Liquid formulation compositions, medicament delivery devices, and methods of preparation and use thereof

Abstract

The invention provides liquid formulation compositions and medicament delivery devices, and methods for preparing and using the same. For example, the liquid formulation composition is an emulsion including a solvent and liquid particles, which includes surfactants and are dispersed in the solvent. The volume average particle size of the liquid particles is less than about 100 μm; the surface tension of the liquid formulation composition is less than about 60 mN/m; and the absolute value of zeta potential is greater than about 15 mV. The containment vessel may be a sprayer or a dropping device. The invention also provides methods for preparation of the liquid formulation compositions and medicament delivery devices as well as methods for using the same in treatment of various diseases and condition, for example, otitis media, otitis externa, rhinitis, sinusitis, lower respiratory tract inflammation, xerostomia (dry mouth), xerophthalmia (dry eyes) and xeromycteria (dry nose).

What is claimed is: 
     
         1 - 165 . (canceled) 
     
     
         166 . A liquid formulation composition, comprising
 water as a solvent;   a surfactant dispersed or dissolved in water comprising a phospholipid present in the formulation at 0.0001 wt % to 25.0 wt %, and   an antioxidant dispersed or dissolved in water comprising vitamin E present in the formulation at 0.001 wt % to 5.0 wt %;   
       wherein the liquid formulation composition is an emulsion of liquid particles having average particle sizes less than 100 μm and is characterized by
 a surface tension of less than 60 mN/m, 
 the absolute value of zeta potential of the liquid formulation composition is greater than 15 mV, and 
 a pH value from 5.0 to 7.4. 
 
     
     
         167 . The liquid formulation composition of  claim 166 , further comprising as solvent one of ethanol, glycerol, medical silicone oil and edible vegetable oil, or a combination thereof, and wherein the surface tension of the liquid formulation composition is less than 40 mN/m and wherein the pH value of the liquid formulation composition is from 6.0 to 7.4. 
     
     
         168 . The liquid formulation composition of  claim 167 , further comprising one of bacteriostatic agent, flavoring agent and stabilizer, or a combination thereof. 
     
     
         169 . The liquid formulation composition of  claim 168 , wherein the phospholipid is a natural phospholipid or a hydrogenated phospholipid. 
     
     
         170 . The liquid formulation composition of  claim 168 , wherein the phospholipid is soya lecithin. 
     
     
         171 . The liquid formulation composition of  claim 166 , wherein the formulation does not comprise an active pharmaceutical ingredient. 
     
     
         172 . The liquid formulation composition of  claim 171 , wherein the volume average particle size of the liquid particles is less than 10 μm. 
     
     
         173 . The liquid formulation composition of  claim 172 , wherein the volume average particle size of the liquid particles is in the range of 50 nm to 10 μm. 
     
     
         174 . The liquid formulation composition of  claim 166 , wherein the phospholipid present in the formulation at 0.1 wt % to 25.0 wt %, and vitamin E present in the formulation at 0.01 wt % to 5.0 wt %. 
     
     
         175 . The liquid formulation composition of  claim 166 , wherein the surfactant dispersed or dissolved in water further comprising one of sterol, poloxamer and lauric acid.