Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a root – bulb – tuber – corm – or...
Reexamination Certificate
2001-12-14
2004-06-08
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a root, bulb, tuber, corm, or...
C424S725000
Reexamination Certificate
active
06746697
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to 1) compositions that are used orally in treating the clinical condition known as xerostomia, that increase salivation, alleviate dry mouth and the sensations of dry mouth, and thereby aid in maintaining or improving oral hygiene, and methods of using same; 2) compositions that cause local oral anesthesia by direct contact, thereby alleviating pain and dryness in the oral cavity and pharynx caused by dental conditions, cough, sore throat, radiotherapy, surgery and other treatments that may affect the oral cavity and methods of using same; 3) compositions that may be described as oral sensates, that produce sensations of tingling, numbness, moistness and other sensations, and methods of using same; 4) as a flavor enhancer and potentiator; 5) compositions that may include any potential combinations of effects as described above in 1, 2, 3, and 4, and methods of using same. More particularly, the invention relates to oral compositions that include an herbal extract that address a variety of oral conditions; produce a variety of oral sensations, and methods of using the same.
DESCRIPTION OF RELATED ART
Heliopsis longipes
S. F. Blake (Asteraceae) is a herbaceous plant species found in Mexico that has been disclosed over fifty years ago as having possible commercial value as a source of insecticide. Little, Jr., E. L.,
Heliopsis longipes
, a
Mexican insecticidal plant species
, Journal of the Washington Academy of Sciences, Vol.38, No.8, pp.269-274 (Aug. 15, 1948). More particularly, the roots of
Heliopsis longipes
have been used in Mexico to make local insecticides. Id. This use of the plant was discontinued over four decades ago. While this was one use of
Heliopsis longipes
roots, these roots have been used primarily as a spice or flavoring, as chewing the root causes numbness and tingling in the mouth and tongue and stimulates salivation. Id. These roots were also chewed to relieve toothache. Id. One incident is reported of an adverse effect, when a great, but undisclosed, quantity of these roots was eaten. Id.
Extracts from the roots of
Heliopsis longipes
have been used in a few medical applications. Id. For example, reportedly, such an extract has been used for treating colds and pneumonia, and an alcoholic extract has been tested for use as an anesthetic for tooth extraction. Id. It has also been reported that an extract of these roots possesses antiseptic properties. Molina-Torres, J., et al.,
Antimicrobial properties of alkamides present in flavouring plants traditionally used in Mesoamerica
: affinin and capsaicin, Journal of Ethnopharmocology, Vol.64, Iss.3, pp.241-248 (March 1999). A crude methanol extract of
Heliopsis longipes
roots has been described as having the potential to generate anti-infective agents, although this extract reportedly does not show any activity in plate diffusion tests against either
E. coli
(Gram negative bacteria) or
B. subtilis
(Gram positive bacteria). Id.; and Gutierrez-Lugo, M. T., et al.,
Antimicrobial and cytotoxic activities of some crude drug extracts from Mexican Medicinal plants
, phytomedicine, Vol.2 (4), pp.341-347 (1996). An ethanol extract of
Heliopsis longipes
roots has been reported as having variable bactericidal effects on
E. coli
and
S. aureus
. Romero-R., C. M., et al.,
Preliminary Studies of the Antibacterial, Insecticidal, and Toxicological Effects of Chiluan Root
(
Heliopsis Longipes
), as translated, Veterinaria Mexico, pp. 151-156, (1989).
