Methods for manufacturing implants

Abstract

Pharmacologically active implants, in particular subcutaneous implants, intrauterine devices, and intravaginal rings, are provided herein. Methods for forming an active ingredient-containing core are described. Methods for laminating an active ingredient-containing core to form a rate-controlling sheath are also described.

What is claimed is: 
     
         1 . A method of forming a pharmacologically active homogenous core matrix mixture, the method comprising:
 combining one or more polymers with one or more active ingredients to form a mixture; and   mixing the mixture sufficient to impart heat and until a homogenous mixture is achieved; wherein heat imparted to the mixture is sufficient to melt the polymer without substantially altering the pharmacological properties of the active ingredient.   
     
     
         2 . The method of  claim 1 , wherein mixing is accomplished via a dual asymmetric mixer. 
     
     
         3 . The method of  claim 1 , wherein mixing is contactless. 
     
     
         4 . The method of  claim 1 , wherein the homogenous mixture has a material uniformity of less than +/−5%. 
     
     
         5 . The method of  claim 1 , further comprising combining the one or more polymers and one or more active ingredients with one or more of an opacifier or a dye. 
     
     
         6 . The method of  claim 1 , further comprising cooling the mixture. 
     
     
         7 . The method of  claim 5 , further comprising processing the cooled mixture to achieve a mean particle diameter of less than 2 inches. 
     
     
         8 . The method of  claim 1 , wherein the one or more active ingredients comprises one or more of estradiol, ethinyl estradiol, etonogestrel, progesterone, ethisterone, norethisterone acetate, norethynodrel, levonorgestrel, or gestodene.