US 12,214,041 B2
Polyurethane excipient
Jennifer Al-Rashid, Exton, PA (US); Jacob Riffey, Exton, PA (US); and John Andrew Zupancich, Exton, PA (US)
Assigned to DSM IP ASSETS B.V., Heerlen (NL)
Appl. No. 17/275,729
Filed by DSM IP Assets B.V., Te Heerlen (NL)
PCT Filed Sep. 16, 2019, PCT No. PCT/US2019/051289
§ 371(c)(1), (2) Date Mar. 12, 2021,
PCT Pub. No. WO2020/060923, PCT Pub. Date Mar. 26, 2020.
Claims priority of provisional application 62/732,073, filed on Sep. 17, 2018.
Claims priority of application No. 18197763 (EP), filed on Sep. 28, 2018.
Prior Publication US 2022/0054638 A1, Feb. 24, 2022
Int. Cl. A61K 47/34 (2017.01); A61K 9/00 (2006.01); A61K 47/32 (2006.01); C08G 18/08 (2006.01); C08G 18/12 (2006.01); C08G 18/32 (2006.01); C08G 18/40 (2006.01); C08G 18/44 (2006.01); C08G 18/48 (2006.01); C08G 18/73 (2006.01); C08G 18/75 (2006.01)
CPC A61K 47/34 (2013.01) [A61K 9/0036 (2013.01); A61K 47/32 (2013.01); C08G 18/0895 (2013.01); C08G 18/12 (2013.01); C08G 18/3206 (2013.01); C08G 18/4018 (2013.01); C08G 18/44 (2013.01); C08G 18/4833 (2013.01); C08G 18/73 (2013.01); C08G 18/758 (2013.01)] 19 Claims
 
1. A method of forming a medical device comprising a step of extruding at least a portion of the medical device from a melt comprising a polyurethane and a bioactive agent, wherein the resulting medical device comprises:
(a) the polyurethane which comprises residues of:
(i) an aliphatic diisocyanate,
(ii) an aliphatic diol comprising a poly(ethylene oxide) moiety,
(iii) an aliphatic diol comprising a polycarbonate moiety, and
(iv) a chain extender; and
(b) the bioactive agent, wherein
the polyurethane has a melting temperature offset (Tm Offset) of from 95° C. to 140° C. and has a weight average molecular weight of from 100,000 to 500,000 g/mol.