US 12,220,486 B2
Polymer compositions for storage and release of polypeptides
Vaishnavi Parikh, Sellersville, PA (US); and Pardeep Gupta, West Chester, PA (US)
Assigned to Saint Joseph's University, Philadelphia, PA (US)
Appl. No. 16/977,222
Filed by Saint Joseph's University, Philadelphia, PA (US)
PCT Filed Mar. 2, 2019, PCT No. PCT/US2019/020453
§ 371(c)(1), (2) Date Sep. 1, 2020,
PCT Pub. No. WO2019/169370, PCT Pub. Date Sep. 6, 2019.
Claims priority of provisional application 62/637,906, filed on Mar. 2, 2018.
Prior Publication US 2021/0154144 A1, May 27, 2021
Int. Cl. A61K 9/14 (2006.01); A61K 38/17 (2006.01); A61K 38/27 (2006.01); A61K 47/34 (2017.01)
CPC A61K 9/146 (2013.01) [A61K 38/27 (2013.01)] 17 Claims
 
1. A method of forming polypeptide-adsorbed poly(lactic-co-glycolic acid) (PLGA) particles,
the method comprising contacting an aqueous suspension comprising PLGA particles with an aqueous solution comprising a polypeptide, whereby the polypeptide is adsorbed on the PLGA particles,
wherein the PLGA particles comprise nanoparticles having a diameter ranging from about 1 nm to about 100 nm;
wherein the PLGA particles comprise a lactic acid-to-glycolic acid ratio from about 1:1 to about 6:1;
wherein the PLGA particles comprise a PLGA polymer having a molecular weight from about 10 kDa to about 50 kDa;
wherein the aqueous solution comprises about 0.001 mg/ml to about 0.2 mg/ml of the polypeptide;
wherein at least a portion of the PLGA particles comprises an ester end-capped PLGA polymer;
wherein the polypeptide comprises a human growth hormone; and
wherein at least a portion of the human growth hormone adsorbed to the surface of the PLGA particles retains its active secondary and tertiary structure as compared to the polypeptide prior to adsorption, and is not significantly denatured by the adsorption process.