US 10,888,614 B2
Emulsions for injectable formulations
Roberta Ondei, Campinas-São Paulo (BR); and Edna Fernandes, Campinas-São Paulo (BR)
Assigned to Croda International Plc
Appl. No. 15/565,983
PCT Filed Apr. 4, 2016, PCT No. PCT/GB2016/050952
§ 371(c)(1), (2) Date Oct. 12, 2017,
PCT Pub. No. WO2016/170302, PCT Pub. Date Oct. 27, 2016.
Claims priority of application No. 1506948.7 (GB), filed on Apr. 23, 2015.
Prior Publication US 2018/0104329 A1, Apr. 19, 2018
Int. Cl. A61K 39/39 (2006.01); A61K 9/107 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/44 (2017.01); A61K 47/18 (2017.01); A61K 39/00 (2006.01)
CPC A61K 39/39 (2013.01) [A61K 9/107 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/18 (2013.01); A61K 47/44 (2013.01); A61K 2039/55566 (2013.01)] 10 Claims
1. A vaccine formulation comprising a water-in-oil emulsion and at least one vaccine antigen, oil, and water, where said emulsion comprises an emulsifier having a general structure (I):
R1.[(AO)n—R2]m  (I)
R1 is the residue of a polyol or polyamine, each said polyol or polyamine having m active hydrogen atoms, where m is an integer of at least 2;
AO is an oxyalkylene group;
each n independently represents an integer in the range from 1 to 100;
each R2 independently represents hydrogen, or an acyl group represented by —C(O)R3 wherein each R3 independently represents a residue of Polyhydroxyalkyl carboxylic acid, polyhydroxyalkenyl carboxylic acid, hydroxyalkyl carboxylic acid, hydroxyalkenyl carboxylic acid, oligomer of hydroxyalkyl carboxylic acid, or oligomer of hydroxyalkenyl carboxylic acid; and
wherein on average at least two R2 groups per molecule are alkanoyl groups as defined.