Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from gramineae
Reexamination Certificate
1999-10-27
2001-06-19
Saucier, Sandra E. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from gramineae
Reexamination Certificate
active
06248372
ABSTRACT:
BACKGROUND OF THE INVENTION
In the United States, otitis media, next to upper respiratory tract infections, is the most common cause for outpatient visits to pediatricians. Fifteen to twenty per cent of children younger than six years of age will contract otitis media. Otitis media is an inflammation of the middle ear characterized by symptoms such as otalgia, hearing loss and fever. One of the primary causes of these symptoms is a build up of fluid in the middle ear. Complications include permanent hearing loss, perforation of the tympanic membrane, acquired cholesteatoma, mastoiditis, and adhesive otitis. Children who develop otitis media in the first years of life are at risk for recurrent acute or chronic disease.
One of the primary causes of otitis media is
Haemophilus influenzae
, which is commonly known as “
H. influenzae
.” It is thought that
H. influenzae
causes otitis media by adhering to nasopharyngeal cells. The adherence of
H. influenzae
to nasopharyngeal cells causes those cells to become infected and to produce secretions. The middle ear becomes infected because mechanical or functional obstruction of the Eustachian tube, which protects the middle ear from nasopharyngeal secretions, results in negative middle ear pressure. This negative pressure causes the nasopharyngeal secretions to enter the middle ear resulting in an infection, such as otitis media, usually with effusion.
Typically, otitis media is treated by means of administering a course of antibiotics consisting of a penicillin derivative. Other supportive therapies, such as analgesics, antipyretics and local heat are also helpful. Often, surgery is required to remove fluid from the middle ear and to relieve the pain experienced by the child.
Currently, no reliable prophylactic treatments are known. It has been demonstrated that human casein inhibits the adhesion of
H. influenzae
to human respiratory tract epithelial cells. See Aniansson et. al.,
Microbial Pathogenesis
1990;8:315-323. Aniansson, et al., found that human casein represents a new mechanism for the protection by breast-milk against respiratory tract infection. Thus, it is thought that human casein may be effective as a prophylactic treatment for otitis media but further study is required.
Rice flour is inexpensive, safe and easily obtained. Rice flour is made from rice kernels that have been either dehusked or dehusked and polished and then ground. Rice flour is a fine, powdery flour which is made from either brown rice or white rice which is ground to a particular size (coarse, regular, fine and extra fine). Brown rice is the entire rice grains with only the inedible outer husk removed. White rice is the rice grain which has had its husks, brans and germs removed. Typically, the majority of particles of coarse rice flour are smaller than 30 mesh; the majority of particles of regular rice flour are smaller than 50 mesh; the majority of particles of fine rice flour are smaller than 80 mesh; and the majority of particles of extra fine rice flour are smaller than 140 mesh.
Rice is also classified by grain lengths such as short-grain, medium-grain and long-grain. The length of long-grain rice is four to five time that of its width. When cooked, it produces light, dry grains that easily separate. Short-grain rice has fat, almost round grains that have a higher starch content than either the long-grain or the medium-grain varieties. When cooked, short-grain rice tends to be moist and viscous, causing the grains to stick together. Medium-grain rice has a size and character between the long-grain and the short-grain varieties. It is shorter and moister than long-grain rice and generally not as starchy as short-grain rice. Through fairly fluffy right after cooking, medium-grain rice begins to clump together upon cooling.
Rice flour has various types with different viscosities and gelatinization temperatures, depending upon the type of rice from which it is made and the process by which it is made. For example, exemplary rice flours include brown rice flours (long and medium-grain), white rice flours (long and medium-grain), waxy flours (short-grain), pregelatinized flours and mixed flours. Rice flour contains mostly carbohydrates (typically 79 to 81% by weight), some protein (typically 5% to 9% by weight), a small amount of fat (typically 0.5% to 1.3% by weight), moisture (typically 10% to 13% by weight), minerals (typically 0.2% to 0.8% by weight) and vitamins (typically about 16 ppm by weight).
Rice flour has been proposed as a basis for oral rehydration therapy, particularly for acute diarrheal diseases. See, e.g., U.S. Pat. No. 5,498,406 to Oltra, et al., entitled, “Oral Rehydration Composition.” U.S. Pat. No. 5,489,440 to Ndife, et al., describes a method for making a rice flour-based oral rehydration solution. In this process, the rice flour is first gelatinized in water under heat and then cooled to permit enzymatic hydrolysis of the slurry of gelatinized rice flour. Next, protease and cellulase enzymes are added to the slurry to permit hydrolysis of the rice flour. The enzymes are then inactivated by heat and the slurry is cooled. A stabilizer, minerals and citric acid are added to the slurry and the slurry is homogenized. After homogenization, the solution is standardized by adding water and the product is sterilized. However, it should be noted that rice flour has not been previously proposed as a treatment for
H. influenzae
infections and their related complications.
For these reasons, a need still exists in the art for a composition and method for the prophylaxis and treatment of infections caused by
Haemophilus influenzae
and its clinical manifestations, such as, for example, otitis media.
DISCLOSURE OF THE INVENTION
The present invention is directed to a rice flour extract (RFE) which can be used in the prophylaxis and treatment of bacterial infections, particularly bacterial infections caused by
Haemophilus influenzae
and to a method of preparing and using such an antibacterial rice flour extract. The anti-
Haemophilus influenzae
rice flour extract of the present invention can be prepared from commercial food grade rice flours or non-commercial food grade rice flours. For example, food grade rice flour can be obtained in large quantities from several commercial sources. Useful suppliers include the following: Comet Rice Ingredients Company of Los Angeles, Calif.; Rivland Partnership of Houston, Tex.; and California Natural Products of Lathrop, Calif. A non-food grade rice flour can be obtained from ICN Biochemicals of Aurora, Ohio.
The rice flour extract of the present invention can be obtained in the following manner with commonly available reagents and materials. After selecting a rice flour, the rice flour is extracted under heat with an extraction solution having a neutral to alkaline pH until the rice flour solution becomes cloudy but does not completely gelatinize. For the purposes of this application, “gelatinization” occurs when one is not able to separate the liquid portion of the solution from the solid portion of the solution. A person of skill in the art is able to conduct viscosity measurements to determine the point at which complete gelatinization would be about to occur. Heat is used to break apart the starch granule but not to cause complete gelatinization of the rice flour. Useful aqueous extraction solutions include, but are not limited to, phosphate buffer solution (PBS) having a pH of about 7.20; a 0.1-0.2 N ammonium bicarbonate solution having a pH of from about 7.9 to about 8.0; or a 1% ammonium hydroxide solution having a pH of about 10.4.
Desirably, the rice flour solution is heated for at least about five minutes and, more desirably, it is heated for about five minutes to about two hours. The rice flour solution is heated at a temperature of about 30° C. to about 80° C. More desirably, the rice flour solution is heated at a temperature of about 37° C. to about 68° C. and, most desirably, it is heated at a temperature of about 50° C. to about 68° C. The extraction solution desirably has a pH of
Anderson Steven Neal
Huang Yung-Sheng
Hwang Shie-Ming
Liu Jim-Wen
Meulbroek Jonathan A.
Abbott Laboratories
Afremova Vera
Dixon J. Michael
Parlet Nickki L.
Saucier Sandra E.
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