IP Library › Granted Patent US 8,568,747
Granted Patent B1
US 8,568,747 · App. 13/670,355 · Granted Oct 29, 2013

Enalapril compositions

Inventors: Lian G. Rajewski (Lawrence, KS); Roger A. Rajewski (Lawrence, KS); John L. Haslam (Lawrence, KS); Kathleen Heppert (Lawrence, KS); Michael C. Beckloff (Leawood, KS); Frank Seagrave (Dublin, OH); Robert Mauro (Miller Place, NY); Peter Colabuono (Las Vegas, NV)
Assignees: Silvergate Pharmaceuticals, Inc.; University of Kansas
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Quick Facts
Patent No.
US 8,568,747
App. No.
13/670,355
Granted
Oct 29, 2013
Kind
B1
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 (10)

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.

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

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

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

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

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

Assignments (16)
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Mar 17, 2025
From: ARBOR PHARMACEUTICALS, LLC; AZURITY PHARMACEUTICALS, INC.; AZURITY PHARMACEUTICALS IRELAND LIMITED; SILVERGATE PHARMACEUTICALS, INC.
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 070531/0487 →
RELEASE OF SECURITY INTEREST Recorded Mar 14, 2025
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: AZURITY PHARMACEUTICALS, INC.; SILVERGATE PHARMACEUTICALS, INC.; ARBOR PHARMACEUTICALS, LLC; SLAYBACK PHARMA LIMITED LIABILITY COMPANY
Reel/Frame 070521/0299 →
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 057531/0556 →
SECURITY INTEREST Recorded Sep 20, 2021
From: SILVERGATE PHARMACEUTICALS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 057532/0550 →
RELEASE OF SECURITY INTEREST Recorded Aug 23, 2021
From: GOLDMAN SACHS BANK USA
To: AZURITY PHARMACEUTICALS, INC.; SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 057253/0348 →
SECURITY INTEREST Recorded Apr 16, 2021
From: SILVERGATE PHARMACEUTICALS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 055938/0895 →
SECURITY INTEREST Recorded May 17, 2019
From: CUTISPHARMA, INC.; SILVERGATE PHARMACEUTICALS, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 049209/0272 →
RELEASE OF SECURITY INTEREST Recorded May 17, 2019
From: WHITE OAK HEALTHCARE FINANCE, LLC, AS AGENT
To: ARGENTUM HOLDINGS, LLC; SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 049211/0188 →
SECURITY INTEREST Recorded Dec 19, 2018
From: ARGENTUM HOLDINGS, LLC; SILVERGATE PHARMACEUTICALS, INC.
To: WHITE OAK HEALTHCARE FINANCE, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 047815/0615 →
RELEASE OF SECURITY INTEREST Recorded Dec 12, 2018
From: COMERICA BANK
To: SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 047753/0401 →
RELEASE OF SECURITY INTEREST Recorded Dec 12, 2018
From: COMERICA BANK
To: SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 047753/0443 →
RELEASE OF SECURITY INTEREST Recorded Dec 28, 2017
From: ESCALATE CAPITAL PARTNERS SBIC III, LP
To: SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 044498/0193 →
SECURITY INTEREST Recorded Nov 23, 2015
From: SILVERGATE PHARMACEUTICALS, INC.
To: COMERICA BANK
Reel/Frame 037123/0437 →
SECURITY INTEREST Recorded Nov 3, 2015
From: SILVERGATE PHARMACEUTICALS, INC.
To: ESCALATE CAPITAL PARTNERS SBIC III, LP
Reel/Frame 036945/0861 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2013
From: RAJEWSKI, LIAN G.; RAJEWSKI, ROGER A.; HASLAM, JOHN L.; HEPPERT, KATHLEEN
To: UNIVERSITY OF KANSAS
Reel/Frame 029946/0416 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2013
From: BECKLOFF, MICHAEL C.; SEGRAVE, FRANK; MAURO, ROBERT; COLABUONO, PETER
To: SILVERGATE PHARMACEUTICALS, INC.
Reel/Frame 029946/0585 →
Continuity (1)
Provisional Application 61710489 · Oct 5, 2012