Electrolyte gels for maintaining hydration and rehydration

Details Electrolyte gels for maintaining hydration and rehydration Electrolyte gels for maintaining hydration and rehydration

1999-05-21

2003-06-03

Tate, Christopher R. (Department: 1651)

Drug, bio-affecting and body treating compositions

Inorganic active ingredient containing

Elemental chlorine or elemental chlorine releasing inorganic...

C424S661000, C424S400000, C424S439000, C424S489000, C424S492000, C424S493000, C424S494000, C424S496000, C424S499000

Reexamination Certificate

active

06572898

ABSTRACT:

FIELD OF THE INVENTION
The invention comprises a gel electrolyte composition for the oral replacement of electrolytes in the body. In particular, the invention relates to a gel rehydration electrolyte composition. The gel rehydration electrolyte composition provides a convenient and effective vehicle for orally administering electrolytes in a way that is readily tolerated by infants, young children, and elderly patients who have difficulty tolerating liquid or frozen forms of electrolytes.
BACKGROUND OF THE INVENTION
Electrolyte solutions are conventionally used to orally replace electrolytes lost during vomiting or diarrhea or as a result of exercise. Electrolyte loss thorough diarrhea and vomiting in particular can cause a severe condition, especially in infants and young children, and may result in death. Diarrhea frequently involves colonization of the small intestine with enteropathogenic strains of
E. Coli
which produce heat stable and/or heat labile enterotoxins. Related enterotoxins are produced by other enteropthogens such as cholera, and also cause diarrhea. These enterotoxins stimulate fluid secretion in the gut lumen and cause diarrhea. Associated fluid loss may lead to death.
In cases of severe dehydration corrective parenteral (intravenous) therapy is often necessary. In cases of mild to moderate dehydration, oral rehydration solutions provide a safe and economical alternative to intravenous therapy. Oral electrolyte solutions used in oral maintenance or rehydration therapy consist of a mixture of electrolytes and a carbohydrate component such as glucose or dextrose. Examples of commercially available oral electrolyte replacement and/or maintenance solutions include Rehydroltye® and Pedialyte®, manufactured by Ross Laboratories, Columbus, Ohio, and Magonate® Liquid, manufactured by Fleming and Company, Fenton, Mo. Frozen formulations of electrolytes sold by PTS Labs have been found to be particularly advantageous in administering electrolytes to children. See, e.g., Santucci et al., Frozen Oral Hydration as an Alternative to Conventional Enteral Fluids.
Archives of Pediatrics
&
Adolescent Medicine,
February 1998, Vol. 152, pp. 142 to 146.
The development of oral rehydration therapy for acute diarrheal diseases of infancy and childhood has significantly reduced related morbidity and mortality, particularly in less developed countries where it constitutes the primary mode of therapy. The World Health Organization (WHO) currently recommends that oral rehydration solutions for treatment of acute diarrheal therapy contain 90 mEq sodium/liter, 20 mEq potassium/liter, 80 mEq chloride/liter, 30 mEq citrate/liter or 30 mEq bicarbonate/liter, and 110 mmol glucose/liter. Glucose is recommended as the carbohydrate component in such oral rehydration solutions. Glucose enhances the membrane transport of sodium, which in turn enables rapid uptake of water. The WHO formulation has been shown to decrease morbidity and mortality.
Substitution of other carbohydrates for glucose in WHO-type formulations has been investigated. Lebenthal et al. (
J. Pediatrics,
1983, 103:29-34) studied the effect of three corn syrup sugars (dextrins) containing glucose polymers of varying lengths having dextrose equivalents of 10, 15 and 24 and determined they were suitable as the sole carbohydrate source in oral rehydration therapy. It has also been established that oral rehydration solutions in which rice and other food sources of starch are substituted for glucose are effective as reported by Carpenter et al. (
New England J. Med.,
1988, 319:1346-1348). Rice-based oral rehydration solutions containing from 3 to 5% rice and having electrolyte levels corresponding to conventional WHO formulations have been found to be effective as reported by Patra et al. (
