US 12,447,197 B2
Multiparticulate granulate comprising insulin
Roman Safonov, Ramat-Gan (IL)
Assigned to Elgan Pharma Ltd, Nazareth (IL)
Filed by Elgan Pharma Ltd, Nazareth (IL)
Filed on Nov. 24, 2022, as Appl. No. 17/993,916.
Application 17/993,916 is a continuation of application No. 16/943,822, filed on Jul. 30, 2020, abandoned.
Application 16/943,822 is a continuation of application No. 16/711,689, filed on Dec. 12, 2019, abandoned.
Application 16/711,689 is a continuation of application No. PCT/US2018/037092, filed on Jun. 12, 2018.
Claims priority of provisional application 62/518,271, filed on Jun. 12, 2017.
Prior Publication US 2023/0181695 A1, Jun. 15, 2023
Int. Cl. A61K 38/28 (2006.01); A23L 33/00 (2016.01); A23L 33/18 (2016.01); A61K 9/14 (2006.01); A61K 9/16 (2006.01)
CPC A61K 38/28 (2013.01) [A23L 33/18 (2016.08); A23L 33/30 (2016.08); A23L 33/40 (2016.08); A61K 9/141 (2013.01); A61K 9/1652 (2013.01)] 8 Claims
 
1. A multiparticulate granulate composition comprising granules each including particles of insulin dispersed on particles of a maltodextrin at a ratio of about 140,000:1 to about 750,000:1 (w/w), wherein the multiparticulate granulate is substantially free of layers of insulin and dextrin and further wherein the multiparticulate granulate has a content uniformity of about 90-120% with a relative standard deviation (RSD) of no more than about 5%.