Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1999-04-14
2004-04-06
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S093460, C435S252500, C435S174000
Reexamination Certificate
active
06716435
ABSTRACT:
TECHNICAL FIELD
This invention relates to systems and methods to inhibit microbial infections and to promote epithelial probiosis when using sanitary health care products such as disposable diapers and other sanitary products. In particular, the invention describes use of probiotic lactic acid bacteria in combination with sanitary health care products to inhibit microbial infections, promote dermal probiosis, and enhance biodegradatability of disposed sanitary products.
BACKGROUND OF THE INVENTION
Sanitary products are widely used in various formats for personal hygiene and medical necessity, and include sanitary napkins, diapers, incontinence guards, wound dressings and the like. By their use, a local tissue environment is produced which promotes growth of microbial pathogens, local infections, irritation, rashes, and related problems.
In addition, disposal of used sanitary products is a major environmental and health care concern. The volume of material and the type of material present in the used sanitary product, due to its absorbent character and purpose of collecting body fluids and waste materials, provides a biological and environmental hazard in disposal of used sanitary products. There is a great need for improvements in biodegradation of used sanitary products: degradation of both, the product itself and the waste product it contains.
The present invention uses a bacterium that is probiotic and heterotrophic to resolve both of the above problems: to inhibit microbial infections associated with use of sanitary products, and to promote biodegradation of the sanitary product after use.
Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other microbial organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow and displace or destroy pathogens and provide other benefits to the host organism (Salminen et al,
Antonie Van Leeuwenhoek
, 70 (2-4): 347-358, 1996; Elmer et al,
JAMA
, 275:870-876, 1996; Rafter,
Scand. J. Gastroenterol
., 30:497-502, 1995; Perdigon et al,
J. Dairy Sci
., 78:1597-1606, 1995; Gandi,
Townsend Lett. Doctors & Patients
, pp.108-110, Jan. 1994; Lidbeck et al,
Eur. J. Cancer Prev
. 1:341-353, 1992).
The nutritional use of probiotic bacteria, especially Lactobacillus and Bifidobacterium strains, that colonize the gut has been previously disclosed (Winberg et al,
Pediatr. Nephrol
. 7:509-514, 1993; Malin et al,
Ann. Nutr. Metab
. 40:137-145, 1996; and U.S. Pat. No. 5,176,911).
Lactic acid producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach,
Ann. Med
. 22:37-41, 1990; Reid et al,
Clin. Microbiol. Rev
., 3:335-344, 1990).
Heterotrophic bacteria play an important role in the biodegradation of animal waste and many natural and synthetic polymers. Bacterial strains including Bacillus, Pseudomonas, Arthrobacter, Achromobacter, Micrococcus and Rhodococcus have been shown to participate in the breakdown of waste products, cellulose materials, petroleum hydrocarbons and their associated products, such as plastics, synthetic rubbers and other synthetic materials.
Bacillus coagulans
is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (Bergey's
Manual of Systemic Bacteriology
, Vol. 2, Sneath, P.H.A. et al., eds., Williams & Wilkins, Baltimore, Md., 1986). Purified
B. coagulans
strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336), amylase (U.S. Pat. No. 4,980,180), lactase (U.S. Pat. No. 4,323,651) and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800).
B. coagulans
has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of
B. coagulans
(referred to as
L. sporogenes
Sakaguti & Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and
B. natto
to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477).
Use of a sanitary product produces frequent dermal mucoidal irritations and/or infections associated with the use of the product. Diaper rash is a common issue in both adults and infants. Rashes can become more serious irritations when opportunistic pathogens introduced into the sanitary product germinate and cause infections on these irritated sites. In addition, vulva-vaginal infections are common with the use of napkins and tampons and are typically caused by Candida or Gardnerella species, e.g.
Candida albicans
and
C. tropicalis
. Toxic Shock Syndrome and other dermal infections caused by Staphylococcal bacteria, e.g.
Staphylococcus aureus
and
S. epidermidis
are also common. Other pathogens which can cause infection after brief periods of dermal irritation and/or use of sanitary products include Trichophyton species, e.g.
T. mentagrophytes
In addition, disposable diapers and other sanitary products present environmental problems in their disposal. Sanitary landfills are overused and accumulate excessive amounts of disposed products. Sanitary products such as diapers, sanitary napkins and tampons biodegrade slowly and occupy considerable space due to the bulk of these products, particularly when containing body excrements or fluids which expand due to their absorbent polymer content.
SUMMARY OF THE INVENTION
It has now been discovered that probiotic acid-producing bacteria are effective in inhibiting, preventing and/or eliminating dermal/epithelial infections by preventing the growth of dermal pathogens which grow upon use of diapers and other sanitary products.
It has also been discovered that bacterial enzymes and other metabolic products of probiotic acid-producing bacteria play an important role in the biodegradation of many sanitary products, including biodegradation of the waste biomaterials, such as when disposed in landfills.
The invention describes compositions and articles of manufacture containing non-pathogenic probiotic acid-producing bacteria, and their methods of use for inhibiting pathogen growth on skin in applications where sanitary products are used, which also provides for degradation of the sanitary products and body waste products contained thereby. The invention contemplates sanitary products as articles of manufacture which contain effective amounts of a probiotic bacterium in various parts of the product so as to achieve the desired result of inhibiting microbial infections on the tissues in contact with the sanitary product and/or enhance biodegradation of the sanitary product and waste products collected upon the sanitary product.
Typically, the probiotic acid-producing bacteria is introduced into or onto portions of the sanitary product by applying a composition containing viable bacteria to the product during a stage of the manufacture of the sanitary product.
In preferred embodiments, the invention contemplates using a lactic acid-producing bacteria, and more preferably using spore-forming Bacillus species, particularly
B. coagulans
, being a preferred embodiment, and
B. coagulans
Hammer being a particularly preferred embodiment.
In one embodiment of the composition, a
Bacillus coagulans
strain is included in the composition in the form of spores. In another embodiment, a
Bacillus coagulans
strain is included in the composition in the form of a dried cell mass. In another embodiment, a
Bacillus coagulans
strain is included in the composition in the form of a stabilized paste. In another embodiment, a
Bacillus coagulans
strain is included in the composition in the form of stabilized gel.
In one embodiment, the composition further includes an effective amount of a bifidogenic oligosaccharide, such as a short or long chain fructooligosaccharide (FOS), a gluco-oligosaccharide or other long-cha
Farmer Sean
Lefkowitz Andrew R.
Ganeden Biotech, Inc.
Mintz Levin Cohn Ferris Glovsky & Popeo PC
Naff David M.
Ware Deborah K.
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