 0.05 wt. % to about 0.5 wt. % of an amino acid;

(h) from about 0.1 wt. % to about 1 wt. % sodium chloride; and

(i) from about 90 wt. % to about 99 wt. % water, wherein each wt. % is based on the total weight of the composition.