Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-05-15
2001-02-13
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S783000, C536S001110
Reexamination Certificate
active
06187753
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to psyllium-containing drink mix compositions comprising acid and granulated, less water soluble base. These compositions have improved aesthetics to encourage consumer compliance with a prescribed dosing regimen.
Products containing larger particle size psyllium seed husk with citric acid and carbonate salts (e.g., potassium bicarbonate; sodium bicarbonate; and/or calcium carbonate) are known, for example Effervescent Metamucil® sold by The Procter & Gamble Company (Physicians Desk Reference for Nonprescription Drugs, 10th Edition, page 642; copyright 1989). These Metamucil products generate carbon dioxide upon mixing with water, which assists in the mixing process. The resulting product has a distinct tart/sour taste which is compatible with the flavors used (lemon-lime; orange).
It has been discovered by the present invention that psyllium-containing drink mix compositions containing acid and certain less water soluble bases (e.g., calcium carbonate) have improved aesthetics when the base is in granulated form in the drink mix compositions. This is especially preferred when small particle size psyllium husk is utilized, when the pH of the drink mix in water is elevated and/or when the composition is prepared as an unflavored composition.
An object of the present invention is therefore to provide psyllium-containing drink mix compositions having acceptable aesthetics, including reduced psyllium gellation rate, good mixability, good suspendability, good taste, and acceptable texture. These and other objects of the present invention will become readily apparent from the detailed description which follows.
All percentages and ratios used herein are by weight, and all measurements made at 25° C., unless otherwise specified. Screen mesh sizes used herein are based on U.S. standards unless otherwise stated.
SUMMARY OF THE INVENTION
The present invention relates to psyllium-containing drink mix compositions comprising:
(a) from about 10% to about 99% psyllium husk;
(b) from about 0% to about 89% carrier materials;
(c) from about 0.5% to about 25% edible acid; and
(d) from about 0.5% to about 25% edible granulated, less water soluble base.
DETAILED DESCRIPTION OF THE INVENTION
The drink mix compositions of the present invention are psyllium-containing compositions in any form suitable for mixing with a liquid to form a psyllium husk suspension for oral consumption. Preferred form is a dry powder in bulk or unit dose form which readily mixes and disperses in the liquid. The components of the compositions according to the present invention, and representative amounts, are described in detail as follows.
Psyllium Husk
The psyllium husk used in the present invention is from psyllium seeds, from plants of the Plantago genus. Various species such as
Plantago lanceolate, P. rugelii,
and
P. major
are known. Commercial psyllium husk include the French (black;
Plantago indica
), Spanish (
P. psyllium
) and Indian (blonde;
P. ovata
). Indian (blonde) psyllium husk is preferred for use herein. Also preferred is psyllium husk which is at least about 85% pure, more preferably at least about 90% pure, and most preferably at least about 95% pure.
The psyllium husk is obtained from the seed coat of the psyllium seeds. It is typical to remove the seed coat from the rest of the seed by, for example, slight mechanical pressure, and then to use only the seed coat. The seed coat is preferably removed and sanitized by methods known in the art. Preferred is sanitized psyllium seed husk having substantially intact cell structure, the sanitization having been accomplished by methods such as ethylene oxide sanitization and superheated steam sanitization (as taught in U.S. Pat. No. 4,911,889, issued Mar. 27, 1990 to Leland et al., the disclosures of which are incorporated herein by reference in their entirety). It is also preferred that the psyllium husk used herein have reduced particle size.
Preferred psyllium husk utilized for compositions of the present invention have a substantial amount of small particle size psyllium husk. Such psyllium husk comprises psyllium husk particle sizes distributed such that more than about 90% is smaller than about 45 mesh, more preferably more than about 80% is smaller than about 60 mesh, and most preferably at least about 80% is smaller than about 80 mesh. Further preferred particle sizes are as follows: less than about 25% larger than about 60 mesh, and at least about 40% smaller than about 80 mesh. More preferred are particle size distribution of: less than about 10% larger than about 60 mesh, at least about 40% within the range of from about 80 mesh to about 200 mesh, and less than about 50% smaller than about 200 mesh. Particle sizes and particle size distributions may be readily determined by one of ordinary skill in the art, for example by sieving using an Alpine Laboratory Air Jet Sieve, Type 200 LS (sold by Alpine American Corp., Natick Mass.).
The drink mix compositions preferably contain from about 10% to about 99%, more preferably from about 20% to about 90%, most preferably from about 25% to about 75%, of psyllium husk.
Edible Acids
The term “edible acids”, as used herein, means any water soluble acid material having a pK
a
of less than about 5, preferably within the range of from about 2 to about 5, and is safe for ingestion by humans. Examples of edible acids include, but are not limited to, citric acid, ascorbic acid, malic acid, succinic acid, tartaric acid, phosphoric acid, monopotassium phosphate, and mixtures thereof. Preferred are ascorbic acid, phosphoric acid, malic acid, and citric acid, with citric acid being most preferred.
The compositions of the present invention typically comprise from about 0.5% to about 25% edible acid, preferably from about 2% to about 10%, and more preferably from about 2% to about 5%. It is to be noted that for purposes of the present invention, it is preferred but not necessary that some or all of the edible acid be coated on the psyllium husk.
Edible Granulated, Less Water Soluble Base
The term “less water soluble base”, as used herein, means any base material having a pK
a
of greater than about 7 which will react with the edible acid in water and is safe for ingestion by humans, and which further has a solubility in water of less than about 1 g/100 ml of water. Examples of edible, less water soluble bases include calcium carbonate, magnesium hydroxide, calcium hydroxide, aluminum hydroxide, magnesium oxide, magnesium carbonate, and mixtures thereof. Most preferred is calcium carbonate.
The term “granulated”, as used herein relative to the less water soluble base materials, means the less water soluble bases which have been processed (e.g., by using typical granulation or agglomeration techniques) with a readily water soluble or dispersible binder material. Suitable binder materials for granulating the less water soluble bases are known, and include, for example, sugars (especially low molecular weight carbohydrates such as sucrose, glucose, fructose, dextrose), polyalcohols (e.g., mannitol, sorbitol), modified starches (e.g., maltodextrin, syrup solids), gums (e.g., pectin, guar gum, acacia gum), modified proteins (e.g., gelatin), agar-agar, and modified celluloses (e.g., carboxymethylcellulose, hydroxypropylmethylcellulose). Further, granulated, less water soluble base materials are known, being taught for example by U.S. Pat. No. 4,684,534, issued Aug. 4, 1987 to Valentine, and Canadian Patent No. 1,258,428, issued Aug. 15, 1989, both incorporated herein by reference in their entirety. In addition, certain granulated, less water soluble base materials are commercially available, such as calcium carbonate granulated with dextrose or maltodextrin sold by J.W.S. Delavau Company, Inc. (Philadelphia, Pa.).
The compositions of the present invention typically comprise from about 0.5% to about 25% edible granulated, less water soluble base, preferably from about 1% to about 15%, and more preferably from about 1% to about 10%. Preferably the granulated, less wate
Noll Joseph Clifford
Tse Hing Cheung
Clark Karen F.
Peselev Elli
The Procter & Gamble & Company
White Loy M.
Zea Betty J.
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