Archives of Disease in Childhood,
1982, 57:910-912), Molla et al. (
The Lancet,
1982, 1317-1319), and Malla et al. (
Journal of Pediatric Gastroenterology and Nutrition,
1989, 8:81-84). U.S. Pat. No. 5,096,894 discloses an oral rehydration solution comprising a mixture of the required electrolytes and rice dextrin containing a distribution of 50-90% short chain glucose polymers consisting of 2 to 6 glucose units.
U.S. Pat. No. 5,270,297 discloses an oral rehydration solution including a blend of simple sugars, more complex carbohydrates, and minerals, particularly magnesium. Other ingredients include electrolyte ions (e.g., potassium, sodium, chloride), vitamins, anabolic nutrients, and other minerals such as calcium. The magnesium and calcium are provided in the form of amino acid chelates to facilitate rehydration and promote endurance.
U.S. Pat. Nos. 4,505,926, 4,539,319, 4,558,063 and 4,594,195 disclose various oral rehydration solutions containing pharmaceutically active ingredients (i.e., drugs) for treatment for enterotoxin induced diarrhea and prevention of death from enteropathogenic
E. coli
infection of gastro-intestinal tract. Drugs incorporated into these prior art rehydration solutions include quaternary aminophenyliminoimidazolidines, 2-amino-immidazoline derivative, and 5,6,7,8-tetrahydro-naphonitrile intermediates.
U.S. Pat. No. 4,942,042 is directed to an anti-diarrhea composition comprising an absorptive component and an electrolyte/sugar component. The absorptive material is a thermally activated, finely powdered, hydrous magnesium aluminum silicate clay capable of absorbing pathogenic intestinal bacteria. The absorptive material is preferably also capable of absorbing diarrhea-associated viruses, intestinal toxins and gases. Suitable absorptive materials are clays such as Smectite (Si
8
Al
4
O
20
OH
4
). Other such clays are argillaceous clays. The electrolyte/sugar component contains a sodium salt, a potassium salt and a sugar. The composition is packaged in solid form and reconstituted by admixture with water prior to administration.
U.S. Pat. No. 5,192,551 discloses rehydration and infant nutrient formulas containing a neutral glycolipid, in particular, gangliotetracosylceramide. The glycolipid binds enteric virus, e.g., rotairuses, which are pathogenic to humans. Rotaviruses are RNA viruses known to replicate in the intestinal epithelial cells of a wide range of animal species, including humans.
Frozen electrolyte compositions and delivering systems are described in U.S. Ser. No 08/786,072, which is incorporated herein by reference.
Electrolytes generally have a disagreeable taste. As such, rehydration/electrolyte solutions are often difficult to administer, especially to young children. While unflavored or flavored oral electrolyte maintenance and replenishing solutions for infants and children are available, such as Fruit-Flavored Pedialyte® manufactured by Ross Laboratories, Columbus, Ohio, frozen electrolyte formulations (such as Revitalice® sold by PTS Labs, Lake Forest, Ill.) have been demonstrated to be better tolerated in administering electrolytes to children. However, even the frozen electrolytes are in some instances not suitable for young children or elderly patients. This invention is direct at fulfilling this need.
SUMMARY OF THE INVENTION
The invention is directed to a gel electrolyte composition for oral administration of electrolytes. More particularly, the invention is directed to a gel rehydration electrolyte composition useful in the maintenance and/or replacement of electrolytes lost through diarrhea, vomiting, during physical exercise, or through other illness. Whereas all prior art oral rehydration solutions are administered in a liquid or frozen form, the composition of the invention is designed to be served in a gel form.
Thus, in a first aspect, the invention provides a gel rehydration electrolyte composition comprising:
(a) from about 80 to about 99 percent by weight water;
(b) from about 20 to about 60 mEq of sodium per liter of water;
(c) from about 15 to about 25 mEq of potassium per liter of water;
(d) from about 25 to about 50 mEq of chloride per liter of water;
(e) from about 20 to about 50 mEq of citrate per liter of water;
(f) from about 20 to about 30 grams of carbohydrate p

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