Tamper-resistant pharmaceutical compositions of opioids and other drugs

Abstract

Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.

1 . A tamper resistant pharmaceutical composition comprising a plurality of multiparticulates each multiparticulate comprising:
 (a) one or more drugs prone to abuse; and   (b) one or more excipients comprising fats, fatty substances, waxes, wax-like substances or mixtures thereof;   wherein the one or more drugs interact ionically with one or more of the excipients and each multiparticulate is in the form of a solid solution.   
     
     
         2 - 6 . (canceled) 
     
     
         7 . The tamper resistant composition of  claim 1 , wherein the one or more excipients that interact ionically with said drug(s) are fatty acids. 
     
     
         8 - 23 . (canceled) 
     
     
         24 . A tamper resistant pharmaceutical composition comprising a plurality of multiparticulates each multiparticulate comprising:
 (a) one or more drugs prone to abuse; and   (b) one or more excipients comprising fats, fatty substances, waxes, wax-like substances or mixtures thereof comprising one or more ionic components;   wherein the ionic component of said one or more excipients interacts with said one or more drugs.   
     
     
         25 . A method of making a tamper resistant pharmaceutical composition comprising:
 (a) dispersing or dissolving a drug prone to abuse in one or more excipients comprising fats, fatty substances, waxes, wax-like substances or mixtures thereof;   (b) forming multiparticulates via a spray congealing process from the material obtained in step (a); and   (c) coating the multiparticulates obtained in step (b).   
     
     
         26 - 29 . (canceled) 
     
     
         30 . A tamper resistant pharmaceutical composition comprising a plurality of multiparticulates made by a process comprising forming multiparticulates via a spray congealing process from a dispersion or solution comprising:
 (i) a drug prone to abuse; and   (ii) one or more excipients comprising fats, fatty substances, waxes, wax-like substances or mixtures thereof; and   (iii) optionally coating the formed multiparticulates.   
     
     
         31 . (canceled) 
     
     
         32 . A tamper resistant pharmaceutical composition made by a process comprising the steps of:
 (a) dissolving a drug prone to abuse in one or more excipients comprising fats, fatty substances, waxes, wax-like substances or mixtures thereof; and   (b) forming multiparticulates via a spray congealing process from the material obtained in step (a); and   (c) coating the multiparticulates obtained in step (b).