US 12,246,087 B2
Composition for intraoral delivery of biologically active peptides and proteins
Joseph Schwarz, Toronto (CA); and Michael Weisspapir, Toronto (CA)
Appl. No. 15/768,758
Filed by PHARCON INC., Toronto (CA)
PCT Filed Oct. 14, 2016, PCT No. PCT/IB2016/002013
§ 371(c)(1), (2) Date Apr. 16, 2018,
PCT Pub. No. WO2017/093810, PCT Pub. Date Jun. 8, 2017.
Claims priority of provisional application 62/241,327, filed on Oct. 14, 2015.
Prior Publication US 2018/0311146 A1, Nov. 1, 2018
Int. Cl. A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 9/20 (2006.01); A61K 38/19 (2006.01); A61K 38/20 (2006.01); A61K 38/22 (2006.01); A61K 38/28 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/24 (2006.01); A61K 47/22 (2006.01); A61K 47/28 (2006.01)
CPC A61K 9/006 (2013.01) [A61K 9/0095 (2013.01); A61K 9/107 (2013.01); A61K 9/2013 (2013.01); A61K 38/19 (2013.01); A61K 38/20 (2013.01); A61K 38/22 (2013.01); A61K 38/28 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/24 (2013.01); A61K 47/22 (2013.01); A61K 47/28 (2013.01)] 7 Claims
 
1. A solid pharmaceutical dosage form, comprising:
a. about 1.1 mg to about 2.2 mg human recombinant insulin, insulin from an animal source, plant origin insulin, modified insulin, or one or more insulin analogs;
b. about 7.5 mg to about 30 mg of a physiologically acceptable polyethoxylated surfactant or mixture of polyethoxylated surfactants;
c. about 0.8 mg to about 10 mg of dimyristoylphosphatidylglycerol (DMPG);
d. about 6 mg to about 10 mg of methyl salicylate;
e. about 5 mg to about 15 mg of lecithin;
f. about 1.2 mg to about 5 mg of menthol;
g. about 2 to about 12 mg of physiologically acceptable triglyceride, selected from the group of medium chain triglycerides or mixtures thereof; and
h. about 2 to about 5 mg of tocopherol acetate.