Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-06-03
2003-07-22
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S023000, C514S025000, C514S054000, C514S058000, C424S439000, C426S066000, C426S067000, C426S648000, C426S658000, C426S810000
Reexamination Certificate
active
06596702
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to compositions for sports beverages containing an amount of trehalose (&agr;,D-glucopyranosyl &agr;,D-glucopyranoside) sufficient to produce an isotonic or hypotonic solution. Suitable salts, amino acids, flavorings, colorings etc. may also be added as may a variety of additional carbohydrates.
BACKGROUND OF THE INVENTION
A wide variety of sports beverages are available for replenishing fluids, nutrients and salts during exercise. Carbohydrates not only replace energy sources but also facilitate transport of salts through the wall of the intestinal tract and enhance the concomitant passage of water. A wide variety of carbohydrates are also used to sweeten, adjust osmolarity and provide a timed release form of glucose. Glucose is often the carbohydrate of choice as it is the principal form of sugar in blood. The nutrients are usually in the form of amino acid residues to prevent breakdown of muscle tissues during extreme exercise. Fats, peptides and proteins are difficult to digest and therefore not generally useful in such beverages. A wide variety of salts and minerals are generally added to sports beverages to enhance fluid uptake and to replace the electrolyte balance disrupted by loss of fluids by perspiration during exercise. The actual ability of salts to maintain electrolyte balance has been disputed and some sports beverages do not contain them. For a review of the importance of hydration during exercise, see Noakes, “Fluid Replacement During Exercise” in Exercise and Sport Science Reviews, Vol. 21, Holloszy ed. (1993) pp. 297-330.
Original sports beverages were hypertonic (>300 mOsm) in order to deliver the greatest concentration of carbohydrates to athletes. It was found that hypertonic beverages, however, caused fluid to flow into the intestines, causing pressure, pain and increased peristalsis which results in diarrhea and increased dehydration. Most sports beverages are now isotonic or slightly hypotonic. Osmolarity is maintained by adjusting the amount of monosaccharides and, in some cases higher glucose polymers.
Canadian Patent Application No. 2,013,820 describes sports beverages containing ten percent by weight of carbohydrates which are a mixture of mono-, di- and polysaccharides which are derived from desalinated and hydrolyzed whey concentrate. European Patent Application Publication No. 587,972 describes a sports beverage without added sugar or artificial sweetener which derives its carbohydrates from fruit juice. European Patent Specification Publication No. 223,540 describes a high energy hypotonic sports beverage containing free glucose and/or sucrose and glucose polymers. The preferred glucose polymers have a degree of polymerization between 4 and 15 and provide a timed release source of glucose. Such polymers of glucose may increase the number of glucose molecules which can be placed in an isotonic solution but do not provide an immediate source of energy as they must be processed over time to individual glucose molecules which are then absorbed through the intestinal tract.
Sports beverages are provided in liquid formulations for immediate ingestion and in dry or concentrated formulations which must be mixed with water prior to ingestion. Commonly, the dry components are simply mixed together for subsequent-rehydration. U.S. Pat. No. 4,871,550 provides a method of producing a dry formulation comprising dry blending in separate batches the various factors and then blending the separate batches together to produce a powder which is more easily dissolved in water.
It would be useful to provide higher concentrations of a readily assimilable form of glucose in a sports beverage without producing a hypertonic sports beverage.
All references cited herein are hereby incorporated by reference.
SUMMARY OF THE INVENTION
The present invention provides sports beverage formulations containing trehalose as the major carbohydrate source and various salts, nutritional components and other additives. The sports beverages are provided in various forms including powders; liquids, both full strength and concentrated, as well as carbonated and non-carbonated; and tablets. Methods of making the formulations include various forms of preparing powders from an aqueous solution of trehalose and any additional components.
DETAILED DESCRIPTION OF THE INVENTION
Trehalose, &agr;-D-glucopyranosyl-&agr;-D-glucopyranoside, is a naturally occurring, non-reducing disaccharide initially found associated with the prevention of desiccation damage in certain plants and animals which dry out without damage and revive when rehydrated. Trehalose has been shown to be useful in preventing denaturation of proteins, viruses and foodstuffs during desiccation. See U.S. Pat. Nos. 4,891,319; 5,149,653; 5,026,566; Blakeley et al. (1990)
Lancet
336:854-855; Roser (July 1991)
Trends in Food Sci. and Tech.
166-169; Colaco et al. (1992)
Biotechnol. Internat.,
345-350; Roser (1991)
BioPharm.
4:47-53; Colaco et al. (1992)
Bio/Tech.
10:1007-1011; and Roser et al. (May 1993)
New Scientist, pp.
25-28.
Trehalose is found extensively in such diverse animal and plant species as bacteria, yeasts, fungi, insects and invertebrates. In insects, it is the major blood sugar. On a routine basis, it is not found in humans, as the only major regular dietary source for man is in certain strains of edible mushrooms. Madzarovova-Nohejlova (1973)
Gastroenterology
65:130-133.
Trehalose is described for use in a peritoneal dialysis system in U.S. Pat. No. 4,879,280 where it is mentioned as one of several disaccharides as a replacement for the prior art system which utilized glucose. Trehalose is mentioned for use in the dialysis system as a disaccharide that will not be readily cleaved to glucose and thus avoid raising the blood glucose level. Trehalose has also been described as suitable for use in parenteral formulations primarily because it can be sterilized by autoclaving without the browning associated with conventional parenteral formulations. Japanese Patent No. 6-70718.
Neotrehalose (O-&agr;-D-glucopyranosyl &bgr;-D-glucopyranoside or O-&bgr;-D-glucopyranosyl &agr;-D-glucopyranoside) has been described for use in foods and beverages because of its sweetness and rapid absorption by the intestines. Canadian Patent Application No. 2,089,241 and U.S. Pat. No. 5,218,096. Trehalose is described as being unsuitable for such use on the grounds that trehalose is not readily hydrolyzed by enzymes such as amylases, not readily metabolized and absorbed by the human body and “does not release energy in a living body.”
Trehalose is not a major component of the human diet, and therefore little in the way of specific information is available on the effects of ingested trehalose. However, information is available on its metabolism. Following oral ingestion, trehalose is not absorbed, as only monosaccharides can pass the intestinal epithelium. Ravich and Bayless (1983)
Clin. Gast.
12:335-356. Trehalose is metabolized by the enzyme trehalase into two molecules of glucose. Sacktor (1968)
Biochem.
60:1007-1012. Trehalase is a normal constituent of most mammalian bodies, including humans, and has been identified in human serum, lymphocytes and the liver, but is principally located in the brush border of both the intestinal tract and the renal proximal tubules. Belfiore et al. (1973)
Clin. Chem.
19:447-452; Eze (1989)
Biochem. Genet.
27:487-495; Yoshida et al. (1993)
Clin. Chim. Acta
215:123-124; and Kramers and Catovsky (1978)
Brit. J. Haematol.
38:453-461. Trehalase is a membrane-bound protein found in the human and animal intestinal tract. Bergoz et al. (1981)
Digestion
22:108-112; Riby and Garland (1985)
Comp. Biochem. Physiol.
82B:821-827; and Chen et al. (1987)
Biochem. J.
247:715-723.
The process by which intestinal trehalase metabolizes exogenous trehalose has been described. Intestinal hydrolases, such as trehalase, are surface components attached to the external side of the luminal membrane microvilli, and may be anchored to the membrane by phosphatidy
Colaco Camilo
Kampinga Jaap
Elan Drug Delivery Limited
Morrison & Foerster / LLP
Wilson James O.
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