US 11,723,979 B2
Compound to treat Sjogren's Syndrome
Mark Tengler, Northlake, TX (US)
Assigned to Spectrix Therapeutics, LLC, Northlake, TX (US)
Filed by Spectrix Therapeutics, LLC, Northlake, TX (US)
Filed on Nov. 25, 2020, as Appl. No. 17/105,187.
Application 17/105,187 is a continuation of application No. 16/114,955, filed on Aug. 28, 2018, granted, now 10,874,741.
Claims priority of provisional application 62/550,756, filed on Aug. 28, 2017.
Prior Publication US 2021/0093574 A1, Apr. 1, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/14 (2006.01); A61K 47/32 (2006.01); A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 8/81 (2006.01); A61K 9/00 (2006.01); A61Q 11/00 (2006.01); A61K 31/27 (2006.01); A61K 31/4178 (2006.01); A61P 37/00 (2006.01); A61K 31/325 (2006.01); A61K 31/4164 (2006.01); A61P 1/00 (2006.01); A61K 31/439 (2006.01)
CPC A61K 47/32 (2013.01) [A61K 8/8188 (2013.01); A61K 9/0056 (2013.01); A61K 9/2027 (2013.01); A61K 9/4866 (2013.01); A61K 31/27 (2013.01); A61K 31/4178 (2013.01); A61Q 11/00 (2013.01); A61K 9/2054 (2013.01); A61K 31/325 (2013.01); A61K 31/4164 (2013.01); A61K 31/439 (2013.01); A61K 2300/00 (2013.01); A61P 1/00 (2018.01); A61P 37/00 (2018.01)] 24 Claims
 
1. A composition comprising:
a therapeutically acceptable dose of an active agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein the active agent is at least one of Cevimeline, Pilocarpine, or Bethanechol, and is in an active pharmaceutical compound-resin complex that comprises a first plurality of immediate release drug-resin particles and a second plurality of drug-resin particles that are coated for modified release coating, wherein the composition has an in vivo fasted serum profile with a first and a second peak, wherein the first peak occurs before 3 hours after ingestion and the second peak occurs after 3 hours after ingestion, wherein both the first and second peaks and 8 hours blood level concentrations are effective to increase salivation.