US 12,083,217 B1
Method of fabricating an extended release subcutaneous medicinal dosage implant system
Jeffrey D. Benner, Salisbury, MD (US); Steven M. Cohen, Saint Petersburg, FL (US); Naresh Kumar Reddy Vutukuru, Ann Arbor, MI (US); Pushkar Shrinivas Kulkarni, Ypsilanti, MI (US); and Srinivasan Shanmugam, Ypsilanti, MI (US)
Assigned to DRUG DELIVERY CO., LLC., Salisbury, MD (US)
Filed by DRUG DELIVERY CO., LLC., Salisbury, MD (US)
Filed on Nov. 22, 2021, as Appl. No. 17/456,011.
Application 17/456,011 is a division of application No. 17/301,654, filed on Apr. 9, 2021, granted, now 11,197,819.
Int. Cl. A61K 9/00 (2006.01); A61K 31/485 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/34 (2017.01); B29C 45/00 (2006.01); B29C 45/47 (2006.01); B29K 67/00 (2006.01); B29K 71/00 (2006.01); B29K 105/00 (2006.01)
CPC A61K 9/0024 (2013.01) [A61K 31/485 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/34 (2013.01); B29C 45/0001 (2013.01); B29C 45/47 (2013.01); B29K 2067/046 (2013.01); B29K 2071/02 (2013.01); B29K 2105/0035 (2013.01)] 8 Claims
OG exemplary drawing
 
1. A method of fabrication of an extended-release subcutaneous medicinal dosage delivery implant system, comprising:
(a) mixing at least one medicinal agent and release controlling polymeric compounds in a feeder to form an injection mixture,
(b) injecting said injection mixture into a segmented screw extruder having a first plurality of heating zones and a second plurality of mixing/shearing zones, each mixing/shearing zone creating a specific predetermined shear rate,
(c) actuating said segmented screw extruder,
(d) advancing said injection mixture along said actuated segmented screw extruder from an input to an output thereof during a mixing time ranging from 8 min to 12 min,
(e) exposing said injection mixture to a temperature regime ranging from 170° C. to 180° C. while passing through said plurality of heating zones, thus forming a melted homogenous injection mixture,
(f) installing a mini-jet implant formation unit at said output of said segmented screw extruder, and
(g) forming a highly homogeneous solid implant in said mini-jet implant formation unit by passing said melted homogeneous injection mixture therethrough during an injection time ranging between 8 sec and 12 sec.