US 11,679,089 B2
Methods of manufacturing amino acid compositions
Thomas Hanlon, Concord, MA (US); Ralph Yamamoto, Woburn, MA (US); Denise K. Kwok, Arlington, MA (US); Daniel Rothenberg, Cambridge, MA (US); and Andrew M. Wood, Newtown, PA (US)
Assigned to AXCELLA HEALTH INC., Cambridge, MA (US)
Filed by AXCELLA HEALTH INC., Cambridge, MA (US)
Filed on Jun. 19, 2019, as Appl. No. 16/446,171.
Claims priority of provisional application 62/687,725, filed on Jun. 20, 2018.
Prior Publication US 2019/0388374 A1, Dec. 26, 2019
Int. Cl. A61K 31/198 (2006.01); A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 31/197 (2006.01)
CPC A61K 31/198 (2013.01) [A61K 9/0053 (2013.01); A61K 9/14 (2013.01); A61K 31/197 (2013.01)] 15 Claims
OG exemplary drawing
 
1. A method of manufacturing a pharmaceutical grade dry blended preparation (PGDBP) comprising at least four pharmaceutical grade amino acid entities, said method comprising:
forming a combination of at least four pharmaceutical grade amino acid entities and blending the combination at a temperature lower than 40° C. for a time sufficient to achieve a PGDBP having a mass of at least 10 kg, the combination being blended substantially lacking solvent,
wherein:
the PGDBP comprises a level of a contaminant that is less than 0.15% (w/w), and
less than 20%, by weight, of at least one of the pharmaceutical grade amino acid entities transforms from a crystalline state to an amorphous state during blending and wherein at least 50% of the pharmaceutical grade amino acid entities are in a crystalline state during blending.