US 12,303,538 B2
High potency stable formulations of vaginal lactobacillus
Thomas P. Parks, San Mateo, CA (US); and Angela Marcobal, Mountain View, CA (US)
Assigned to Osel, Inc., Mountain View, CA (US)
Filed by Osel, Inc., Mountain View, CA (US)
Filed on Jul. 9, 2021, as Appl. No. 17/372,325.
Application 17/372,325 is a continuation of application No. 16/825,225, filed on Mar. 20, 2020, granted, now 11,083,761.
Application 16/825,225 is a continuation of application No. 16/627,118, abandoned, previously published as PCT/US2018/040884, filed on Jul. 5, 2018.
Claims priority of provisional application 62/529,756, filed on Jul. 7, 2017.
Prior Publication US 2021/0330721 A1, Oct. 28, 2021
Int. Cl. A61K 35/747 (2015.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 35/00 (2006.01); A61K 45/06 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61P 15/02 (2006.01); A61P 31/04 (2006.01); C12N 1/04 (2006.01); C12N 1/20 (2006.01)
CPC A61K 35/747 (2013.01) [A61K 9/0034 (2013.01); A61K 9/19 (2013.01); A61K 45/06 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61P 15/02 (2018.01); A61P 31/04 (2018.01); C12N 1/04 (2013.01); C12N 1/20 (2013.01); A61K 2035/115 (2013.01)] 20 Claims
 
1. An aqueous bacterial suspension of vaginal Lactobacillus species, having no animal-derived excipients, where the suspension results from a combination of a cell pellet of vaginal Lactobacillus species with an aqueous preservation medium comprising:
(i) trehalose at between 5-20%, w/v;
(ii) xylitol at between 2-9%, w/v;
(iii) sodium ascorbate 0.5-1.5%, w/v; and
(iv) sodium phosphate at between 10-50 mM
wherein the aqueous preservation medium contains no glycerol and vitamin E.