US 12,268,708 B2
Storage stable formulations of sulfated glycosaminoglycans and fragments derived therefrom for the treatment of pain and other medical conditions
Thomas Michael Vaughn, Franklin, TN (US); David J. Fairfax, Slingerlands, NY (US); John Quinn, Troy, NY (US); Karl F. Popp, Schodack Landing, NY (US); and Thomas Edward D'Ambra, Big Torch Key, FL (US)
Assigned to ADORA ANIMAL HEALTH CORPORATION, Franklin, TN (US)
Filed by ADORA ANIMAL HEALTH CORPORATION, Franklin, TN (US)
Filed on Jun. 27, 2024, as Appl. No. 18/757,390.
Application 18/757,390 is a continuation of application No. 18/476,580, filed on Sep. 28, 2023, granted, now 12,059,430.
Claims priority of provisional application 63/411,363, filed on Sep. 29, 2022.
Prior Publication US 2024/0350532 A1, Oct. 24, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/737 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 45/06 (2006.01); A61P 19/02 (2006.01); A61P 29/00 (2006.01)
CPC A61K 31/737 (2013.01) [A61K 9/0014 (2013.01); A61K 9/06 (2013.01); A61K 45/06 (2013.01); A61P 19/02 (2018.01); A61P 29/00 (2018.01)] 29 Claims
 
1. A process for producing a storage stable purified polysulfated glycosaminoglycan, said process comprising:
providing a polysulfated glycosaminoglycan starting material containing components above 1,000 Daltons and components below 1,000 Daltons;
subjecting said polysulfated glycosaminoglycan starting material to tangential flow filtration under conditions effective to reduce the amount of components below 1,000 Daltons in the starting material to produce a purified polysulfated glycosaminoglycan having an average molecular weight ranging from 3,000 to 15,000 Daltons; and
recovering the purified polysulfated glycosaminoglycan, which is characterized by one or more of properties (i) to (v) as follows:
(i) no more than 10 wt % of contaminants with a molecular weight below 1,000 Daltons;
(ii) no more than 20 wt % of contaminants with a molecular weight below 3,000 Daltons;
(iii) a sulfate to carboxylate ratio of between 3 to 4;
(iv) containing not more than 5000 ppm of acetic acid; and
(v) maintaining a white or off-white color after storage at room temperature for at least 6 months following initiation of storage.