Co-processed botanical plant composition

Details Co-processed botanical plant composition Co-processed botanical plant composition

1998-05-22

2001-05-15

Lee, Howard C. (Department: 1623)

Drug, bio-affecting and body treating compositions

Designated organic nonactive ingredient containing other...

Carbohydrate or lignin, or derivative

C514S770000, C514S783000, C514S960000, C424S464000, C424S465000

Reexamination Certificate

active

06232351

ABSTRACT:

The present invention relates to a particulate co-processed plant composition that includes a botanical plant, microcrystalline cellulose, and calcium carbonate. The composition is particularly useful in vitamin and nutritional supplement formulations. The present invention is an improvement on the known co-processed microcrystalline cellulose formulations. In the present invention, the botanical plant, microcrystalline cellulose, and calcium carbonate are processed together in an aqueous medium and dried to yield a particulate product.
BACKGROUND OF THE INVENTION
Microcrystalline cellulose finds widespread use as a pharmaceutical excipient because it possesses desirable compressibility characteristics. Microcrystalline cellulose is a purified, partially de-polymerized cellulose that is prepared by treating alpha cellulose, in the form of a pulp manufactured from fibrous plant material, with mineral acids. It is a white, odorless, tasteless, relatively free flowing powder that is insoluble in water, organic solvents, dilute alkalis and dilute acids. U.S. Pat. No. 2,978,446 issued to Battista et al. and U.S. Pat. No. 3,146,168 issued to Baftista describe microcrystalline cellulose and its manufacture; the latter patent concerns microcrystalline cellulose for pharmaceutical applications. Both are incorporated herein by reference in their entirety.
Unfortunately, microcrystalline cellulose is relatively costly to manufacture. This limits its use in price-sensitive formulations like vitamins and nutritional supplements. Thus, a lower cost replacement that has tabletting characteristics similar to those of microcrystalline cellulose is desired.
One solution is proposed by U.S. Pat. No. 5,585,115, which describes a particulate agglomerate of microcrystalline cellulose and from about 0.1-20% silicon dioxide. Another solution is proposed by U.S. Pat. No. 4,744,987, which describes a particulate co-processed microcrystalline cellulose and calcium carbonate in a ratio of 75:25 to 35:65.
Although these proposed solutions may be cheaper than simply using microcrystalline cellulose alone, each still requires a major amount of microcrystalline cellulose. Thus, there is still a need for a product that is suitable for tabletting and that has acceptable compressibility characteristics but contains less microcrystalline cellulose than the co-processed microcrystalline cellulose products in the prior art.
The present invention solves that need by providing a composition that includes three components: a botanical plant, microcrystalline cellulose, and calcium carbonate, a that are co-processed in a manner that produces a particulate product having unexpectedly good performance characteristics, but contains a minor amount of microcrystalline cellulose. For example, the product provides excellent compressibility, flow properties, and rapid disintegration.
Moreover, the composition of the present invention eliminates the need for wet granulation.
SUMMARY OF THE INVENTION
In accordance with the present invention, a novel composition is provided that is useful for nutritional supplements and vitamins. The composition is a particulate co-processed composition that includes a botanical plant, microcrystalline cellulose, and calcium carbonate, with the botanical plant being present in an amount from about 1% to about 75%, the microcrystalline cellulose being present in an amount from about 1% to about 50%, and the calcium carbonate being present in an amount from about 1% to about 75%.
The botanical plant is preferably a natural ingredient suitable for oral ingestion by a human. Preferably, the botanical plant is selected from the group consisting of edible grains, plants, roots, and mixtures thereof. More preferably, the botanical plant is selected from the group consisting of alfalfa, wheat, oat, barley, rice, corn, watercress, parsley, brassica and umbelliferous plants, spinach, spirolina, and mixtures thereof.
The microcrystalline cellulose may be derived from any source. The term “microcrystalline cellulose” as used in the foregoing specification and the appended claims means both the wet cake from a conventional microcrystalline cellulose process and the dried or finished product. The wet cake is material that has not yet been dried and is oftentimes referred to as hydrocellulose. The dried or finished product is commercially available under the tradename EMCOCEL® from Edward Mendell Co. or as Avicel® from FMC Corp.
The calcium carbonate can be derived from any source such as by precipitation, mining, and harvesting (e.g., from oyster shells).
The three components are intimately associated in the co-processed product and may be present as agglomerates of the three components. The particulate co-processed composition is preferably a spray dried material. Preferably, the particle size of the co-processed product is such that substantially all particles are less than No. 60 sieve (250 &mgr;m) and preferably have an average particle size in the range of from 20 &mgr;m to 150 &mgr;m.
The particulate co-processed composition is prepared by forming a well-dispersed aqueous slurry of the botanical plant, microcrystalline cellulose, and calcium carbonate and then drying by removing water resulting in the particulate co-processed product.
The aqueous well-dispersed slurry of the three components is preferably formed by introducing the microcrystalline cellulose, calcium carbonate, and botanical plant into an aqueous medium, with their addition being in the order mentioned, in amounts that yield a relatively concentrated slurry of at least 1% solids. The aqueous slurry is preferably dried by spray drying to yield the particulate co-processed product.
It is therefore an object of the present invention to provide an oral solid dosage form for one or more active ingredients that is economical to manufacture, maintains its integrity during storage, and possesses excellent disintegration and dissolution properties when exposed, e.g., to gastrointestinal fluid.
The present invention is further directed to a mixture of an active ingredient(s) and the particulate co-processed composition of the present invention. The ratio of active ingredient to the co-processed composition is from about 1:99 to about 99:1, by weight.
The present invention is further directed to a compressed solid dosage form comprising an active ingredient(s) and the novel co-processed composition described herein, wherein the active ingredient(s) and the co-processed composition have been directly compressed into the solid dosage.
It is to be noted that, unless otherwise stated, all percentages stated in this specification and appended claims refer to percentages by weight.
These and other objects, advantages, and features of the present invention will be better understood upon review of the following detailed description.


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