Methods For Ensuring Resuspension Of Paliperidone Palmitate Formulations

Abstract

Provided are populations of syringes that respectively contain paliperidone palmitate extended release injectable suspension, wherein each of the syringes have been shipped to a destination, and the syringes were each maintained in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. The present disclosure also provides pharmaceutical products comprising a paliperidone palmitate extended-release injectable suspension within a syringe for administration to a patient suffering from schizophrenia, wherein the syringe has undergone pre-shipping storage and has been shipped, and wherein the syringe has been maintained in an orientation during the shipping that varies from the orientation of the syringe during pre-shipping storage.

What is claimed: 
     
         1 . A population of syringes that respectively contain paliperidone palmitate extended release injectable suspension, wherein each of the syringes have been stored prior to shipping and shipped to a destination, and the syringes were each maintained in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. 
     
     
         2 . The population according to  claim 1 , comprising at least 100 individual syringes. 
     
     
         3 . A pharmaceutical product comprising a paliperidone palmitate extended-release injectable suspension within a syringe for administration to a patient suffering from schizophrenia, wherein the syringe has undergone pre-shipping storage and has been shipped, and wherein the syringe has been maintained in an orientation during the shipping that varies from the orientation of the syringe during pre-shipping storage. 
     
     
         4 . The pharmaceutical product according to  claim 3 , wherein the syringe was housed within a container comprising an outer surface that included instructions for maintaining the container during shipping in an orientation that corresponds to the desired orientation of the syringe, that bears markings that indicate an orientation of the container that corresponds to maintaining the desired orientation, or both. 
     
     
         5 . The pharmaceutical product according to  claim 3 , wherein, following the shipping, the syringe contains no more than about 1.5 mm of residue representing non-resuspended paliperidone palmitate after injection of the suspension. 
     
     
         6 . The pharmaceutical product according to  claim 3 , wherein the suspension contains about 273, 410, 546, or 819 mg of paliperidone palmitate. 
     
     
         7 . The pharmaceutical product according to  claim 3 , wherein the suspension contains about 1092 or 1560 mg of paliperidone palmitate. 
     
     
         8 . The pharmaceutical product according to  claim 3 , wherein the shipping orientation varied from the orientation of the syringe during pre-shipping storage by about 45 degrees to about 135 degrees. 
     
     
         9 . The pharmaceutical product according to  claim 3 , wherein the pre-shipping storage orientation was tip down, and the shipping orientation is tip up or substantially horizontal. 
     
     
         10 . The pharmaceutical product according to  claim 3 , wherein the pre-shipping storage orientation was tip down, and the shipping orientation is substantially horizontal. 
     
     
         11 . The pharmaceutical product according to  claim 3 , wherein the pre-shipping storage orientation of the syringe was tip-down.