Composition and method useful for treating colic

Details Composition and method useful for treating colic Composition and method useful for treating colic

2002-02-11

2004-03-09

Weddington, Kevin E. (Department: 1614)

Drug, bio-affecting and body treating compositions

Extract or material containing or obtained from a...

C514S783000

Reexamination Certificate

active

06703022

ABSTRACT:

BACKGROUND OF THE INVENTION
Infantile colic is characterized by episodes during which an infant is irritable, cries or screams excessively, and draws up the legs. Episodes of colic tend to be worse in the evenings and do not respond to the usual means of comforting, such as feeding, cuddling, or diaper changing.
Infantile colic is common, occurring in approximately one in ten babies. It often first appears around the third or fourth week after birth, and usually clears up on its own by the age of twelve weeks. It is thought to be due to a spasm in the intestines, although there is no proof of this, and the cause of the presumed spasm is unknown. See The American Medical Association Encyclopedia of Medicine, Charles B. Clayton ed. 1989, Random House, New York, page 288.
In the past, colic has been treated with antispasmodic drugs, but these drugs are now not usually recommended for babies under 6 months of age. The most common treatment for colic today is to simply wait for the baby to grow out of the condition.
Z. Weizman et al.
The Journal of Pediatrics,
1993, 122, 650-652 evaluated the effect of a beverage prepared from natural flavors, glucose, and dried extracts of 1) chamomile (
Matricaria chamomilla
), 2) vervain (
Verbena officinalis
), 3) licorice (
Glycyrrhiza glabra
), 4) fennell (
Foeniculum vulgare
) and balm-mint (
Melissa officinalis
) on infantile colic in a prospective double-blind study. It was found that the tea eliminated colic in 57% of the infants, whereas placebo was helpful in only 26% of the infants. Additionally, the mean colic score was reported to have been significantly improved in tea-treated infants.
Although some success in treating colic has been reported using herbal extracts, such preparations are not ideally suited for treating infantile colic. For example, it is difficult to accurately determine the dose of the active ingredient(s) in an extract or tea. It is also difficult to provide a reproducible dose using these materials. Finally, use of extracts and teas is limited due to the presence of contaminates that are present as a result of the manner in which the extracts and teas are prepared. The difficulties in determining an accurate dosage, and the presence of impurities are especially problematic for the treatment of infants, since infants can be significantly effected by small variations in dose or by the presence of small quantities of impurities.
Thus, there is currently a need for compositions and methods that are useful for treating colic. In particular, there is a need for methods and compositions that can conveniently be used for treating infants suffering from colic.
SUMMARY OF THE INVENTION
The present invention provides compositions that are useful for treating colic. Accordingly, the invention provides a composition comprising an aqueous emulsion of fennel oil.
The invention also provides a composition comprising 1) milk or formula and 2) fennel oil.
The invention also provides a therapeutic method for treating colic in a mammal comprising administering to a mammal in need of such therapy an effective amount of fennel oil.
The invention also provides a therapeutic method for treating colic in a mammal (e.g. a human) comprising administering to a mammal in need of such therapy an effective amount of a composition of the invention.
The invention also provides fennel oil having an estragole concentration of less than 2%.
The invention also provides a therapeutic method for treating colic in a mammal comprising administering to a mammal in need of such therapy an effective amount of anethole.
The invention also provides a composition comprising an aqueous emulsion of anethole.
The invention also provides a composition comprising 1) milk or formula and 2) anethole.
The invention also provides the use of 1) fennel oil, 2) water, milk, or formula, and optionally 3) an emulsifying agent to prepare a medicament useful for treating colic. Preferably, the medicament is in the form of an emulsion.
The invention also provides the use of 1) anethole, 2) water, milk, or formula, and optionally 3) an emulsifying agent to prepare a medicament useful for treating colic. Preferably, the medicament is in the form of an emulsion.
Representative compositions of the invention have been shown to be useful for treating colic (e.g reducing or eliminating one or more of the associated symptoms). The compositions provide a measurable, reproducible, and convenient source of fennel oil (or anrthole), that can readily be administered to infants. Thus, the compositions overcome difficulties associated with the use of extracts and teas.
DETAILED DESCRIPTION
Fennel oil is typically obtained from the dried ripe fruit of
Foeniculum vulgare
Miller (Fam Umbelliferae) by steam distillation. It comprises anethole [C
10
H
12
O] as the chief constituent (typically 50-90%, although amounts can vary depending on source), as well as d-pinene, phellandrene, dipentene, fenchone, methylchavicol, estragole, anisaldehyde and anisic acid. See Remmingtons Pharmaceutical Sciences, 18th ed. Alfonso R. Gennaro editor, 1990, Mack Publishing, Easton Pa. 1294; and PDR For Herbal Medicines, 1998, Medical Economics Company, Montvale N.J., 850-852. Fennel oil is commercially available from a variety of sources including Good Hope Botanicals, 830 Sweetser Ave., E, Novato, Calif., 94945, USA; and Polarome International, Inc., Jersey City, N.J., USA).
Estragole (1-allyl-4-methoxybenzene), is typically present in a concentration of 2-5% by weight in fennel oil from natural sources. Because estragole has been reported to produce mutagenic and carcinogenic effects in mice at certain doses (N. R. Drinkwater,
J. Natl. Cancer Inst.,
1976, 57(6), 1323-1331), the compositions of the invention preferably comprise fennel oil from a source that provides oil with a low concentration of estragole.
Additionally, applicant has discovered that compositions of the invention can be prepared from fennel oil wherein the concentration of estragole has been reduced. The concentration of estragole in fennel oil from a natural source can be reduced using any suitable separation technique known in the field of chemistry. For example, the concentration of estragole in fennel oil can conveniently be reduced by subjecting the oil to fractional distillation to remove estragole. Accordingly, fennel oil can be prepared having an estragole concentration of less than 2%, less than about 1%, less than about 0.5%, less than about 0.25%, less than about 0.2%, or less than about 0.1% weight percent.
The invention thus provides fennel oil having a reduced estragole concentration (e.g. a concentration of less than 2%, less than about 1%, less than about 0.5%, less than about 0.25%, less than about 0.2%, or less than about 0.1% by weight), which is useful for preparing the compositions of the invention.
Additionally, the concentration of anethole, an active ingredient in the compositions of the invention, can vary from 50-90% by weight in fennel oil from natural sources. As a result of this variability, it can be difficult to prepare compositions of the invention with a predictable anethole concentration using fennel oil from natural sources.
Applicant has discovered that the concentration of anethole in fennel oil can conveniently be standardized prior to preparing compositions of the invention. Anethole, in pure form, can be purchased commercially (for example, from Polarome, Inc., Jersey City, N.J., USA). Thus, fennel oil with a standardized concentration of anethole can be prepared by adding anethole to a natural oil (or an oil with a reduced estragole concentration) until a specific anethole concentration is obtained.
Thus, fennel oil having a standardized anethole concentration of at least about 55%, at least about 60%, at least about 65%, at least about 70%, or at least about 75% by weight can be prepared. For preparing the compositions of the invention, fennel oil having a standardized anethole concentration in the range of from about 55% to about 75% by weight (or preferably from about 60% to about 70%)

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