# US 8,568,747 B1 · Enalapril compositions

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- Number: US 8,568,747 B1
- Document ID: US8568747B1
- Status: Granted
- Kind: B1
- Application number: 13/670,355
- Filed: 2012-11-06
- Granted: 2013-10-29
- Earliest claimed: 2012-10-05
- Assignees: Silvergate Pharmaceuticals, Inc.; University of Kansas
- Applicants: University of Kansas; Silvergate Pharmaceuticals
- Inventors: Lian G. Rajewski; Roger A. Rajewski; John L. Haslam; Kathleen Heppert; Michael C. Beckloff; Frank Seagrave; Robert Mauro; Peter Colabuono
- Web page: https://patentgrep.com/patent/US8568747B1

## CPC

- 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)}
- A43B 11/00: Footwear with arrangements to facilitate putting-on or removing, e.g. with straps
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/143: {with inorganic compounds}
- A61K 9/145: {with organic compounds}
- A61K 31/401: Proline; Derivatives thereof, e.g. captopril
- A61K 38/05: Dipeptides
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- 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
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 9/12: Antihypertensives
- 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)
- A43B: CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Provided herein are stable enalapril powder compositions for oral liquid formulation. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.

## Claims

### Claim 1

A pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of:
(a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof,
(b) about 85% (w/w) mannitol, and
(c) about 1% (w/w) colloidal silicon dioxide,
wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25±5° C. and 55±10% relative humidity.

### Claim 2 (depends on 1)

The pharmaceutical powder of claim 1, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.

### Claim 3 (depends on 1)

The pharmaceutical powder of claim 1, wherein the powder is reconstituted in water for the oral liquid.

### Claim 4 (depends on 1)

The pharmaceutical powder of claim 1, wherein the powder is reconstituted in syrup for the oral liquid.

### Claim 5 (depends on 1)

The pharmaceutical powder of claim 1, wherein the powder is stable for at least six months at ambient, accelerated or refrigerated conditions.

### Claim 6 (depends on 1)

The pharmaceutical powder of claim 1, wherein the powder is 150 mg enalapril, 890 mg mannitol and 10 mg colloidal silicon dioxide.