Sustained release solid dosage forms for modulating the colonic microbiome
AssigneeAxial Therapeutics, Inc.
InventorsRyan Barrett, Hitesh Bhagat, Anthony Stewart Campbell
Life of this patent
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Abstract
Described are sustained-release solid dosage forms of epigallocatechin gallate (EGCG) or aminosterol compositions. In one aspect of the invention the sustained-release solid dosage forms of EGCG or an aminosterol are capsules comprising a plurality of coated solid particulates. Another aspect of the invention relates to methods of inhibiting, ameliorating, reducing the likelihood of, delaying the onset of, treating or preventing an amyloid disorder, comprising the step of administering to a subject in need a therapeutically effective amount of the solid dosage form. In certain aspects, the amyloid disorder is Parkinson's Disease.
Claims26
A sustained-release solid dosage form of epigallocatechin gallate (EGCG), comprising a plurality of solid particulates selected from mini-tablets, beads, granules, and pellets, or being in a form of a single solid dosage form, and wherein the solid particulates or the single solid dosage form each comprise:
- a core comprising EGCG and a release rate controlling material
- selected from the group consisting of hydroxypropyl methyl cellulose, acrylic ester copolymer, methacrylic ester copolymer, and alkylammonium methacrylate copolymer;
- wherein the sustained-release solid dosage form releases 10-50% of the EGCG within 24 hours, 30-80% of the EGCG within 48 hours, and at least 60% of the EGCG within 72 hours of administration of said dosage form to a human subject;
- wherein the sustained-release solid dosage form comprises a total amount of EGCG in the range of from about 50 mg to about 1,000 mg;
- and
- wherein the EGCG has a purity of at least 98%.
Dependencies are inferred from the claim text.