| 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.
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