US 11,672,760 B2
Microemulsion compositions
Elena Solfato, Catania (IT); Ilenia Abbate, Acireale (IT); Cristina Maria Concetta Zappulla, Catania (IT); Manuela Santonocito, Mascalucia (IT); Santa Viola, Paterno (IT); Sandro De Falco, Naples (IT); and Francesco Giuliano, Mascalucia (IT)
Assigned to SIFI S.p.A., Catania (IT); and Consiglio Nazionale delle Ricerche, Rome (IT)
Filed by SIFI S.p.A., Aci Sant' Antonio (IT); and Consiglio Nazionale delle Ricerche, Rome (IT)
Filed on Mar. 19, 2021, as Appl. No. 17/207,520.
Application 17/207,520 is a continuation of application No. 16/590,246, filed on Oct. 1, 2019, granted, now 10,980,745.
Application 16/590,246 is a continuation of application No. PCT/IT2019/000048, filed on Jun. 11, 2019.
Prior Publication US 2021/0205217 A1, Jul. 8, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/107 (2006.01); A61P 27/02 (2006.01); A61P 27/04 (2006.01); A61K 9/00 (2006.01); A61K 31/05 (2006.01); A61K 31/44 (2006.01); A61K 31/5575 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/26 (2006.01); A61K 47/44 (2017.01)
CPC A61K 9/1075 (2013.01) [A61K 9/0048 (2013.01); A61K 31/05 (2013.01); A61K 31/44 (2013.01); A61K 31/5575 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/44 (2013.01); A61P 27/02 (2018.01); A61P 27/04 (2018.01)] 40 Claims
 
1. A pharmaceutical composition that is an oil-in-water microemulsion, comprising:
a) a lipid phase comprising an oily component, one or more surfactant(s), and one or more co-surfactant(s);
b) an aqueous phase comprising one or more surfactant(s), and one or more co-surfactant(s); and
c) a pharmaceutically active compound, wherein:
the weight/volume ratio between the total amount of surfactant and co-surfactant in the lipid phase to the total amount of surfactant and co-surfactant in the aqueous phase is from 2 to 10;
the weight/volume ratio between the amount of oily component in the lipid phase to the total amount of surfactant and co-surfactant in the aqueous phase is from 0.2 to 1.0; and
in the resulting oil-in-water microemulsion, the average particle size is less than 30 nm and the polydispersity index (PDI) is within the range 0.02-0.380, inclusive.