# US 11,433,094 B2 · Water-activated mucoadhesive compositions to reduce intestinal absorption of nutrients

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- Number: US 11,433,094 B2
- Document ID: US11433094B2
- Status: Granted
- Kind: B2
- Application number: 17/227,484
- Filed: 2021-04-12
- Published: 2021-08-05
- Granted: 2022-09-06
- Earliest claimed: 2015-09-24
- Assignees: The Brigham and Women's Hospital, Inc.
- Applicants: The Brigham and Women's Hospital, Inc.
- Inventors: Jeffrey M. Karp; Yuhan Lee; Ali Tavakkoli; Tarawatie E. Deelman
- Web page: https://patentgrep.com/patent/US11433094B2

## CPC

- A61K 31/737: Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate (A61K31/727 takes precedence)
- A61K 31/7024: Esters of saccharides
- A61K 31/721: Dextrans
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

This disclosure relates to compositions including formulated sucralfate or other aluminum-crosslinked sulfated agents for delivery of agents to biological surfaces and/or the modulation of nutrient absorption through the intestinal lining as well as methods for the manufacture of and the use of these compositions for treating disorders including diabetes type II and clinical obesity that require a modulation of certain nutrients to the body.

## Claims

### Claim 1

A composition comprising particles comprising an aluminum cross-linked sulfated agent, wherein the composition forms a paste with an aqueous liquid in the absence of acid, and wherein the aluminum cross-linked sulfated agent has the following chemical formula:
C12H30Al8S8O51.(x−n)Al(OH)3.—[Al—(OH)i]m-zH2O
wherein:
x is less than or equal to 8;
0<n<x;
m is greater than or equal to 2;
i=1, 2, or 3; and
z<3(x−n)+(6−i)m.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition releases less than 15% by weight of its original aluminum content in an acidic fluid of pH 1.0.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition releases less than 2% by weight of its original aluminum content in an acidic fluid of pH 3.5.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the composition further comprises a therapeutic agent.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the therapeutic agent comprises insulin, metformin, a sulfonylurea, an alpha-glucosidase inhibitor, thiazolidinedione, an amylin analog, a bile acid sequestrant, a DPP-4 inhibitor, a dopamine agonist, an incretin mimetic, a non-sulfonylurea secretagogue, or meglinitide.

### Claim 6 (depends on 4)

The composition of claim 4, wherein the therapeutic agent comprises orlistat, lorcaserin, sibutramine, rimonabant, exenatide, pramlintide, topiramate, or phentermine.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the composition further comprises an antimicrobial agent.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the composition is formulated for oral administration and comprises an enteric coating.

### Claim 9 (depends on 8)

The composition of claim 8, wherein the composition is formulated for release in the intestine of a subject.

### Claim 10 (depends on 1)

A method of treating a subject, the method comprising administering to the subject the composition of claim 1.

### Claim 11 (depends on 10)

The method of claim 10, wherein the composition modulates nutritional absorption by the subject.

### Claim 12 (depends on 10)

The method of claim 10, wherein the subject has pre-diabetes, type II diabetes, obesity, mucositis, or a microbial infection.

### Claim 13 (depends on 10)

The method of claim 10, wherein the composition forms a coating on healthy mucosa of the intestine of the subject.