Heliopsis longipes
roots are known to contain a bioactive alkamide, affinin, identified as N-isobutyl-2E, 6Z, 8E-decatrienamide or N-isobutyldeca-trans-2,cis-6,-trans-8-trienamide. Respectively, Id.; and Crombie, L., et al.,
Amides of Vegetable Origin
. part X. The Stereochemistry and Synthesis of Affinin, Journal of Chemical Society, pp.4970-4976 (1963). Affinin has also been identified as N-isobutyl 2,6,8-decatrienoamide in one publication, in another publication, and N-isobutyldodeca-2-trans-6-cis-8-trans-trienamide in another publication. Respectively, Jacobson, M., et al., Correction of the Source of “Affinin” (N-Isobutyl-2,6,8-Decatrienoamide, Journal of Organic Chemistry 12, pp.731-732 (1947) (emphasis added); and Ogura, M., et al., Ethnopharmacologic studies. I. Rapid solution to a problem—oral use of
Heliopsis longipes
—by means of a multidisciplinary approach, Journal of Ethnopharmacology, 5, pp.215-219 (1982) (emphasis added). Purified affinin, prepared from an ethanol extract of
Heliopsis longipes
roots, has been reported as being toxic to certain microorganisms, the toxicity varying for Gram positive and Gram negative bacteria. Molina-Torres, J., et al. An aqueous solution of affinin, prepared from a powder of an ethanol extract of
Heliopsis longipes
roots, has also been reported as having an analgesic effect when administered orally to mice at doses of from 2.5 to 10.0 mg/kg, with severe depression of normal motor activity and two out of five deaths occurring at the highest dose. Ogura, M., et al.
In the one publication where affinin is identified as N-isobutyl-dodeca-2-trans-6-cis-8-trans-trienamide, it was said to be identical with spilanthol, the pungent principle of several Spilanthes species. Ogura, M., et al. However, in the publication of Little, Jr., affinin is said to be similar to spilanthol, which has been isolated from flower heads of a species of Spilanthes. Little, Jr., E. L., at p.270. The flowers and leaves of Spilanthes acmella L. var. oleracea Clarke are reported as having been used as a spice and as a folk medicine for stammering, toothache, stomatitis and throat complaints. Ramsewak, R. S., et al., Bioactive N-isobutylamides from the flower buds of
Spilanthes acmella
, Phytochemistry 51, pp. 729-732 (1999).
SUMMARY OF THE INVENTION
1) The present invention provides compositions based on
Heliopsis longipes
root that are used orally in treating the clinical condition known as xerostomia, or more generally, dry mouth, that increase salivation, alleviating dry mouth and the sensations of dry mouth, and in maintaining or improving oral hygiene, and methods of using the same.
2) The present invention provides compositions based on
Heliopsis longipes
root that may provide some degree of local anesthesia and a sensation of numbness to all or portions of the oropharynx including teeth, gums, lips, tongue, palates, throat, and to the upper respiratory passageways such as the trachea, and bronchi. This provides some degree of relief from pain, dryness, irritation, and inflammation to these regions. There my be an improvement in swallowing that is impaired by illness and drying of the oropharynx. An anti-bacterial and anti-viral affect may also occur with reductions in bacterial and viral counts, and improvement from infections of these anatomical regions.
3) The present invention provides compositions based on
Heliopsis longipes
root that may cause desirable sensations to the same anatomical regions, these sensations consisting of tingling, numbness, moistness, acerbic taste, soothing, and other sensations.
4) The present invention provides compositions that may enhance other flavors, natural and artificial, and combinations of them—by increasing their strength and qualities, and by potentiating flavors in duration and quality.
The herbal composition includes an extract from
Heliopsis longipes
root in an amount sufficient to promote the above goals and an oral carrier for said extract. A suitable amount of the extract is from about 0.01 to about 10 weight percent of the overall composition. preferably, the extract is present in an amount sufficient to provide the above benefits for a prolonged period, i.e., for one minute or more.
A particular advantage of the inventive compositions is that they employ an extract of the
Heliopsis longipes
root, and thus, use a very small amount of the plant itself. This is especially important because the plant is believed to grow in a narrow geographic region, and thus, could become endangered if there were to be overly ag
Litman Richard C.
Naff David M.
Phytos, Inc.
Ware Deborah K.
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