	US 12,246,055 B2
	Lipid-controlled release compositions
Fredrik Tiberg, Lund (SE); Catalin Nistor, Lund (SE); Markus Johnsson, Lund (SE); David Hemmerlin, Basel (CH); Johannes Kluge, Basel (CH); and Priyanga Wickramanayake, Basel (CH)
Assigned to CAMURUS AB, (SE)
Appl. No. 17/606,864
Filed by CAMURUS AB, Lund (SE)
PCT Filed May 29, 2020, PCT No. PCT/EP2020/065073 § 371(c)(1), (2) Date Oct. 27, 2021, PCT Pub. No. WO2020/240017, PCT Pub. Date Dec. 3, 2020.
Claims priority of application No. 1950645-0 (SE), filed on May 29, 2019.
Prior Publication US 2022/0202898 A1, Jun. 30, 2022
Int. Cl. A61K 38/00 (2006.01); A61K 38/12 (2006.01); A61K 47/10 (2017.01); A61K 47/24 (2006.01); A61M 5/28 (2006.01); A61M 5/31 (2006.01); A61M 5/315 (2006.01); A61J 1/06 (2006.01)

CPC A61K 38/12 (2013.01) [A61K 38/00 (2013.01); A61K 47/10 (2013.01); A61K 47/24 (2013.01); A61M 5/31513 (2013.01); A61J 1/065 (2013.01); A61M 2205/0222 (2013.01)]

23 Claims

1. A glass syringe or a glass cartridge, comprising:

an inner surface containing a lipid-based pre-formulation having a total lipid content, wherein at least the inner surface of the glass syringe or glass cartridge is in contact with the lipid-based pre-formulation and said inner surface is free of pre-applied silicone lubricant, and wherein the lipid-based pre-formulation comprises

a) 20-80 wt % of a diacyl glycerol having a fatty acid composition of at least 98% oleic acid (18:1);

b) 20-80 wt % of a phospholipid;

c) 1-30 wt % of a solvent; and

d) a bioactive agent;

wherein a) and b) are collectively at least 94 wt % of the total lipid content of the lipid-based pre-formulation, and the lipid-based pre-formulation is a clear liquid having a viscosity of less than 1000 mPas at 20° C., and is essentially free of visual precipitates after storage for at least 1 month at a temperature of less than or equal to 10° C., and subsequent equilibration at room temperature for a period of at least one hour.