Probiotic delivery systems

Abstract

Suppository compositions are provided combining a pharmaceutically acceptable matrix material that is solid outside of the human body and in a dry environment, but which melts at body temperature; and apple cider vinegar and one or more species of probiotic bacteria dispersed within the matrix material; wherein the matrix material contains a mixture of fatty acids that are solid at room temperature. Methods for supplementing and nourishing the microbiome of the rectum of a male or female and the microbiome of the vagina of a female are also disclosed. Oral dosage forms of the compositions of the present invention are also provided.

1 - 30 . (canceled) 
     
     
         31 . A suppository composition comprising:
 a multi-chamber capsule characterized by
 (a) a first chamber within the suppository containing one or more species of probiotic bacteria, and 
 (b) a second chamber within the suppository containing at least one other beneficial ingredient selected from the group consisting of; a source of nutrition for the probiotic bacteria, a source of nutrition for the existing microbiome, a fatty acid, a nutrient ingredient capable of coating the walls of a user's rectum or vagina in use, and combinations thereof, 
   wherein, the first chamber and the second chamber are separated by at least one wall, and wherein the suppository composition is adapted to be inserted into a rectum or vagina of a user and wherein the suppository is solid at room temperature and in a dry environment, but which melts at body temperature when in contact with the mucosa of the rectum or vagina.   
     
     
         32 . The suppository composition according to  claim 31 , further comprising at least one antioxidant. 
     
     
         33 . The suppository composition according to  claim 32 , wherein the antioxidant comprises vitamin C. 
     
     
         34 . The composition of  claim 31 , wherein said source of nutrition comprises apple cider vinegar. 
     
     
         35 . The composition of  claim 31 , wherein said composition further comprises one or more anti-inflammatory nutritional supplements selected from the group consisting of Vitamin A, Vitamin B 6 , Vitamin D, Vitamin K 2  (MK 1), potassium, folic acid, L-camitine, quercetin, magnesium, calcium, alpha-lipoic acid, fiber, omega-3 fatty acids, Nuclear factor-like 2 (NRF2) activators, L-glutathione, L-glutamate and gamma-aminobutyric acid (GABA) dispersed within said matrix material. 
     
     
         36 . The composition of  claim 31 , wherein said composition further comprises one or more items selected from the group consisting of lemon juice, lactic acid, chamomile, coenzyme Q-10, collagen, gelatin, green tea extract, lactose, galactose, fructose, isomaltose, dextrose, glucose, amylopectin, inulin, resistant starch, corn starch, oligosaccharides, rosemary leaf extract, fiber, oregano oil, curcumin, coffee, ginger, petroleum jelly, mineral oil, shark liver oil, flax seed oil, magnesium, calcium, potassium, sodium chloride, green barley, mint, agrimony, aniseed-basil, aniseed-fennel, cayenne, Echinacea, garlic, honey, molasses, horseradish, lavender, marshmallow, olive oil, milk, peppermint, slippery elm, buttermilk, goldenrod, St John's wort, uva ursi, yarrow, bee pollen and bee propolis dispersed within said matrix material. 
     
     
         37 . The composition of  claim 31 , wherein said probiotic bacteria comprise one or more bacteria species selected from the group consisting of  Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus brevis, Bifidobacterium longum, Lactobacillus salivarius, Lactococcus lactis, Bacillus coagulans, Lactobacillus bulgaricus, Lactobacillus gasseri  and  Bifidobacterium bifidum.    
     
     
         38 . The composition of  claim 31 , wherein said matrix comprises one or more pharmaceutically acceptable items selected from the group consisting of polyethylene glycol, hydrogels, cocoa butter, glycerinated gelatin, petrolatum, mineral oil, shark liver oil and shea butter. 
     
     
         39 . The composition of  claim 31 , further comprising at least one species of Archaea microorganisms native to the human colon. 
     
     
         40 . A method for supplementing and nourishing the microbiome of the lower gastro-intestinal tract of a male or female subject, comprising inserting into the rectum of said male or female subject the suppository composition of  claim 31 . 
     
     
         41 . A method for supplementing and nourishing the microbiome of the vagina, comprising inserting in the vagina of a female the suppository composition of  claim 31 . 
     
     
         42 . A microbiota transplantation method for a patient in need thereof, comprising administering the suppository composition of  claim 31  to said patient, wherein said composition is formulated to supply the microbiome needs of said patient. 
     
     
         43 . The suppository composition according to  claim 31 , wherein the probiotic bacteria is a transplanted microbiome. 
     
     
         44 . A dosage form for the delivery of probiotic bacteria and nutritional supplements to the gastrointestinal tract to supplement and nourish the existing microbiome thereof, comprising a multi-chamber capsule comprising at least two chambers including a first chamber containing one or more species of freeze dried probiotic bacteria dispersed within a fatty acid matrix,
 wherein the fatty acid matrix comprises a mixture of fatty acids that are solid at room temperature and in a dry environment, but melts when at body temperature and in contact with the mucosa of the gastrointestinal tract, and   a second chamber containing a source of nutrition for the probiotic bacteria and for the existing microbiome that is dispersed in a pharmaceutically acceptable matrix material,   wherein the pharmaceutically acceptable matrix material is solid at room temperature and in a dry environment, but melts when at body temperature and in contact with the mucosa of the gastrointestinal tract,   and wherein the dosage form is an oral capsule,   and wherein at least one chamber is coated with an enteric coating adapted to allow the coated chamber to dissolve at a predetermined gastrointestinal location.   
     
     
         45 . The composition of  claim 44 , where said mixture of fatty acids comprises at least 90 wt % of saturated fatty acids 
     
     
         46 . The composition of  claim 44 , wherein at least 50 wt % of the saturated fatty acids of said mixture of fatty acids is lauric acid. 
     
     
         47 . The composition of  claim 44 , wherein said mixture of fatty acids comprises coconut oil. 
     
     
         48 . The composition of  claim 44 , wherein said mixture of fatty acids comprises shea butter. 
     
     
         49 . The dosage form according to  claim 44  wherein the probiotic bacteria is a transplanted microbiome. 
     
     
         50 . A blister pack containing at least two dosage forms for the delivery of probiotic bacteria and nutritional supplements to a user including a first dosage form and a second dosage form, wherein each dosage form comprises a suppository composition comprising:
 a multi-chamber capsule characterized by
 (a) a first chamber containing one or more species of probiotic bacteria, and 
 (b) a second chamber containing at least one other beneficial ingredient selected from the group consisting of; a source of nutrition for the probiotic bacteria, a source of nutrition for the existing microbiome, a fatty acid, a nutrient ingredient capable of coating the walls of a user's rectum or vagina in use, and combinations thereof, 
   wherein, the first chamber and the second chamber are separated by at least one wall, and wherein the dosage form is adapted to be inserted into a rectum or vagina of a user and wherein the dosage form is solid at room temperature and in a dry environment, but which melts at body temperature when in contact with the mucosa of the rectum or vagina,   and wherein the bacteria in the first dosage form is different than the bacteria in the second dosage form.   
     
     
         51 . The dosage form according to  claim 50 , wherein the probiotic bacteria is a transplanted microbiome. 
     
     
         52 . A dosage form comprising a probiotic bacteria and a source of nutrition for the probiotic bacteria wherein the dosage form is selected from the group consisting of a cooling gel, a gel capsule, a hydrogel, a hydrogel capsule, a tablet, a cream, an ointment, freeze dried and as a liquid capable of being delivered to a user's gastrointestinal system for delivery with an enema syringe or with a syringe for vaginal irrigation, for delivery by tubing, or for delivery by a rectal or vaginal applicator.