US 12,303,501 B2
Lipophilic active oral film formulation and method of making the same
Carolin Madwar, Montréal (CA); Nadine Paiement, St-Laurent (CA); Rodolphe Obeid, Pierrefonds (CA); Justin W. Conway, Carignan (CA); and Erick Gonzalez-Labrada, Cote Saint-Luc (CA)
Appl. No. 17/291,582
Filed by INTELGENX CORP., St-Laurent (CA)
PCT Filed Nov. 4, 2019, PCT No. PCT/CA2019/051564
§ 371(c)(1), (2) Date May 5, 2021,
PCT Pub. No. WO2020/093146, PCT Pub. Date May 14, 2020.
Application 17/291,582 is a continuation in part of application No. 16/383,813, filed on Apr. 15, 2019, granted, now 11,602,504.
Claims priority of provisional application 62/755,878, filed on Nov. 5, 2018.
Prior Publication US 2021/0393611 A1, Dec. 23, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/47 (2006.01); A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 31/352 (2006.01); A61K 47/44 (2017.01)
CPC A61K 31/47 (2013.01) [A61K 9/006 (2013.01); A61K 9/107 (2013.01); A61K 31/352 (2013.01); A61K 47/44 (2013.01)] 20 Claims
 
1. An emulsion based oral film dosage form for human or animal administration comprising:
a. an unbuffered oil in water emulsion based continuously cast film layer comprising:
i. a carrier oil;
ii. an amphiphilic pharmaceutical active; and
iii. a water soluble film forming polymer;
b. wherein the amphiphilic pharmaceutical active exhibits surfactant properties;
c. wherein the combined quantity of carrier oil and amphiphilic pharmaceutical active is more than about 20% (wt/wt) of the oral film dosage form; and
d. wherein the film layer has a contact angle of less than 90 degrees.