Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
1994-10-26
2001-11-06
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S489000, C424S490000, C424S738000, C514S782000, C514S892000, C514S911000
Reexamination Certificate
active
06312730
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a powder that comprises psyllium particles coated with gum arabic.
Psyllium seed husk has use as a fiber supplement and a bulk laxative drug because the psyllium seed husk has a capacity for substantial swelling when ingested. This swelling makes the psyllium husk a useful bulking agent. Ingestion of psyllium seed husk has been demonstrated to yield a number of benefits to the consumer, including Taxation, appetite suppression and cholesterol reduction.
The psyllium seed includes a husk portion that is a cleaned, dried seed coat of the psyllium seed. The husk portion is separated from the seed by winnowing and thrashing. Typically, the husk portion of the psyllium seed is ground into a powder to make the bulk laxative drug. The psyllium bulk laxative drug powder is then ingested by a consumer after the consumer stirs the powder into a glass of water.
The use of the psyllium husk powder as a bulk laxative has not been universally accepted by consumers, however, because the powder does not readily disperse in water. In particular, the psyllium husk powder does not disperse in water with simple stirring. Instead, the psyllium husk powder aggregates to form gel-coated lumps. The gel-coated lumps have interiors that are substantially dry. Additionally, the gel-coated lumps tend to float on the surface of water causing the lumps to clump into large masses.
Attempts have been made to improve the dispersibility of psyllium husk powder in water. The attempts have included controlling particle size of the psyllium powder during a processing step of size reduction. The Meer et al. patent, U.S. Pat. No. 4,996,051, issued Feb. 26, 1991, describes a product that includes apple fiber, fructose, gum arabic, flavors and psyllium husk powder having a particle size that passes through a No. 50 mesh screen.
The attempts have also included coating the particles of psyllium powder with a surface coating. One surface coating described by Colliopoulos et al. in U.S. Pat. No. 4,459,280, includes a dispersing agent, maltodextrin. A second surface coating described by Powell et al. U.S. Pat. No. 4,321,263, includes one of the dispersing agents, propylene glycol (PG) or polyvinyl pyrrolidone (PVP) or a blend of PG and PVP. The use of PVP and PG is, however, limited by handling problems resulting from high viscosities developed in PVP and PG solutions.
The PG or PVP dispersing agents are applied to psyllium particles with non-aqueous solvent carriers such as volatile alcohol. The use of volatile alcohol to deliver PG, PVP or blends of PG and PVP to psyllium powder surfaces during processing has presented safety problems to many processors because the alcohol is flammable.
A third attempt to improve psyllium husk powder dispersibility has included cold blending. Cold blending includes mixing psyllium powder with granular diluents such as sucrose and dextrose. Other granular diluents include chemical compounds capable of reacting when in contact with moisture to produce carbon dioxide. The granular diluents are added in concentrations of up to 50% of the cold blend.
The cold blending of psyllium with granular diluents has created a situation where the more dense diluent will fall to the bottom of a glass of water while the psyllium powder will ball up near or on the surface of the water. Moreover, the solubility of the granular diluents is much higher than the psyllium husk powder. This increased solubility favors rapid dispersibility, and more importantly, dissolution of the granular diluents. However, the psyllium powder is left behind in an undispersed state.
One other problem of cold blending psyllium powder with a granular diluent such as sucrose or dextrose is that these diluents are metabolizable sugars. As such, their use by consumers in a psyllium bulk laxative is limited to non-diabetic consumers.
One other attempt to improve psyllium dispersibility has included preparing a tablet having a psyllium powder component. The Casillan patent, U.S. Pat. No. 4,999,200, describes a tablet that includes psyllium powder, a gelling agent such as polysorbate 80, a binding agent such as polyvinyl pyrollidone or acacia and a disintegrant such as microcrystalline cellulose. The tablet disintegrates in the gastrointestinal tract of a consumer.
Another attempt to improve psyllium powder dispersibility has included coextrusion of psyllium husks with citric acid under controlled heating conditions. The coextrusion is believed to effect a reduction in microbial growth and to improve dispersibility.
SUMMARY OF THE INVENTION
The present invention includes a rapidly dispersible powder having use as a laxative and a fiber supplement, a method for making the powder and a method for preparing a treatment for constipation and fiber supplementation.
The powder includes psyllium particles coated with gum arabic. The powder, having use as a bulk laxative and fiber supplement, disperses rapidly in dispersing media such as water.
The method for making the rapidly dispersible powder includes fluidizing the psyllium particles and applying to the fluidized particles, an aqueous solution that includes gum arabic. The gum arabic solution is applied to the fluidized particles in a manner that promotes a uniform distribution of the gum arabic solution over the psyllium particles. The gum arabic solution is also applied in a manner that produces a powder having a particle size distribution, moisture and bulk density that improve dispersibility of psyllium in water.
The method for treating constipation and providing fiber supplementation includes providing an effective quantity of the rapidly dispersible powder. The method also includes providing an effective quantity of dispersing media such as water and rapidly dispersing the powder into the dispersing media.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention includes a rapidly dispersible powder having use as a laxative and a fiber supplement, that includes psyllium particles coated with gum arabic. The present invention also includes a method for making the powder and a method for preparing a constipation treatment and a fiber supplement using the powder.
The psyllium-gum arabic particles preferably include a gum arabic content of at least about 5% by weight. Most preferably, the gum arabic content is about 5% by weight. The powder also includes a moisture concentration within a range of about 2.8 to 6.6% by weight. The powder may optionally include flavorants and a sweetener such as aspartame. The remaining powder weight is substantially psyllium.
The rapidly dispersible powder of the present invention includes a bulk density within a range of about 0.394 to about 0.609. The powder has an approximate particle size distribution range as described in Table 1.
TABLE 1
Particle Size Distribution
Percent Retained on
U.S. Standard Sieve Screen
Screen
10 mesh
0.0
40 mesh
0.0-2.4
60 mesh
2.4-28
100 mesh
30.6-55
140 mesh
16.4-36.0
200 mesh
3.6-16.0
PAN
0.6-9.0
The rapidly dispersible powder does not form lumps when stirred into water with a spoon for ten seconds. In one dispersibility test, five grams of the powder was stirred into 227 milliliters of water with a spoon. The powder particles did not clump together or aggregate at the top of the glass. The powder was substantially dispersed in the water.
The psyllium component of the powder is derived from the husk of the psyllium seeds. Psyllium seeds, also called plantago seeds and flea seeds, are acceptably obtained from the plants
Plantago ovata, Plantago psyllium L.
or
P. Arenaria. Plantago ovata
is the major commercial source of psyllium. The psyllium seeds are small, dark, reddish brown, odorless, and almost tasteless seeds.
The husk is separated from the psyllium seed and is ground into particles. In one preferred psyllium husk particle embodiment, illustrated in Table 2, the psyllium husk particles included a moisture of about 9% by weight and a bulk density of about 0.617. The psyllium husk particles als
Johnson & Johnson. Merck Consumer Pharmaceuticals, Co.
Spear James M.
Woodcock Washburn Kurtz Mackiewicz & Norris LLP
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