US 10,376,560 B2
Aqueous solution formulations of vancomycin
Andrew Xian Chen, San Diego, CA (US)
Assigned to LATITUDE PHARMACEUTICALS, INC., San Diego, CA (US)
Filed by LATITUDE PHARMACEUTICALS, INC., San Diego, CA (US)
Filed on Jul. 13, 2017, as Appl. No. 15/649,284.
Application 15/649,284 is a continuation of application No. PCT/US2016/016829, filed on Feb. 5, 2016.
Claims priority of provisional application 62/113,322, filed on Feb. 6, 2015.
Prior Publication US 2017/0304396 A1, Oct. 26, 2017
Int. Cl. A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 38/14 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 31/405 (2006.01); A61K 31/7028 (2006.01)
CPC A61K 38/14 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 31/405 (2013.01); A61K 31/7028 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01); A61K 47/22 (2013.01)] 15 Claims
 
1. A clear and injectable solution composition, said solution composition comprising:
(a) a glycopeptide selected from the group consisting of vancomycin having an empirical formula of C66H75Cl2N9O24, norvancomycin or salts thereof, at a concentration of about 0.1% w/v to about 12% w/v;
(b) tryptophan having an empirical formula of C11H12N2O2 selected from the group consisting of the L-form, the D-form, a mixture of the L- and D-forms or salts thereof, at a concentration between about 0.1% w/v to 2.5% w/v, wherein tryptophan inhibits formation of crystalline degradation product-1 (CDP-1);
(c) water, wherein the pH of the solution composition is between about 3 to about 6; and CDP-1 is no more than 4% based on high performance liquid chromatography (HPLC) peak area after storage at 2-8° C. for 20 months.