Device for Deterring Abuse of Drugs

Abstract

The present disclosure relates to devices for deterring drug abuse and methods thereof. More particularly, the disclosure relates to devices for deterring drug abuse by using physical deterrents and/or deterrent substances, including a mechanism that releases a deterrent substance when improper access of the drug is attempted, and methods thereof.

1 . A formulation comprising naltrexone hydrochloride (“HCl”) in a solution comprising ethanol and water. 
     
     
         2 . The composition of  claim 1 , wherein naltrexone HCl is dissolved in the solution at a concentration of 23 mg/ml. 
     
     
         3 . The composition of  claim 1 , wherein naltrexone HCl is dissolved in the solution at a concentration of 37 mg/ml. 
     
     
         4 . The composition of  claim 1 , further comprising one or more of:
 a. a colorant;   b. a thickening or gelling agent; or   c. a foul odor.   
     
     
         5 . The composition of  claim 4 , wherein the colorant is D&C Red No. 33, FD&C Red No. 40, FD&C Green No. 3, D&C Violet No. 2 or Vitamin B12, wherein the thickening or gelling agent is hyroxypropyl cellulose, and wherein the foul odor is butyric acid. 
     
     
         6 . A method for deterring drug abuse comprising contacting an opioid drug dose with the formulation of  claim 1  for a suitable amount of time to compromise the integrity of the drug dosage. 
     
     
         7 . The method of  claim 6 , wherein the opioid drug dose comprises:
 an immediate release tablet, caplet or capsule;   an extended release tablet, caplet or capsule;   a liquid formulation for oral consumption;   a liquid formulation for IV injection; or   a syrup or liquid concentrate.   
     
     
         8 . The method of  claim 6 , wherein the drug dosage is contacted with the formulation of  claim 1  for between 2 minutes and 24 hours. 
     
     
         9 . The method of  claim 6 , wherein the drug dosage is contacted with the formulation of  claim 1  for between 0 and 10 seconds. 
     
     
         10 . The method of  claim 6 , further comprising compromising the physical integrity of the opioid drug dose before or simultaneously with contacting the drug dose with the formulation of  claim 1 . 
     
     
         11 - 18 . (canceled) 
     
     
         19 . A method of accessing a drug provided inside a housing having a physical deterrent and a chemical deterrent, the method comprising:
 providing:
 a housing configured to contain a carousel wherein a drug is stored, 
 a lid attached to the housing, the lid having an access port through which the drug may be accessed, 
 a physical deterrent that prevents rotation of the carousel or rotation of the lid relative to the carousel, and blocks access to the access port when the physical deterrent is in a secure position, 
 a locking mechanism that prevents and/or significantly hinders the physical deterrent from moving from the secure position to an unsecured position, wherein the physical deterrent no longer blocks access to the access port when in the unsecured position, and 
 a chemical deterrent substance located in the carousel that is released when the drug is accessed while the physical deterrent is in the secure position and the locking mechanism is in the locked mode; 
 unlocking the locking mechanism; 
 moving the physical deterrent into the unsecure position; and 
 accessing the drug. 
   
     
     
         20 . A device for a fixed quantity unit of a drug, the device comprising:
 a carousel comprising:
 (i) a drug within one or more spaces; 
 (ii) a piston adjacent to each space; 
 (iii) a chemical deterrent substance within the piston; 
 (iv) a trigger attached to the carousel 
   wherein the trigger is capable of activating the release of the chemical deterrent substance onto the drug.   
     
     
         21 . The device of  claim 20 , further comprising one or more of:
 a pharmaceutical foil which covers the top of the carousel; or   a cover comprising cutouts to enable access to each space capable of holding the drug,   wherein the cover is attached to the carousel.   
     
     
         22 . The device of  claim 20 , wherein the device is disposable. 
     
     
         23 . The device of  claim 20 , further comprising a protective case, wherein the device 
       may be inserted into the protective case. 
     
     
         24 . The device of  claim 20 , further comprising a child-resistant cap comprising:
 a lower piece comprising a tubular projection in the center, and ridges, teeth, slots or grooves on the top surface, wherein the tubular projection is striated and the tubular projection is inserted into and attaches to the center of the carousel;   an upper piece comprising a tubular projection in the center, and raised ridges or teeth on the bottom surface, wherein the tubular projection of the upper piece is inserted into and attaches to the tubular projection of the lower piece; and   two or more access ports in the lower piece and the upper piece, wherein the upper piece and lower piece each include one access port through which a dose of medication may be dispensed and one access port that enables manual activation of the trigger;   wherein a dose of medication may be accessed by depressing the top of the upper piece of the child-resistant cap, which causes the upper piece to contact the lower piece, and turning the cap clockwise or counter-clockwise to the next available dose.   
     
     
         25 . The device of  claim 20 , further comprising:
 a housing comprising a physical deterrent configured to encase the carousel, wherein the housing is under negative pressure;   a positioner, wherein the positioner is attached to the housing and is located between the housing and the carousel; and   a lid, wherein the lid contains an access port for accessing the drug.   
     
     
         26 . The device of  claim 25 , wherein the housing is fluidly connected to one or more of the carousel, the positioner, or the lid such that a reduction in or release of the negative pressure in the housing activates the pistons and releases the chemical deterrent substance to each space in the carousel. 
     
     
         27 . A device for a fixed quantity unit of a drug, the device comprising:
 a carousel comprising:
 (i) a drug within one or more spaces; 
 (ii) threading on the outer surface of the carousel; 
 (iii) a child-resistant cap comprising:
 a first piece comprising a tubular projection in the center, wherein the tubular projection is inserted into and attaches to the center of the carousel, wherein the first piece has one or more access ports for accessing one or more doses of medication; 
 a second piece comprising a sealing surface or liner; 
 a third piece comprising ridges, teeth, groves or slots on the top surface, and threading on the inner surface of the sides; and 
 a fourth piece comprising raised ridges or teeth on the bottom surface; wherein the third piece is inserted into and attached to the fourth piece, and the combined third and fourth piece is attached to the carousel by the threading on the outer surface of the carousel, and wherein a dose of medication may be accessed by depressing the top of the child-resistant cap and turning in a counter-clockwise direction; 
 
 (iv) a compartment on the bottom of the carousel that contains a mail-back or disposal bag; and 
 (v) a removable cap which covers the compartment. 
   
     
     
         28 . A method of loading a drug into a carousel, the method comprising:
 providing the carousel configured to comprise:
 (i) a drug within one or more spaces; 
 (ii) a piston adjacent to each space; 
 (iii) a chemical deterrent substance within the piston; and 
 (iv) a trigger; 
 wherein the trigger is capable of activating the release of the chemical deterrent substance onto the drug; and 
   inserting the drug into the appropriate number of spaces in the carousel.   
     
     
         29 . The method of  claim 28 , further comprising one or more of:
 covering the top of the carousel with pharmaceutical foil; or   attaching a cover to the carousel, the cover comprising cutouts to enable access to each space capable of holding the drug.   
     
     
         30 - 35 . (canceled)