# US 12,005,141 B2 · Pharmaceutical solution of amlodipine

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- Number: US 12,005,141 B2
- Document ID: US12005141B2
- Status: Granted
- Kind: B2
- Application number: 18/339,267
- Filed: 2023-06-22
- Published: 2023-10-19
- Granted: 2024-06-11
- Earliest claimed: 2021-02-01
- Assignees: Liqmeds Worldwide Limited
- Applicants: Liqmeds Worldwide Limited
- Inventors: Jayanta Kumar Mandal; Malay Patel; Swati Nagar; Michael Paul DeHart
- Web page: https://patentgrep.com/patent/US12005141B2

## CPC

- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- 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 31/4418: having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
- 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
- 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

Disclosed herein is a liquid pharmaceutical formulation substantially free of water, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin. Also disclosed herein is a liquid pharmaceutical formulation substantially free of water and ethanol, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin.

## Claims

### Claim 1

An oral liquid pharmaceutical formulation, comprising:
about 1 mg/mL of amlodipine, as amlodipine besylate;
at least one pharmaceutically acceptable excipient; and
a vehicle comprising from about 73% w/w to about 98% w/w glycerin;
wherein the oral liquid pharmaceutical formulation has a water content of less than or equal to about 5% w/w.

### Claim 2 (depends on 1)

The formulation of claim 1, wherein the amount of amlodipine is present in an amount of 1 mg/mL, as amlodipine besylate.

### Claim 3 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 76% w/w to about 98% w/w glycerin.

### Claim 4 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 78% w/w to about 98% w/w glycerin.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 80% w/w to about 98% w/w glycerin.

### Claim 6 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 82% w/w to about 94% w/w glycerin.

### Claim 7 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 84% w/w to about 92% w/w glycerin.

### Claim 8 (depends on 1)

The formulation of claim 1, wherein the vehicle comprises about 84% w/w to about 90% w/w glycerin.

### Claim 9 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent, an antioxidant, a co-solvent, a flavoring agent, or a combination thereof.

### Claim 10 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent in an amount of from about 0.1% w/w to about 11% w/w.

### Claim 11 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent in an amount of from about 4% w/w to about 11% w/w.

### Claim 12 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent in an amount of from about 8% w/w to about 11% w/w.

### Claim 13 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent comprising maltitol in an amount of from about 5.5% w/w to about 7.0% w/w.

### Claim 14 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent comprising maltitol in an amount of from about 5.6% w/w to about 6.6% w/w.

### Claim 15 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a sweetener agent comprising maltitol in an amount of from about 5.6% w/w to about 6.0% w/w.

### Claim 16 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises an antioxidant in an amount of from about 0.01% w/w to about 0.09% w/w.

### Claim 17 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises an antioxidant in an amount of from about 0.01% w/w to about 0.07% w/w.

### Claim 18 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises an antioxidant in an amount of from about 0.01% w/w to about 0.05% w/w.

### Claim 19 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a co-solvent in an amount of from about 1% w/w to about 15% w/w.

### Claim 20 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a co-solvent in an amount of from about 1% w/w to about 10% w/w.

### Claim 21 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a co-solvent in an amount of from about 1% w/w to about 8% w/w.

### Claim 22 (depends on 1)

The formulation of claim 1, wherein the at least one pharmaceutically acceptable excipient comprises a co-solvent in an amount of from about 1% w/w to about 5% w/w.

### Claim 23 (depends on 1)

A container comprising written material and a bottle comprising the formulation of claim 1.

### Claim 24 (depends on 1)

The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 4% w/w.

### Claim 25 (depends on 1)

The formulation of claim 1, wherein the liquid pharmaceutical formulation has a water content of less than or equal to about 3% w/w.

### Claim 26 (depends on 1)

A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is treatment of hypertension, the symptomatic treatment of chronic stable angina, the treatment of vasospastic angina, or the treatment of a coronary artery disease; and wherein the patient is an adult patient or a pediatric patient.

### Claim 27 (depends on 1)

A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1, wherein the condition is treatment of hypertension; and wherein the patient is an adult patient or a pediatric patient.

### Claim 28 (depends on 1)

A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is the symptomatic treatment of chronic stable angina; and wherein the patient is an adult patient or a pediatric patient.

### Claim 29 (depends on 1)

A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is the treatment of vasospastic angina; and wherein the patient is an adult patient or a pediatric patient.

### Claim 30 (depends on 1)

A method for the treatment of a condition, which comprises administering to a patient in need thereof a therapeutically effective amount of the formulation of claim 1; wherein the condition is treatment of a coronary artery disease; and wherein the patient is an adult patient or a pediatric patient.