Drug Delivery Company, LLC

Atossa Therapeutics, Inc.

Srinivasan Shanmugam

Naresh Kumar Reddy Vutukuru

Jeffrey David Benner

Steven M Cohen

Pushkar Shrinivas Kulkarni

Steven C Quay

The present disclosure provides sustained release compositions of (Z)-endoxifen and polymorphs and salts thereof and methods of making sustained release compositions of (Z)-endoxifen and polymorphs and salts thereof. The present disclosure also provides methods for treating disorders susceptible to (Z)-endoxifen, including hormone dependent disorders and mood disorders.

Sustained release compositions of endoxifen

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.

Method of fabricating an extended release subcutaneous medicinal dosage implant system

An extended-release bio absorbable subcutaneous medicinal dosage delivery implant system 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 range between 36 and 46.4 weight percent, and polycaprolactone in the 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&#xb0; C.-180&#xb0; 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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Ypsilanti, MI, United States of America

Srinivasan Shanmugam