Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1998-01-07
2002-01-08
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S484000, C424S493000, C424S488000, C424S418000, C424S410000
Reexamination Certificate
active
06337082
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a new saccharide-based matrix which can be used in food products and to a method of making same, as well as methods of using the new material.
Food technology in recent years has focused on providing high quality food products which are low in calorie content and low in cost. Similarly, the pharmaceutical industry is concerned with efficient delivery systems which are relatively inexpensive and accessible. To this end, ingredients are constantly being sought for their versatility and compatibility with major food products and common medicaments such as analgesics, antibiotics, etc.
Carbohydrates have always been a major component of the human diet. Sugars, in particular, have been used extensively as a food ingredient. Materials containing both simple sugars and polymers of saccharides have also been used as ingredients in food products in pharmaceutical delivery systems. Food grade saccharides are available as mon-, di-, tri-, tetra-, pentasaccharides and oligomers and as carbohydrates having a large number of monosaccharide molecules, e.g., greater than 10 monosaccharide units, which are known as polysaccharides.
Saccharide-based products can have varying degrees of low-monomer saccharides, or sugars, oligomers, and polysaccharides, such as starch. Some saccharide-based products are prepared by hydrolysis of starch and are classified by the degree of starch polymer hydrolysis. The measuring unit is referred to as D.E. or dextrose equivalent. D.E. is defined as reducing sugars expressed as dextrose and reported as a percentage of the dry substance.
A saccharide-based product having high short-carbon-chain content, e.g, glucose and low-unit oligomers thereof, usually results in a higher dextrose equivalent (D.E.). However, saccharide-based material having greater long-carbon-chain content, e.g, high monomer unit oligomers and polymers, usually results in a lower D.E. rating.
For example, maltodextrins contain a mix of sugars and polysaccharides which range from long-chain oligomers resulting from starch hydrolysis to sugars having a low number of monomeric units. Under FDA guidelines, maltodextrin consists of non-sweet, nutritive saccharide polymers having a D.E. of less than 20, while corn syrup solids is regarded by the FDA as having a D.E. greater than 20. The present inventors, however, refers to maltodextrins collectively as saccharide-based material consisting of non-sweet nutritive saccharide polymers and other oligomers having six-carbon monomer units which collectively provide a carrier material capable of forming a matrix.
Maltodextrins have been used as a nonfat additive. One of the greatest advantages of maltodextrins is that they do not act adversely on the intestinal tract. Consequently, they are particularly useful as a bulking agent as a fat substitute. Moreover, maltodextrins are generally recognized as safe (GRAS) by the united States Food and Drug Administration.
Unfortunately, the ability to disperse maltodextrins and to use them in different products is limited by their physical and chemical cohesiveness. They are unlike their high sugar counterparts in that they are relatively unreactive and physically resistive to mixing and dispersing. While artisans have been able to process sugar to enhance its utility in food and medicaments, the maltodextrins do not appear to be as versatile.
In U.S. Pat. No. 4,855,326, issued Aug. 8, 1989, various substances having pharmacological properties were combined with sugar and spun into fibers to product a water-soluble product. The various examples enumerated in the patent all involved the use of water-soluble medicaments and were directed to enhancing the solubility rate of the different substances. The patent describes methods for combining a medicament with any one or more of the water soluble melt spinnable sugars and spinning the combination to produce a readily soluble floss form of the medicament. The disclosure of such patent is incorporated herein by reference.
In U.S. Pat. No. 5,011,532, issued Apr. 30, 1991, oleaginous substances such as vegetable oil, mineral oil, baby oil, margarine, lanolin, cocoa butter and the like are disclosed as characteristically lacking affinity for water. The '532 patent explains how this characteristic is altered by mixing the oleaginous substance with sugar and melt-spinning the mixture in a cotton candy spinning machine or the equivalent. As so modified, the products disperse in water, forming a colloidal or pseudo-colloidal dispersion. Such modification enabled such widely disparate procedures as (1) incorporating shortening oil in a cake mix containing flour but no egg to which water is added to produce a batter, and (b) producing a confection or medicated lozenge by dehydrating the dispersion and allowing the melted residue to solidify. The disclosure of the '532 patent is incorporated herein by reference.
Other disclosures dealing with spinning substances with one or more sugars will be found in U.S. Pat. Nos. 4,873,085, 4,997,856, 5,028,632, and 5,034,421, issued, respectively, Oct. 10, 1989, Mar. 5, 1991, Jul. 2, 1991, and Jul. 23, 1991.
The above-identified disclosures are directed to melt-spinning sugar by introducing the sugar to a cotton candy spinning machine. Generally such equipment is operated at a room temperature of around 200° C. at a speed of about 3500 r.p.m. Melt-spin in such equipment relies on the characteristics of sucrose, such as high crystallinity and high physical and chemical lability. Thus, it has been the belief of the artisan that sucrose is an important ingredient in feedstock for melt-spin processing.
In fact, attempts to spin low-sucrose-containing saccharides have been generally unsuccessful. Feedstock having low D.E. or no sucrose as a carrier component chars during melt-spinning and is generally non-processible, especially on a commercial scale.
SUMMARY OF THE INVENTION
The present invention includes a saccharide-based matrix resulting from a maltodextrin feedstock which has been subjected to melt-spin conditions sufficient to induce flash flow of the feedstock so that the resulting matrix possesses physically- or chemically-altered structure from that of the feedstock. The maltodextrin feedstock of the present invention is a saccharide-based solid material consisting of non-sweet, nutritive saccharide polymers and other glucose-bearing oligomers as well as glucose units, which collectively provide a carrier material capable of forming a matrix. The dextrose equivalent (D.E.) of the maltodextrin feedstock is less than 40, and in a preferred embodiment is between 20 and 40. In yet another preferred embodiment, the maltodextrin has a D.E. between 10 and 20.
Maltodextrins useful herein are solid maltodextrins. Examples of solid maltodextrins are those which have a D.E. of up to about 45 D.E. Several useful maltodextrins have a D.E. of 42. It is intended to include these maltodextrins within the scope of the present invention.
The carrier component provided by the feedstock has a high glucose profile. A high glucose profile means that the elements include a large amount of six-carbon mono- and disaccharides as well as other glucose-based oligomers.
Preferably the combined amount of mono-, di-, and tri-saccharides in the feedstock is 25% or greater on a dry solids basis. In other embodiments, the combined amount of mono- and di-saccharides in the feedstock is 15% or greater on a dry solids basis. The feedstock contains no sucrose, or sucrose in insignificant amounts with respect to the overall carbohydrate profile. Is it note that while other materials such as sucrose and other sugars may be incorporated in the feedstock for other purposes, the resulting method and product will still be within the present invention.
The process of the present invention includes subjecting the feedstock simultaneously to flash heating and applied physical force such that the solid material experiences sufficient internal flow to transform the feedstock to a solid matrix which has a physically- a
Fuisz Richard C.
Yang Robert K.
Benston, Jr. William E.
Levis John F.
Page Thurman K.
Schmidt Richard D.
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