Pharmaceutical composition for reducing protein bound uremic toxins
Inventors
SHYAM, Ankit • CHHUNCHHA, Alpesh
Assignees
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Publication Number
US-12048713-B2
Publication Date
2024-07-30
Expiration Date
Abstract
The present invention relates to a composition/formulation for reducing uremic toxins, particularly protein bound uremic toxins in chronic kidney disease (CKD). More particularly, the pharmaceutical composition/formulation comprises a synergistic combination of Inulin and Betaine or their pharmaceutically acceptable salts for reducing protein bound uremic toxins. The present application also provides various compositions/formulations and process of preparing the same.
Core Innovation
The invention relates to a pharmaceutical composition comprising a combination of inulin or pharmaceutically acceptable salts thereof and betaine or pharmaceutically acceptable salts thereof. The composition is presented as a synergistic combination intended to address protein-bound uremic toxins in chronic kidney disease (CKD).
The amount of the inulin or pharmaceutically acceptable salts thereof ranges from 90 to 99% by wt. of the composition. The amount of betaine or pharmaceutically acceptable salts thereof ranges from 0.5 to 10% by wt. of the composition.
Optional additional active ingredients include resistant starch, short chain fatty acid(s), and omega-3 fatty acid. The composition may be formulated with pharmaceutically acceptable salts and pharmaceutically acceptable excipients, and may be provided in oral dosage forms.
The document reports a study in a 5/6 nephrectomy induced CKD rat model and reports % decrease in indoxyl sulphate (IS) and p-cresyl sulphate (PCS) for combination groups versus individual components and an activated charcoal reference. The document concludes synergistic efficacy and no observed mortality over 13 weeks.
Claims Coverage
The independent claim coverage centers on two composition claims that define a synergistic combination of inulin and betaine, with two separate weight-range constraints for the components. Together with the dependent claims, the coverage includes at least four main inventive feature themes: the inulin/betaine combination with wt.% constraints, optional additional active ingredients with wt.% constraints, constrained excipient and dosage-form selections, and an indicated use in CKD for reducing protein-bound uremic toxins.
Inulin-betaline combination with inulin at 90 to 99 wt.%
A pharmaceutical composition comprising a combination of inulin or pharmaceutically acceptable salts thereof and betaine or pharmaceutically acceptable salts thereof, wherein an amount of the inulin or pharmaceutically acceptable salts thereof ranges from 90 to 99% by wt. of the composition.
Inulin-betaline combination with betaine at 0.5 to 10 wt.%
A pharmaceutical composition comprising a combination of inulin or pharmaceutically acceptable salts thereof and betaine or pharmaceutically acceptable salts thereof, wherein an amount of betaine or pharmaceutically acceptable salts thereof ranges from 0.5 to 10% by wt. of the composition.
Optional additional actives with defined wt.% ranges
The pharmaceutical composition further including additional active ingredients selected from resistant starch, short chain fatty acid(s) or pharmaceutically acceptable salts, omega-3 fatty acid, or combinations thereof.
Pharmaceutically acceptable excipients selected from specified types or combinations
The pharmaceutical composition whose pharmaceutically acceptable excipients are chosen from the listed excipient categories or combinations of them.
Oral dosage forms for the inulin-betaline composition
The pharmaceutical composition formulated in one of several specified dosage forms including tablet, capsule, sachet, pill, hard capsule filled with liquid or solid, soft capsule, powder, granule, suspension, solution, modified release formulation, emulsion, or syrup.
Reducing protein-bound uremic toxins in chronic kidney disease
The pharmaceutical composition is used to reduce protein-bound uremic toxins in chronic kidney disease (CKD).
The independent claim set establishes a synergistic pharmaceutical composition defined by an inulin/betaine combination with defined wt.% constraints for either the inulin component or the betaine component. Dependent claims extend the coverage to optional additional actives, constrained excipient selections, specified oral dosage forms, and an indicated use for reducing protein-bound uremic toxins in CKD.
Stated Advantages
Synergistic efficacy versus individual components is reported, with % decrease in indoxyl sulphate (IS) and p-cresyl sulphate (PCS) for combination groups.
No observed mortality over 13 weeks is reported in the described study.
Documented Applications
Use of the pharmaceutical composition to reduce protein-bound uremic toxins in chronic kidney disease (CKD).
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