	US 12,257,351 B2
	Minimizing aeration of suspensions during in-line mixing
Rosaleen McLaughlin, Swindon (GB); Simon Andrew Martyn Howes, Swindon (GB); and Jonathon Whitehouse, Swindon (GB)
Assigned to Catalent U.K. Swindon Zydis Limited, Swindon (GB)
Filed by Catalent U.K. Swindon Zydis Limited, Swindon (GB)
Filed on Feb. 21, 2020, as Appl. No. 16/798,067.
Claims priority of provisional application 62/809,293, filed on Feb. 22, 2019.
Prior Publication US 2020/0268677 A1, Aug. 27, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/50 (2006.01); A61K 45/06 (2006.01)

CPC A61K 9/5084 (2013.01) [A61K 9/5015 (2013.01); A61K 9/5036 (2013.01); A61K 9/5089 (2013.01); A61K 45/06 (2013.01)]

11 Claims

1. A method of making a pharmaceutical composition comprising:

providing a matrix solution/suspension comprising a matrix former, a structure former, anti-aerating agent, and a solvent; and

mixing a plurality of hydrophobic coated active pharmaceutical ingredient (API) particles into the matrix solution/suspension to form a pharmaceutical suspension comprising 0.1% w/w to less than 0.6% w/w of the anti-aerating agent, wherein the plurality of hydrophobic coated API particles comprises greater than 70% w/w and no more than 90% w/w of API, and wherein the mixing comprises mixing for at least 2 hours and up to 6 hours, such that a particle size (d50) of the hydrophobic coated API particles decreases no more than 30% over the first 2 hours of the mixing;

dosing the pharmaceutical suspension into preformed blister packs, wherein a dosed weight of the dosed pharmaceutical suspension is within 10% of a target dosed weight.