US 9,808,442 B2
Enalapril formulations
Gerold L. Mosher, Kansas City, MO (US); and David W. Miles, Kansas City, MO (US)
Assigned to SILVERGATE PHARMACEUTICALS, INC., Greenwood Village, CO (US)
Filed by Silvergate Pharmaceuticals, Inc., Greenwood Village, CO (US)
Filed on Jun. 5, 2017, as Appl. No. 15/613,622.
Application 15/613,622 is a continuation of application No. 15/081,603, filed on Mar. 25, 2016, granted, now 9,669,008.
Claims priority of provisional application 62/310,198, filed on Mar. 18, 2016.
Prior Publication US 2017/0266159 A1, Sep. 21, 2017
Int. Cl. A61K 31/401 (2006.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01); A61K 9/00 (2006.01)
CPC A61K 31/401 (2013.01) [A61K 9/0053 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01)] 30 Claims
1. A method of treating hypertension in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation comprising:
(i) about 1 mg/ml enalapril maleate;
(ii) a buffer comprising about 1.82 mg/ml citric acid and about 0.15 mg/ml sodium citrate dihydrate;
(iii) about 1 mg/ml of a preservative that is sodium benzoate; and
(iv) water;
wherein the pH of the stable oral liquid formulation is less than about 3.5;
wherein the stable oral liquid formulation is stable at about 5±3° C. for at least 12 months; and
wherein the stable oral liquid formulation has about 95% or greater of the initial enalapril amount and about 5% w/w or less total impurities or related substances at the end of the given storage period.