US 9,808,426 B2
Ternary mixture formulations
Guru V. Betageri, Chino Hills, CA (US); Sunil A. Agnihotri, Exton, PA (US); and Kumaresh Soppimath, Monmouth Junction, NJ (US)
Assigned to WESTERN UNIVERSITY OF HEALTH SCIENCES, Pomona, CA (US)
Filed by WESTERN UNIVERSITY OF HEALTH SCIENCES, Pomona, CA (US)
Filed on Sep. 28, 2016, as Appl. No. 15/278,606.
Application 15/278,606 is a division of application No. 13/881,381, granted, now 9,492,387, previously published as PCT/US2011/058570, filed on Oct. 31, 2011.
Prior Publication US 2017/0128368 A1, May 11, 2017
Int. Cl. A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/496 (2006.01); A61K 31/685 (2006.01)
CPC A61K 9/1694 (2013.01) [A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1652 (2013.01); A61K 9/5015 (2013.01); A61K 9/5026 (2013.01); A61K 9/5031 (2013.01); A61K 9/5089 (2013.01); A61K 31/496 (2013.01); A61K 31/685 (2013.01)] 6 Claims
OG exemplary drawing
 
1. A process for making a free-flowing powder pharmaceutical formulation comprising the steps of:
(a) dissolving a phospholipid component, a poorly water-soluble drug substance component, and a surfactant component in a water partially miscible or water non-miscible solvent or combination of partially miscible or water non-miscible solvents to form a first solution;
(b) dissolving a solubilizing aid component in water to form a second solution;
(c) adding a water-miscible solvent to the second solution to form a third solution;
(d) combining the first solution and with the third solution to form a clear homogenous solution; and
(e) producing a free flowing powder comprising a homogenous solid dispersion consisting of the phospholipid component, the poorly water-soluble drug substance component, the surfactant component, and the solubilizing aid component by spray drying the clear homogenous solution, precipitating the clear homogenous solution, or coating the clear homogenous solution onto a surface of an inert substrate;
wherein the phospholipid component comprises soy phosphatidyl choline, egg phosphatidyl choline, dimyristoyl-phosphocholine, dimyristoyl-phosphoglycerol, distearoyl-phosphatidylcholine, distearoyl-phosphatidylglycerol, dipalmitoyl-phosphocholine, or a combination thereof;
wherein the solubilizing aid component comprises lactose, polydextrose, a cyclodextrin, an amino alkyl methacrylate copolymers, or a combination thereof; and
wherein in the free flowing powder, the phospholipid component, the poorly water-soluble drug substance component, the surfactant component, and the solubilizing aid component are present in weight/weight ratios of (1.5−2):1:(0.5−1):(5.8−10), respectively.