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The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Patent No.:

US 12083217 B1

PDFFull Text
Date of Patent:
Sep. 10, 2024

Filed:

Nov. 22, 2021

Method of fabricating an extended release subcutaneous medicinal dosage implant system

Applicant:

Drug Delivery Co., Llc., Salisbury, MD (US);

Inventors:

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);

Srinivasan Shanmugam, Ypsilanti, MI (US);

Assignee:

DRUG DELIVERY CO., LLC., Salisbury, MD (US);

Attorney:

Rosenberg, Klein & Lee

Primary Examiner:

Carlos A Azpuru

Int. Cl.
CPC ...
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);
U.S. Cl.
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);
Abstract

A method of fabricating an extended release subcutaneous medicinal dosage implant system which includes an implant fabricated from a highly homogeneously mixed composition including a medicinal agent in combination with release controlling polymers which include poly (DL-lactide) and polycaprolactone. In one implementation for treating an opioid disease, the formulation composition includes naltrexone at 40 weight percent, poly (DL-lactide) in the approximate range between 36 and 46.4 weight percent, and polycaprolactone in the approximate range between 24 and 11.6 weight percent. In addition, in order to provide anti-biofouling quality and prevent foreign body adsorption/interaction with the material of the implant, polyethylene glycol is added in a preferred content of 2.0%. The manufacturing process includes hot melt extrusion and a mini jet based implant formation stage with the optimized process space were the temperature of the process ranges from 170° C.-180° C., mixing time through the HME process ranging from 8 minutes to 12 minutes, and injection time ranging from 8 seconds to 12 seconds. The resulting implants have a uniquely shaped free of defects bio absorbable solid body.

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