Formulations and methods of manufacturing formulations for use in colonic evacuation
AssigneeRedHill Biopharma Ltd.
InventorsReza Fathi, Patrick Laughlin Mclean
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Abstract
Formulations and methods of manufacturing formulations for use in colonic evacuation are disclosed herein, in an embodiment, a solid dosage formulation includes an intra-granular fraction intermingled with an extra-granular fraction, wherein the intra-granular fraction includes granules comprising at least one osmotic evacuant agent, at least one antacid, and a first pharmaceutically acceptable excipient component, and wherein the extra-granular fraction includes one or more organic acids, a non-metallic lubricating element, and a second pharmaceutically acceptable excipient component.
Claims21
-24. (canceled)
A 24-hour supply of pharmaceutical tablets comprising:
- at least 25 tablets, wherein each of the at least 25 tablets comprises an intra-granular fraction combined with an extra-granular fraction, and a coating layer sufficiently designed to delay dissolution of the tablet beyond the mouth of the patient,
- wherein the intra-granular fraction includes granules comprising micronized sodium picosulfate, microcrystalline cellulose, magnesium oxide, and crospovidone,
- wherein the intra-granular fraction excludes sodium starch glycolate,
- wherein the extra-granular fraction includes one or more organic acids, microcrystalline cellulose, and crospovidone, and
- wherein the extra-granular fraction excludes sodium starch glycolate and magnesium stearate, wherein the organic acid is one of ascorbic acid, citric acid, tartaric acid, or combinations thereof.
A bowel cleansing product comprising:
- a container having at least 25 tablets, wherein each of the at least 25 tablets comprises an intra-granular fraction combined with an extra-granular fraction, and a coating layer sufficiently designed to delay dissolution of the tablet beyond the mouth of the patient,
- wherein the intra-granular fraction includes granules comprising micronized sodium picosulfate, microcrystalline cellulose, magnesium oxide, and crospovidone,
- wherein the intra-granular fraction excludes sodium starch glycolate,
- wherein the extra-granular fraction includes one or more organic acids, microcrystalline cellulose, and crospovidone, and
- wherein the extra-granular fraction excludes sodium starch glycolate and magnesium stearate, and wherein the organic acid is one of ascorbic acid, citric acid, tartaric acid, or combinations thereof.
Dependencies are inferred from the claim text.