Targeted gastrointestinal tract delivery of probiotic organisms and/or therapeutic agents

A capsule-in-capsule oral delivery system comprising:

• an inner biodegradable capsule contained within an outer biodegradable capsule,
• wherein the inner capsule comprises a first therapeutic agent, and
• wherein the inner capsule is coated with a reverse enteric coating comprising 5 mg/cm2 to 10 mg/cm2 of dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer (2:1:1) that solubilizes in the proximal colon of a subject at a pH below 6.9 to deliver the first therapeutic agent in the proximal colon;
• and
• the outer biodegradable capsule containing the inner biodegradable capsule and a second therapeutic agent,
• wherein the outer biodegradable capsule is coated with an enteric coating comprising poly(methacrylic acid-co-methyl-methacrylate) 1:1 copolymer and poly(methacrylic acid-co-methyl-methacrylate) 1:2 copolymer that solubilizes in the ileum of the subject at a pH of about 7 to about 8 to deliver the second therapeutic agent to the ileum,
• wherein the enteric coating comprises 5 mg/cm2 to 10 mg/cm2 of poly(methacrylic acid-co-methyl-methacrylate) 1:1 copolymer and poly(methacrylic acid-co-methyl-methacrylate) 1:2 copolymer in a 75/25 ratio,
• wherein the second therapeutic agent in the outer biodegradable capsule is delivered to the ileum without leakage of the first therapeutic agent in the proximal area of the colon, and
• wherein each of the first therapeutic agent and the second therapeutic agent comprise a probiotic comprising a species from at least one of a Lactobacillus genus and a Bifidobacterium genus and at least one additional agent that is selected from the group consisting of:
• acetaminophen, metformin, linaclotide, lipids, nutritional agents, statins, diabetogenic foods, nutrients, vitamins, prebiotics, pH encapsulated glucose, anti-inflammatory agents, an ileal brake hormone releasing substance, an antibiotic, a tumor Necrosis Factor (TNF) antagonist, human bacterial fecal flora, and osmotic agents.

A capsule-in-capsule oral delivery system comprising:

• an inner biodegradable capsule contained within an outer biodegradable capsule,
• wherein the inner biodegradable capsule contains an inner therapeutic agent,
• wherein the inner biodegradable capsule comprises hydroxypropylmethyl cellulose and is coated with a reverse enteric coating that solubilizes in the proximal colon of a subject at a pH below 6.9, and
• wherein the reverse enteric coating comprises 5 mg/cm2 to 10 mg/cm2 of dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer (2:1:1) copolymer;
• and
• the outer biodegradable capsule contains the inner biodegradable capsule and an outer therapeutic agent, and is coated with an enteric coating that solubilizes in the ileum of the subject at a pH of about 7 to about 8,
• wherein the enteric coating comprises 5 mg/cm2 to 10 mg/cm2 of poly(methacrylic acid-co-methyl-methacrylate) 1:1 copolymer and poly(methacrylic acid-co-methyl-methacrylate) 1:2 copolymer in a 75/25 ratio,
• wherein the outer therapeutic agent in the outer biodegradable capsule is delivered to the ileum without leakage of the inner therapeutic agent in the proximal area of the colon, and
• wherein each of the inner therapeutic agent and the outer therapeutic agent comprise a probiotic comprising a species from at least one of a Lactobacillus genus and a Bifidobacterium genus and at least one additional agent that is selected from the group consisting of:
• acetaminophen, metformin, linaclotide, lipids, nutritional agents, statins, diabetogenic foods, nutrients, vitamins, prebiotics, pH encapsulated glucose, anti-inflammatory agents, an ileal brake hormone releasing substance, an antibiotic, a tumor Necrosis Factor (TNF) antagonist, human bacterial fecal flora, and osmotic agents.