# US 11,298,321 B1 · Methods for treating metabolic disorder

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- Number: US 11,298,321 B1
- Document ID: US11298321B1
- Status: Granted
- Kind: B1
- Application number: 17/509,215
- Filed: 2021-10-25
- Granted: 2022-04-12
- Earliest claimed: 2021-07-12
- Assignees: King Abdulaziz University
- Applicants: King Abdulaziz University
- Inventors: Khalid M. El-Say; Tarek A Ahmed; Raed I. Felimban; Hossam H. Tayeb; Waleed Y Rizg; Fuad H. AlNadwi; Abdelsattar M. Omar
- Web page: https://patentgrep.com/patent/US11298321B1

## CPC

- A61K 9/2095: {Tabletting processes}
- A61K 9/2068: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/2013)}
- A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer}
- A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine
- A61K 31/64: Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- B82Y 5/00: Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
- 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
- B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES

## Abstract

Provided are a self-nanoemulsifying 3D printer ink composition and a method of using such composition to manufacture a 3D-printed tablet having compartmentalized active pharmaceutical ingredients. In particular, the 3D-printed tablet composition includes glimepiride and/or rosuvastatin in a curcuma oil based self-nanoemulsifying drug delivery system (SNEDDS). The disclosure also provides a method of treating a metabolic disorder or disease by administering a therapeutically effective amount of the 3D-printed tablet to a subject in need thereof.

## Claims

### Claim 1

A method of treating a metabolic disorder or disease in a subject in need thereof, comprising
administering to the subject a therapeutically effective amount of a 3D-printed tablet, wherein the 3D-printed tablet comprises glimepiride (GLMP) and rosuvastatin (RSV) or pharmaceutically acceptable salts thereof, and 10-20 wt. % of curcuma oil in a self-nanoemulsifying drug delivery system (SNEDDS),
wherein the 3D-printed tablet is a multi-compartmentalized tablet having at least one layer of GLMP and at least one layer of RSV in separate compartments, wherein each compartment is configured to release GLMP or RSV at a different rate,
wherein the GLMP and rosuvastatin RSV are at a weight ratio of about 3:1 to 1:3, and
wherein the metabolic disorder or disease is selected from the group consisting of diabetes, hyperlipidemia, and liver disease.

### Claim 2 (depends on 1)

The method of claim 1, wherein the metabolic disorder or disease is diabetes.

### Claim 3 (depends on 1)

The method of claim 1, wherein the metabolic disorder or disease is hyperlipidemia.

### Claim 4 (depends on 1)

The method of claim 1, wherein the metabolic disorder or disease is fatty liver disease.

### Claim 5 (depends on 1)

The method of claim 1, wherein the 3D-printed tablet is orally, rectally, or vaginally administered.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject is a human.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject is a non-human animal.

### Claim 8 (depends on 1)

The method of claim 1, wherein multiple doses of the 3D-printed tablet are administered to the subject.

### Claim 9 (depends on 8)

The method of claim 8, wherein the 3D-printed tablet is administered daily.

### Claim 10 (depends on 8)

The method of claim 8, wherein the 3D-printed tablet is administered weekly.

### Claim 11 (depends on 8)

The method of claim 8, wherein the 3D-printed tablet is administered monthly.

### Claim 12 (depends on 8)

The method of claim 8, wherein the 3D-printed tablet is administered three times a day.

### Claim 13 (depends on 8)

The method of claim 8, wherein the 3D-printed tablet is administered twice a day.