US 11,654,114 B2
Oral prolonged drug delivery platforms
Mahmoud Fahmy Ali El Sabahy, College Station, TX (US); and Mostafa Ahmad Mostafa Mohammad Hamad, Assiut (EG)
Assigned to EGY-NANO PHARMA, LP, Assiut (EG)
Appl. No. 16/615,322
Filed by Egy-Nano Pharma, LP, Assiut (EG)
PCT Filed May 18, 2018, PCT No. PCT/US2018/033462
§ 371(c)(1), (2) Date Nov. 20, 2019,
PCT Pub. No. WO2018/226383, PCT Pub. Date Dec. 13, 2018.
Claims priority of provisional application 62/516,557, filed on Jun. 7, 2017.
Prior Publication US 2020/0163894 A1, May 28, 2020
Int. Cl. A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61P 3/10 (2006.01); A61K 9/48 (2006.01); A61K 38/28 (2006.01)
CPC A61K 9/4866 (2013.01) [A61K 9/0034 (2013.01); A61K 9/4858 (2013.01); A61K 38/28 (2013.01)] 14 Claims
 
1. An oral dosage form of a pH-responsive drug delivery composition, comprising:
a polymer matrix consisting of two layers, the two layers crosslinked to each other, each layer of the two layers comprising crosslinked polymers, the crosslinked polymers derived from chitosan and pectin;
insulin;
a protease inhibitor; and
an absorption enhancer,
wherein each of the insulin, the protease inhibitor, and the absorption enhancer are entrapped between the two layers of the polymer matrix, within the two layers of the polymer matrix, or entrapped within and between the two layers of the polymer matrix;
wherein the drug delivery composition protects the insulin at an acidic pH; and
wherein the drug delivery composition, at neutral pH, forms a swollen matrix that unrolls and adheres to a mucosal surface and releases the insulin over a period of at least 24 hours.