# US 12,599,553 B2 · Aqueous suspension suitable for oral administration

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- Number: US 12,599,553 B2
- Document ID: US12599553B2
- Status: Granted
- Kind: B2
- Application number: 19/254,167
- Filed: 2025-06-30
- Published: 2025-10-23
- Granted: 2026-04-14
- Earliest claimed: 2016-06-08
- Assignees: Liqmeds Worldwide Limited
- Applicants: Liqmeds Worldwide Limited
- Inventors: Sandip P. Mehta; Henil Alpeshbhai Patel; Jayanta Kumar Mandal
- Web page: https://patentgrep.com/patent/US12599553B2

## CPC

- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/10: Dispersions; Emulsions
- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- 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
- A61K 47/38: Cellulose; Derivatives thereof
- A61K 47/40: Cyclodextrins; Derivatives thereof
- 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)

## Abstract

The present invention provides liquid oral dosage form of lipid lowering agent suitable for oral administration to human or animals.

## Claims

### Claim 1

An aqueous suspension for oral administration, comprising:
atorvastatin in an amount of about 4 mg/mL;
a suspending agent in an amount of about 2% w/w comprising carboxymethyl cellulose sodium in an amount of about 0.7% w/w and magnesium aluminum silicate in an amount of about 1.3% w/w;
one or more pharmaceutically acceptable excipients selected from the group consisting of a co-solvent, a preservative, a sweetener, a buffer, and a flavoring agent;
and
a vehicle comprising water;
wherein the aqueous suspension does not contain a surfactant and the atorvastatin has a d90 particle size of from 1 μm to 15 μm.

### Claim 2 (depends on 1)

The aqueous suspension of claim 1, wherein atorvastatin is present in an amount of 4 mg/mL.

### Claim 3 (depends on 1)

The aqueous suspension of claim 1, wherein the preservative is present in an amount of from 0.01% w/w to 0.5% w/w.

### Claim 4 (depends on 1)

The aqueous suspension of claim 1, wherein the co-solvent is selected from the group consisting of alcohol, glycerin, a polyhydric alcohol, propylene glycol, and a combination thereof.

### Claim 5 (depends on 1)

The aqueous suspension of claim 1, wherein the preservative is selected from the group consisting of benzyl alcohol, chlorobutol, chlorocresol, an alkyl ester of paraben, phenol, phenyl ethanol, sodium benzoate, propylene glycol, chloroform, and a combination thereof.

### Claim 6 (depends on 1)

The aqueous suspension of claim 1, wherein the preservative is selected from the group consisting of benzyl alcohol, chlorobutol, chlorocresol, an alkyl ester of paraben, phenol, phenyl ethanol, sodium benzoate, propylene glycol, chloroform, and a combination thereof and the preservative is present in an amount of from 0.01% w/w to 0.5% w/w.

### Claim 7 (depends on 1)

The aqueous suspension of claim 1, wherein the preservative comprises an alkyl ester of paraben.

### Claim 8 (depends on 1)

The aqueous suspension of claim 1, wherein the preservative comprises an alkyl ester of paraben in an amount of from 0.01% w/w to 0.5% w/w.

### Claim 9 (depends on 1)

The aqueous suspension of claim 1, wherein the sweetener is selected from the group consisting of sucrose, glucose, glycerin, sorbitol, saccharin sodium, sucralose, aspartame, acesulfame potassium, and a combination thereof.

### Claim 10 (depends on 1)

The aqueous suspension of claim 1, wherein the sweetener is selected from the group consisting of sucrose, glucose, glycerin, sorbitol, saccharin sodium, sucralose, aspartame, acesulfame potassium, and a combination thereof and the sweetener is present in an amount of from 0.1% w/w to 2% w/w.

### Claim 11 (depends on 1)

The aqueous suspension of claim 1, wherein the flavoring agent is present in an amount of from 0.01% w/w to 2.0% w/w.

### Claim 12 (depends on 1)

The aqueous suspension of claim 1, wherein the pH of the aqueous suspension ranges from 5 to 10.

### Claim 13 (depends on 1)

The aqueous suspension of claim 1, wherein the pH of the aqueous suspension ranges from 6 to 9.