Oral delivery of therapeutic mammalian cells
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Publication Number
US-11707489-B2
Publication Date
2023-07-25
Expiration Date
Abstract
Described herein are oral delivery systems for use in delivering live mammalian cells to the intestinal tract of an individual.
Core Innovation
An oral delivery composition is provided in which a plurality of live mammalian cells are suspended in a matrix comprising about 1.0% to about 2.0% methyl cellulose and about 1.0% to about 2.0% alginate gel. The enteric coating surrounds the live mammalian cells suspended in the matrix, and the live mammalian cells maintain viability in the intestine of the individual. The disclosed system supports site-specific release in the gastrointestinal tract, including intestinal regions such as ileum/colon.
The disclosed compositions include live-cell formulations suitable for oral delivery using enteric-coated capsules, including monophasic and biphasic capsule-in-capsule formats. The enteric coating is pH-triggered, and release is directed to intestinal regions based on the pH environment within the GI tract. The live mammalian cells are embedded within a methylcellulose/alginate matrix positioned within the enteric-coated structure.
The disclosure focuses on preserving live-cell viability during oral delivery and enabling therapeutic use after intestinal release. The compositions are described as maintaining viability and as supporting retained viability and immune modulation upon delivery. Therapeutic contexts described include gastrointestinal inflammatory and autoimmune disorders such as inflammatory bowel disease and Crohn’s disease.
Claims Coverage
The claim coverage includes two independent claims: a live-cell oral delivery composition with an enteric-coated, matrix-suspended formulation, and a method of making the same. The inventive features center on a defined methyl cellulose/alginate matrix, an enteric coating surrounding the live cells, maintained viability in the intestine, and a manufacturing sequence of admixing cells into the matrix followed by applying the enteric coating.
Enteric-coated live-cell oral composition with methyl cellulose/alginate matrix
A composition of live mammalian cells formulated for oral delivery, comprising an enteric coating, a matrix comprising about 1.0% to about 2.0% methyl cellulose and about 1.0% to about 2.0% alginate gel, and a plurality of live mammalian cells suspended in the matrix, wherein the enteric coating surrounds the live mammalian cells suspended in the matrix, and wherein the live mammalian cells maintain viability in the intestine of the individual.
Admixing live cells into methyl cellulose/alginate matrix and applying enteric coating
A method of making a composition of live mammalian cells formulated for oral delivery comprising admixing a plurality of live mammalian cells with a matrix comprising about 1.0% to about 2.0% methyl cellulose and about 1.0% to about 2.0% alginate gel to provide a cell-matrix, and applying an enteric coating to the cell-matrix.
Overall, the claim coverage is directed to oral formulations and preparation of live mammalian cells using an enteric coating that surrounds live cells suspended in a defined methyl cellulose/alginate matrix, with maintained viability in the intestine, and a complementary manufacturing sequence of admixing into the matrix followed by applying an enteric coating.
Stated Advantages
Live mammalian cells maintain viability in the intestine of the individual.
The compositions support site-specific release in the gastrointestinal tract, including intestinal regions such as ileum/colon.
The compositions are described as supporting retained viability and immune modulation upon delivery.
Documented Applications
Treatment of gastrointestinal inflammatory or autoimmune disorders, including inflammatory bowel disease and Crohn’s disease, by administering the disclosed oral composition to an individual.
Crohn’s-like ileitis/inflammatory bowel disease model assessment with histologic improvement after oral administration.
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